Import Alert 66-41

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 66-41
Published Date: 03/18/2024
Type: DWPE

Import Alert Name:

Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.

Reason for Alert:

NOTE: The revision of this Import Alert, dated 09/21/2023, removes PAC code and updates the guidance section. Changes to the import alert are bracketed by asterisks (***).

Unapproved new drugs present public health and safety risks because they have not been reviewed by FDA for safety or effectiveness. Without FDA review, there is no way to know if these drugs are safe and effective for their intended use, whether they are manufactured in a way that ensures consistent drug quality, or whether their labels are complete and accurate. Unapproved new drugs have resulted in patient harm, and the agency works to protect patients from the risks posed by these drugs.

In part, the Federal Food, Drug, and Cosmetic Act (FD&C Act) defines "drug" as (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (B) or (C).

Under section 201 (p) of the FD&C Act, a drug is a new drug if it "is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof" (i.e., not GRAS/E). Further, under section 201(p) of the FD&C Act, a drug that is so recognized is still a new drug if it has not been used to a material extent or for a material time under such conditions.

In general, "new drugs" may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a), unless they are nonprescription drugs governed by and lawfully marketed under section 505G of the FD&C Act.

Guidance:

Divisions may detain without physical examination (DWPE), shipments of the unapproved new drugs listed on the Red List of this Import Alert.

***Divisions should follow the guidance in the Regulatory Procedures Manual (RPM) Chapter 9-2 for Personal Importation shipments. Commercial or promotional shipments, and products subject to DWPE are generally not amenable to the use of enforcement discretion.***

*** Recommendations for addition to DWPE of products not listed on the Red List and currently under detention status should be routed to CDER/OC/ODSIR/DGDDP/ICB for refusal and CDER concurrence for addition to import alert. Recommendations for addition to DWPE of products not listed on the Red List that have been refused entry and CDER approved for addition to import alert should be routed to Division of Import Operations (DIO) for review. ***

Release of Articles Subject to Detention Without Physical Examination Under this Import Alert: In order to secure release of an individual shipment subject to detention without physical examination under this import alert, the owner, consignee and/or another responsible party for the affected goods should provide evidence that the shipment does not contain unapproved new drug products.

Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):

In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the condition that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future entries will be in compliance with the FD&C Act. This may require five consecutive non-violative commercial shipments to confirm the effectiveness of any corrective actions. For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention Without Physical Examination (DWPE)".

If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or, be sent via email to: Importalerts2@fda.hhs.gov.

Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.

Questions or issues involving compliance of imported drug products should be addressed to the CDER Imports Compliance Branch at CDERImports@fda.hhs.gov.

                                                                                                                                                                       

Product Description:

Unapproved new drugs

Charge:

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
[Unapproved New Drug, Section 505(a)]

OASIS charge code: UNAPPROVED

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


ARGENTINA


Guillermo Rivera
Date Published : 09/30/2009
Chivilcoy 4820 , Buenos Aires, ARGENTINA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                      

OP Online-Pharmacy.cc
Date Published : 09/30/2009
Online Pharmacy SA, Corrientes 1820 , Buenos Aires , Capital Federal 1108, ARGENTINA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 10/07/2020

Desc: Abarelix
Notes:                         

64 R - - 21 Somatropin (Hormone)
Date Published: 10/07/2020

Notes:                         

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 10/07/2020

Notes:                         

UNILEVER DE ARGENTINA SA
Date Published : 01/06/2011
Calle Hipolito Bouchard 710 , Ciudad Autonoma Buenos Aires, Buenos Aires ARGENTINA
53 D - - 02 Perfumes (Fragrance Preparations)
Date Published: 01/06/2011

Desc: Rexona Antiperspirant
Notes: Argentina

53 D - - 99 Other Fragrance Preparations, N.E.C.
Date Published: 01/06/2011

Desc: Rexona Antiperspirant
Notes: Argentina

62 W - - 99 Astringent/Anti-Perspirant N.E.C.
Date Published: 01/06/2011

Desc: Rexona Antiperspirant
Notes: Argentina


ARMENIA


ARSSI ALLIANCE LLC
Date Published : 08/11/2023
24 5.Ovanisyan Str. , Yerevan, Yerevan ARMENIA
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/11/2023

Desc: Aramax Victory Derma Liquid

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/25/2023

Desc: Aramax Victory Immune Booster

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/11/2023

Desc: Aramax Victory Derma Liquid

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/25/2023

Desc: Aramax Victory Immune Booster


AUSTRALIA


AUSTRALIAN HEALTH INDUSTRY CO.
Date Published : 09/29/2020
17 Birmingham Ave , Villawood, New South Wales AUSTRALIA
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/29/2020

Desc: Eaoron Jacaranda Miracle Mask (for sensitive skin)

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/29/2020

Desc: Eaoron Ageless Stem Cell Mask

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/29/2020

Desc: Eaoron Jacaranda Miracle Mask (Ceramide)

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/29/2020

Desc: Eaoron Hyaluronic Acid Collagen Essence V

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/29/2020

Desc: Eaoron Instant Whitening Face Mask

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 09/29/2020

Desc: Eaoron Jacaranda Miracle Mask (for sensitive skin)

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 09/29/2020

Desc: Eaoron Instant Whitening Face Mask

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 09/29/2020

Desc: Eaoron Jacaranda Miracle Mask (Ceramide)

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 09/29/2020

Desc: Eaoron Ageless Stem Cell Mask

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/29/2020

Desc: Eaoron Hyaluronic Acid Collagen Essence V

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/29/2020

Desc: Eaoron Instant Whitening Face Mask

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/29/2020

Desc: Eaoron Jacaranda Miracle Mask (for sensitive skin)

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/29/2020

Desc: Eaoron Ageless Stem Cell Mask

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/29/2020

Desc: Eaoron Jacaranda Miracle Mask (Ceramide)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2020

Desc: Eaoron Hyaluronic Acid Collagen Essence V

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2020

Desc: Eaoron Jacaranda Miracle Mask (for sensitive skin)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2020

Desc: Eaoron Ageless Stem Cell Mask

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2020

Desc: Eaoron Jacaranda Miracle Mask (Ceramide)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2020

Desc: Eaoron Instant Whitening Face Mask

Alphapharm
Date Published : 11/07/2011
Chase Bldg 2wentworth Park Road , Glebe, NSW AUSTRALIA
61 B - - 02 Cyproterone Acetate (Anti-Androgen)
Date Published: 11/07/2011

Desc: Cyproterone Acetate
Notes: Australia

BIO HEALTH PHARMACEUTICALS
Date Published : 09/28/2012
12 Giffard St , SILVERWATER , Silverwater, New South Wales AUSTRALIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/28/2012

Desc: Sunchih Premium GPSP
Notes: NOTE; Bio Health Pharmaceuticals is a contract manufacturer for Concord International; FEI #3009408545.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/28/2012

Desc: Sunchih Bee Plus
Notes: NOTE: Bio Health Pharmaceuticals is a contract manufacturer for Concord International, FEI #3009408545.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/28/2012

Desc: Vita Cordy
Notes: NOTE; Bio Health Pharmaceuticals is a contract manufacturer for Concord International; FEI #3009408545

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/28/2012

Desc: Vita Cordy
Notes: NOTE; Bio Health Pharmaceuticals is a contract manufacturer for Concord International; FEI #3009408545

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/28/2012

Desc: Sunchih Bee Plus
Notes: NOTE: Bio Health Pharmaceuticals is a contract manufacturer for Concord International, FEI #3009408545.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/28/2012

Desc: Sunchih Premium GPSP
Notes: NOTE; Bio Health Pharmaceuticals is a contract manufacturer for Concord International; FEI #3009408545

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2012

Desc: Sunchih Bee Plus
Notes: NOTE: Bio Health Pharmaceuticals is a contract manufacturer for Concord International, FEI #3009408545.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2012

Desc: Sunchih Premium GPSP
Notes: NOTE; Bio Health Pharmaceuticals is a contract manufacturer for Concord International; FEI #3009408545.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2012

Desc: Vita Cordy
Notes: NOTE; Bio Health Pharmaceuticals is a contract manufacturer for Concord International; FEI #3009408545

Brands Rmj P L
Date Published : 12/10/2009
490 500 Wellington , Mulgrave, AUSTRALIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/10/2009

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

61 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

62 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

63 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

64 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

65 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

66 L - - 99 Thyromimetic N.E.C.
Date Published: 12/10/2009

Desc: Bowtech Lectric Soda Crystals

66 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

CONCORD INTERNATIONAL TRADING PTY LTD
Date Published : 09/28/2012
12 Giffard St , Silverwater, New South Wales AUSTRALIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/28/2012

Desc: Sunchih Premium GPSP

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/28/2012

Desc: Sunchih Bee Plus

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/28/2012

Desc: Vita Cordy

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/28/2012

Desc: Sunchih Premium GPSP

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/28/2012

Desc: Vita Cordy

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/28/2012

Desc: Sunchih Bee Plus

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2012

Desc: Sunchih Premium GPSP

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2012

Desc: Sunchih Bee Plus

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2012

Desc: Vita Cordy

Cat Media Pty Limited
Date Published : 04/03/2013
18 Jubilee Ave , Warriewood, New South Wales AUSTRALIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/03/2013

Desc: Photo Age Reverse Night Serum
Notes: NOTE; labels contain claims for reversing wrinkles; sunspots; and imperfections

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/03/2013

Desc: Photo Age Reverse Cream
Notes: NOTE; labels contain claims for reversing wrinkles; sunspots; and imperfections.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2013

Desc: Photo Age Reverse Night Serum
Notes: NOTE; labels contain claims for reversing wrinkles; sunspots; and imperfections

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2013

Desc: Photo Age Reverse Cream
Notes: NOTE; labels contain claims for reversing wrinkles; sunspots; and imperfections.

E-pharmacy.net
Date Published : 09/30/2009
World Pharmacy Supplies , C/-suite 9, 14 Norton Street , Leichhardt, AUSTRALIA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 06/24/2020

Desc: Abarelix
Notes:                   

64 R - - 21 Somatropin (Hormone)
Date Published: 06/24/2020

Notes:                   

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                     

Liberty Lifestyle Pty LTd.
Date Published : 09/30/2009
Po Box 103 Concord West , Sydney, AUSTRALIA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 07/20/2020

Desc: Abarelix
Notes:                             

64 R - - 21 Somatropin (Hormone)
Date Published: 07/20/2020

Notes:                             

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                             

Melcare Biomedical Pty
Date Published : 03/24/2015
451 West Mount Cotton Rd , Mount Cotton, Qld AUSTRALIA
56 K - - 99 Miscellaneous Antibiotics, N.E.C.
Date Published: 03/24/2015

Desc: Optimel Antibacterial Manuka Eye Drops

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/24/2015

Desc: Optimel Antibacterial Manuka Eye Drops

Milk And Co Pty Ltd
Date Published : 12/15/2015
15 Cotter St, , Richmond Victoria, AUSTRALIA
53 A - - -- Baby Prod
Date Published: 12/15/2015

Desc: Spotty Tots Cream (rash & diaper cream)
Notes: Product labeling makes claims

53 L - - -- Skin Care Prep
Date Published: 12/15/2015

Desc: Spotty Tots Cream (rash & diaper cream)
Notes: Product labeling makes claims

53 M - - -- Suntan Preparations
Date Published: 12/15/2015

Desc: Spotty Tots Cream (rash & diaper cream)
Notes: Product labeling makes claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/15/2015

Desc: Spotty Tots Cream (rash & diaper cream)
Notes: Product labeling makes claims

Natural Vitality
Date Published : 06/09/2017
11 Aldinga St , Brendale, Queensland AUSTRALIA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/09/2017

Desc: Body Brilliance
Notes: Product label makes medical claims

Nutricia Australia
Date Published : 01/06/2016
Level 4 Building D12-24 Talavera , Macquarie Parkmacquarie Park, AUSTRALIA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/06/2016

Desc: SOUVENAID DIETARY SUPPLEMENTS
Notes: Product labels made disease claims for Alzheimer?s disease

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/06/2016

Desc: SOUVENAID DIETARY SUPPLEMENTS
Notes: Product labels made disease claims for Alzheimer?s disease

Pro-Ma Systems (Aust.) Pty. Ltd.
Date Published : 01/07/2014
14 Kingston Dr , Helensvale, Queensland AUSTRALIA
53 G - - 03 Foundations (Makeup Preparations, not for Eyes)
Date Published: 01/07/2014

Desc: Aloe Oil Free Foundation
Notes: Country; Australia

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 01/07/2014

Desc: Infiniti Beauty Fluids
Notes: Country; Australia

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 01/07/2014

Desc: Platinum Reverse Wrinkle Serum
Notes: Country; Australia

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 01/07/2014

Desc: Intense Vita-Firm For Eyes
Notes: Country; Australia

SUPERCHARGE FOOD PTY LTD
Date Published : 03/22/2021
17 Brisbane St Bondi Junction , New South Wale, AUSTRALIA
02 G - - 99 Flours and Meals N.E.C.
Date Published: 03/22/2021

Desc: Love Your Gut Micron 5 Diatomaceous Earth Capsules
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'It's also anti-bacterial, anti-viral, anti-fungal and anti-parasitic.'

02 G - - 99 Flours and Meals N.E.C.
Date Published: 03/22/2021

Desc: Love Your Gut Diatomaceous Earth Powder
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Most people who ingest Diatomaceous Earth on a daily basis state they generally feel better because the bad bacteria, parasites and heavy metals are being removed from the body and so, the immune system has less work to do.'

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 03/22/2021

Desc: Fulvic Humic Concentrate
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Fulvic Humic Concentrate can be beneficial for people suffering from the symptoms of Leaky gut, IBS, Crohns [sic] disease, bloating, constipation, diarrhoea [sic] . . . small intestine bacterial overgrowth (SIBO) and inflammatory bowel disease (IBD) . . . [A]nyone experiencing hangovers and people with heavy metal overload, adrenal fatigue issues and metabolic disorders.'

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/22/2021

Desc: Fulvic Humic Concentrate
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Fulvic Humic Concentrate can be beneficial for people suffering from the symptoms of Leaky gut, IBS, Crohns [sic] disease, bloating, constipation, diarrhoea [sic] . . . small intestine bacterial overgrowth (SIBO) and inflammatory bowel disease (IBD) . . . [A]nyone experiencing hangovers and people with heavy metal overload, adrenal fatigue issues and metabolic disorders.'

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/22/2021

Desc: Love Your Gut Diatomaceous Earth Powder
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Most people who ingest Diatomaceous Earth on a daily basis state they generally feel better because the bad bacteria, parasites and heavy metals are being removed from the body and so, the immune system has less work to do.'

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/22/2021

Desc: Love Your Gut Micron 5 Diatomaceous Earth Capsules
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'It's also anti-bacterial, anti-viral, anti-fungal and anti-parasitic.'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/22/2021

Desc: Fulvic Humic Concentrate
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Fulvic Humic Concentrate can be beneficial for people suffering from the symptoms of Leaky gut, IBS, Crohns [sic] disease, bloating, constipation, diarrhoea [sic] . . . small intestine bacterial overgrowth (SIBO) and inflammatory bowel disease (IBD) . . . [A]nyone experiencing hangovers and people with heavy metal overload, adrenal fatigue issues and metabolic disorders.'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/22/2021

Desc: Love Your Gut Diatomaceous Earth Powder
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Most people who ingest Diatomaceous Earth on a daily basis state they generally feel better because the bad bacteria, parasites and heavy metals are being removed from the body and so, the immune system has less work to do.'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/22/2021

Desc: Love Your Gut Micron 5 Diatomaceous Earth Capsules
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'It's also anti-bacterial, anti-viral, anti-fungal and anti-parasitic.'

Sensuous
Date Published : 10/01/2015
13 Knightsbridge Pde W , Paradise Point, Queensland AUSTRALIA
60 L - - 99 Analgesic, N.E.C.
Date Published: 10/01/2015

Desc: Edge Delay Gel for Men

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/01/2015

Desc: Edge Delay Gel for Men

The Dispensary
Date Published : 09/30/2009
Nt Lusk , 25 Hipwwod Street , Brisbane 4170, AUSTRALIA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 07/20/2020

Desc: Abarelix
Notes:                         

64 R - - 21 Somatropin (Hormone)
Date Published: 07/20/2020

Notes:                         

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                         

Ultra Mix (Aust) Pty Ltd
Date Published : 05/19/2016
6 Mcarthur St , West Footscray, Victoria AUSTRALIA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 05/19/2016

Desc: Outback Pain Relief Roll-On

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/19/2016

Desc: Outback Pain Relief Roll-On

54 A - - 99 Vitamin, N.E.C.
Date Published: 10/03/2016

Desc: Outback Joint Care Nutritional Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/19/2016

Desc: Outback Pain Relief Roll-On

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/03/2016

Desc: Outback Joint Care Nutritional Supplement

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 05/19/2016

Desc: Outback Pain Relief Roll-On

Valu Pharmaceuticals.com
Date Published : 09/30/2009
Libery Lifestyle Pty Ltd , Barry West, Pob 103 Concord West , Sydney, Nsw 2138 AUSTRALIA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 10/07/2020

Desc: Abarelix
Notes:                                                                                   

64 R - - 21 Somatropin (Hormone)
Date Published: 10/07/2020

Notes:                                                                                   

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                                                                                   

WallCann IP Pty Ltd
Date Published : 09/30/2009
Drew Canning, 81c Marine Parade , Seacliff, AUSTRALIA
62 I - - -- A-Neoplastic
Date Published: 09/30/2009

Notes: 8/20/2007 Curaderm-BEC5 Cream                                                                  8/30/2007

64 X - - 06 Salicylic Acid (Keratolytic)
Date Published: 09/30/2009

Notes: Curaderm-BEC5 Cream                                                                    8/30/2007

64 X - - -- Keratolytic
Date Published: 09/30/2009

Notes: Curaderm-BEC5 Cream                                                                   8/30/2007

Wallace Service P/L Clive Wallace
Date Published : 09/30/2009
81 c Marine Parade , South Australia , Seacliff, AUSTRALIA
65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 09/30/2009

Desc:
Notes: Web Site:Desc://www.levin-rx.com 5/27/2005

i-pharmacy
Date Published : 09/30/2009
P.o. Box W66 , Shop 3, 14-16 Military Rd. , Watson's Bay, AUSTRALIA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 06/24/2020

Desc: Abarelix
Notes:                    

64 R - - 21 Somatropin (Hormone)
Date Published: 06/24/2020

Notes:                    

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                     


AUSTRIA


Lenus Pharma GmbH
Date Published : 06/17/2016
Seebockgasse 59 , Vienna, Wien AUSTRIA
41 G - - 99 Medical Foods, N.E.C.
Date Published: 06/17/2016

Desc: Profertil

54 A - - 99 Vitamin, N.E.C.
Date Published: 06/17/2016

Desc: Profertil

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/17/2016

Desc: Profertil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/17/2016

Desc: Profertil

Nowicky Pharma
Date Published : 03/16/2022
Margaretenstrasse 7 , A-1040 , Vienna, AUSTRIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/16/2022

Notes: Ukrain UKRAIN is an injectable promoted as an anticancer drug. This product should be refused unless it is coming in under 21 CFR 312.160 or has an IND in effect. 2/6/2004

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 03/16/2022

Notes: Ukrain UKRAIN is an injectable promoted as an anticancer drug. This product should be refused unless it is coming in under 21 CFR 312.160 or has an IND in effect. 2/6/2004

61 - - - -- Human and Animal Drugs
Date Published: 03/16/2022

Notes: Ukrain UKRAIN is an injectable promoted as an anticancer drug. This product should be refused unless it is coming in under 21 CFR 312.160 or has an IND in effect. 2/6/2004

62 - - - -- Human and Animal Drugs
Date Published: 03/16/2022

Notes: Ukrain UKRAIN is an injectable promoted as an anticancer drug. This product should be refused unless it is coming in under 21 CFR 312.160 or has an IND in effect. 2/6/2004

63 - - - -- Human and Animal Drugs
Date Published: 03/16/2022

Notes: Ukrain UKRAIN is an injectable promoted as an anticancer drug. This product should be refused unless it is coming in under 21 CFR 312.160 or has an IND in effect. 2/6/2004

64 - - - -- Human and Animal Drugs
Date Published: 03/16/2022

Notes: Ukrain UKRAIN is an injectable promoted as an anticancer drug. This product should be refused unless it is coming in under 21 CFR 312.160 or has an IND in effect. 2/6/2004

65 - - - -- Human and Animal Drugs
Date Published: 03/16/2022

Notes: Ukrain UKRAIN is an injectable promoted as an anticancer drug. This product should be refused unless it is coming in under 21 CFR 312.160 or has an IND in effect. 2/6/2004

66 - - - -- Human and Animal Drugs
Date Published: 03/16/2022

Notes: Ukrain UKRAIN is an injectable promoted as an anticancer drug. This product should be refused unless it is coming in under 21 CFR 312.160 or has an IND in effect. 2/6/2004

SKYLINE HANDELS GMBH
Date Published : 08/01/2019
Mariahilfer Strase 72 , Vienna, Vienna AUSTRIA
53 - - - -- Cosmetics
Date Published: 01/29/2020

Desc: Jungle Juice (all variations - e.g. ultra strong super premium etc.)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

53 - - - -- Cosmetics
Date Published: 10/01/2019

Desc: Locker Room (all label color variations)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

53 - - - -- Cosmetics
Date Published: 01/29/2020

Desc: Iron Horse (all variations - e.g. ultra strong super premium etc.)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

53 - - - -- Cosmetics
Date Published: 10/01/2019

Desc: Rush Ultra Strong (all label color variations)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

53 - - - -- Cosmetics
Date Published: 01/29/2020

Desc: The New Amsterdam (all variations - e.g. ultra strong super premium etc.)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

53 - - - -- Cosmetics
Date Published: 10/01/2019

Desc: Super Rush Liquid Incense (all label color variations)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

53 - - - -- Cosmetics
Date Published: 08/01/2019

Desc: Gold Rush Leather Cleaner
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list); '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them; creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles; such as the throat and anus. Not only do they enhance sexual pleasure; they produce a sensation of heat and excitement for a couple of minutes...'.

53 - - - -- Cosmetics
Date Published: 01/29/2020

Desc: Fist F*ck (all variations - e.g. ultra strong super premium etc.)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

53 - - - -- Cosmetics
Date Published: 01/29/2020

Desc: Rush (all variations - e.g. ultra strong super premium etc.)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/29/2020

Desc: Iron Horse (all variations - e.g. ultra strong super premium etc.)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 10/01/2019

Desc: Super Rush Liquid Incense (all label color variations)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/29/2020

Desc: Rush (all variations - e.g. ultra strong super premium etc.)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/01/2019

Desc: Gold Rush Leather Cleaner
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list); '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them; creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles; such as the throat and anus. Not only do they enhance sexual pleasure; they produce a sensation of heat and excitement for a couple of minutes...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 10/01/2019

Desc: Locker Room (all label color variations)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/29/2020

Desc: Jungle Juice (all variations - e.g. ultra strong super premium etc.)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/29/2020

Desc: The New Amsterdam (all variations - e.g. ultra strong super premium etc.)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 10/01/2019

Desc: Rush Ultra Strong (all label color variations)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/29/2020

Desc: Fist F*ck (all variations - e.g. ultra strong super premium etc.)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

66 - - - -- Human and Animal Drugs
Date Published: 10/01/2019

Desc: Rush Ultra Strong (all label color variations)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

66 - - - -- Human and Animal Drugs
Date Published: 10/01/2019

Desc: Locker Room (all label color variations)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

66 - - - -- Human and Animal Drugs
Date Published: 08/01/2019

Desc: Gold Rush Leather Cleaner
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list); '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them; creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles; such as the throat and anus. Not only do they enhance sexual pleasure; they produce a sensation of heat and excitement for a couple of minutes...'.

66 - - - -- Human and Animal Drugs
Date Published: 01/29/2020

Desc: Iron Horse (all variations - e.g. ultra strong super premium etc.)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

66 - - - -- Human and Animal Drugs
Date Published: 01/29/2020

Desc: Rush (all variations - e.g. ultra strong super premium etc.)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

66 - - - -- Human and Animal Drugs
Date Published: 10/01/2019

Desc: Super Rush Liquid Incense (all label color variations)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

66 - - - -- Human and Animal Drugs
Date Published: 01/29/2020

Desc: Jungle Juice (all variations - e.g. ultra strong super premium etc.)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

66 - - - -- Human and Animal Drugs
Date Published: 01/29/2020

Desc: Fist F*ck (all variations - e.g. ultra strong super premium etc.)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.

66 - - - -- Human and Animal Drugs
Date Published: 01/29/2020

Desc: The New Amsterdam (all variations - e.g. ultra strong super premium etc.)
Notes: The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'.


BAHAMAS


ASAP Service Limited
Date Published : 06/27/2018
P.O. Box N-1836 , Suite A 003 , Nassau, BAHAMAS
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

61 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

62 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

63 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

64 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

65 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

66 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

Lenex Labs
Date Published : 09/30/2009
Wavecrest House West Bay St , P O Box N-8174 , Nassau, BAHAMAS
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All products. Boston district received promotional material and mail order solicitation for drugs from Alpha Omega Labs. The material accompanied a letter from Lenex Labs in which Lenex stated that Alphas Omega would service orders on Lenex's former products. The firm offers a variety of products, including cancer inhibitors, weight loss products, and treatment for toxic bowel syndrome.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

NEW LIFE NATURAL VEGETATION CELL
Date Published : 08/25/2017
Lucaya Shopping Cent 14 , Freeport City, BAHAMAS
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/25/2017

Desc: Bilberry Raspberry Tonic
Notes: Drug claims made on product labeling and product website

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/25/2017

Desc: Sea Moss Bladderwrack Mix
Notes: Drug claims made on product labeling and product website

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/25/2017

Desc: Nerve Tonic
Notes: Drug claims made on product labeling and product website

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/25/2017

Desc: Cat Island Restoration Tonic
Notes: Drug claims made on product labeling and product website

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/25/2017

Desc: Male ThunderStrike
Notes: Drug claims made on product labeling and product website

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/25/2017

Desc: Special Healing Tonic
Notes: Drug claims made on product labeling and product website

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/25/2017

Desc: Iron Plus Formula
Notes: Drug claims made on product labeling and product website

56 G - - 99 Antifungal N.E.C.
Date Published: 08/25/2017

Desc: Draco Tonic
Notes: Drug claims made on product labeling and product website

60 N - - 14 Testosterone (Androgen)
Date Published: 08/25/2017

Desc: Male ThunderStrike
Notes: Drug claims made on product labeling and product website

62 C - - 99 Anti-Hypertensive N.E.C.
Date Published: 08/25/2017

Desc: Nerve Tonic
Notes: Drug claims made on product labeling and product website

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 08/25/2017

Desc: Special Healing Tonic
Notes: Drug claims made on product labeling and product website

62 V - - 99 Anti-Viral N.E.C.
Date Published: 08/25/2017

Desc: Cat Island Restoration Tonic
Notes: Drug claims made on product labeling and product website

64 B - - 99 Diuretic N.E.C.
Date Published: 08/25/2017

Desc: Sea Moss Bladderwrack Mix
Notes: Drug claims made on product labeling and product website

64 N - - 07 Iron Dextran (Inj) (Hematinic)
Date Published: 08/25/2017

Desc: Iron Plus Formula
Notes: Drug claims made on product labeling and product website

66 S - - 40 Inositol Niacinate (Vasodilator)
Date Published: 08/25/2017

Desc: Chelation
Notes: Drug claims made on product labeling and product website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/25/2017

Desc: Iron Plus Formula
Notes: Drug claims made on product labeling and product website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/25/2017

Desc: Draco Tonic
Notes: Drug claims made on product labeling and product website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/25/2017

Desc: Special Healing Tonic
Notes: Drug claims made on product labeling and product website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/25/2017

Desc: Cat Island Restoration Tonic
Notes: Drug claims made on product labeling and product website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/25/2017

Desc: Sea Moss Bladderwrack Mix
Notes: Drug claims made on product labeling and product website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/25/2017

Desc: Male ThunderStrike
Notes: Drug claims made on product labeling and product website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/25/2017

Desc: Bilberry Raspberry Tonic
Notes: Drug claims made on product labeling and product website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/25/2017

Desc: Chelation
Notes: Drug claims made on product labeling and product website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/25/2017

Desc: Nerve Tonic
Notes: Drug claims made on product labeling and product website

Planet Systems, Inc.
Date Published : 09/30/2009
John Variss , 58 Shirley St.,1st Floor PO Box 88 15670 , Nassau, BAHAMAS
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                           2/8/2007


BANGLADESH


ACI FOODS LTD
Date Published : 04/12/2018
Aci Center, 245 Tejgaon Industial Area , P. T. Inst. , Dhaka, BANGLADESH
61 L - - 14 Chlorhexidine Gluconate
Date Published: 04/12/2018

Desc: Savlon Antiseptic
Notes: The products appear to be unapproved new drugs as the product label contains drug claims

61 X - - 06 Chlorcyclizine HCl (Anti-Histaminic)
Date Published: 04/12/2018

Desc: Savlon Antiseptic Cream
Notes: The products appear to be unapproved new drugs as the product label contains drug claims

Aci
Date Published : 04/12/2018
48 Waterworks Road , Narayanganj, BANGLADESH
61 L - - 14 Chlorhexidine Gluconate
Date Published: 04/12/2018

Desc: Savlon Antiseptic
Notes: The products appear to be unapproved new drugs as the product label contains drug claims

61 X - - 06 Chlorcyclizine HCl (Anti-Histaminic)
Date Published: 04/12/2018

Desc: Savlon Antiseptic Cream
Notes: The products appear to be unapproved new drugs as the product label contains drug claims

Kohinoor Chemical Co.(Bd)Ltd
Date Published : 04/18/2016
36 Shahid Tejuddin Ahmed Soronitejgaon , Dhaka, BANGLADESH
53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 04/18/2016

Desc: Tibet Pumpkin Hair Oil
Notes: Medical claims on product labeling

PRAN AGRO LTD
Date Published : 03/02/2018
Pran-Rfl Center , 105 Middle Badda , Dhaka, BANGLADESH
07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 03/02/2018

Desc: Curry Leaf Chanachur (blend of noodles; peanuts; pulses and rice)

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.
Date Published: 03/02/2018

Desc: Curry Leaf Chanachur (blend of noodles; peanuts; pulses and rice)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/02/2018

Desc: Curry Leaf Chanachur (blend of noodles; peanuts; pulses and rice)

PRAN Agro Ltd.
Date Published : 03/02/2018
No. 55 Natore City Bypass Road , Natore, BANGLADESH
07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 03/02/2018

Desc: Curry Leaf Chanachur (blend of noodles; peanuts; pulses and rice)

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.
Date Published: 03/02/2018

Desc: Curry Leaf Chanachur (blend of noodles; peanuts; pulses and rice)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/02/2018

Desc: Curry Leaf Chanachur (blend of noodles; peanuts; pulses and rice)

SPICY AGRO PRODUCTS LTD.
Date Published : 04/12/2018
Kotowali , 3 104 Roomghata Monzur Mohol, Floor , Chittagong, BANGLADESH
61 L - - 14 Chlorhexidine Gluconate
Date Published: 04/12/2018

Desc: Savlon Antiseptic
Notes: The products appear to be unapproved new drugs as the product label contains drug claims.

61 X - - 06 Chlorcyclizine HCl (Anti-Histaminic)
Date Published: 04/12/2018

Desc: Savlon Antiseptic Cream
Notes: The products appear to be unapproved new drugs as the product label contains drug claims.

Sufia Chemical Industry
Date Published : 12/02/2016
287/1 East Nakhal Para , Dhaka, Dhaka BANGLADESH
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 12/02/2016

Desc: Biddut Tooth Powder

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/02/2016

Desc: Biddut Tooth Powder


BARBADOS


GLOBAL DRUG SUPPLY
Date Published : 09/01/2016
Unit 5-28 Warrens Industrial Pk , Saint Michael, BARBADOS
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/01/2016

Notes: All Drug and Drug Products

56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/01/2016

Notes: All Drug and Drug Products

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/01/2016

Notes: All Drug and Drug Products

61 - - - -- Human and Animal Drugs
Date Published: 09/01/2016

Notes: All Drug and Drug Products

62 - - - -- Human and Animal Drugs
Date Published: 09/01/2016

Notes: All Drug and Drug Products

63 - - - -- Human and Animal Drugs
Date Published: 09/01/2016

Notes: All Drug and Drug Products

64 - - - -- Human and Animal Drugs
Date Published: 09/01/2016

Notes: All Drug and Drug Products

65 - - - -- Human and Animal Drugs
Date Published: 09/01/2016

Notes: All Drug and Drug Products

66 - - - -- Human and Animal Drugs
Date Published: 09/01/2016

Notes: All Drug and Drug Products


BELGIUM


Laboratoires Ndv
Date Published : 02/23/2012
B 1930 Zaventen , Brixtonlaan, BELGIUM
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/05/2012

Desc: Nelly De Vust Slimming Oil

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 02/23/2012

Desc: Slimming Oil
Notes: Belgium

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/23/2012

Desc: Slimming Oil
Notes: Belgium

Link2biz Nv
Date Published : 03/07/2011
Leuvensesteenweg 573unit 9a , Zaventemzaventem, BELGIUM
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/07/2011

Desc: Melanic MT2 (Tanning Injectable)
Notes: Belgium


BELIZE


Generic Viagra. Bz
Date Published : 09/30/2009
5870 Manatee Drive , Button Wood Bay, BELIZE
65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 09/30/2009

Desc:
Notes: >>> Firm operates from website

Meds India, Ltd.
Date Published : 09/30/2009
20 Macaw Avenue , Belmopan, C.A., BELIZE
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                       

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009


BERMUDA


Zellyn Cell Research
Date Published : 09/30/2009
P O Box H M 1120 , Hamilton, BERMUDA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: Oxygenesis Live Cell Therapy. And all other products. 4/21/1994

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009


BRAZIL


CASA GRANADO LABORATORIOS FARMAC
Date Published : 10/04/2013
Av Tancredo Neves, 30 Ja , Rio De Janeiro, BRAZIL
53 D - - 03 Powders (Dusting and Talcum, excluding Aftershave Talc) (Fragrance Preparations)
Date Published: 10/04/2013

Desc: Polvilho Antisseptico-Pink (Pink Antiseptic Foot Powder)

53 H - - 99 Other Manicuring Preparations, N.E.C.
Date Published: 10/04/2013

Desc: Polvilho Antisseptico-Pink (Pink Antiseptic Foot Powder)

53 L - - 04 Foot Powders and Sprays (Skin Care Preparations)
Date Published: 10/04/2013

Desc: Polvilho Antisseptico-Pink (Pink Antiseptic Foot Powder)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/04/2013

Desc: Polvilho Antisseptico-Pink (Pink Antiseptic Foot Powder)

Fitoterapicos A Cura
Date Published : 09/30/2009
Rua Estrela Dione, 340 , Riacho das Pedras , Contagem, BR-MG BRAZIL
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/30/2009

Notes: GPI-DR Emagrece Sim Dietary Supplements (all Levels) 12/12/2005                         This website makes direct reference to treatmenst for cancer cures as well as treatments for AIDS and diabetes. Additionally, a letter that accompanies the imported product states in Spanish that this product has been used to treat patients with cancer, leukemia, and HIV positive obtaining good results even on those patients with terminal conditions. We are not aware of any substantial scientific evidence that establishes that this product is generally recognized as safe and effective for its intended use. This product is not the subject of an approved new or abbreviated new drug application.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/16/2019

Notes: Emagrece Sim Dietary Supplement, 12/23/2005

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Emagrece Sim Dietary Supplement, 12/23/2005

61 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Emagrece Sim Dietary Supplement, 12/23/2005

62 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Emagrece Sim Dietary Supplement, 12/23/2005

63 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Emagrece Sim Dietary Supplement, 12/23/2005

64 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Emagrece Sim Dietary Supplement, 12/23/2005

65 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Emagrece Sim Dietary Supplement, 12/23/2005

66 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Emagrece Sim Dietary Supplement, 12/23/2005

PHYTOTHERM SIM
Date Published : 09/30/2009
Rua Estrela Dione 300 , CONTAGEM, BR-MG BRAZIL
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/30/2009

Notes: GPI-DR Emagrace Sim Dietary Supplement (all levels) 12/23/2005                          This website makes direct reference to treatmenst for cancer cures as well as treatments for AIDS and diabetes. Additionally, a letter that accompanies the imported product states in Spanish that this product has been used to treat patients with cancer, leukemia, and HIV positive obtaining good results even on those patients with terminal conditions. We are not aware of any substantial scientific evidence that establishes that this product is generally recognized as safe and effective for its intended use. This product is not the subject of an approved new or abbreviated new drug application.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/24/2019

Notes: Emagrece Sim Dietary Supplement (all Levels); 12/23/2005

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 07/24/2019

Notes: Emagrece Sim Dietary Supplement (all Levels); 12/23/2005

61 - - - -- Human and Animal Drugs
Date Published: 07/24/2019

Notes: Emagrece Sim Dietary Supplement (all Levels); 12/23/2005

62 - - - -- Human and Animal Drugs
Date Published: 07/24/2019

Notes: Emagrece Sim Dietary Supplement (all Levels); 12/23/2005

63 - - - -- Human and Animal Drugs
Date Published: 07/24/2019

Notes: Emagrece Sim Dietary Supplement (all Levels); 12/23/2005

64 - - - -- Human and Animal Drugs
Date Published: 07/24/2019

Notes: Emagrece Sim Dietary Supplement (all Levels); 12/23/2005

65 - - - -- Human and Animal Drugs
Date Published: 07/24/2019

Notes: Emagrece Sim Dietary Supplement (all Levels); 12/23/2005

66 - - - -- Human and Animal Drugs
Date Published: 07/24/2019

Notes: Emagrece Sim Dietary Supplement (all Levels); 12/23/2005

Pineda Laboratorio
Date Published : 04/23/2020
Rua Monte Alegre 1142 , Sao Paulo, Sao Paulo BRAZIL
53 - - - -- Cosmetics
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 07 Myobloc
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

Zipmed Mesoone
Date Published : 09/08/2010
Rua Erico Mota, 1149a , Fortaleza, Ceara BRAZIL
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/08/2010

Notes: All Drug Products; NOTE: Drug products from Zipmed Mesoone are intended for injection and are therefore also subject to the guidance found in Import Alert #62-05.; Brazil

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/08/2010

Notes: All Drug Products; NOTE: Drug products from Zipmed Mesoone are intended for injection and are therefore also subject to the guidance found in Import Alert #62-05.; Brazil

61 - - - -- Human and Animal Drugs
Date Published: 09/08/2010

Notes: All Drug Products; NOTE: Drug products from Zipmed Mesoone are intended for injection and are therefore also subject to the guidance found in Import Alert #62-05.; Brazil

62 - - - -- Human and Animal Drugs
Date Published: 09/08/2010

Notes: All Drug Products; NOTE: Drug products from Zipmed Mesoone are intended for injection and are therefore also subject to the guidance found in Import Alert #62-05.; Brazil

63 - - - -- Human and Animal Drugs
Date Published: 09/08/2010

Notes: All Drug Products; NOTE: Drug products from Zipmed Mesoone are intended for injection and are therefore also subject to the guidance found in Import Alert #62-05.; Brazil

64 - - - -- Human and Animal Drugs
Date Published: 09/08/2010

Notes: All Drug Products; NOTE: Drug products from Zipmed Mesoone are intended for injection and are therefore also subject to the guidance found in Import Alert #62-05.; Brazil

65 - - - -- Human and Animal Drugs
Date Published: 09/08/2010

Notes: All Drug Products; NOTE: Drug products from Zipmed Mesoone are intended for injection and are therefore also subject to the guidance found in Import Alert #62-05.; Brazil

66 - - - -- Human and Animal Drugs
Date Published: 09/08/2010

Notes: All Drug Products; NOTE: Drug products from Zipmed Mesoone are intended for injection and are therefore also subject to the guidance found in Import Alert #62-05.; Brazil


BRITISH VIRGIN ISLANDS


Canadian Pharmacy
Date Published : 09/30/2009
See Phuket 12 De Castro Street , Tortola, NY 12345 BRITISH VIRGIN ISLANDS
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 09/30/2009

Notes: Abarelix;                                          

64 R - - 21 Somatropin (Hormone)
Date Published: 09/09/2020

Notes:                                          

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                                          

Hormone Boutique
Date Published : 09/30/2009
CWP, PO Box 3149 , Pasea Estate, Road Town , Tortola, BRITISH VIRGIN ISLANDS
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                     

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009


BULGARIA


Doych
Date Published : 06/28/2021
Brezovsko Shose Str. 133 , Plovdiv, Plovdiv BULGARIA
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 06/28/2021

Desc: LIPOMEZIN
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): (website) "[A]fter starting Lipomezin, in the first month my total cholesterol went from 290 to 205… A friend recommended Lipomezin as way of using herbs to lower my cholesterol… Grape Seed Extract - Lipomezin's superior form of grape seed extract acts as a potent antioxidant to inhibit the oxidation that takes LDL cholesterol problems from bad to worse"; (label) “Beat Cholesterol the Natural Way… Helps maintain a healthy cholesterol level”.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 06/28/2021

Desc: RENOHELP
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): (website) "Encourages normal, balanced levels of inflammation. . . protecting your kidney structures and balancing inflammation throughout your entire urinary system… Helps maintain healthy blood pressure… Renohelp works to keep your blood pressure in the healthy range”; (label) “Helps maintain normal kidney functions and relieve symptoms of gout”.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/28/2021

Desc: LIPOMEZIN
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): (website) "[A]fter starting Lipomezin, in the first month my total cholesterol went from 290 to 205… A friend recommended Lipomezin as way of using herbs to lower my cholesterol… Grape Seed Extract - Lipomezin's superior form of grape seed extract acts as a potent antioxidant to inhibit the oxidation that takes LDL cholesterol problems from bad to worse"; (label) “Beat Cholesterol the Natural Way… Helps maintain a healthy cholesterol level”.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/28/2021

Desc: LIPOMEZIN
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): (website) "[A]fter starting Lipomezin, in the first month my total cholesterol went from 290 to 205… A friend recommended Lipomezin as way of using herbs to lower my cholesterol… Grape Seed Extract - Lipomezin's superior form of grape seed extract acts as a potent antioxidant to inhibit the oxidation that takes LDL cholesterol problems from bad to worse"; (label) “Beat Cholesterol the Natural Way… Helps maintain a healthy cholesterol level”.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/28/2021

Desc: RENOHELP
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): (website) "Encourages normal, balanced levels of inflammation. . . protecting your kidney structures and balancing inflammation throughout your entire urinary system… Helps maintain healthy blood pressure… Renohelp works to keep your blood pressure in the healthy range”; (label) “Helps maintain normal kidney functions and relieve symptoms of gout”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/28/2021

Desc: RENOHELP
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): (website) "Encourages normal, balanced levels of inflammation. . . protecting your kidney structures and balancing inflammation throughout your entire urinary system… Helps maintain healthy blood pressure… Renohelp works to keep your blood pressure in the healthy range”; (label) “Helps maintain normal kidney functions and relieve symptoms of gout”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/28/2021

Desc: LIPOMEZIN
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): (website) "[A]fter starting Lipomezin, in the first month my total cholesterol went from 290 to 205… A friend recommended Lipomezin as way of using herbs to lower my cholesterol… Grape Seed Extract - Lipomezin's superior form of grape seed extract acts as a potent antioxidant to inhibit the oxidation that takes LDL cholesterol problems from bad to worse"; (label) “Beat Cholesterol the Natural Way… Helps maintain a healthy cholesterol level”.


CAMEROON


LES LABORATOIRES B&B
Date Published : 08/23/2023
2107 , Yaounde, CAMEROON
53 - - - -- Cosmetics
Date Published: 08/23/2023

Desc: LA LA LA Lotion Tonique Et Eclaircissante

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/23/2023

Desc: LA LA LA Lotion Tonique Et Eclaircissante

Tip Top Beauty Supply
Date Published : 06/28/2013
Sonac Street Kumba Suite 26 , Kumba, CAMEROON
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 06/28/2013

Desc: Rapid Clair Super Eclaircissant and Super Lighening Antiseptic Soap
Notes: Cameroon

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 06/28/2013

Desc: Biopur Paris Gentle Super Whitening Restorative Day Day Cream
Notes: Cameroon

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 06/28/2013

Desc: Civic Lightening Beauty Lotion
Notes: Cameroon

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/28/2013

Desc: Rapid Clair Super Eclaircissant and Super Lighening Antiseptic Soap
Notes: Cameroon

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/28/2013

Desc: Biopur Paris Gentle Super Whitening Restorative Day Day Cream
Notes: Cameroon

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/28/2013

Desc: Civic Lightening Beauty Lotion
Notes: Cameroon


CANADA


1217215 Alberta Ltd.
Date Published : 05/21/2012
109, 3016 - 10 Avenue NE , Calgary, Alberta CANADA
33 A - - 06 Flavored Candy, Hard (Live Savers, Etc.), with Nuts or Nut Products (not Coconut or Suckers)(without
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: Canada;

33 E - - 06 Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: Canada;

33 E - - 11 Mint Candy, Hard, without Nuts and Fruit (without Chocolate)
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: Canada;

33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: Canada;

33 S - - 06 Lollipop (without Chocolate)
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: Canada

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: Canada;

34 F - - 08 Chocolate Suckers and Novelties, without Nuts and Fruit
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: Canada;

60 Q - - 56 Benzocaine (Anesthetic)
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: Canada;

1217215 Alberta Ltd.
Date Published : 05/21/2012
1220 28 St Ne , Calgary, Ab CANADA
33 A - - 06 Flavored Candy, Hard (Live Savers, Etc.), with Nuts or Nut Products (not Coconut or Suckers)(without
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: canada

33 E - - 06 Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: canada

33 E - - 11 Mint Candy, Hard, without Nuts and Fruit (without Chocolate)
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: canada

33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: canada

33 S - - 06 Lollipop (without Chocolate)
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: canada

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: canada

34 F - - 08 Chocolate Suckers and Novelties, without Nuts and Fruit
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: canada

60 Q - - 56 Benzocaine (Anesthetic)
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: canada

2156619 Ontario Inc
Date Published : 11/08/2011
149 Victoria St , Barrie, ON CANADA
55 Q - - 19 Petrolatum (Pharmaceutic Necessity - Ointment Base)
Date Published: 11/08/2011

Desc: Pursan Topical Antimicrobial Ointment
Notes: Canada

55 Q - - 32 Lanolin (Pharmaceutic Necessity - Water in Oil Emulsion)
Date Published: 11/08/2011

Desc: Pursan Topical Antimicrobial Skin Cleanser
Notes: Canada

55 Q - - 46 Sodium Formaldehyde Sulfoxylate (Pharmaceutic Necessity - Preservative)
Date Published: 11/08/2011

Desc: Purkenz Topical Antimicrobial Skin Cleanser
Notes: Canada

2187954 ALBERTA INC
Date Published : 11/08/2023
1135 Pacific Ave , Kelowna, British Columbia CANADA
53 D - - 02 Perfumes (Fragrance Preparations)
Date Published: 11/08/2023

Desc: Smelling Salts
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

60 B - - 01 Ammonium Chloride (Acidifier)
Date Published: 11/08/2023

Desc: Smelling Salts
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

66 B - - 30 Ammonia Spirit, Arommatic (Stimulant)
Date Published: 11/08/2023

Desc: Smelling Salts
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

2187954 ALBERTA INC
Date Published : 11/08/2023
1606 Findlay Rd , Kelowna, British Columbia CANADA
53 D - - 02 Perfumes (Fragrance Preparations)
Date Published: 11/08/2023

Desc: Smelling Salts
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

60 B - - 01 Ammonium Chloride (Acidifier)
Date Published: 11/08/2023

Desc: Smelling Salts
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

66 B - - 30 Ammonia Spirit, Arommatic (Stimulant)
Date Published: 11/08/2023

Desc: Smelling Salts
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

2187954 ALBERTA INC.
Date Published : 11/08/2023
Suite 162-210A 12A St N , Lethbridge, Alberta CANADA
53 D - - 02 Perfumes (Fragrance Preparations)
Date Published: 11/08/2023

Desc: Smelling Salts
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

60 B - - 01 Ammonium Chloride (Acidifier)
Date Published: 11/08/2023

Desc: Smelling Salts
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

66 B - - 30 Ammonia Spirit, Arommatic (Stimulant)
Date Published: 11/08/2023

Desc: Smelling Salts
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

2201371 Ontario Inc.
Date Published : 09/01/2015
1111 Flint Rd Unit 25 , North York, Ontario CANADA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/01/2015

Desc: Various Maca Powder Supplements (including Inka Organic Peruvian Wild Maca Powder and Red and Black Maca)

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/01/2015

Desc: Nutridom Cranberry 25X

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/01/2015

Desc: Nutridom Cranberry 25X

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/01/2015

Desc: Various Maca Powder Supplements (including Inka Organic Peruvian Wild Maca Powder and Red and Black Maca)

2201371 Ontario Inc.
Date Published : 09/01/2015
1111 Flint Rd Unit 25 , North York, Ontario CANADA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/01/2015

Desc: Nutridom Cranberry 25X

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/01/2015

Desc: Various Maca Powder Supplements (including Inka Organic Peruvian Wild Maca Powder and Red and Black Maca)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/01/2015

Desc: Nutridom Cranberry 25X

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/01/2015

Desc: Various Maca Powder Supplements (including Inka Organic Peruvian Wild Maca Powder and Red and Black Maca)

381922 Ontario Ltd.
Date Published : 09/30/2009
39 Prosperity Ave , Port Colborne, Ontario CANADA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: 2/11/2000

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 2/11/2000

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 2/11/2000

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 2/11/2000

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 2/11/2000

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 2/11/2000

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 2/11/2000

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 2/11/2000

7338457 Canada Inc dba Karma Nutritionals
Date Published : 06/14/2013
207-27090 Gloucester Way , Langley, British Columbia CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/14/2013

Desc: PhD Pharma-Greens Unflavoured Diet Supplement

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/14/2013

Desc: PhD Pharma-Greens Lemon Lime Diet Supplement

7338457 Canada Inc dba Karma Nutritionals
Date Published : 06/14/2013
207-27090 Gloucester Way , Langley, British Columbia CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/14/2013

Desc: PhD Pharma-Greens Unflavoured Diet Supplement

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/14/2013

Desc: PhD Pharma-Greens Lemon Lime Diet Supplement

7338457 Canada Inc dba Karma Nutritionals
Date Published : 06/14/2013
207-27090 Gloucester Way , Langley, British Columbia CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/14/2013

Desc: PhD Pharma-Greens Lemon Lime Diet Supplement

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/14/2013

Desc: PhD Pharma-Greens Unflavoured Diet Supplement

77Canadapharmacy.com
Date Published : 09/30/2009
Pharmacy Network , Vancouver, British Columbia CANADA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                           

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

8046255 Canada Inc. DBA Viatrexx
Date Published : 06/15/2020
1360 Louis-Marchand St , Beloeil, Quebec CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/16/2022

Desc: FNGS DX
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘FNGS-DX is an Advanced Micro Blend of nutrients designed to aid in relief and detox of symptoms or exposure to mold or fungus…’.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/16/2022

Desc: PAINEXX
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘PAINEXX helps relieve pain and inflammation in muscles and joints (such as sprains, bruises, nerve pain and lingering pain)…’.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-MuSkel-Neural Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-Prolo Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-Intra-Cell Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-Male Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-Infla Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-Neuro Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-Relief Oral Spray
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-Arthros Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-Hair Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-Lymph 1 Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-Immunexx Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-Ithurts Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-Adipose Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-GI Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-Collagen Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-Connectissue Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-Mesenchyme Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-Ouch Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-Systemic Detox Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-ANC/CNS Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-Facial Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-Neuro 3 Sterile Multi-Dose Injectable
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Viatrexx-Articula Sterile Multi-Dose Injectable
Notes: 6/15/2020

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Immunexx Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-ANC/CNS Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Facial Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Hair Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Adipose Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Collagen Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Connectissue Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Systemic Detox Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Arthros Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-GI Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Articula Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Ouch Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Infla Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Neuro Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Prolo Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Ithurts Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-MuSkel-Neural Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Male Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Mesenchyme Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Intra-Cell Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Relief Oral Spray
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Neuro 3 Sterile Multi-Dose Injectable
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Lymph 1 Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Lymph 1 Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Adipose Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Mesenchyme Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Male Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Systemic Detox Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Immunexx Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Infla Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Ithurts Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Collagen Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Connectissue Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-MuSkel-Neural Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Relief Oral Spray
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Prolo Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Arthros Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Articula Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-ANC/CNS Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-GI Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Hair Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Neuro 3 Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Intra-Cell Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Facial Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Ouch Sterile Multi-Dose Injectable
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Neuro Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Prolo Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Ithurts Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Neuro Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Connectissue Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Neuro 3 Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-MuSkel-Neural Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-ANC/CNS Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Collagen Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Adipose Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Ouch Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Mesenchyme Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Immunexx Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Relief Oral Spray
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Facial Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Lymph 1 Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Infla Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Intra-Cell Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Articula Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Male Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Arthros Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Hair Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Systemic Detox Sterile Multi-Dose Injectable
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-GI Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Neuro Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Adipose Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Neuro 3 Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Lymph 1 Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Hair Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Collagen Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-MuSkel-Neural Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Articula Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-GI Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Prolo Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Immunexx Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Ouch Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Mesenchyme Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Arthros Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Infla Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Intra-Cell Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Systemic Detox Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Connectissue Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-ANC/CNS Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Ithurts Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Facial Sterile Multi-Dose Injectable
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Relief Oral Spray
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Male Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Arthros Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Infla Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Male Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Ithurts Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Connectissue Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Intra-Cell Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Adipose Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Neuro 3 Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Systemic Detox Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Facial Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Hair Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Articula Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Mesenchyme Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-MuSkel-Neural Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-ANC/CNS Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Neuro Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-GI Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Lymph 1 Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Immunexx Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Prolo Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Ouch Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Collagen Sterile Multi-Dose Injectable
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Relief Oral Spray
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-GI Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Collagen Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Mesenchyme Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Adipose Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Systemic Detox Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Male Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Prolo Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Hair Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Ithurts Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-ANC/CNS Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Neuro 3 Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Infla Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Facial Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Relief Oral Spray
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Ouch Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-MuSkel-Neural Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Intra-Cell Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Lymph 1 Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Immunexx Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Connectissue Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Articula Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Arthros Sterile Multi-Dose Injectable
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Neuro Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/16/2022

Desc: PAINEXX
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘PAINEXX helps relieve pain and inflammation in muscles and joints (such as sprains, bruises, nerve pain and lingering pain)…’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/16/2022

Desc: FNGS DX
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘FNGS-DX is an Advanced Micro Blend of nutrients designed to aid in relief and detox of symptoms or exposure to mold or fungus…’.

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-GI Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-ANC/CNS Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Lymph 1 Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Hair Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Arthros Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Male Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Articula Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Mesenchyme Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Adipose Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Relief Oral Spray
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-MuSkel-Neural Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Facial Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Prolo Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Collagen Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Connectissue Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Ouch Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Systemic Detox Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Neuro Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Infla Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Ithurts Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Immunexx Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Neuro 3 Sterile Multi-Dose Injectable
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Viatrexx-Intra-Cell Sterile Multi-Dose Injectable
Notes: 6/15/2020

Abas Pharmacy
Date Published : 09/30/2009
Lakeside Computer Source, Box 136 , Camp Morton, MB ROC OMO, CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 08/20/2020

Desc: Abarelix
Notes:                       

64 R - - 21 Somatropin (Hormone)
Date Published: 08/20/2020

Notes:                       

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                       

Abbott Renuka Pharmacy Ltd.
Date Published : 09/30/2009
420 Abbott Street , Vancouver, BC CANADA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                           

Absorb Science Inc
Date Published : 12/02/2015
110-1000 Roosevelt Cres , North Vancouver, British Columbia CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/02/2015

Desc: Detoxy Femme
Notes: Labeling on product and on Firm?s website makes drug claims.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/02/2015

Desc: Pain 45
Notes: Labeling on product and on Firm's website makes drug claims.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/02/2015

Desc: Viagreat-SX
Notes: Labeling on product and on Firm's website makes drug claims.

Acenzia Inc.
Date Published : 08/15/2022
1580 Rossi Dr , Oldcastle, Ontario CANADA
54 B - - 06 Iodine (Mineral)
Date Published: 08/15/2022

Desc: Lonovo Iodine Oral Spray
Notes: This product appears to be an unapproved new drug as the product’s promotional website and product labeling includes statements such as (not an all-inclusive list): “Insufficient daily iodine intake has serious effects including infertility… cancers, poor thyroid function and many other issues.”; “Iodine also reduces bacteria loading on the skin.”; “World class antibacterial and antiviral element”; “How Iodine Defeats Unwanted Bacteria.”; “A strong immune system fights disease…Pure Iodine Oral Spray daily immune support essential for health.”

54 Y - - 06 Bee Pollen (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 08/15/2022

Desc: Lonovo Iodine Oral Spray
Notes: This product appears to be an unapproved new drug as the product’s promotional website and product labeling includes statements such as (not an all-inclusive list): “Insufficient daily iodine intake has serious effects including infertility… cancers, poor thyroid function and many other issues.”; “Iodine also reduces bacteria loading on the skin.”; “World class antibacterial and antiviral element”; “How Iodine Defeats Unwanted Bacteria.”; “A strong immune system fights disease…Pure Iodine Oral Spray daily immune support essential for health.”

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/15/2022

Desc: Lonovo Iodine Oral Spray
Notes: This product appears to be an unapproved new drug as the product’s promotional website and product labeling includes statements such as (not an all-inclusive list): “Insufficient daily iodine intake has serious effects including infertility… cancers, poor thyroid function and many other issues.”; “Iodine also reduces bacteria loading on the skin.”; “World class antibacterial and antiviral element”; “How Iodine Defeats Unwanted Bacteria.”; “A strong immune system fights disease…Pure Iodine Oral Spray daily immune support essential for health.”

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/15/2022

Desc: Lonovo Iodine Oral Spray
Notes: This product appears to be an unapproved new drug as the product’s promotional website and product labeling includes statements such as (not an all-inclusive list): “Insufficient daily iodine intake has serious effects including infertility… cancers, poor thyroid function and many other issues.”; “Iodine also reduces bacteria loading on the skin.”; “World class antibacterial and antiviral element”; “How Iodine Defeats Unwanted Bacteria.”; “A strong immune system fights disease…Pure Iodine Oral Spray daily immune support essential for health.”

Adv Care Pharmacy Inc.
Date Published : 09/30/2009
Amr Bannis, 50 Heathcote Ave , Toronto , North York, ON CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 08/20/2020

Desc: Abarelix
Notes:                          

64 R - - 21 Somatropin (Hormone)
Date Published: 08/20/2020

Notes:                          

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                          

Advanced Orthomolecular Research Inc
Date Published : 05/07/2014
3900-12th St , NE , Calgary, Alberta CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/24/2020

Desc: "Ortho-Eyes" Lubricant Eye Drops (Labeled as a dietary supplement)
Notes: The website www.aor.ca that describes Ortho Eyes product; promotes one of its ingrediants N-acetyl-carnosine to improve eyesite; treat corneal dtsrophy; corneal trophic keratitus and bullous keratopathy. Based on its intended uses this product is a drug. We are not aware of any substantial scientific evidence that this product is generally recognized as safe and effective for the conditions recommended on its labeling. 6/1/2006

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/24/2020

Desc: "Ortho-Eyes" Lubricant Eye Drops (Labeled as a dietary supplement)
Notes: The website www.aor.ca that describes Ortho Eyes product; promotes one of its ingrediants N-acetyl-carnosine to improve eyesite; treat corneal dtsrophy; corneal trophic keratitus and bullous keratopathy. Based on its intended uses this product is a drug. We are not aware of any substantial scientific evidence that this product is generally recognized as safe and effective for the conditions recommended on its labeling. 6/1/2006

Akc Nutraceuticals Inc.
Date Published : 11/13/2012
141-269, 6200 Mckay Avenue , Burnabyburnaby, BRITISH COLUMBIA CANADA
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 11/13/2012

Desc: BeautyGen Eye Elixir

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 11/13/2012

Desc: BeautyGen Extra Lifting Essence

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 11/13/2012

Desc: BeautyGen Ideal Calming Serum

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 11/13/2012

Desc: BeautyGen Duet Bright Essence/Complex

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 11/13/2012

Desc: BeautyGen Glowing Protector

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/13/2012

Desc: BeautyGen Eye Elixir

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/13/2012

Desc: BeautyGen Ideal Calming Serum

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/13/2012

Desc: BeautyGen Duet Bright Essence/Complex

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/13/2012

Desc: BeautyGen Glowing Protector

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/13/2012

Desc: BeautyGen Extra Lifting Essence

Altesse Cosmetique Inc
Date Published : 09/30/2009
BP 452 BR , Montreal, QC CANADA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: Capillary Serum with Placenta. The buffalo district recently detained two hair lotions with claims of anti-hair loss. The district detained the products based on violation of 21 CFR 310.527(b) in that the products were represented as external hair loss prevention lotions which is regarded as a new drug within the meaning of section 201(p) for which a new drug application (NDA) under section 505 is required for marketing. The shipments were commercial entries which appeared to be for distribution and sale in the United States.

Americana Meds
Date Published : 09/30/2009
Kelsie Mercer , 319 South River road , Elora, Ontario, Quebec CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 04/08/2020

Desc: Abarelix
Notes:                        

64 R - - 21 Somatropin (Hormone)
Date Published: 04/08/2020

Notes:                        

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                        

Aptecha Inc
Date Published : 09/13/2019
Box 1158-293 Main St. , Stonewall, Manitoba CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 10/07/2020

Desc: Abarelix
Notes:                         

64 R - - 21 Somatropin (Hormone)
Date Published: 10/07/2020

Notes:                         

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 10/07/2020

Notes:                         

Arborg Pharmacy
Date Published : 09/30/2009
273 Main Street, Box 640 , Arborg, MB, CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 09/30/2009

Notes: Abarelix;                            

64 R - - 21 Somatropin (Hormone)
Date Published: 09/09/2020

Notes:                            

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                            

Attogram Corp.
Date Published : 09/17/2019
7-13 Holland Dr , Bolton, Ontario CANADA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/17/2019

Notes: Calfcart Cartilage Cream, 8/19/1994

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Calfcart Cartilage Cream, 8/19/1994

61 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Calfcart Cartilage Cream, 8/19/1994

62 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Calfcart Cartilage Cream, 8/19/1994

63 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Calfcart Cartilage Cream, 8/19/1994

64 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Calfcart Cartilage Cream, 8/19/1994

65 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Calfcart Cartilage Cream, 8/19/1994

66 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Calfcart Cartilage Cream, 8/19/1994

Avaria Health & Beauty Corp
Date Published : 02/09/2016
550 Parkside Dr #A1 , Waterloo, ON CANADA
53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 02/09/2016

Desc: Smiles To Go Teeth Whitening Gel Pen
Notes: Product labeling and website makes claims.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/09/2016

Desc: Smiles To Go Teeth Whitening Gel Pen
Notes: Product labeling and website makes claims.

BIOCEAN CANADA
Date Published : 06/28/2013
280 Rue Marquette , Sherbrooke, QC CANADA
53 U - - 12 Skin Care Preparations, Cosmetic products containing animal by-products (other animal by-products)
Date Published: 06/28/2013

Desc: Anti Agining Regenerative Facial Skin Care System
Notes: Canada

53 U - - 12 Skin Care Preparations, Cosmetic products containing animal by-products (other animal by-products)
Date Published: 06/28/2013

Desc: Rocacea Skin Care System
Notes: Canada

53 U - - 12 Skin Care Preparations, Cosmetic products containing animal by-products (other animal by-products)
Date Published: 06/28/2013

Desc: Eczema & Psoriasis Skin Care System
Notes: Canada

54 B - - 99 Mineral N.E.C.
Date Published: 06/28/2013

Desc: Rocacea Skin Care System
Notes: Canada

54 B - - 99 Mineral N.E.C.
Date Published: 06/28/2013

Desc: Anti Agining Regenerative Facial Skin Care System
Notes: Canada

54 B - - 99 Mineral N.E.C.
Date Published: 06/28/2013

Desc: Eczema & Psoriasis Skin Care System
Notes: Canada

54 H - - 05 Omega-3 (Fats and Lipid Substances)
Date Published: 06/28/2013

Desc: Eczema & Psoriasis Skin Care System
Notes: canada

54 H - - 05 Omega-3 (Fats and Lipid Substances)
Date Published: 06/28/2013

Desc: Rocacea Skin Care System
Notes: Canada

54 H - - 05 Omega-3 (Fats and Lipid Substances)
Date Published: 06/28/2013

Desc: Anti Agining Regenerative Facial Skin Care System
Notes: Canada

Babyboomer-Reboot
Date Published : 10/09/2012
427 Fitzwilliam St. Ste #J , Nanaimo, British Columbia CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/09/2012

Desc: Baby Boomer Reboot Cellton Marine Phytoplankton capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/09/2012

Desc: Baby Boomer Reboot Cellton Marine Phytoplankton capsules

Bell Lifestyle Products Inc.
Date Published : 03/06/2023
3164 Pepper Mill Court , Mississauga, CANADA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/06/2023

Desc: Virux Capsules

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/06/2023

Desc: Ezee Digestion Tea

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/06/2023

Desc: Virux Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/06/2023

Desc: Ezee Digestion Tea

Biomedica Labs
Date Published : 09/30/2009
Street address not available , Duncan, BC CANADA
54 F C R 99 Herbals & Botanicals (not Teas), N.E.C., Hum Fd Dietary Suppl Multi Ingr, NonSterile Powder
Date Published: 09/13/2019

Desc: Recovery Biostructural Medicines
Notes: 4/29/2003

Bioxem Inc.
Date Published : 09/30/2009
470 Sir-Wilfrid-Laurier Blvd Bureau 103 , Mont-Saint-Hilaire, Quebec CANADA
54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 09/30/2009

Notes: Agrumax 8/19/2003

Black Mountain IDA Pharmacy (1979) Ltd.
Date Published : 09/30/2009
11-590 Hwy 33w , Kelowna, British Columbia CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 05/26/2020

Desc: Abarelix
Notes:                                                                       

64 R - - 21 Somatropin (Hormone)
Date Published: 05/26/2020

Notes:                                                                       

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                                                                        

Botanikur Inc.
Date Published : 09/08/2020
257 Armand-Majeau St S Local 3 , Saint-Roch-De-L'Achigan, Quebec CANADA
54 B - - -- Mineral
Date Published: 09/08/2020

Desc: Tahua Bones Herbal Supplement
Notes: The product appears to be an unapproved new drug as the product's promotional website includes claims such as (not an all-inclusive list): 'soothe the pain of small and medium joints' ; 'stopping bleeding or hemorrhage' ; 'regulating the blood cholesterol' ; 'keeping at bay diseases of the digestive tract'.

54 E - - -- Herbal and Botanical
Date Published: 09/08/2020

Desc: Tahua Bones Herbal Supplement
Notes: The product appears to be an unapproved new drug as the product's promotional website includes claims such as (not an all-inclusive list): 'soothe the pain of small and medium joints' ; 'stopping bleeding or hemorrhage' ; 'regulating the blood cholesterol' ; 'keeping at bay diseases of the digestive tract'.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/29/2020

Desc: Tahua Reno Herbal Supplement

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 02/29/2024

Desc:            EZ-DIGEST Herbal Supplement

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 09/08/2020

Desc: Tahua Bones Herbal Supplement
Notes: The product appears to be an unapproved new drug as the product's promotional website includes claims such as (not an all-inclusive list): 'soothe the pain of small and medium joints' ; 'stopping bleeding or hemorrhage' ; 'regulating the blood cholesterol' ; 'keeping at bay diseases of the digestive tract'.

54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 10/02/2023

Desc: Tahua Kalm-Kids Herbal Supplement

54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 09/08/2020

Desc: Tahua Bones Herbal Supplement
Notes: The product appears to be an unapproved new drug as the product's promotional website includes claims such as (not an all-inclusive list): 'soothe the pain of small and medium joints' ; 'stopping bleeding or hemorrhage' ; 'regulating the blood cholesterol' ; 'keeping at bay diseases of the digestive tract'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2020

Desc: Tahua Reno Herbal Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/29/2024

Desc:            EZ-DIGEST Herbal Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/02/2023

Desc: Tahua Kalm-Kids Herbal Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/08/2020

Desc: Tahua Bones Herbal Supplement
Notes: The product appears to be an unapproved new drug as the product's promotional website includes claims such as (not an all-inclusive list): 'soothe the pain of small and medium joints' ; 'stopping bleeding or hemorrhage' ; 'regulating the blood cholesterol' ; 'keeping at bay diseases of the digestive tract'.

Brasserie Maltco Inc.
Date Published : 12/12/2023
1750 Rue Du Perigord , Quebec, Quebec CANADA
29 B - - 06 Soft Drink, Imitation Fruit Flavored, Carbonated
Date Published: 12/12/2023

Desc: Mind Blow Energy Drink Pink Lemonade
Notes: Product appears to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

29 B - - 60 Soda Water, Carbonated
Date Published: 12/12/2023

Desc: Mind Blow Energy Drink Pink Lemonade
Notes: Product appears to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

29 B - - 60 Soda Water, Carbonated
Date Published: 12/12/2023

Desc: Mind Blow Energy Drink Original Flavor
Notes: Product appears to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

29 B - - 99 Carbonated Soft Drink, N.E.C.
Date Published: 12/12/2023

Desc: Mind Blow Energy Drink Original Flavor
Notes: Product appears to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

29 B - - 99 Carbonated Soft Drink, N.E.C.
Date Published: 12/12/2023

Desc: Mind Blow Energy Drink Pink Lemonade
Notes: Product appears to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

29 S - - 99 Carbonated Water (Nonmedicinal), N.E.C.
Date Published: 12/12/2023

Desc: Mind Blow Energy Drink Original Flavor
Notes: Product appears to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

29 S - - 99 Carbonated Water (Nonmedicinal), N.E.C.
Date Published: 12/12/2023

Desc: Mind Blow Energy Drink Pink Lemonade
Notes: Product appears to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 12/12/2023

Desc: Mind Blow Energy Drink Pink Lemonade
Notes: Product appears to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 12/12/2023

Desc: Mind Blow Energy Drink Original Flavor
Notes: Product appears to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

66 V - - -- Patent Medicines, Etc
Date Published: 12/12/2023

Desc: Mind Blow Energy Drink Original Flavor
Notes: Product appears to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

66 V - - -- Patent Medicines, Etc
Date Published: 12/12/2023

Desc: Mind Blow Energy Drink Pink Lemonade
Notes: Product appears to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

Bryson Garden Remedies
Date Published : 09/30/2009
1695 Franklin St , Vancouver, BC CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: 3/21/2005

CANLAB RESEARCH
Date Published : 03/21/2020
18 Saint-Viateur St W , Montreal, Quebec CANADA
56 F - - 99 Peptide N.E.C.
Date Published: 03/21/2020

Desc: PT 141 Peptide
Notes: The product appears to be an unapproved new drug, drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1) because it is an article (other than food) intended to cure, mitigate, treat, or prevent disease in man and/or to affect the structure or function of the body. Examples of claims observed on the firm's social media website that establish the intended use of "PT-141" include, but may not be limited to, the following: On the CanLab Research Facebook social media account, on June 24, 2019, the firm posted a chromatogram report under the heading "PT-141: 98.24%." In the comments to the post, various commenters discuss how they use the product. A commenter named Joel Grotrian asked "May i (sic) ask what this means and what this peptide does?" and a commenter named Michael Shofield replied "[I]t will give you a hard-on for an entire day." Jean-Francois Tremblay, who is identified as the President of CanLab Research in the entry documents, replied to the conversation that "Often, 1 mg will do." When a commenter asked "Jean-Francois Tremblay is subQ the only way to administer or is there another option for my wife?," Jean-Francois Tremblay replied "intranasal works, but at much higher dose" and posts a link to a journal article about the use of PT-141 for erectile dysfunction. "PT-141" is also a new drug under section 201(p) of the FD&C Act, 21 U.S.C. 321(p) because this product is not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in its labeling. Under section 505(a) of the FD&C Act, a new drug may not be legally marketed in the United States without an FDA-approved application. FDA approves a new drug based on scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. There is no FDA-approved application in effect for "PT-141."

CANUSA Health Group
Date Published : 09/13/2019
865 Brawley Road West , Whitby, ON CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 09/13/2019

Desc: Abarelix
Notes:                          

64 R - - 21 Somatropin (Hormone)
Date Published: 10/07/2020

Notes:                          

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 10/07/2020

Notes:                          ;

CONSUMER HEALTH ORGANIZATION OF CANADA (DR. GEORGE MERKL)
Date Published : 09/13/2019
250 SHEPPARD AVE , WILLOWDALE, Ontario CANADA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: 9/11/2019

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 9/11/2019

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 9/11/2019

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 9/11/2019

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 9/11/2019

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 9/11/2019

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 9/11/2019

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 9/11/2019

CRESCITA SKIN SCIENCES INC.
Date Published : 07/08/2013
2805 Louis-R.-Renaud Pl , Laval, Quebec CANADA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/08/2013

Desc: InnovHyalHA Volumizing HydraSerum Optimal Hydration

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/11/2013

Desc: Pure Ultimate Youth Hand Care Cream SPF 30

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/11/2013

Desc: Pure Ultimate Youth Hand Care Cream SPF 30

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/08/2013

Desc: InnovHyalHA Volumizing HydraSerum Optimal Hydration

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 07/11/2013

Desc: Pure Ultimate Youth Hand Care Cream SPF 30

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/11/2013

Desc: Pure Ultimate Youth Hand Care Cream SPF 30

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2013

Desc: InnovHyalHA Volumizing HydraSerum Optimal Hydration

CRUE COSMETICS
Date Published : 04/26/2023
199 De Shannon St , Bromont, Quebec CANADA
53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 04/26/2023

Desc: Swirly Curly Advanced Hair Growth Elixir
Notes: The product appears to be an unapproved new drug within the meaning of Section 201(p) of the Act [21 U.S.C. § 321(p)], in that its label includes statements such as: “[E]xperience hair growth like never before” and “Advanced Hair Growth Elixir”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/26/2023

Desc: Swirly Curly Advanced Hair Growth Elixir
Notes: The product appears to be an unapproved new drug within the meaning of Section 201(p) of the Act [21 U.S.C. § 321(p)], in that its label includes statements such as: “[E]xperience hair growth like never before” and “Advanced Hair Growth Elixir”.

CV Technologies Inc.
Date Published : 05/10/2010
9411 20 Ave Nw , Edmonton, Alberta CANADA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/10/2010

Desc: Cold FX (not labeled as a dietary supplement)
Notes: Canada

Can America Drugs
Date Published : 09/30/2009
12 Carina Cove Mb , Winnipeg, MB CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 04/08/2020

Desc: Abarelix
Notes:                          

64 R - - 21 Somatropin (Hormone)
Date Published: 04/08/2020

Notes:                          

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                          

CanCap Pharmaceutical Ltd.
Date Published : 08/31/2011
180-13111 Vanier Pl , Richmond, British Columbia CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/31/2011

Desc: Ph.D M-2 (Male Formula) Dietary Supplement
Notes: OASIS Declared Manufacturer; Canada

CanPharm
Date Published : 09/30/2009
P.O. Box #88614 , Surrey, BC V3W 2P2, CANADA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                   

Canada Drug Delivery
Date Published : 09/30/2009
5765 Turner Rd Suite 233 , Nanaimo, BC CANADA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                      

Canada Med Express
Date Published : 09/30/2009
330 Mccowan Road, Suite 1508 , Scarborough , Ontario M1J 3N3, CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 09/30/2009

Notes: Abarelix;                        

64 R - - 21 Somatropin (Hormone)
Date Published: 09/09/2020

Notes:                        

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                        

Canada Prescriptions Plus
Date Published : 09/30/2009
11420-142 Street , Edmonton, AB CANADA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                                  

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Canada Rx Connection
Date Published : 09/30/2009
11 Ayr Blvd. , Winnipeg, MB CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 05/26/2020

Desc: Abarelix
Notes:                             

64 R - - 21 Somatropin (Hormone)
Date Published: 05/26/2020

Notes:                             

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                             

Canada Value Meds
Date Published : 09/30/2009
Junodis Solutions, 47 Regent Avenue , Hamilton , Ontario, CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 10/07/2020

Desc: Abarelix
Notes:                          

64 R - - 21 Somatropin (Hormone)
Date Published: 10/07/2020

Notes:                          

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                          

CanadaDrugsOnline.com
Date Published : 09/13/2019
1364 Cliveden Ave , Delta, BC CANADA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/13/2019

Desc: Isotretinoin
Notes: 2/9/2007

Canadiansdrugstore.com
Date Published : 09/30/2009
1609-200 Ronald Street , Winnipeg, MB CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 04/08/2020

Desc: Abarelix
Notes:                            

64 R - - 21 Somatropin (Hormone)
Date Published: 04/08/2020

Notes:                            

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/13/2019

Desc: Isotretinoin
Notes:                            

Canus Goats Milk Skin Care Prod
Date Published : 10/08/2014
5924 Henri-Bourassa Blvd W , Saint-Laurent, Quebec CANADA
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 10/16/2014

Desc: Canus Goat's Milk Soap With Lavender Oil
Notes:                                                                                                                                                                                              

53 U - - 10 Personal Cleanliness, Cosmetic products containing animal by-products (other animal by-products)
Date Published: 10/16/2014

Desc: Canus Goat's Milk Soap With Lavender Oil
Notes:                                                                                                                                                                                              

53 U - - 12 Skin Care Preparations, Cosmetic products containing animal by-products (other animal by-products)
Date Published: 10/08/2014

Desc: Caprina Goat's Milk Lip Balm
Notes:                                                                                                                                                                                                                

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/08/2014

Desc: Caprina Goat's Milk Lip Balm
Notes:                                                                                                                                                                                                                

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/16/2014

Desc: Canus Goat's Milk Soap With Lavender Oil
Notes:                                                                                                                                                                                              

Capsule Factory Nutraceuticals Ltd.
Date Published : 09/30/2021
969 Juliana Dr , Woodstock, Ontario CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2021

Desc: TUDCA LIVER PROTECTANT
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘It shows great potency in treating bile acid backup in the liver…’; ‘TUDCA can also protect and help rehabilitate the liver, and in general protects cells from free radical damage…’; ‘Research has validated TUDCA as a potent and effective treatment for repairing and supporting the liver from alcohol-induced damage, as well as from damage as a result of compounds that must do a double pass through the liver…’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2021

Desc: TUDCA LIVER PROTECTANT
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘It shows great potency in treating bile acid backup in the liver…’; ‘TUDCA can also protect and help rehabilitate the liver, and in general protects cells from free radical damage…’; ‘Research has validated TUDCA as a potent and effective treatment for repairing and supporting the liver from alcohol-induced damage, as well as from damage as a result of compounds that must do a double pass through the liver…’.

Carapex
Date Published : 09/26/2014
1420 Rue De Gentilly , Chambly, QC CANADA
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 09/26/2014

Desc: Hemp & Omega 3 Botanical Conditioner
Notes: Unapproved New Drug

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 09/26/2014

Desc: Carapex Moisturizing Aloe Conditioner
Notes: Unapproved New Drug

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 09/26/2014

Desc: Carapex Moisturizing Aloe Shampoo
Notes: Unapproved New Drug

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 09/26/2014

Desc: Hemp & Omega 3 Botanical Shampoo
Notes: Unapproved New Drug

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/26/2014

Desc: Carapex Moisturizing Aloe Shampoo
Notes: Unapproved New Drug

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/26/2014

Desc: Hemp & Omega 3 Botanical Shampoo
Notes: Unapproved New Drug

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/26/2014

Desc: Hemp & Omega 3 Botanical Conditioner
Notes: Unapproved New Drug

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/26/2014

Desc: Carapex Moisturizing Aloe Conditioner
Notes: Unapproved New Drug

Computerized Body Reading
Date Published : 09/08/2010
707 27 St N , Lethbridge, ALBERTA CANADA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/08/2010

Notes: Supplements/Homeopathic Remedies; Canada

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/08/2010

Notes: Supplements/Homeopathic Remedies; Canada

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/08/2010

Notes: Supplements/Homeopathic Remedies; Canada

61 - - - -- Human and Animal Drugs
Date Published: 09/08/2010

Notes: Supplements/Homeopathic Remedies; Canada

62 - - - -- Human and Animal Drugs
Date Published: 09/08/2010

Notes: Supplements/Homeopathic Remedies; Canada

63 - - - -- Human and Animal Drugs
Date Published: 09/08/2010

Notes: Supplements/Homeopathic Remedies; Canada

64 - - - -- Human and Animal Drugs
Date Published: 09/08/2010

Notes: Supplements/Homeopathic Remedies; Canada

65 - - - -- Human and Animal Drugs
Date Published: 09/08/2010

Notes: Supplements/Homeopathic Remedies; Canada

66 - - - -- Human and Animal Drugs
Date Published: 09/08/2010

Notes: Supplements/Homeopathic Remedies; Canada

Confab Laboratories Inc.
Date Published : 09/30/2009
4355 Sir-Wilfrid-Laurier Blvd , Saint-Hubert, Quebec CANADA
66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 11/17/2011

Desc: Calidou Sun Lotion
Notes: Canada; 6/8/00

Continenial Cosmetics
Date Published : 09/30/2009
390 , Ontario, ONTARIO CANADA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/27/2019

Desc: Alpecin Special Vitamin Hair Lotion
Notes: 9/30/2009

Contract Pharmaceuticals Limited Canada
Date Published : 05/23/2012
7600 East Danbro Cres , Mississauga, Ontario CANADA
61 H - - 45 Sodium Sulfacetamide (Anti-Bacterial, Part III)
Date Published: 05/23/2012

Desc: Clenia Foaming Wash 6oz
Notes: Canada

Creekside Health
Date Published : 08/27/2013
12233 Riverside Way , Richmond, BC CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/27/2013

Desc: OPC-10 Dietary supplement powder grape juice powder
Notes: Note; Structure/function claims found on package labeling and website

Creekside Health Products Inc
Date Published : 08/27/2013
1206 Galliano St , Coquitlam, BC CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/27/2013

Desc: OPC-10 Dietary supplement powder grape juice powder
Notes: Note; Structure/function claims found on package labeling and website

Cybermed Industries
Date Published : 09/30/2009
204-1010 View St. , Victoria, BC CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: 5/26/2005 Power Enlarge Patch is offered for sale on this firms internet site at www.enlargepatch.com. This product is promoted as a transdermal patch that infuses its ingrediants directly into the bloodstream, bypassing the digestive system. Based on its intended uses, Power Enlarge Patch is a drug. As labeled and formulated, this drug is not generally recognized as safe and effectived bt experts and is a new drug marketed without and approved new drug application. Furthermore, because this product is a transdermal drug, the method of administration or application suggested in the labeling causes it to be a new drug. See 21 CFR 310.2(h)(5) Per CDER the appropriate charge is 505 (a).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 5/26/2005

David Health International (c/o 2201371 Ontario Inc.)
Date Published : 09/01/2015
62 Alness Street Unit 6 , Toronto, ON CANADA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/01/2015

Desc: Various Maca Powder Supplements (including Inka Organic Peruvian Wild Maca Powder and Red and Black Maca)

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/01/2015

Desc: Nutridom Cranberry 25X

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/01/2015

Desc: Various Maca Powder Supplements (including Inka Organic Peruvian Wild Maca Powder and Red and Black Maca)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/01/2015

Desc: Nutridom Cranberry 25X

Defining Presence Marketing Group Inc.
Date Published : 09/30/2009
Universal Needs Sj Inc., Pob 370 , 1250 University Street , Montreal, Quebec, CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 08/20/2020

Desc: Abarelix
Notes:                

64 R - - 21 Somatropin (Hormone)
Date Published: 08/20/2020

Notes:                

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                  

Delta Pharma Inc.
Date Published : 03/11/2016
1655 Rte Transcanadienne , Dorval, Quebec CANADA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/11/2016

Desc: Jouviance Restructiv Collagen Boost-Needle Free Wrinkle Filler
Notes: Problem(s); Claims on product label and on firm's website

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/11/2016

Desc: Jouviance Restructiv Collagen Boost-Needle Free Wrinkle Filler
Notes: Problem(s); Claims on product label and on firm's website

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 03/11/2016

Desc: Jouviance Restructiv Collagen Boost-Needle Free Wrinkle Filler
Notes: Problem(s); Claims on product label and on firm's website

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 03/11/2016

Desc: Jouviance Restructiv Collagen Boost-Needle Free Wrinkle Filler
Notes: Problem(s); Claims on product label and on firm's website

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 03/11/2016

Desc: Jouviance Restructiv Collagen Boost-Needle Free Wrinkle Filler
Notes: Problem(s); Claims on product label and on firm's website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/11/2016

Desc: Jouviance Restructiv Collagen Boost-Needle Free Wrinkle Filler
Notes: Problem(s); Claims on product label and on firm's website

Dermolab Pharma Ltd.
Date Published : 11/13/2018
1421 Nobel St , Sainte-Julie, Quebec CANADA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 11/13/2018

Desc: Protect Ombracreme

65 L - - 99 Protectant N.E.C.
Date Published: 11/13/2018

Desc: Protect Ombracreme

66 P - - 18 Zinc Oxide (Ultraviolet Screen/Sunscreen)
Date Published: 11/13/2018

Desc: Protect Ombracreme

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 11/13/2018

Desc: Protect Ombracreme

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/13/2018

Desc: Protect Ombracreme

Direct Drugs
Date Published : 09/30/2009
1569 Orange Street , Winnipeg, MB CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 08/06/2020

Desc: Abarelix
Notes:                         

64 R - - 21 Somatropin (Hormone)
Date Published: 08/06/2020

Notes:                         

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                         

Discount Prescription Drugs Online
Date Published : 09/30/2009
Domain Discreet , P.O. Box 278 , Yarmouth, CANADA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                                             

Drugdelivery.ca/Canadian Drug Delivery Inc. (Andrina Owens)
Date Published : 09/30/2009
11215 Jasper Ave Suite 601 , Edmonton, AB CANADA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                      

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

E Com Consultant
Date Published : 09/30/2009
4 Cobbler St , Brampton, Ontario CANADA
54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 09/30/2009

Notes: psorcure oil; psorcure ointmint; psorcure capsules; psorclean tablets; psorcalm capsules; immunopsor drops 5/25/2006 www.clinicpsoriasis.com www.psorcure.com

Eastwood Bio-Medical Research Inc.
Date Published : 09/30/2009
1130-4871 Shell Rd , Richmond, British Columbia CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/13/2019

Desc: Eleotin
Notes: 12/1/2003

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: 12/1/2003

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/13/2019

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 P - - 99 Anti-Diabetic N.E.C.
Date Published: 09/30/2009

Notes: 12/1/2003

61 P - - 99 Anti-Diabetic N.E.C.
Date Published: 09/13/2019

Desc: Eleotin
Notes: 12/1/2003

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: Eleotin, (and all products from this firm making #1130-4871 Shell Road GPI = DR). The product labe indicates Eleotin is a supplement, but refers customers to the firms website at www.eastwoodcos.com which claims the product can be use to treat diabetes. The product can also be purchased from the firms website. The website claims Eleotin restores the bodys own ability to control blood glucose levels and results in long-term molecular level changes to assist the body to recover glucose normalcy. According to the firms website, Eastwood Bio-Medical Research Inc. is engaged in the development and commercialization of safe and effective treatment for non-insulin dependant diabetes mellitus and cancer.

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Easy Ac
Date Published : 08/09/2019
Rideau Street , Box 20111 , Ottawa, ON CANADA
31 - - - -- Coffee/Tea
Date Published: 08/09/2019

Desc: Essiac

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/09/2019

Desc: Essiac

66 - - - -- Human and Animal Drugs
Date Published: 08/09/2019

Desc: Essiac

Eau Zone Huiles & Fragrances Lee
Date Published : 10/16/2012
1625 Chabanel St W 825ite 960 , Bureau , Montreal, Quebec CANADA
53 D - - 99 Other Fragrance Preparations, N.E.C.
Date Published: 10/16/2012

Desc: Hold Me Tight Vaginal Tightening Gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/16/2012

Desc: Hold Me Tight Vaginal Tightening Gel

Eddys Herbs
Date Published : 08/09/2019
3 King Street , PO Box 938 , St Catharines, ON CANADA
31 - - - -- Coffee/Tea
Date Published: 08/09/2019

Desc: Burdock Blend Capsules

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/09/2019

Desc: Burdock Blend Capsules

66 - - - -- Human and Animal Drugs
Date Published: 08/09/2019

Desc: Burdock Blend Capsules

Enerex Botanicals Ltd
Date Published : 09/30/2009
8531 Eastlake Drive , Burnaby, BC CANADA
54 A - - 99 Vitamin, N.E.C.
Date Published: 03/15/2022

Desc: Serrapeptase (Serratia Peptidase Enzyme)
Notes: Note: product may be entering as a dietary supplement, therefore, we have included the product code "54[][]99" along with the appropriate drug code. The product's accompanying literature and indicates Serrapeptase(Serratia Peptidase Enzyme), among other claims, is " used to treat arterial blockage in coronary patients" and the product has anti-inflammatory and pain blocking benefits. The firm's website,                  makes similar claims. 8/23/2005

54 B - - 99 Mineral N.E.C.
Date Published: 03/15/2022

Desc: Serrapeptase (Serratia Peptidase Enzyme)
Notes: Note: product may be entering as a dietary supplement, therefore, we have included the product code "54[][]99" along with the appropriate drug code. The product's accompanying literature and indicates Serrapeptase(Serratia Peptidase Enzyme), among other claims, is " used to treat arterial blockage in coronary patients" and the product has anti-inflammatory and pain blocking benefits. The firm's website,                  makes similar claims. 8/23/2005

54 C - - 99 Protein N.E.C.
Date Published: 03/15/2022

Desc: Serrapeptase (Serratia Peptidase Enzyme)
Notes: Note: product may be entering as a dietary supplement, therefore, we have included the product code "54[][]99" along with the appropriate drug code. The product's accompanying literature and indicates Serrapeptase(Serratia Peptidase Enzyme), among other claims, is " used to treat arterial blockage in coronary patients" and the product has anti-inflammatory and pain blocking benefits. The firm's website,                  makes similar claims. 8/23/2005

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 03/15/2022

Desc: Serrapeptase (Serratia Peptidase Enzyme)
Notes: Note: product may be entering as a dietary supplement, therefore, we have included the product code "54[][]99" along with the appropriate drug code. The product's accompanying literature and indicates Serrapeptase(Serratia Peptidase Enzyme), among other claims, is " used to treat arterial blockage in coronary patients" and the product has anti-inflammatory and pain blocking benefits. The firm's website,                  makes similar claims. 8/23/2005

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/15/2022

Desc: Serrapeptase (Serratia Peptidase Enzyme)
Notes: Note: product may be entering as a dietary supplement, therefore, we have included the product code "54[][]99" along with the appropriate drug code. The product's accompanying literature and indicates Serrapeptase(Serratia Peptidase Enzyme), among other claims, is " used to treat arterial blockage in coronary patients" and the product has anti-inflammatory and pain blocking benefits. The firm's website,                  makes similar claims. 8/23/2005

54 G - - 99 Animal By-Products and Extracts, N.E.C.
Date Published: 03/15/2022

Desc: Serrapeptase (Serratia Peptidase Enzyme)
Notes: Note: product may be entering as a dietary supplement, therefore, we have included the product code "54[][]99" along with the appropriate drug code. The product's accompanying literature and indicates Serrapeptase(Serratia Peptidase Enzyme), among other claims, is " used to treat arterial blockage in coronary patients" and the product has anti-inflammatory and pain blocking benefits. The firm's website,                  makes similar claims. 8/23/2005

54 H - - 99 Fats and Lipid Substances, N.E.C.
Date Published: 03/15/2022

Desc: Serrapeptase (Serratia Peptidase Enzyme)
Notes: Note: product may be entering as a dietary supplement, therefore, we have included the product code "54[][]99" along with the appropriate drug code. The product's accompanying literature and indicates Serrapeptase(Serratia Peptidase Enzyme), among other claims, is " used to treat arterial blockage in coronary patients" and the product has anti-inflammatory and pain blocking benefits. The firm's website,                  makes similar claims. 8/23/2005

54 I - - 99 Fiber, N.E.C.
Date Published: 03/15/2022

Desc: Serrapeptase (Serratia Peptidase Enzyme)
Notes: Note: product may be entering as a dietary supplement, therefore, we have included the product code "54[][]99" along with the appropriate drug code. The product's accompanying literature and indicates Serrapeptase(Serratia Peptidase Enzyme), among other claims, is " used to treat arterial blockage in coronary patients" and the product has anti-inflammatory and pain blocking benefits. The firm's website,                  makes similar claims. 8/23/2005

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/15/2022

Desc: Serrapeptase (Serratia Peptidase Enzyme)
Notes: Note: product may be entering as a dietary supplement, therefore, we have included the product code "54[][]99" along with the appropriate drug code. The product's accompanying literature and indicates Serrapeptase(Serratia Peptidase Enzyme), among other claims, is " used to treat arterial blockage in coronary patients" and the product has anti-inflammatory and pain blocking benefits. The firm's website,                  makes similar claims. 8/23/2005

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/15/2022

Desc: Serrapeptase (Serratia Peptidase Enzyme)
Notes: Note: product may be entering as a dietary supplement, therefore, we have included the product code "54[][]99" along with the appropriate drug code. The product's accompanying literature and indicates Serrapeptase(Serratia Peptidase Enzyme), among other claims, is " used to treat arterial blockage in coronary patients" and the product has anti-inflammatory and pain blocking benefits. The firm's website,                  makes similar claims. 8/23/2005

Enerex Botanicals Ltd
Date Published : 10/03/2011
6741 Cariboo Roadunit 305 Building D , Burnabyburnaby, BRITISH COLUMBIA CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/03/2011

Desc: Bamboo Silica
Notes: Canada

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/03/2011

Desc: Bamboo Silica
Notes: canada

English Bay Blending
Date Published : 02/29/2024
1066 Cliveden Ave , Delta, British Columbia CANADA
34 G - - 01 Chocolate Candy Bar, with Nuts and Fruit
Date Published: 02/29/2024

Desc: GEM Calm Essentials; Banana Cinnamon Bites
Notes: The product appears to be a new drug within the meaning of section 201 (p) of the FD&C Act, without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. Labeling on manufacturer’s website, for the products sold under this brand, makes claims for ingredients used in the product, but are not limited to the following: “Coconut”: “May help people struggling with obesity lose body fat”, “Linked to numerous health benefits, including…lower blood sugar levels” and “Lower levels of low-density lipoprotein (LDL) "bad" cholesterol in the body, which can lower the overall risk of heart disease… Higher levels of HDL cholesterol correlate to a lower risk of heart disease because HDL cholesterol is responsible for removing extra LDL cholesterol from the blood and plaque buildup from the blood vessels… Lower total cholesterol levels and reduced plaque buildup lower the overall risk of heart disease, heart attack, and stroke”. “Dates”: “Helps prevent constipation”, “Helps control blood sugar levels…and preventing a spike in blood sugar levels” and “Help reduce inflammation… Phenolic acid, which acts as an anti-inflammatory and may reduce the risk of cancer and heart disease”. The product appears to be a new drug within the meaning of by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for the intended uses.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 02/29/2024

Desc: GEM Calm Essentials; Banana Cinnamon Bites
Notes: The product appears to be a new drug within the meaning of section 201 (p) of the FD&C Act, without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. Labeling on manufacturer’s website, for the products sold under this brand, makes claims for ingredients used in the product, but are not limited to the following: “Coconut”: “May help people struggling with obesity lose body fat”, “Linked to numerous health benefits, including…lower blood sugar levels” and “Lower levels of low-density lipoprotein (LDL) "bad" cholesterol in the body, which can lower the overall risk of heart disease… Higher levels of HDL cholesterol correlate to a lower risk of heart disease because HDL cholesterol is responsible for removing extra LDL cholesterol from the blood and plaque buildup from the blood vessels… Lower total cholesterol levels and reduced plaque buildup lower the overall risk of heart disease, heart attack, and stroke”. “Dates”: “Helps prevent constipation”, “Helps control blood sugar levels…and preventing a spike in blood sugar levels” and “Help reduce inflammation… Phenolic acid, which acts as an anti-inflammatory and may reduce the risk of cancer and heart disease”. The product appears to be a new drug within the meaning of by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for the intended uses.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/29/2024

Desc: GEM Calm Essentials; Banana Cinnamon Bites
Notes: The product appears to be a new drug within the meaning of section 201 (p) of the FD&C Act, without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. Labeling on manufacturer’s website, for the products sold under this brand, makes claims for ingredients used in the product, but are not limited to the following: “Coconut”: “May help people struggling with obesity lose body fat”, “Linked to numerous health benefits, including…lower blood sugar levels” and “Lower levels of low-density lipoprotein (LDL) "bad" cholesterol in the body, which can lower the overall risk of heart disease… Higher levels of HDL cholesterol correlate to a lower risk of heart disease because HDL cholesterol is responsible for removing extra LDL cholesterol from the blood and plaque buildup from the blood vessels… Lower total cholesterol levels and reduced plaque buildup lower the overall risk of heart disease, heart attack, and stroke”. “Dates”: “Helps prevent constipation”, “Helps control blood sugar levels…and preventing a spike in blood sugar levels” and “Help reduce inflammation… Phenolic acid, which acts as an anti-inflammatory and may reduce the risk of cancer and heart disease”. The product appears to be a new drug within the meaning of by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for the intended uses.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/29/2024

Desc: GEM Calm Essentials; Banana Cinnamon Bites
Notes: The product appears to be a new drug within the meaning of section 201 (p) of the FD&C Act, without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. Labeling on manufacturer’s website, for the products sold under this brand, makes claims for ingredients used in the product, but are not limited to the following: “Coconut”: “May help people struggling with obesity lose body fat”, “Linked to numerous health benefits, including…lower blood sugar levels” and “Lower levels of low-density lipoprotein (LDL) "bad" cholesterol in the body, which can lower the overall risk of heart disease… Higher levels of HDL cholesterol correlate to a lower risk of heart disease because HDL cholesterol is responsible for removing extra LDL cholesterol from the blood and plaque buildup from the blood vessels… Lower total cholesterol levels and reduced plaque buildup lower the overall risk of heart disease, heart attack, and stroke”. “Dates”: “Helps prevent constipation”, “Helps control blood sugar levels…and preventing a spike in blood sugar levels” and “Help reduce inflammation… Phenolic acid, which acts as an anti-inflammatory and may reduce the risk of cancer and heart disease”. The product appears to be a new drug within the meaning of by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for the intended uses.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/29/2024

Desc: GEM Calm Essentials; Banana Cinnamon Bites
Notes: The product appears to be a new drug within the meaning of section 201 (p) of the FD&C Act, without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. Labeling on manufacturer’s website, for the products sold under this brand, makes claims for ingredients used in the product, but are not limited to the following: “Coconut”: “May help people struggling with obesity lose body fat”, “Linked to numerous health benefits, including…lower blood sugar levels” and “Lower levels of low-density lipoprotein (LDL) "bad" cholesterol in the body, which can lower the overall risk of heart disease… Higher levels of HDL cholesterol correlate to a lower risk of heart disease because HDL cholesterol is responsible for removing extra LDL cholesterol from the blood and plaque buildup from the blood vessels… Lower total cholesterol levels and reduced plaque buildup lower the overall risk of heart disease, heart attack, and stroke”. “Dates”: “Helps prevent constipation”, “Helps control blood sugar levels…and preventing a spike in blood sugar levels” and “Help reduce inflammation… Phenolic acid, which acts as an anti-inflammatory and may reduce the risk of cancer and heart disease”. The product appears to be a new drug within the meaning of by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for the intended uses.

Enrich International
Date Published : 08/09/2019
Unknown , Summerland, BC CANADA
31 - - - -- Coffee/Tea
Date Published: 08/09/2019

Desc: Native Legend Tea

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/09/2019

Desc: Native Legend Tea

66 - - - -- Human and Animal Drugs
Date Published: 08/09/2019

Desc: Native Legend Tea

Essiac Corporation
Date Published : 08/09/2019
2211-1081 Ambleside Drive , Ottawa, ON CANADA
31 - - - -- Coffee/Tea
Date Published: 08/09/2019

Desc: Essiac

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/09/2019

Desc: Essiac

66 - - - -- Human and Animal Drugs
Date Published: 08/09/2019

Desc: Essiac

Essiac Products Inc
Date Published : 08/09/2019
4 Howard Avenue , Campbellton, NB CANADA
31 - - - -- Coffee/Tea
Date Published: 08/09/2019

Desc: Essiac

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/09/2019

Desc: Essiac

66 - - - -- Human and Animal Drugs
Date Published: 08/09/2019

Desc: Essiac

Euro-Pharm International Canada
Date Published : 09/27/2012
9400 Langelier Blvd , Saint-leonard, QC CANADA
66 F - - 05 Colchicine (Suppressant)
Date Published: 09/27/2012

Desc: Colchicine

Ever Bamboo Inc
Date Published : 12/14/2012
919 Centre St Nw , #261 , Calgary, Alberta CANADA
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/14/2012

Desc: Bamboo Charcoal face and Body Soap Bar
Notes: Note; Make claims that product has anti-inflammatory and anti-bacterial properties etc

Everest Foods
Date Published : 08/09/2019
Unit 407, 10 Caxton Close , Halifax, NS CANADA
31 - - - -- Coffee/Tea
Date Published: 08/09/2019

Desc: Essiac Powder

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/09/2019

Desc: Essiac Powder

66 - - - -- Human and Animal Drugs
Date Published: 08/09/2019

Desc: Essiac Powder

Factors Group of Nutritional Companies Inc.
Date Published : 12/03/2013
1550 United Blvd , Coquitlam, British Columbia CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/03/2013

Desc: Ultimate Male Energy

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/03/2013

Desc: Ultimate Her Energy

Flor Nutraceuticals Canada
Date Published : 11/24/2015
305-1550 Eastern Ave , North Vancouver, British Columbia CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/24/2015

Desc: Herpaflor Daily Formula
Notes: Labeling on product and on product website makes drug claims

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/24/2015

Desc: Herpaflor Topical Formula (Liquid)
Notes: Labeling on product and on product website makes drug claims

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/24/2015

Desc: Herpaflor Dietary Supplement Tablets
Notes: Labeling on product and on product website makes drug claims

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/24/2015

Desc: Herpaflor Outbreak Response
Notes: Labeling on product and on product website makes drug claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/24/2015

Desc: Herpaflor Topical Formula (Liquid)
Notes: Labeling on product and on product website makes drug claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/24/2015

Desc: Herpaflor Outbreak Response
Notes: Labeling on product and on product website makes drug claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/24/2015

Desc: Herpaflor Dietary Supplement Tablets
Notes: Labeling on product and on product website makes drug claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/24/2015

Desc: Herpaflor Daily Formula
Notes: Labeling on product and on product website makes drug claims

Formulex Canada Inc.
Date Published : 09/30/2009
5950 Ch De La Cote-de-liesse , Mont-royal, Quebec CANADA
54 A - - 99 Vitamin, N.E.C.
Date Published: 09/30/2009

Notes: 5/19/2000; Preventac Tablets, PremeTab, SomaTac, UriTab Caplets

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: 5/19/2000; Preventac Tablets, PremeTab, SomaTac, UriTab Caplets

60 L A A 05 Aspirin (Analgesic), Human - Non/Rx Single Ingredient, Prompt Release Tablets
Date Published: 09/18/2019

Notes: 5/19/2000; Preventac Tablets, PremeTab, SomaTac, UriTab Caplets

60 L B A 05 Aspirin (Analgesic), Human - Non/Rx Combination Ingredient, Prompt Release Tablets
Date Published: 09/18/2019

Notes: 5/19/2000; Preventac Tablets, PremeTab, SomaTac, UriTab Caplets

Fraser Valley Online
Date Published : 09/30/2009
Po Box 435 , Abbotsford , British Columbia V25 5Z5, CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 08/20/2020

Desc: Abarelix
Notes:                    

64 R - - 21 Somatropin (Hormone)
Date Published: 08/20/2020

Notes:                    

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                      

Germiphene Corporation
Date Published : 09/15/2022
1379 Colborne St E , Ss 13 , Brantford, Ontario CANADA
62 F - - 08 Chlorhexidine HCl (Anti-Infective, Topical)
Date Published: 09/15/2022

Notes: Original DWPE date: 6/10/2004

Gero Vita International
Date Published : 09/30/2009
2255 B Queen Street East Suite 820 , Toronto, ON CANADA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All drugs. 4/6/1995. Updated 8/18/1997

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Gero Vita Laboratories
Date Published : 09/30/2009
130A Denison Street , Markham, ON CANADA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: Gero Vita Laboratories is currently listed on the attachment to import alert 66-41 for their promotion and distribution of Prostata. Evidence has been provided to FDA which indicates the firm is also promotng and distributing to individuals in the US numerous other drug products (including but sexual vitatlity) SOD complex (fights disease and free radicals) Medi-Zyme N (anti inflammatory). Serezac (helps alleviate depression), Lung Support Formula (moistens lungs and breaks up sputum, strengthens kidneys), Vita Potencia (protects heart health, helps control stress) ACF 223 (reduces risk of heart disease, cancer, ect) which would be considered unapproved new drugs.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Go Print Inc
Date Published : 08/09/2019
3 King Street , PO Box 938 , St Catharines, ON CANADA
31 - - - -- Coffee/Tea
Date Published: 08/09/2019

Desc: Burdock Blend Capsules

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/09/2019

Desc: Burdock Blend Capsules

66 - - - -- Human and Animal Drugs
Date Published: 08/09/2019

Desc: Burdock Blend Capsules

Gold Shield Corporation
Date Published : 09/30/2009
23-845 Dakota Street-300 , Winnipeg, MB CANADA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                         

Good Samritan Rx
Date Published : 09/30/2009
Dr Morgan Campbell Inc. , 124 3185 King George Hwy , Surrey, British Columbia CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 07/20/2020

Desc: Abarelix
Notes:                          

64 R - - 21 Somatropin (Hormone)
Date Published: 07/20/2020

Notes:                          

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                          

Group R R International
Date Published : 09/30/2009
2306 Sherbrooke East, Suit 1 , Montreal, QC CANADA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/27/2019

Desc: Hair Regrowth Liniment (AKA Formula 101)
Notes:                                                                                                                                                                                                            

Groupe Parima Inc.
Date Published : 02/15/2011
4450 Cousens St , Saint-Laurent, Quebec CANADA
60 Q - - 07 Lidocaine
Date Published: 02/15/2011

Desc: AnaMantle HC Forte
Notes: Canada

60 Q - - 40 Lidocaine HCl (Anesthetic)
Date Published: 02/15/2011

Desc: AnaMantle HC Forte
Notes: Canada

61 H - - 45 Sodium Sulfacetamide (Anti-Bacterial, Part III)
Date Published: 09/16/2019

Desc: Prascion Cleanser
Notes: 10/31/2012

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 02/15/2011

Desc: AnaMantle HC Forte
Notes: Canada

Happy Molecules
Date Published : 04/26/2012
195 Wakina Drive , Edmontonedmonton, AB CANADA
53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations)
Date Published: 04/26/2012

Desc: Bath Salts

53 B - - 99 Other Bath Preparations, N.E.C.
Date Published: 04/26/2012

Desc: Bath Salts

Hazelaid
Date Published : 08/07/2012
2689 Rue De Chateauguay , Montrealmontreal, QUEBEC CANADA
76 M - - EF Ring, Teething, Non-Fluid Filled
Date Published: 08/07/2012

Desc: Teeting Ring
Notes: Canada

Health 2000 Pharmacy
Date Published : 09/30/2009
105-6905 Nicholson Rd. , Delta, British Columbia CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 04/08/2020

Desc: Abarelix
Notes:                              

64 R - - 21 Somatropin (Hormone)
Date Published: 04/08/2020

Notes:                              

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                              

Heibert Net Inc
Date Published : 09/30/2009
Al Wong , 8181, 120 A Street, Suite #2 , Surrey BC, CANADA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                   

Herbal Care Direct Inc
Date Published : 09/30/2009
2319 Fairview St Unit 608 , Burlington, Ontario CANADA
54 B - - 99 Mineral N.E.C.
Date Published: 09/30/2009

Notes: 8/11/2006; Product may be entering as a dietary supplement; therefore; we have included the product code 54-99 along with the drug code. The product labeling for the product does not make any drug claims however; the firms website that provides drug related information on the products                        and their ordering website that also provides drug related information                            makes claims as curing kidney infections.

54 C - - 99 Protein N.E.C.
Date Published: 08/29/2019

Notes: 8/11/2006; Product may be entering as a dietary supplement; therefore; we have included the product code 54-99 along with the drug code. The product labeling for the product does not make any drug claims however; the firms website that provides drug related information on the products                        and their ordering website that also provides drug related information                            makes claims as curing kidney infections.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 09/30/2009

Notes: 8/11/2006; Product may be entering as a dietary supplement; therefore; we have included the product code 54-99 along with the drug code. The product labeling for the product does not make any drug claims however; the firms website that provides drug related information on the products                        and their ordering website that also provides drug related information                            makes claims as curing kidney infections.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/29/2019

Notes: 8/11/2006; Product may be entering as a dietary supplement; therefore; we have included the product code 54-99 along with the drug code. The product labeling for the product does not make any drug claims however; the firms website that provides drug related information on the products                        and their ordering website that also provides drug related information                            makes claims as curing kidney infections.

54 I - - 99 Fiber, N.E.C.
Date Published: 09/30/2009

Notes: 8/11/2006; Product may be entering as a dietary supplement; therefore; we have included the product code 54-99 along with the drug code. The product labeling for the product does not make any drug claims however; the firms website that provides drug related information on the products                        and their ordering website that also provides drug related information                            makes claims as curing kidney infections.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2009

Notes: 8/11/2006; Product may be entering as a dietary supplement; therefore; we have included the product code 54-99 along with the drug code. The product labeling for the product does not make any drug claims however; the firms website that provides drug related information on the products                        and their ordering website that also provides drug related information                            makes claims as curing kidney infections.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 8/11/2006; Product may be entering as a dietary supplement; therefore; we have included the product code 54-99 along with the drug code. The product labeling for the product does not make any drug claims however; the firms website that provides drug related information on the products                        and their ordering website that also provides drug related information                            makes claims as curing kidney infections.

Herbal Life And Essence Co.
Date Published : 09/30/2009
2416 Main St Unit: , Vancouver, BC CANADA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/29/2019

Notes: All products. GPI = DR. IND - 54. 11/25/2005. This firm is connected to the website                      that is promoting various products for use as a street drug alternative. The agency considers any product that is promoted as a street drug alternative to be an unapproved new drug and a misbranded drug in violation of secions 505 and 502 of the FFDCA.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All products. GPI = DR. IND - 54. 11/25/2005. This firm is connected to the website                      that is promoting various products for use as a street drug alternative. The agency considers any product that is promoted as a street drug alternative to be an unapproved new drug and a misbranded drug in violation of secions 505 and 502 of the FFDCA.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products. GPI = DR. IND - 54. 11/25/2005. This firm is connected to the website                      that is promoting various products for use as a street drug alternative. The agency considers any product that is promoted as a street drug alternative to be an unapproved new drug and a misbranded drug in violation of secions 505 and 502 of the FFDCA.

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products. GPI = DR. IND - 54. 11/25/2005. This firm is connected to the website                      that is promoting various products for use as a street drug alternative. The agency considers any product that is promoted as a street drug alternative to be an unapproved new drug and a misbranded drug in violation of secions 505 and 502 of the FFDCA.

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products. GPI = DR. IND - 54. 11/25/2005. This firm is connected to the website                      that is promoting various products for use as a street drug alternative. The agency considers any product that is promoted as a street drug alternative to be an unapproved new drug and a misbranded drug in violation of secions 505 and 502 of the FFDCA.

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products. GPI = DR. IND - 54. 11/25/2005. This firm is connected to the website                      that is promoting various products for use as a street drug alternative. The agency considers any product that is promoted as a street drug alternative to be an unapproved new drug and a misbranded drug in violation of secions 505 and 502 of the FFDCA.

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products. GPI = DR. IND - 54. 11/25/2005. This firm is connected to the website                      that is promoting various products for use as a street drug alternative. The agency considers any product that is promoted as a street drug alternative to be an unapproved new drug and a misbranded drug in violation of secions 505 and 502 of the FFDCA.

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products. GPI = DR. IND - 54. 11/25/2005. This firm is connected to the website                      that is promoting various products for use as a street drug alternative. The agency considers any product that is promoted as a street drug alternative to be an unapproved new drug and a misbranded drug in violation of secions 505 and 502 of the FFDCA.

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products. GPI = DR. IND - 54. 11/25/2005. This firm is connected to the website                      that is promoting various products for use as a street drug alternative. The agency considers any product that is promoted as a street drug alternative to be an unapproved new drug and a misbranded drug in violation of secions 505 and 502 of the FFDCA.

Herdt & Charton 1971 Inc
Date Published : 09/30/2009
9393 Louis H. Lafontaine , Anjou, QC CANADA
61 M B J 11 Magnesium Sulfate (Anti-Convulsant), Human - Non/Rx Combination Ingredient, NonSterile Ointment
Date Published: 09/04/2019

Desc: OSMOPAK PLUS
Notes: 3/26/1998

Homeolab USA Inc.
Date Published : 09/30/2009
3025 De L'Assomption Blvd , Montreal, Quebec CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Desc: Homeopathic Human Growth Hormone Pellets
Notes: 8/3/09

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 M - - 04 Chorionic Gonadotropin (Gonad-Stimulating Principle)
Date Published: 01/22/2010

Desc: Homeopathic Weigh Loss Formula

64 R - - 18 Human Growth Hormone (Hormone)
Date Published: 09/30/2009

Desc: Homeopathic Human Growth Hormone Pellets
Notes: 8/3/09

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/22/2010

Desc: Homeopathic Weigh Loss Formula

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Hometown Meds
Date Published : 09/30/2009
43 Roslyn Road , Winnipeg, MB CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 06/24/2020

Desc: Abarelix
Notes:                      

64 R - - 21 Somatropin (Hormone)
Date Published: 06/24/2020

Notes:                      

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                       

Icanrx.com
Date Published : 09/30/2009
Contact Media Group , 12840 16th Avenue #203 , White Rock, British Columbia CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 07/20/2020

Desc: Abarelix
Notes:                 

64 R - - 21 Somatropin (Hormone)
Date Published: 07/20/2020

Notes:                 

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                 

Imported Drugs
Date Published : 09/30/2009
Canam Shopping Services, Ltd. , Suite#234 15-180 Central Road , Duncan, BC CANADA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                        

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Innercleanse 2000 Inc
Date Published : 09/30/2009
2319 Fairview St Unit 608 , Burlington, Ontario CANADA
54 B - - 99 Mineral N.E.C.
Date Published: 09/30/2009

Notes: Product may be entering as a dietary supplement; therefore; we have included the product code 54-99 along with the drug code. The product labeling for the product does not make any drug claims however; the firms website that provides drug related information on the products                        and their ordering website that also provides drug related information                            makes claims as curing kidney infections.

54 C - - 99 Protein N.E.C.
Date Published: 09/30/2009

Notes: Product may be entering as a dietary supplement; therefore; we have included the product code 54-99 along with the drug code. The product labeling for the product does not make any drug claims however; the firms website that provides drug related information on the products                        and their ordering website that also provides drug related information                            makes claims as curing kidney infections.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 09/30/2009

Notes: Product may be entering as a dietary supplement; therefore; we have included the product code 54-99 along with the drug code. The product labeling for the product does not make any drug claims however; the firms website that provides drug related information on the products                        and their ordering website that also provides drug related information                            makes claims as curing kidney infections.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: Product may be entering as a dietary supplement; therefore; we have included the product code 54-99 along with the drug code. The product labeling for the product does not make any drug claims however; the firms website that provides drug related information on the products                        and their ordering website that also provides drug related information                            makes claims as curing kidney infections.

54 I - - 99 Fiber, N.E.C.
Date Published: 09/30/2009

Notes: Product may be entering as a dietary supplement; therefore; we have included the product code 54-99 along with the drug code. The product labeling for the product does not make any drug claims however; the firms website that provides drug related information on the products                        and their ordering website that also provides drug related information                            makes claims as curing kidney infections.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2009

Notes: Product may be entering as a dietary supplement; therefore; we have included the product code 54-99 along with the drug code. The product labeling for the product does not make any drug claims however; the firms website that provides drug related information on the products                        and their ordering website that also provides drug related information                             makes claims as curing kidney infections.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: Product may be entering as a dietary supplement; therefore; we have included the product code 54-99 along with the drug code. The product labeling for the product does not make any drug claims however; the firms website that provides drug related information on the products                        and their ordering website that also provides drug related information                             makes claims as curing kidney infections.

Inventures Technologies Inc.
Date Published : 11/18/2013
670 Wilsey Rd , Fredericton, Nb CANADA
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 11/18/2013

Desc: Anti-Aging Oxygen Booster Serum

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 11/18/2013

Desc: Antioxidant Pomegranate Night Serum

53 L - - 07 Night (Skin Care Preparations)
Date Published: 11/18/2013

Desc: Antioxidant Pomegranate Night Serum

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/18/2013

Desc: Anti-Aging Oxygen Booster Serum

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/18/2013

Desc: Antioxidant Pomegranate Night Serum

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/18/2013

Desc: Anti-Aging Oxygen Booster Serum

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/18/2013

Desc: Antioxidant Pomegranate Night Serum

JP CANTRADE INC
Date Published : 02/22/2017
10-20 Staffern Dr , Concord, Ontario CANADA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 02/22/2017

Desc: ERA ORGANICS POWERFUL DEEP WRINKLE FILLER
Notes: Product does not meet OTC monograph for skin bleaching products Medical claims made on product label and website

65 Q - - 02 Botox
Date Published: 02/22/2017

Desc: ERA ORGANICS POWERFUL DEEP WRINKLE FILLER
Notes: Product does not meet OTC monograph for skin bleaching products Medical claims made on product label and website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/22/2017

Desc: ERA ORGANICS POWERFUL DEEP WRINKLE FILLER
Notes: Product does not meet OTC monograph for skin bleaching products Medical claims made on product label and website

Jamieson Laboratories
Date Published : 03/26/2015
2 St Clair Ave W 16 Th Floor , Toronto, Ontario CANADA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/26/2015

Notes: Jamieson Calcium Magnesium Caplets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/26/2015

Desc: Jamieson Calcium Magnesium Caplets

Kue
Date Published : 09/08/2010
31 Melchior Cres , Markham, Ontario CANADA
62 H - - 99 Anti-Microbial N.E.C.
Date Published: 09/08/2010

Desc: HINI Flu Virus Hand Sanitizing Gel
Notes: Canada

Kue Personal Care Products
Date Published : 09/08/2010
Po Box 490 , Aurora, ONTARIO CANADA
62 H - - 99 Anti-Microbial N.E.C.
Date Published: 09/08/2010

Desc: HINI Flu Virus Hand Sanitizing Gel
Notes: Canada

Labomar Canada Inc
Date Published : 04/12/2013
50 Hymus Blvd , Pointe-Claire, Quebec CANADA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/27/2022

Desc: Vivier Corrector 2
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘SKIN BLEACHING AND CORRECTING CREAM WITH HYDROQUINONE USP 2% . . . DRUG FACTS . . . MEDICINAL INGREDIENT . . . 2% Hydroquinone USP. . . PURPOSE . . . Skin Bleaching and Correcting . . . USE . . . To gradually lighten hyperpigmentation of the skin such as age spots, liver spots, freckles, or hyperpigmentation….’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/27/2022

Desc: Vivier Advanced Skin Lightening Serum
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘ADVANCED SKIN LIGHTENING SERUM HYDROQUINONE USP 2%GEL . . . Drug Facts . . . Active Ingredient . . . Hydroquinone USP 2% . . . Skin bleaching . . . Use . . . To gradually lighten hyperpigmentation of the skin such as age spots, liver spots, freckles or hyperpigmentation….’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 04/27/2022

Desc: Vivier Corrector 2
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘SKIN BLEACHING AND CORRECTING CREAM WITH HYDROQUINONE USP 2% . . . DRUG FACTS . . . MEDICINAL INGREDIENT . . . 2% Hydroquinone USP. . . PURPOSE . . . Skin Bleaching and Correcting . . . USE . . . To gradually lighten hyperpigmentation of the skin such as age spots, liver spots, freckles, or hyperpigmentation….’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 04/27/2022

Desc: Vivier Advanced Skin Lightening Serum
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘ADVANCED SKIN LIGHTENING SERUM HYDROQUINONE USP 2%GEL . . . Drug Facts . . . Active Ingredient . . . Hydroquinone USP 2% . . . Skin bleaching . . . Use . . . To gradually lighten hyperpigmentation of the skin such as age spots, liver spots, freckles or hyperpigmentation….’.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/27/2022

Desc: Vivier Corrector 2
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘SKIN BLEACHING AND CORRECTING CREAM WITH HYDROQUINONE USP 2% . . . DRUG FACTS . . . MEDICINAL INGREDIENT . . . 2% Hydroquinone USP. . . PURPOSE . . . Skin Bleaching and Correcting . . . USE . . . To gradually lighten hyperpigmentation of the skin such as age spots, liver spots, freckles, or hyperpigmentation….’.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/27/2022

Desc: Vivier Advanced Skin Lightening Serum
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘ADVANCED SKIN LIGHTENING SERUM HYDROQUINONE USP 2%GEL . . . Drug Facts . . . Active Ingredient . . . Hydroquinone USP 2% . . . Skin bleaching . . . Use . . . To gradually lighten hyperpigmentation of the skin such as age spots, liver spots, freckles or hyperpigmentation….’.

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 04/27/2022

Desc: Vivier Corrector 2
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘SKIN BLEACHING AND CORRECTING CREAM WITH HYDROQUINONE USP 2% . . . DRUG FACTS . . . MEDICINAL INGREDIENT . . . 2% Hydroquinone USP. . . PURPOSE . . . Skin Bleaching and Correcting . . . USE . . . To gradually lighten hyperpigmentation of the skin such as age spots, liver spots, freckles, or hyperpigmentation….’.

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 04/27/2022

Desc: Vivier Advanced Skin Lightening Serum
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘ADVANCED SKIN LIGHTENING SERUM HYDROQUINONE USP 2%GEL . . . Drug Facts . . . Active Ingredient . . . Hydroquinone USP 2% . . . Skin bleaching . . . Use . . . To gradually lighten hyperpigmentation of the skin such as age spots, liver spots, freckles or hyperpigmentation….’.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 07/16/2013

Desc: Clarite 4 Skin Bleaching Cream

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 07/16/2013

Desc: Seequin 4 IDS Liquid Serum

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 07/16/2013

Desc: Sunbalance Skin Lightening Cream SPF 15

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 09/17/2021

Desc: DIFFERIN DARK SPOT CORRECTING SERUM

63 V - - 99 Depigmentor N.E.C.
Date Published: 07/16/2013

Desc: Seequin 4 IDS Liquid Serum

63 V - - 99 Depigmentor N.E.C.
Date Published: 07/16/2013

Desc: Sunbalance Skin Lightening Cream SPF 15

63 V - - 99 Depigmentor N.E.C.
Date Published: 07/16/2013

Desc: Clarite 4 Skin Bleaching Cream

63 V - - -- Depigmentor
Date Published: 04/27/2022

Desc: Vivier Advanced Skin Lightening Serum
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘ADVANCED SKIN LIGHTENING SERUM HYDROQUINONE USP 2%GEL . . . Drug Facts . . . Active Ingredient . . . Hydroquinone USP 2% . . . Skin bleaching . . . Use . . . To gradually lighten hyperpigmentation of the skin such as age spots, liver spots, freckles or hyperpigmentation….’.

63 V - - -- Depigmentor
Date Published: 04/27/2022

Desc: Vivier Corrector 2
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘SKIN BLEACHING AND CORRECTING CREAM WITH HYDROQUINONE USP 2% . . . DRUG FACTS . . . MEDICINAL INGREDIENT . . . 2% Hydroquinone USP. . . PURPOSE . . . Skin Bleaching and Correcting . . . USE . . . To gradually lighten hyperpigmentation of the skin such as age spots, liver spots, freckles, or hyperpigmentation….’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/12/2013

Desc: Pretz Spray Moisturizing Nasal with Yerba Santa

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 04/12/2013

Desc: Pretz Spray Moisturizing Nasal with Yerba Santa

77 N - - UP Cream, nasal, topical, mechanical allergen particle barrier
Date Published: 04/12/2013

Desc: Pretz Spray Moisturizing Nasal with Yerba Santa

Laboratoire Manuves
Date Published : 09/30/2009
880 Selkirk , Pointe-claire, QC CANADA
54 F - - 45 Fenugreek (Herbal & Botanicals, not Teas)
Date Published: 09/30/2009

Notes: 3/13/2008. Diabetin (Ampoules)

61 P - - 99 Anti-Diabetic N.E.C.
Date Published: 09/30/2009

Notes: 3/13/2008. Diabetin (Ampoules)

LePharmacy Inc.
Date Published : 09/30/2009
7310 Mountain Sights Avenue , Montreal, Quebec CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 08/20/2020

Desc: Abarelix
Notes:                                   ;                                   ;                              ;

64 R - - 21 Somatropin (Hormone)
Date Published: 08/20/2020

Notes:                                   ;                                   ;                              ;

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                                   ;                                   ;                              ;

Les Entreprises Stefmar Inc.
Date Published : 03/28/2016
828 De Martigny St W , Saint-Jerome, Quebec CANADA
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 03/28/2016

Desc: Goats Milk & Argan Oil Body Wash Freshly Original
Notes: The Goats Milk & Argan Oil Hand & Body Lotion Freshly Original and Goats Milk & Argan Oil Body Wash Freshly Original products appear to be unapproved new drugs as the product labeling include claims such as:PATCHOULI OIL: Also known to help heal skin problems such as psoriasis, dermatitis, and eczema.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 03/28/2016

Desc: Goats Milk & Argan Oil Body Wash Midnight Orchid
Notes: The Goats Milk & Argan Oil Hand & Body Lotion Midnight Orchid and Goats Milk & Argan Oil Body Wash Midnight Orchid products appear to be unapproved new drugs as the product labeling include claims such as:[A] ntiseptic properties and BERGAMOT OIL … Helps treat … acne.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 03/28/2016

Desc: Goats Milk & Argan Oil Hand & Body Lotion Midnight Orchid
Notes: The Goats Milk & Argan Oil Hand & Body Lotion Midnight Orchid and Goats Milk & Argan Oil Body Wash Midnight Orchid products appear to be unapproved new drugs as the product labeling include claims such as:[A] ntiseptic properties and BERGAMOT OIL … Helps treat … acne.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 03/28/2016

Desc: Goats Milk & Argan Oil Hand & Body Lotion Freshly Original
Notes: The Goats Milk & Argan Oil Hand & Body Lotion Freshly Original and Goats Milk & Argan Oil Body Wash Freshly Original products appear to be unapproved new drugs as the product labeling include claims such as:PATCHOULI OIL: Also known to help heal skin problems such as psoriasis, dermatitis, and eczema.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/28/2016

Desc: Goats Milk & Argan Oil Hand & Body Lotion Freshly Original
Notes: The Goats Milk & Argan Oil Hand & Body Lotion Freshly Original and Goats Milk & Argan Oil Body Wash Freshly Original products appear to be unapproved new drugs as the product labeling include claims such as:PATCHOULI OIL: Also known to help heal skin problems such as psoriasis, dermatitis, and eczema.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/28/2016

Desc: Goats Milk & Argan Oil Body Wash Midnight Orchid
Notes: The Goats Milk & Argan Oil Hand & Body Lotion Midnight Orchid and Goats Milk & Argan Oil Body Wash Midnight Orchid products appear to be unapproved new drugs as the product labeling include claims such as:[A] ntiseptic properties and BERGAMOT OIL … Helps treat … acne.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/28/2016

Desc: Goats Milk & Argan Oil Hand & Body Lotion Midnight Orchid
Notes: The Goats Milk & Argan Oil Hand & Body Lotion Midnight Orchid and Goats Milk & Argan Oil Body Wash Midnight Orchid products appear to be unapproved new drugs as the product labeling include claims such as:[A] ntiseptic properties and BERGAMOT OIL … Helps treat … acne.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/28/2016

Desc: Goats Milk & Argan Oil Body Wash Freshly Original
Notes: The Goats Milk & Argan Oil Hand & Body Lotion Freshly Original and Goats Milk & Argan Oil Body Wash Freshly Original products appear to be unapproved new drugs as the product labeling include claims such as:PATCHOULI OIL: Also known to help heal skin problems such as psoriasis, dermatitis, and eczema.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/28/2016

Desc: Goats Milk & Argan Oil Hand & Body Lotion Freshly Original
Notes: The Goats Milk & Argan Oil Hand & Body Lotion Freshly Original and Goats Milk & Argan Oil Body Wash Freshly Original products appear to be unapproved new drugs as the product labeling include claims such as:PATCHOULI OIL: Also known to help heal skin problems such as psoriasis, dermatitis, and eczema.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/28/2016

Desc: Goats Milk & Argan Oil Body Wash Midnight Orchid
Notes: The Goats Milk & Argan Oil Hand & Body Lotion Midnight Orchid and Goats Milk & Argan Oil Body Wash Midnight Orchid products appear to be unapproved new drugs as the product labeling include claims such as:[A] ntiseptic properties and BERGAMOT OIL … Helps treat … acne.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/28/2016

Desc: Goats Milk & Argan Oil Hand & Body Lotion Midnight Orchid
Notes: The Goats Milk & Argan Oil Hand & Body Lotion Midnight Orchid and Goats Milk & Argan Oil Body Wash Midnight Orchid products appear to be unapproved new drugs as the product labeling include claims such as:[A] ntiseptic properties and BERGAMOT OIL … Helps treat … acne.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/28/2016

Desc: Goats Milk & Argan Oil Body Wash Freshly Original
Notes: The Goats Milk & Argan Oil Hand & Body Lotion Freshly Original and Goats Milk & Argan Oil Body Wash Freshly Original products appear to be unapproved new drugs as the product labeling include claims such as:PATCHOULI OIL: Also known to help heal skin problems such as psoriasis, dermatitis, and eczema.

Let's Feed
Date Published : 06/20/2018
450 Matheson Blvd E Unit 38 , Mississauga, Ontario CANADA
21 L - - 05 Dates, Topping or Syrup
Date Published: 06/20/2018

Desc: Date Syrup

Lgi Labs
Date Published : 04/23/2020
219 Old Yonge St , Aurora, ON CANADA
65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 07 Myobloc
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

Life Force Laboratories
Date Published : 09/30/2009
2255 B. Queen St., East, Suite 820 , Toronto, ON CANADA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: Gero Vita International may be doing business as Life Force Laboratories. 12/5/1997

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

MEDISAVE
Date Published : 09/30/2009
1364 CLIVEDEN AVE , DELTA, BC CANADA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                  

Masi Bardi
Date Published : 04/07/2016
4677 9th Ave W , Vancouver, British Columbia CANADA
31 K - - 99 Tea, N.E.C.
Date Published: 04/07/2016

Desc: 14 Day Detox Tea
Notes: The product appears to be an unapproved new drug as the associated product website; www.steepwellness.com; includes disease claims for product ingredients and tea in general such as; 'Lemon Balm- [C]ontains eugenol; which acts like a natural anti-inflammatory that helps soothe painful conditions...'; 'Milk Thistle- [R]eversing the harmful effects of alcohol consumption ... Studies have shown that milk thistle can also decrease blood sugar levels as well as lower cholesterol...'; 'Rooibos- Polyphenol in Rooibos tea have anti-inflammatory properties that assist in preventing heart related illnesses ... It can also be used as a natural remedy to irritable bowel syndrome ... may help alleviate several skin problems ... sunburns...'; and 'Tea is a natural source of fluoride that can help protect against tooth decay and gum disease...'.

31 M - - 01 Tea With Fruit (peels, chunks, bits or pieces)
Date Published: 04/07/2016

Desc: 14 Day Detox Tea
Notes: The product appears to be an unapproved new drug as the associated product website; www.steepwellness.com; includes disease claims for product ingredients and tea in general such as; 'Lemon Balm- [C]ontains eugenol; which acts like a natural anti-inflammatory that helps soothe painful conditions...'; 'Milk Thistle- [R]eversing the harmful effects of alcohol consumption ... Studies have shown that milk thistle can also decrease blood sugar levels as well as lower cholesterol...'; 'Rooibos- Polyphenol in Rooibos tea have anti-inflammatory properties that assist in preventing heart related illnesses ... It can also be used as a natural remedy to irritable bowel syndrome ... may help alleviate several skin problems ... sunburns...'; and 'Tea is a natural source of fluoride that can help protect against tooth decay and gum disease...'. ;

31 M - - 99 Blended Teas, N.E.C.
Date Published: 04/07/2016

Desc: 14 Day Detox Tea
Notes: The product appears to be an unapproved new drug as the associated product website; www.steepwellness.com; includes disease claims for product ingredients and tea in general such as; 'Lemon Balm- [C]ontains eugenol; which acts like a natural anti-inflammatory that helps soothe painful conditions...'; 'Milk Thistle- [R]eversing the harmful effects of alcohol consumption ... Studies have shown that milk thistle can also decrease blood sugar levels as well as lower cholesterol...'; 'Rooibos- Polyphenol in Rooibos tea have anti-inflammatory properties that assist in preventing heart related illnesses ... It can also be used as a natural remedy to irritable bowel syndrome ... may help alleviate several skin problems ... sunburns...'; and 'Tea is a natural source of fluoride that can help protect against tooth decay and gum disease...'. ;

31 P - - 99 Tea Substitutes, N.E.C.
Date Published: 04/07/2016

Desc: 14 Day Detox Tea
Notes: The product appears to be an unapproved new drug as the associated product website; www.steepwellness.com; includes disease claims for product ingredients and tea in general such as; 'Lemon Balm- [C]ontains eugenol; which acts like a natural anti-inflammatory that helps soothe painful conditions...'; 'Milk Thistle- [R]eversing the harmful effects of alcohol consumption ... Studies have shown that milk thistle can also decrease blood sugar levels as well as lower cholesterol...'; 'Rooibos- Polyphenol in Rooibos tea have anti-inflammatory properties that assist in preventing heart related illnesses ... It can also be used as a natural remedy to irritable bowel syndrome ... may help alleviate several skin problems ... sunburns...'; and 'Tea is a natural source of fluoride that can help protect against tooth decay and gum disease...'. ;

Matol Botanical International Ltd
Date Published : 09/30/2009
290 Labrosse Avenue , Pointe-Claire, QUEBEC CANADA
65 J - - 31 Progesterone (Progestin)
Date Published: 09/30/2009

Notes: 2/6/2008

Matrix Logistics
Date Published : 04/12/2013
2525 29 St Ne , Calgarycalgary, ALBERTA CANADA
53 L - - -- Skin Care Prep
Date Published: 04/12/2013

Desc: DermaSilk Double Chin Firming Serum

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 04/12/2013

Notes: DermaSilk Double Chin Firming Serum

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 04/12/2013

Notes: DermaSilk Double Chin Firming Serum

61 - - - -- Human and Animal Drugs
Date Published: 04/12/2013

Notes: DermaSilk Double Chin Firming Serum

62 - - - -- Human and Animal Drugs
Date Published: 04/12/2013

Notes: DermaSilk Double Chin Firming Serum

63 - - - -- Human and Animal Drugs
Date Published: 04/12/2013

Notes: DermaSilk Double Chin Firming Serum

64 - - - -- Human and Animal Drugs
Date Published: 04/12/2013

Notes: DermaSilk Double Chin Firming Serum

65 - - - -- Human and Animal Drugs
Date Published: 04/12/2013

Notes: DermaSilk Double Chin Firming Serum

66 - - - -- Human and Animal Drugs
Date Published: 04/12/2013

Notes: DermaSilk Double Chin Firming Serum

Mcneil Consumer Healthcare
Date Published : 01/18/2011
88 McNabb St , Markham, Ontario CANADA
66 B - - 44 Nicotine Delivery System
Date Published: 01/18/2011

Desc: Nicorette Gum
Notes: Canada

Med Marijuana Inc.
Date Published : 06/22/2010
93 Orchard Dr , Middle Sackville, Nova Scotia CANADA
54 H - - 05 Omega-3 (Fats and Lipid Substances)
Date Published: 06/22/2010

Desc: Med Marijuana (Cannabis Sativa Seed Oil)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/22/2010

Desc: Med Marijuana (Cannabis Sativa Seed Oil)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/22/2010

Desc: Med Marijuana (Cannabis Sativa Seed Oil)

MediMart Pharmacy
Date Published : 09/30/2009
1511-690 Kenaston Blvd , Winnipeg, MB CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 05/26/2020

Desc: Abarelix
Notes:                           

64 R - - 21 Somatropin (Hormone)
Date Published: 05/26/2020

Notes:                           

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                           

Medical Compounding Software
Date Published : 09/30/2009
Box 421 Arnold Street , Richmond Hill, ON CANADA
65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 09/30/2009

Desc:
Notes: Web Sites //www.rapidtabs.com

MedicineShoppePharmacy
Date Published : 09/30/2009
#122, 1959 ? 152 street , Surrey, BC CANADA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/11                      

Medisis Pharmacy Inc.
Date Published : 09/30/2009
Hooman Tabarsi , 7505 Victoria Dr. , Vancouver, BC CANADA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                     

Medisis Pharmacy Inc.
Date Published : 09/30/2009
Hooman Tabarsi , 7505 Victoria Dr. , Vancouver, BC CANADA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                      2/8/2007

Mike Crowig
Date Published : 04/26/2012
195 Wakina Dr Nw , Edmonton, AB CANADA
53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations)
Date Published: 04/26/2012

Desc: Bath Salts

53 B - - 99 Other Bath Preparations, N.E.C.
Date Published: 04/26/2012

Desc: Bath Salts

Mikhail Zayat Enr
Date Published : 04/10/2012
121 DE CHATEAUGUAY STREET , Bromont, CA-QC CANADA
62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 04/10/2012

Desc: Royal Oregano Oil
Notes: Canada

Moore Spa Incorporated
Date Published : 06/03/2014
13680 Bridgeport Rd Unit 7 , Richmond, British Columbia CANADA
61 W - - 99 A-Fungal N.E.C.
Date Published: 06/03/2014

Desc: Dr. Dobias Healing Solution - All Natural Herbal Spray for Wounds; Cuts; Skin Incisions; Hotspots; Insect Bites; and More.

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 06/03/2014

Desc: Dr. Dobias Healing Solution - All Natural Herbal Spray for Wounds; Cuts; Skin Incisions; Hotspots; Insect Bites; and More.

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 06/03/2014

Desc: Dr. Dobias Healing Solution - All Natural Herbal Spray for Wounds; Cuts; Skin Incisions; Hotspots; Insect Bites; and More.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/03/2014

Desc: Dr. Dobias Healing Solution - All Natural Herbal Spray for Wounds; Cuts; Skin Incisions; Hotspots; Insect Bites; and More.

My Drugs Canada and / Or My-drugs.ca
Date Published : 09/30/2009
Jonathan Valicenti , Po Box 370, 1250 University St. , Montreal, Quebec, CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 05/26/2020

Desc: Abarelix
Notes:                                                                                                                                                                                                

64 R - - 21 Somatropin (Hormone)
Date Published: 05/26/2020

Notes:                                                                                                                                                                                                

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                                                                                                                                                                                                

NATURAL WELLNESS NOW HEALTH PROD
Date Published : 10/05/2017
106-555 Foster Ave , Coquitlam, British Columbia CANADA
54 B - - 08 Magnesium (Mineral)
Date Published: 10/05/2017

Desc: Trusii H2 Now- Ultra High Concentration Effervescent Magnesium H2 Tablets
Notes: NuEra Nutraceutical Inc.; Richmond; BC; Canada appears to be a contract manufacturer

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/05/2017

Desc: Trusii H2 Now- Ultra High Concentration Effervescent Magnesium H2 Tablets
Notes: NuEra Nutraceutical Inc.; Richmond; BC; Canada appears to be a contract manufacturer.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/05/2017

Desc: Trusii H2 Now- Ultra High Concentration Effervescent Magnesium H2 Tablets
Notes: NuEra Nutraceutical Inc.; Richmond; BC; Canada appears to be a contract manufacturer

NNS Organics Limited
Date Published : 05/26/2017
2769 Lawrencetown Rd , Lawrencetown, Nova Scotia CANADA
54 A - - 12 Folic Acid (Vitamin)
Date Published: 05/26/2017

Desc: Blood Pressure Management Formula Caplets
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as: (label) '…Blood Pressure Management 120's Herbal Supplement…; …Blood Pressure Management Formulla**…; …Plant based formula to support healthy blood pressure**…'; (novascotiaorganics.com) '…[H]elp you manage your diet to support healthy blood pressure…; [E]ffective nutrient to help manage healthy cholesterol levels…; …Our Blood Pressure Management Formula includes … nutrients with cholesterol-managing … properties…'

54 F - - 10 Garlic (Herbal & Botanicals, not Teas)
Date Published: 05/26/2017

Desc: Blood Pressure Management Formula Caplets
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as: (label) '…Blood Pressure Management 120's Herbal Supplement…; …Blood Pressure Management Formulla**…; …Plant based formula to support healthy blood pressure**…'; (novascotiaorganics.com) '…[H]elp you manage your diet to support healthy blood pressure…; [E]ffective nutrient to help manage healthy cholesterol levels…; …Our Blood Pressure Management Formula includes … nutrients with cholesterol-managing … properties…'

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/26/2017

Desc: Blood Pressure Management Formula Caplets
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as: (label) '…Blood Pressure Management 120's Herbal Supplement…; …Blood Pressure Management Formulla**…; …Plant based formula to support healthy blood pressure**…'; (novascotiaorganics.com) '…[H]elp you manage your diet to support healthy blood pressure…; [E]ffective nutrient to help manage healthy cholesterol levels…; …Our Blood Pressure Management Formula includes … nutrients with cholesterol-managing … properties…'

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/26/2017

Desc: Blood Pressure Management Formula Caplets
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as: (label) '…Blood Pressure Management 120's Herbal Supplement…; …Blood Pressure Management Formulla**…; …Plant based formula to support healthy blood pressure**…'; (novascotiaorganics.com) '…[H]elp you manage your diet to support healthy blood pressure…; [E]ffective nutrient to help manage healthy cholesterol levels…; …Our Blood Pressure Management Formula includes … nutrients with cholesterol-managing … properties…'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/26/2017

Desc: Blood Pressure Management Formula Caplets
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as: (label) '…Blood Pressure Management 120's Herbal Supplement…; …Blood Pressure Management Formulla**…; …Plant based formula to support healthy blood pressure**…'; (novascotiaorganics.com) '…[H]elp you manage your diet to support healthy blood pressure…; [E]ffective nutrient to help manage healthy cholesterol levels…; …Our Blood Pressure Management Formula includes … nutrients with cholesterol-managing … properties…'

NNS Organics Limited
Date Published : 05/26/2017
2769 Lawrencetown Rd , Lawrencetown, Nova Scotia CANADA
54 A - - 12 Folic Acid (Vitamin)
Date Published: 05/26/2017

Desc: Blood Pressure Management Formula Caplets
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as: (label) '…Blood Pressure Management 120's Herbal Supplement…; …Blood Pressure Management Formulla**…; …Plant based formula to support healthy blood pressure**…'; (novascotiaorganics.com) '…[H]elp you manage your diet to support healthy blood pressure…; [E]ffective nutrient to help manage healthy cholesterol levels…; …Our Blood Pressure Management Formula includes … nutrients with cholesterol-managing … properties…'

54 F - - 10 Garlic (Herbal & Botanicals, not Teas)
Date Published: 05/26/2017

Desc: Blood Pressure Management Formula Caplets
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as: (label) '…Blood Pressure Management 120's Herbal Supplement…; …Blood Pressure Management Formulla**…; …Plant based formula to support healthy blood pressure**…'; (novascotiaorganics.com) '…[H]elp you manage your diet to support healthy blood pressure…; [E]ffective nutrient to help manage healthy cholesterol levels…; …Our Blood Pressure Management Formula includes … nutrients with cholesterol-managing … properties…'

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/26/2017

Desc: Blood Pressure Management Formula Caplets
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as: (label) '…Blood Pressure Management 120's Herbal Supplement…; …Blood Pressure Management Formulla**…; …Plant based formula to support healthy blood pressure**…'; (novascotiaorganics.com) '…[H]elp you manage your diet to support healthy blood pressure…; [E]ffective nutrient to help manage healthy cholesterol levels…; …Our Blood Pressure Management Formula includes … nutrients with cholesterol-managing … properties…'

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/26/2017

Desc: Blood Pressure Management Formula Caplets
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as: (label) '…Blood Pressure Management 120's Herbal Supplement…; …Blood Pressure Management Formulla**…; …Plant based formula to support healthy blood pressure**…'; (novascotiaorganics.com) '…[H]elp you manage your diet to support healthy blood pressure…; [E]ffective nutrient to help manage healthy cholesterol levels…; …Our Blood Pressure Management Formula includes … nutrients with cholesterol-managing … properties…'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/26/2017

Desc: Blood Pressure Management Formula Caplets
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as: (label) '…Blood Pressure Management 120's Herbal Supplement…; …Blood Pressure Management Formulla**…; …Plant based formula to support healthy blood pressure**…'; (novascotiaorganics.com) '…[H]elp you manage your diet to support healthy blood pressure…; [E]ffective nutrient to help manage healthy cholesterol levels…; …Our Blood Pressure Management Formula includes … nutrients with cholesterol-managing … properties…'

NNS Organics Limited
Date Published : 05/26/2017
2769 Lawrencetown Rd , Lawrencetown, Nova Scotia CANADA
54 A - - 12 Folic Acid (Vitamin)
Date Published: 05/26/2017

Desc: Blood Pressure Management Formula Caplets
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as: (label) '…Blood Pressure Management 120's Herbal Supplement…; …Blood Pressure Management Formulla**…; …Plant based formula to support healthy blood pressure**…'; (novascotiaorganics.com) '…[H]elp you manage your diet to support healthy blood pressure…; [E]ffective nutrient to help manage healthy cholesterol levels…; …Our Blood Pressure Management Formula includes … nutrients with cholesterol-managing … properties…'

54 F - - 10 Garlic (Herbal & Botanicals, not Teas)
Date Published: 05/26/2017

Desc: Blood Pressure Management Formula Caplets
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as: (label) '…Blood Pressure Management 120's Herbal Supplement…; …Blood Pressure Management Formulla**…; …Plant based formula to support healthy blood pressure**…'; (novascotiaorganics.com) '…[H]elp you manage your diet to support healthy blood pressure…; [E]ffective nutrient to help manage healthy cholesterol levels…; …Our Blood Pressure Management Formula includes … nutrients with cholesterol-managing … properties…'

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/26/2017

Desc: Blood Pressure Management Formula Caplets
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as: (label) '…Blood Pressure Management 120's Herbal Supplement…; …Blood Pressure Management Formulla**…; …Plant based formula to support healthy blood pressure**…'; (novascotiaorganics.com) '…[H]elp you manage your diet to support healthy blood pressure…; [E]ffective nutrient to help manage healthy cholesterol levels…; …Our Blood Pressure Management Formula includes … nutrients with cholesterol-managing … properties…'

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/26/2017

Desc: Blood Pressure Management Formula Caplets
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as: (label) '…Blood Pressure Management 120's Herbal Supplement…; …Blood Pressure Management Formulla**…; …Plant based formula to support healthy blood pressure**…'; (novascotiaorganics.com) '…[H]elp you manage your diet to support healthy blood pressure…; [E]ffective nutrient to help manage healthy cholesterol levels…; …Our Blood Pressure Management Formula includes … nutrients with cholesterol-managing … properties…'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/26/2017

Desc: Blood Pressure Management Formula Caplets
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as: (label) '…Blood Pressure Management 120's Herbal Supplement…; …Blood Pressure Management Formulla**…; …Plant based formula to support healthy blood pressure**…'; (novascotiaorganics.com) '…[H]elp you manage your diet to support healthy blood pressure…; [E]ffective nutrient to help manage healthy cholesterol levels…; …Our Blood Pressure Management Formula includes … nutrients with cholesterol-managing … properties…'

Naticura Inc.
Date Published : 06/12/2017
249 Hillhurst Blvd , North York, Ontario CANADA
62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 06/12/2017

Desc: Naticura Alleviate Natural Hemorrhoid Relief

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/12/2017

Desc: Naticura Alleviate Natural Hemorrhoid Relief

Natropractica (AKA:Christoper Scipio(Natropractica@aol.com))
Date Published : 09/30/2009
1950 West Broadway , Vancouver, BC CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2009

Notes: 8/25/2006. "Green Sun" Anti-Viral Gel. This product is promoted on Natropractica's website www.natropractica.com, for use as an "effective barrier which inhibits the ability of HPV, Herpes and other STIs (Sexual transmitted Infections) from replicating on the surface of the skin and inhibits their ability to adhere to the skin. We developed our own anti-viral gel lube with Carrageenan and other substances we were already working with in the protocol and developed our own formula. Also, the following metatag key words are connected to this website: "anti-viral" "genital herpes" "Genital Herpes Syndrome" "Varicella zoster" "shingles" "Sexually transmitted disease" "STDS" "AIDS" "HIV" and "incurable disease" ect. Based on its intended uses this product is a drug. Further, we are not aware of any substantial scientific evidence that this product is generally safe and effective for the conditions recommended or suggested in its labeling.

Natural Health Organic Sulfur Prod
Date Published : 04/04/2014
1346 - 129b Street ***Auto Credit , Surreysurrey, BC CANADA
46 Y - - 99 Food Additives For Human Use, N.E.C.
Date Published: 04/04/2014

Desc: Organic Sulfur - methylsulfonylmethane

Nature'S Artifacts
Date Published : 11/22/2010
3135 Universal Dr , Suite 14 , Mississauga, On CANADA
77 K - - CO Inhaler, Nasal
Date Published: 11/22/2010

Desc: Himalayan Salt Inhaler
Notes: Canada; * Note: Label Declared Manufacturer

Natures Artifacts
Date Published : 11/22/2010
27 2455 Cawthra Road , Mississauga , MISSISSAUGA, CA-ON CANADA
77 K - - CO Inhaler, Nasal
Date Published: 11/22/2010

Desc: Himalayan Salt Inhaler
Notes: Canada; *Note; Label Declared Manufacturer

Natures Formulae Health Products Ltd.
Date Published : 08/23/2013
2130 Leckie Pl Suite 300 , Kelowna, British Columbia CANADA
20 D - - 99 Berry Juice, N.E.C. Berry Juice or Concentrates
Date Published: 08/23/2013

Desc: Youth juice restore dietary supplement

21 D - - 03 Berries, Mixed, Juices or Concentrates
Date Published: 08/23/2013

Desc: Youth juice restore dietary supplement

21 D - - 99 Mixed Fruit, Juices or Concentrates N.E.C.,
Date Published: 08/23/2013

Desc: Youth juice restore dietary supplement

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/23/2013

Desc: Youth juice restore dietary supplement

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/23/2013

Desc: Youth juice restore dietary supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/23/2013

Desc: Youth juice restore dietary supplement

Nestle Canada, Inc. - North York Head Office
Date Published : 03/26/2015
1700-25 Sheppard Ave W , North York, Ontario CANADA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/26/2015

Notes: Nestle Materna Pre-natal Postpartum Vitamin & Mineral Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/26/2015

Desc: Nestle Materna Pre-natal Postpartum Vitamin & Mineral Supplement

New Action Products
Date Published : 08/09/2019
8 Waterloo Street , Fort Erie, ON CANADA
31 - - - -- Coffee/Tea
Date Published: 08/09/2019

Desc: Caisse's Herbal Tea (kit)

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/09/2019

Desc: Caisse's Herbal Tea (kit)

66 - - - -- Human and Animal Drugs
Date Published: 08/09/2019

Desc: Caisse's Herbal Tea (kit)

New Action Products
Date Published : 08/09/2019
PO Box 141 Stn Main , Grimsby, Ontario CANADA
31 - - - -- Coffee/Tea
Date Published: 08/09/2019

Desc: Caisse's Herbal Tea (kit)

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/09/2019

Desc: Caisse's Herbal Tea (kit)

66 - - - -- Human and Animal Drugs
Date Published: 08/09/2019

Desc: Caisse's Herbal Tea (kit)

Newco Enterprise Inc.
Date Published : 06/11/2013
402-5793 10th St NE , Calgary, Alberta CANADA
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 06/11/2013

Desc: Brocco Fusion Sulforaphane Ointment

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/11/2013

Desc: Brocco Fusion Sulforaphane Ointment

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/11/2013

Desc: Brocco Gen 10 Sulforaphane Glucosindate Capsules Dietary Supplement
Notes: Note; Website makes claims that appear to make the product a new drug

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/11/2013

Desc: Brocco Gen 10 Sulforaphane Glucosindate Capsules Dietary Supplement
Notes: Note; Website makes claims that appear to make the product a new drug

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/11/2013

Desc: Brocco Fusion Sulforaphane Ointment

Newton Pharmacy Inc.
Date Published : 09/30/2009
100-7455 132 St. , Surrey, BC CANADA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Desc:
Notes: John Leung,Pharmacy Manager 2/8/2007, Liscense Number 03528, WebSite: www.canpharm.com

North Pharmacy Inc
Date Published : 09/30/2009
110-165 Kimta Road , Victoria, CANADA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                    2/8/2007

NuEra Nutraceutical Inc
Date Published : 08/16/2017
12031 No. 5 Rd , Richmond, British Columbia CANADA
54 B - - 08 Magnesium (Mineral)
Date Published: 10/05/2017

Desc: Trusii H2 Now- Ultra High Concentration Effervescent Magnesium H2 Tablets
Notes: NuEra Nutraceutical Inc.; Richmond; BC; Canada appears to be a contract manufacturer.

54 Y - - 04 Ginseng Unconventional Dietary Speciality for Humans or Animals
Date Published: 08/16/2017

Desc: REDSENOL-1 CAPSULES
Notes: Medical claims made in product websites

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/05/2017

Desc: Trusii H2 Now- Ultra High Concentration Effervescent Magnesium H2 Tablets
Notes: NuEra Nutraceutical Inc.; Richmond; BC; Canada appears to be a contract manufacturer.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/16/2017

Desc: REDSENOL-1 CAPSULES
Notes: Medical claims made in product websites

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/05/2017

Desc: Trusii H2 Now- Ultra High Concentration Effervescent Magnesium H2 Tablets
Notes: NuEra Nutraceutical Inc.; Richmond; BC; Canada appears to be a contract manufacturer.

Nutra Med
Date Published : 09/30/2009
2-3006 Boys Rd , Duncan, British Columbia CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: Shipper. 4/29/2003 "Recovery Biostructural Medicines" for relief of chronic pain and inflammation.

OnlineCanadaMeds
Date Published : 09/30/2009
#400-601 6th Street , New Westminster, British Columbia CANADA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 7/8/2007                             

Organic Connections Ltd.
Date Published : 08/09/2019
33230 Pettit Rd. , Box 78 , Wainfleet, Ontario CANADA
31 - - - -- Coffee/Tea
Date Published: 08/09/2019

Desc: Caisse's Herbal Tea (kit)

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/09/2019

Desc: Caisse's Herbal Tea (kit)

66 - - - -- Human and Animal Drugs
Date Published: 08/09/2019

Desc: Caisse's Herbal Tea (kit)

Organika Health Products
Date Published : 06/15/2012
13480 Verdum Pl , Richmond, British Columbia CANADA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/15/2012

Desc: Formula Candida Capsules
Notes: Canada

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/15/2012

Desc: Konjac Root Vegetarian Capsules;
Notes: Canada

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/15/2012

Desc: Fibro-M Vegetarian Capsules;
Notes: Canada

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/15/2012

Desc: Antacid Relief
Notes: Canada

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/15/2012

Desc: Konjac Root Vegetarian Capsules;
Notes: Canada

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/15/2012

Desc: Antacid Relief
Notes: Canada

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/15/2012

Desc: Fibro-M Vegetarian Capsules
Notes: Canada

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/15/2012

Desc: Formula Candida Capsules
Notes: Canada

Orion Group
Date Published : 05/03/2010
53 King St , Wolfville, Nova Scotia CANADA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/03/2010

Desc: Aromatherapy Scentuelle for women female libido booster
Notes: Canada

Outer Coast Seaweeds Ltd
Date Published : 11/07/2013
2105 Otter Point Road , Sooke, BC CANADA
53 L - - -- Skin Care Prep
Date Published: 11/07/2013

Desc: Sea Flora Sea Kelp Body Polish

53 L - - -- Skin Care Prep
Date Published: 11/07/2013

Desc: Sea Flora Ocean Mud Pedi Scrub

53 L - - -- Skin Care Prep
Date Published: 11/07/2013

Desc: Sea Flora Nourishing Seaweed Alaria Body Wrap

53 L - - -- Skin Care Prep
Date Published: 11/07/2013

Desc: Sea Flora Therapeutic Firming Seaweed Gel

53 L - - -- Skin Care Prep
Date Published: 11/07/2013

Desc: Sea Flora Rich Laminaria Facial Moisturizer

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/07/2013

Desc: Sea Flora Rich Laminaria Facial Moisturizer

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/07/2013

Desc: Sea Flora Ocean Mud Pedi Scrub

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/07/2013

Desc: Sea Flora Sea Kelp Body Polish

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/07/2013

Desc: Sea Flora Therapeutic Firming Seaweed Gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/07/2013

Desc: Sea Flora Nourishing Seaweed Alaria Body Wrap

PLZ Corp.
Date Published : 07/19/2012
6080 Vipond Dr , Mississauga, Ontario CANADA
63 J - - 17 Zinc Acetate (Chelating Agent)
Date Published: 07/19/2012

Desc: Ivy Dry Anti-Itch
Notes: Canada

PROVITA NUTRITION AND HEALTH INC
Date Published : 04/24/2023
1102-1225 Kingsway Ave , Port Coquitlam, British Columbia CANADA
54 E - - 91 Boswellia (Herbal & Botanical Teas)
Date Published: 04/24/2023

Desc: Prostate Pro Dietary Supplements Capsules

54 F - - 50 Hawthorn (Herbal & Botanicals, not Teas)
Date Published: 04/24/2023

Desc: Nervine Herbal Supplement Capsules

54 F - - 58 Saw Palmetto (Herbal & Botanicals, not Teas)
Date Published: 04/24/2023

Desc: Prostate Pro Dietary Supplements Capsules

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/24/2023

Desc: Prostate Pro Dietary Supplements Capsules

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/24/2023

Desc: Nervine Herbal Supplement Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/24/2023

Desc: Nervine Herbal Supplement Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/24/2023

Desc: Prostate Pro Dietary Supplements Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2023

Desc: Prostate Pro Dietary Supplements Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2023

Desc: Nervine Herbal Supplement Capsules

Paladin Labs Inc
Date Published : 10/05/2012
6111 Ave Royalmount , Montreal, QC CANADA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/05/2012

Desc: Canthacur-PS Wart

Patheon Inc.
Date Published : 05/03/2018
111 Consumers Dr , Whitby, Ontario CANADA
64 L - - 44 Methylprednisolone (Glucocorticoid)
Date Published: 05/03/2018

Desc: Neo Medrol Acne Lotion

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/03/2018

Desc: Neo Medrol Acne Lotion

Pearl E. Bally
Date Published : 08/09/2019
11 Bayside Private , Ottawa, ON CANADA
31 - - - -- Coffee/Tea
Date Published: 08/09/2019

Desc: Canadian Native Tea

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/09/2019

Desc: Canadian Native Tea

66 - - - -- Human and Animal Drugs
Date Published: 08/09/2019

Desc: Canadian Native Tea

Pegasus Natural Supplements Inc.
Date Published : 09/30/2009
Unknown , Richmond, BC CANADA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/20/2019

Desc: Careseng #1 (Capsules & Liquids)
Notes: 1/15/2004

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/20/2019

Desc: Careseng #2
Notes: 3/1/2004

Pegasus Pharmaceut
Date Published : 09/30/2009
156 11786 River R , Richmond, BC CANADA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/20/2019

Desc: Careseng #1 (Capsules & Liquids)
Notes: 1/15/2004

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/20/2019

Desc: Careseng #2
Notes: 3/1/2004

Pegasus Pharmaceuticals Group
Date Published : 09/30/2009
3331 No 3. Road , Richmond, BC CANADA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: Capsules and Liquids 1/13/2004

Pegasus Pharmaceuticals Inc
Date Published : 09/30/2009
#156-11786 River Rd , Richmond, BC CANADA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/20/2019

Desc: Careseng #2
Notes: 3/1/2004

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/20/2019

Desc: Careseng #1 (Capsules & Liquids)
Notes: 1/15/2004

Pfizer Canada Inc
Date Published : 04/30/2014
5975 Whittle Rd , Mississaugamississauga, ON CANADA
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/30/2014

Desc: Preparation H Cream with Bio-Dyne
Notes: Product label indicates Pfizer Consumer Healthcare is a division of Pfizer Canada Inc.

55 Q - - 19 Petrolatum (Pharmaceutic Necessity - Ointment Base)
Date Published: 04/30/2014

Desc: Preparation H Cream with Bio-Dyne
Notes: Product label indicates Pfizer Consumer Healthcare is a division of Pfizer Canada Inc.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/30/2014

Desc: Preparation H Cream with Bio-Dyne
Notes: Product label indicates Pfizer Consumer Healthcare is a division of Pfizer Canada Inc.

Pfizer Consumer Healthcare
Date Published : 04/30/2014
5975 Whittle Road, 2nd Floor , Mississauga, PRINCE EDWARD ISLAND CANADA
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/30/2014

Desc: Preparation H Cream with Bio-Dyne
Notes: Product label indicates Pfizer Consumer Healthcare is a division of Pfizer Canada Inc. ;

55 Q - - 19 Petrolatum (Pharmaceutic Necessity - Ointment Base)
Date Published: 04/30/2014

Desc: Preparation H Cream with Bio-Dyne
Notes: Product label indicates Pfizer Consumer Healthcare is a division of Pfizer Canada Inc. ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/30/2014

Desc: Preparation H Cream with Bio-Dyne
Notes: Product label indicates Pfizer Consumer Healthcare is a division of Pfizer Canada Inc. ;

Ph.D Nutraceuticals
Date Published : 08/31/2011
279 Jarvis Street , Unit 1009 , Toronto, Ontario CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/31/2011

Desc: Ph.D M-2 (Male Formula) Dietary Supplement
Notes: Lable Declared Manufacturer; Canada

PharmaTech 2000
Date Published : 09/30/2009
16508 100 St , Edmonton, AB CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: 7/25/2005

Pharmacy Online.com
Date Published : 09/30/2009
Barney Briton , #500, 400 Crowfoot Cresc. NW , Calagary, Alberta CANADA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                          ;Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril. 5/19/2005

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                          ;Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril. 5/19/2005

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                          ;Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril. 5/19/2005

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                          ;Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril. 5/19/2005

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                          ;Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril. 5/19/2005

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                          ;Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril. 5/19/2005

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                          ;Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril. 5/19/2005

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                          ;Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril. 5/19/2005

Pharmacy Rx Drugs, Inc.
Date Published : 09/30/2009
9 Sundown Court , Thornhill , Thornhill, ON CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 05/26/2020

Desc: Abarelix
Notes:                        

64 R - - 21 Somatropin (Hormone)
Date Published: 05/26/2020

Notes:                          

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                          

Pharmavigor
Date Published : 09/30/2009
11750 Av 4e , Montreal, QC CANADA
54 F - - 45 Fenugreek (Herbal & Botanicals, not Teas)
Date Published: 09/30/2009

Notes: 3/13/2008. Diabetin (Ampoules)

61 P - - 99 Anti-Diabetic N.E.C.
Date Published: 09/30/2009

Notes: 3/13/2008. Diabetin (Ampoules)

Pharmawest Pharmacy Ltd
Date Published : 09/30/2009
Unit # 101 20560 56th Ave. , Langley, Bc CANADA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                           

Pharmawest Pharmacy Ltd.
Date Published : 09/30/2009
69-15515-24 Avenue , Surrey, British Columbia CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 08/06/2020

Desc: Abarelix
Notes:                         

64 R - - 21 Somatropin (Hormone)
Date Published: 08/06/2020

Notes:                         

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                         

Pilot Mound Pharmacy
Date Published : 09/30/2009
Darcey Mosquin , Box 89 , Pilot Mound, MB, CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 06/15/2020

Desc: Abarelix
Notes:                             

64 R - - 21 Somatropin (Hormone)
Date Published: 06/15/2020

Notes:                             

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                             

Pmt Logistics
Date Published : 04/23/2020
138 Industrial Pkwy North , Aurora, ON CANADA
65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 07 Myobloc
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

Polydex Pharmaceuticals, Ldt.
Date Published : 09/30/2009
Unknown Street , Montreal, QC CANADA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/03/2019

Desc: Dextran Sulfate

Prairie Naturals Health Products
Date Published : 10/23/2018
56 Fawcett Rd , Coquitlam, British Columbia CANADA
54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 10/23/2018

Desc: Ephedrine Hydrochloride

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 10/23/2018

Desc: Ephedrine Hydrochloride

60 C - - 21 Ephedrine (Adrenergic)
Date Published: 10/23/2018

Desc: Ephedrine Hydrochloride

60 C - - 22 Ephedrine HCl (Adrenergic)
Date Published: 10/23/2018

Desc: Ephedrine Hydrochloride

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/23/2018

Desc: Ephedrine Hydrochloride

Prime Nutrisource Inc.
Date Published : 07/06/2015
41 Pullman Crt , Scarborough, Ontario CANADA
54 A - - 99 Vitamin, N.E.C.
Date Published: 07/06/2015

Desc: BRAZIL ACAI POWDER 4X CONCENTRATED

54 A - - 99 Vitamin, N.E.C.
Date Published: 07/06/2015

Desc: BRAZIL ACAI MULTI-VITAMIN

54 A - - 99 Vitamin, N.E.C.
Date Published: 07/06/2015

Desc: BRAZIL ACAI MAX

54 A - - 99 Vitamin, N.E.C.
Date Published: 07/06/2015

Desc: BRAZIL ACAI 20;1 CONCENTRATED

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/01/2015

Desc: Nutridom Cranberry 25X
Notes:                                                                                                                                      

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/01/2015

Notes: Various Maca Powder Supplements (including Inka Organic Peruvian Wild Maca Powder and Red and Black Maca);                                                                                                                                       

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/01/2015

Desc: Various Maca Powder Supplements (including Inka Organic Peruvian Wild Maca Powder and Red and Black Maca)
Notes:                                                                                                                                       

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/06/2015

Desc: BRAZIL ACAI POWDER 4X CONCENTRATED

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/02/2019

Desc: BRAZIL ACAI MAX
Notes: 7/6/2015

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/06/2015

Desc: BRAZIL ACAI 20;1 CONCENTRATED

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/06/2015

Desc: BRAZIL ACAI MULTI-VITAMIN

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/01/2015

Desc: Nutridom Cranberry 25X
Notes:                                                                                                                                      

Pro-Ma Systems Canada Ltd
Date Published : 01/07/2014
6125 12th St Se Unit 8 , Calgary, ALBERTA CANADA
53 G - - 03 Foundations (Makeup Preparations, not for Eyes)
Date Published: 01/07/2014

Desc: Aloe Oil Free Foundation
Notes: Country; Canada

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 01/07/2014

Desc: Infiniti Beauty Fluids
Notes: Country; Canada

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 01/07/2014

Desc: Platinum Reverse Wrinkle Serum
Notes: Country; Canada

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 01/07/2014

Desc: Intense Vita-Firm For Eyes
Notes: Country; Canada

Prodemdis Enr.
Date Published : 09/30/2009
St. Hubert , Quebec, CANADA
66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 09/30/2009

Notes: Calidou Sun Lotion 6/8/2000

Products Ab Aromas Naturales Inc
Date Published : 06/06/2019
6147 Boul Couture , Saint-Leonard, QC CANADA
28 O - - 99 Essential Oils for Flavoring, n.e.c.
Date Published: 06/06/2019

Desc: Aromatherapy & Fragrance Essential Oils
Notes: Scents subject to DWPE under this listing are; "Ylang;" "Eucalyptus;" "Marjoram;" "Rose;" "Apple;" "Rosemary;" "Mandarin;" "Grapefruit;" "Anti-Smoke;" "Bergamot;" "Lavender;" "Muscle Mist Spray;" "Peppermint;" and "Pine".

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/06/2019

Desc: Aromatherapy & Fragrance Essential Oils
Notes: Scents subject to DWPE under this listing are; "Ylang;" "Eucalyptus;" "Marjoram;" "Rose;" "Apple;" "Rosemary;" "Mandarin;" "Grapefruit;" "Anti-Smoke;" "Bergamot;" "Lavender;" "Muscle Mist Spray;" "Peppermint;" and "Pine".

Prollenium Inc
Date Published : 04/23/2020
219 Old Yonge St , Aurora, ON CANADA
65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 07 Myobloc
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

Prollenium Medical Technologies Inc.
Date Published : 04/23/2020
138 Industrial Pky N , Aurora, Ontario CANADA
53 - - - -- Cosmetics
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 07 Myobloc
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

RHEMA HEALTH PRODUCTS Limited
Date Published : 09/28/2022
601-19055 Airport Way , Pitt Meadows, British Columbia CANADA
41 E - - -- Meal Replacements
Date Published: 09/28/2022

Desc: HEAL Complete Plant-Based Meal Replacement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2022

Desc: HEAL Complete Plant-Based Meal Replacement

RX Trust Pharmacy
Date Published : 09/30/2009
Kevin Liang (admin@idig.net) , PO Box 97008, Richmond Main PO , Richmond, British Columbia CANADA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                          

Ra Botanicals Llc
Date Published : 10/04/2013
13721 114 Avenue , Surrey, BC CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/04/2013

Desc: RaLeptin; RaPain

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/04/2013

Desc: RaLeptin; RaPain

Rapiflex Distribution
Date Published : 09/30/2009
1795 Marie-Victorin St , Saint-Bruno, Quebec CANADA
61 M B J 11 Magnesium Sulfate (Anti-Convulsant), Human - Non/Rx Combination Ingredient, NonSterile Ointment
Date Published: 09/17/2019

Desc: OSMOPAK PLUS
Notes: Shipper - This product is used as a drawing salve for the inflammation of subcutaneous tissues.; 3/26/1998

Ravi Devgan, Dr. dba:Total Wellness Center
Date Published : 09/16/2019
42 Redpath Avenue , Toronto, ON CANADA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/16/2019

Notes: Life Crystals, Oral 32oz; Life Crystals, 5 cc I.V; Chondriana, 6 cc I.V.; Immumostin LV047; Note: All the above products are reported to be used in a treatment regimen promoted by The Total Wellness Centers, one of which is operated by Dr. Ravi Devgan. Available literature promotes the procedure as effective for the treatment of AIDS, Epstein Barr Virus and cancer, by cleansing the blood. A video tape, entitled New Frontiers in Molecular Biology Life Crystal Capturing the Sun promotes use of these products and is narrated by Dr. Merkl, who is also the President of                                                                 ; 7/6/1994

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Life Crystals, Oral 32oz; Life Crystals, 5 cc I.V; Chondriana, 6 cc I.V.; Immumostin LV047; Note: All the above products are reported to be used in a treatment regimen promoted by The Total Wellness Centers, one of which is operated by Dr. Ravi Devgan. Available literature promotes the procedure as effective for the treatment of AIDS, Epstein Barr Virus and cancer, by cleansing the blood. A video tape, entitled New Frontiers in Molecular Biology Life Crystal Capturing the Sun promotes use of these products and is narrated by Dr. Merkl, who is also the President of                                                                 ; 7/6/1994

61 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Life Crystals, Oral 32oz; Life Crystals, 5 cc I.V; Chondriana, 6 cc I.V.; Immumostin LV047; Note: All the above products are reported to be used in a treatment regimen promoted by The Total Wellness Centers, one of which is operated by Dr. Ravi Devgan. Available literature promotes the procedure as effective for the treatment of AIDS, Epstein Barr Virus and cancer, by cleansing the blood. A video tape, entitled New Frontiers in Molecular Biology Life Crystal Capturing the Sun promotes use of these products and is narrated by Dr. Merkl, who is also the President of                                                                 ; 7/6/1994

62 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Life Crystals, Oral 32oz; Life Crystals, 5 cc I.V; Chondriana, 6 cc I.V.; Immumostin LV047; Note: All the above products are reported to be used in a treatment regimen promoted by The Total Wellness Centers, one of which is operated by Dr. Ravi Devgan. Available literature promotes the procedure as effective for the treatment of AIDS, Epstein Barr Virus and cancer, by cleansing the blood. A video tape, entitled New Frontiers in Molecular Biology Life Crystal Capturing the Sun promotes use of these products and is narrated by Dr. Merkl, who is also the President of                                                                 ; 7/6/1994

63 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Life Crystals, Oral 32oz; Life Crystals, 5 cc I.V; Chondriana, 6 cc I.V.; Immumostin LV047; Note: All the above products are reported to be used in a treatment regimen promoted by The Total Wellness Centers, one of which is operated by Dr. Ravi Devgan. Available literature promotes the procedure as effective for the treatment of AIDS, Epstein Barr Virus and cancer, by cleansing the blood. A video tape, entitled New Frontiers in Molecular Biology Life Crystal Capturing the Sun promotes use of these products and is narrated by Dr. Merkl, who is also the President of                                                                 ; 7/6/1994

64 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Life Crystals, Oral 32oz; Life Crystals, 5 cc I.V; Chondriana, 6 cc I.V.; Immumostin LV047; Note: All the above products are reported to be used in a treatment regimen promoted by The Total Wellness Centers, one of which is operated by Dr. Ravi Devgan. Available literature promotes the procedure as effective for the treatment of AIDS, Epstein Barr Virus and cancer, by cleansing the blood. A video tape, entitled New Frontiers in Molecular Biology Life Crystal Capturing the Sun promotes use of these products and is narrated by Dr. Merkl, who is also the President of                                                                 ; 7/6/1994

65 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Life Crystals, Oral 32oz; Life Crystals, 5 cc I.V; Chondriana, 6 cc I.V.; Immumostin LV047; Note: All the above products are reported to be used in a treatment regimen promoted by The Total Wellness Centers, one of which is operated by Dr. Ravi Devgan. Available literature promotes the procedure as effective for the treatment of AIDS, Epstein Barr Virus and cancer, by cleansing the blood. A video tape, entitled New Frontiers in Molecular Biology Life Crystal Capturing the Sun promotes use of these products and is narrated by Dr. Merkl, who is also the President of                                                                 ; 7/6/1994

66 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Life Crystals, Oral 32oz; Life Crystals, 5 cc I.V; Chondriana, 6 cc I.V.; Immumostin LV047; Note: All the above products are reported to be used in a treatment regimen promoted by The Total Wellness Centers, one of which is operated by Dr. Ravi Devgan. Available literature promotes the procedure as effective for the treatment of AIDS, Epstein Barr Virus and cancer, by cleansing the blood. A video tape, entitled New Frontiers in Molecular Biology Life Crystal Capturing the Sun promotes use of these products and is narrated by Dr. Merkl, who is also the President of                                                                 ; 7/6/1994

Rhema Health Products Limited
Date Published : 07/16/2013
1751 Brigantine Dr , Coquitlam, British Columbia CANADA
25 Y - - 99 Vegetable & Vegetable Products Not Mentioned Elsewhere, N.E.C.
Date Published: 07/16/2013

Desc: Leafgreens w/broccoli powder
Notes: canada

Ropack, Inc. (Site A & B)
Date Published : 09/30/2009
10801 Mirabeau St , Anjou, Quebec CANADA
54 A - - 99 Vitamin, N.E.C.
Date Published: 09/30/2009

Notes: Preventac Tablets, PremeTab, SomaTac, UriTab Caplets; Packer and shipper for Formulex; Canada 5/19/2000

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: Preventac Tablets, PremeTab, SomaTac, UriTab Caplets; Packer and shipper for Formulex; Canada 5/19/2000

60 L A A 05 Aspirin (Analgesic), Human - Non/Rx Single Ingredient, Prompt Release Tablets
Date Published: 09/16/2019

Desc: Preventac Tablets PremeTab SomaTac UriTab Caplets
Notes: Packer and shipper for Formulex; Canada 5/19/2000

60 L B A 05 Aspirin (Analgesic), Human - Non/Rx Combination Ingredient, Prompt Release Tablets
Date Published: 09/16/2019

Desc: Preventac Tablets PremeTab SomaTac UriTab Caplets
Notes: Packer and shipper for Formulex; Canada 5/19/2000

Ross Healthcare Inc.
Date Published : 05/01/2015
6-1520 Cliveden Ave , Delta, British Columbia CANADA
63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic)
Date Published: 05/01/2015

Desc: PCxx One Minute Topical Fluoride Foam

Rx Resources Inc.
Date Published : 09/30/2009
Box 11 Group, 100 Rr2 , Lorette Roa Oyo , Manitoba, CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 08/20/2020

Desc: Abarelix
Notes:                          

64 R - - 21 Somatropin (Hormone)
Date Published: 08/20/2020

Notes:                          

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                          

SPC Inc
Date Published : 09/30/2009
2446 Bank Street, Suite 424 , Ottawa, ON CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2009

Notes: 3/27/2008. Dietary Supplement for Restless Legs.

STAY WYLD ORGANICS LTD
Date Published : 07/18/2022
1911 Hwy 99 , Pemberton, BC CANADA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/18/2022

Desc: Chaga Powder

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/18/2022

Desc: Turkey Tail Powder

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/18/2022

Desc: Turkey Tail Capsules

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/18/2022

Desc: Immunity Boost Capsules

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/18/2022

Desc: Lion's Mane Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/18/2022

Desc: Chaga Powder

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/18/2022

Desc: Turkey Tail Powder

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/18/2022

Desc: Turkey Tail Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/18/2022

Desc: Immunity Boost Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/18/2022

Desc: Lion's Mane Capsules

Serotril Sciences, International
Date Published : 09/30/2009
125A-1030 Denman Street , Suite 100 , Vancouver, BC CANADA
54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 12/03/2019

Desc: Serotril
Notes: Serotril Active ingredient is Hypercum perforatum which is St. Johns Wort.; CDER has determined that this product is being promoted as an alternative to prescription drugs such as Fen-Phen and Imipramine and is intended to treat obesity and depression and claims to correct the biochemical cause of weight loss. The product is described as an MAO Inhibitor. MAO inhibitors are a class of anti-depressants which can pose health risks to patients if cetain dietary restrictions are not observed during therapy.; 2/9/1999

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/03/2019

Desc: Serotril
Notes: Serotril Active ingredient is Hypercum perforatum which is St. Johns Wort.; CDER has determined that this product is being promoted as an alternative to prescription drugs such as Fen-Phen and Imipramine and is intended to treat obesity and depression and claims to correct the biochemical cause of weight loss. The product is described as an MAO Inhibitor. MAO inhibitors are a class of anti-depressants which can pose health risks to patients if cetain dietary restrictions are not observed during therapy.; 2/9/1999

Sigan Industries Inc.
Date Published : 08/09/2010
296 Orenda Rd , Brampton, Ontario CANADA
53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 03/08/2022

Desc: Nugain Hair Regrowth Formula
Notes: Product label lists ingredient kopexil which is unapproved in the US and makes hair growth claims. Published on 08/01/2014

55 Q - - 64 Propylene Glycol (Pharmaceutic Necessity - Solvent)
Date Published: 03/08/2022

Desc: Nugain Hair Regrowth Formula
Notes: Product label lists ingredient kopexil which is unapproved in the US and makes hair growth claims. Published on 08/01/2014

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/08/2022

Desc: Nugain Hair Regrowth Formula
Notes: Product label lists ingredient kopexil which is unapproved in the US and makes hair growth claims. Published on 08/01/2014

Sino Pharmaceuticals Corporation
Date Published : 04/02/2012
Unit 152 - 11782 River Road , Richmond, CA-BC CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/02/2012

Desc: Flu-X Oral Spray
Notes: Canada

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/02/2012

Desc: Flu-X Oral Spray
Notes: Canada

Skoah Distribution Inc
Date Published : 10/04/2013
1547 Venables St , Vancouver, BC CANADA
53 G - - 05 Lipstick (Makeup Preparations, not for Eyes)
Date Published: 02/17/2016

Desc: Skoah Lip Dip 30 (Lip Balm)

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/04/2013

Desc: Skoah Skin Boost Serum
Notes: structure/function claims found on package labeling and website.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/04/2013

Desc: Skoah Gold Serum
Notes: structure/function claims found on package labeling and website.

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 01/13/2014

Desc: Kalm Down Mask

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 02/17/2016

Desc: Skoah Lip Dip 30 (Lip Balm)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/04/2013

Desc: Skoah Gold Serum
Notes: structure/function claims found on package labeling and website.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/04/2013

Desc: Skoah Skin Boost Serum
Notes: structure/function claims found on package labeling and website.

Solaris Worldwide
Date Published : 09/30/2009
1364 Cliveden Ave. , Delta, BC CANADA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                                 

Sosen Usa Inc
Date Published : 03/11/2016
1286 Mill St , Montreal, Quebec CANADA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/11/2016

Desc: Jouviance Restructiv Collagen Boost-Needle Free Wrinkle Filler
Notes: Problem(s); Claims on product label and on firm's website

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/11/2016

Desc: Jouviance Restructiv Collagen Boost-Needle Free Wrinkle Filler
Notes: Problem(s); Claims on product label and on firm's website

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 03/11/2016

Desc: Jouviance Restructiv Collagen Boost-Needle Free Wrinkle Filler
Notes: Problem(s); Claims on product label and on firm's website

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 03/11/2016

Desc: Jouviance Restructiv Collagen Boost-Needle Free Wrinkle Filler
Notes: Problem(s); Claims on product label and on firm's website

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 03/11/2016

Desc: Jouviance Restructiv Collagen Boost-Needle Free Wrinkle Filler
Notes: Problem(s); Claims on product label and on firm's website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/11/2016

Desc: Jouviance Restructiv Collagen Boost-Needle Free Wrinkle Filler
Notes: Problem(s); Claims on product label and on firm's website

Stephen Health Agency
Date Published : 06/22/2010
1600 Bedford Highway , Bedford, NS CANADA
54 H - - 05 Omega-3 (Fats and Lipid Substances)
Date Published: 06/22/2010

Desc: Med Marijuana (Cannabis Sativa Seed Oil)
Notes: Canada

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/22/2010

Desc: Med Marijuana (Cannabis Sativa Seed Oil)
Notes: Canada

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/22/2010

Desc: Med Marijuana (Cannabis Sativa Seed Oil)
Notes: Canada

Stephen Health Agency
Date Published : 06/22/2010
93 Orchard Dr , Middle Sackville, NS CANADA
54 H - - 05 Omega-3 (Fats and Lipid Substances)
Date Published: 06/22/2010

Desc: Med Marijuana (Cannabis Sativa Seed Oil)
Notes: Canada

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/22/2010

Desc: Med Marijuana (Cannabis Sativa Seed Oil)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/22/2010

Desc: Med Marijuana (Cannabis Sativa Seed Oil)

Sun Labs LTD
Date Published : 09/30/2009
17-7000 McLeod Road , Niagara Falls , Niagara Falls, ON CANADA
60 C - - 22 Ephedrine HCl (Adrenergic)
Date Published: 09/30/2009

Notes: 9/16/1997

Swiss Medica, Inc
Date Published : 09/16/2019
53 Yonge Street, 3rd Floor , Toronto, ON CANADA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/16/2019

Notes: Essential Oil Pain Neutralizer 024 Fibromyalgia;                                   ; 11/1/2006

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Essential Oil Pain Neutralizer 024 Fibromyalgia;                                   ; 11/1/2006

61 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Essential Oil Pain Neutralizer 024 Fibromyalgia;                                   ; 11/1/2006

62 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Essential Oil Pain Neutralizer 024 Fibromyalgia;                                   ; 11/1/2006

63 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Essential Oil Pain Neutralizer 024 Fibromyalgia;                                   ; 11/1/2006

64 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Essential Oil Pain Neutralizer 024 Fibromyalgia;                                   ; 11/1/2006

65 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Essential Oil Pain Neutralizer 024 Fibromyalgia;                                   ; 11/1/2006

66 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Essential Oil Pain Neutralizer 024 Fibromyalgia;                                   ; 11/1/2006

TAB LABS INC
Date Published : 03/06/2024
19720 94a Ave Unit D107 , Langley, British Columbia CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/06/2024

Desc:       The Original Oral Irritation Chewing Gum

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/06/2024

Desc:       The Original Oral Irritation Chewing Gum

TAME
Date Published : 09/30/2009
404-250 Mcdermont Avenue , Winnipeg , Manitobal, CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 06/24/2020

Desc: Abarelix
Notes:                               

64 R - - 21 Somatropin (Hormone)
Date Published: 06/24/2020

Notes:                               

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                                

TCE Group
Date Published : 09/30/2009
Amr Bannis, 50 Heathcote Avenue , Toronto , North York, ON CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 09/30/2009

Notes: Abarelix;                          

64 R - - 21 Somatropin (Hormone)
Date Published: 09/09/2020

Notes:                          

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                          

Taro Pharmaceuticals Inc.
Date Published : 01/13/2012
130 East Dr , Brampton, Ontario CANADA
63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 01/13/2012

Desc: Lustra Hydroquinone USP 4%
Notes: canada

The Candy Tree
Date Published : 05/21/2012
112,1220-28 Street Ne , Calgary, AB CANADA
33 A - - 06 Flavored Candy, Hard (Live Savers, Etc.), with Nuts or Nut Products (not Coconut or Suckers)(without
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: canada

33 E - - 06 Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: canada

33 E - - 11 Mint Candy, Hard, without Nuts and Fruit (without Chocolate)
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: canada

33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: canada

33 S - - 06 Lollipop (without Chocolate)
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: canada

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: canada

34 F - - 08 Chocolate Suckers and Novelties, without Nuts and Fruit
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: canada

60 Q - - 56 Benzocaine (Anesthetic)
Date Published: 05/21/2012

Desc: Oral Sex Lollipops (Various Flavors)
Notes: canada

The Herb House
Date Published : 08/09/2019
3232 Eglinton Avenue , Scarborough, ON CANADA
31 - - - -- Coffee/Tea
Date Published: 08/09/2019

Desc: Essiac

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/09/2019

Desc: Essiac

66 - - - -- Human and Animal Drugs
Date Published: 08/09/2019

Desc: Essiac

The U.P.P. Group
Date Published : 09/30/2009
74 Perry Drive , Sylvan Lake , Sylvan Lake, AB CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 06/24/2020

Desc: Abarelix
Notes:                                          

64 R - - 21 Somatropin (Hormone)
Date Published: 06/24/2020

Notes:                                          

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 06/24/2020

Notes:                                          

The Winning Combination Inc.
Date Published : 09/11/2013
1099 Wilkes Ave Unit 6 , Winnipeg, Manitoba CANADA
60 C - - 21 Ephedrine (Adrenergic)
Date Published: 09/11/2013

Desc: Ephedrine HCL

60 C - - 22 Ephedrine HCl (Adrenergic)
Date Published: 09/11/2013

Desc: Ephedrine HCL

The Wolfe Clinic
Date Published : 09/13/2019
5 Scotsville Road , Inverness, NS CANADA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/13/2019

Notes: Super Concentrated Aloe Vera WLA 132 C-Max; Coral Calcium & Coral Calcium Gold Cesium Calcium; Pro-Max; Pak-of-Life; 12/17/1997

Total Body Care Inc
Date Published : 02/09/2016
120a Van Kirk Dr , Brampton, Ontario CANADA
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 02/09/2016

Desc: Diabetics Dry skin lotion with Intensive Moisturizers

61 P - - 99 Anti-Diabetic N.E.C.
Date Published: 02/09/2016

Desc: Diabetics Dry skin lotion with Intensive Moisturizers

Total Wellness Center
Date Published : 09/13/2019
21219 Woodbine Avenue , R.R.1 , Queensville, ON CANADA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: Organotherapy - (Live Cell Fractions Therapy) Car-T-Cell (Shark cartilage) Natcell M - mesenchyme, Natcell C - cerebrum, Natcell T - thymus; 7/6/1994

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Organotherapy - (Live Cell Fractions Therapy) Car-T-Cell (Shark cartilage) Natcell M - mesenchyme, Natcell C - cerebrum, Natcell T - thymus; 7/6/1994

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Organotherapy - (Live Cell Fractions Therapy) Car-T-Cell (Shark cartilage) Natcell M - mesenchyme, Natcell C - cerebrum, Natcell T - thymus; 7/6/1994

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Organotherapy - (Live Cell Fractions Therapy) Car-T-Cell (Shark cartilage) Natcell M - mesenchyme, Natcell C - cerebrum, Natcell T - thymus; 7/6/1994

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Organotherapy - (Live Cell Fractions Therapy) Car-T-Cell (Shark cartilage) Natcell M - mesenchyme, Natcell C - cerebrum, Natcell T - thymus; 7/6/1994

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Organotherapy - (Live Cell Fractions Therapy) Car-T-Cell (Shark cartilage) Natcell M - mesenchyme, Natcell C - cerebrum, Natcell T - thymus; 7/6/1994

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Organotherapy - (Live Cell Fractions Therapy) Car-T-Cell (Shark cartilage) Natcell M - mesenchyme, Natcell C - cerebrum, Natcell T - thymus; 7/6/1994

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Organotherapy - (Live Cell Fractions Therapy) Car-T-Cell (Shark cartilage) Natcell M - mesenchyme, Natcell C - cerebrum, Natcell T - thymus; 7/6/1994

True Form Packaging Inc
Date Published : 02/14/2017
9160 Yellowhead Trail NW , Edmonton, Alberta CANADA
54 A - - 99 Vitamin, N.E.C.
Date Published: 02/14/2017

Desc: VigRX for Men

54 A - - 99 Vitamin, N.E.C.
Date Published: 08/20/2020

Desc: Flush the Fat with Internal Flush- Dietary Supplement
Notes: 5/25/2016

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/20/2020

Desc: Flush the Fat with Internal Flush- Dietary Supplement
Notes: 5/25/2016

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/20/2020

Desc: VigRX for Men

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/20/2020

Desc: Flush the Fat with Internal Flush- Dietary Supplement
Notes: 5/25/2016

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/14/2017

Desc: VigRX for Men

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/14/2017

Desc: VigRX for Men

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/20/2020

Desc: Flush the Fat with Internal Flush- Dietary Supplement
Notes: 5/25/2016

Unique Seafarms ltd.
Date Published : 09/30/2009
3145 Headland Rd , Nanaimo, British Columbia CANADA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: Marune Phytoplankton. Core Marine Phytoplankton. Capsules % Liquid. 5/3/2006.

United Research Center
Date Published : 09/13/2019
1414 Place Bonaventure , Montreal, QC CANADA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/13/2019

Desc: OTC Transdermal Patches For Weight Control
Notes: Nicotine transdermal patch drug products are now acceptable for OTC marketing via approved NDA's; Note: One firm in Canada has been identified as currently promoting such patches-United Research Center, 1414 Place Bonaventure, Montreal, Quebec, Canada, H5A 1H3 (FEI #1000595188, MID #XQUNIRES1414MON) under the name of "The Svelt Patch")

Universal Needs SJ Inc
Date Published : 09/30/2009
Po Box 370 , 1250 University St. , Montreal, Quebec, CANADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 08/20/2020

Desc: Abarelix
Notes:                               

64 R - - 21 Somatropin (Hormone)
Date Published: 08/20/2020

Notes:                               

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                               

Urist Cosmetics Inc
Date Published : 09/30/2011
1167-11871 Horseshoe Way , Richmond, British Columbia CANADA
53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 10/04/2012

Desc: Procerin XT Topical Activator Foam Scalp Serum

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/30/2011

Desc: Pereppe Skin Brightening Cream

63 V - - 99 Depigmentor N.E.C.
Date Published: 09/13/2019

Desc: Pereppe Skin Brightening Cream
Notes: 9/30/2011

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/04/2012

Desc: Procerin XT Topical Activator Foam Scalp Serum

Valeant Canada Consumer Products
Date Published : 07/11/2014
35 Fulton Way , Richmond Hill, ON CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/11/2014

Desc: COLD-FX EXTRA
Notes: COLD-FX Extra Label: Clinically proven to reduce FREQUENCY, SEVERITY, DURATION of cold and flu symptoms and CVT-E002 is scientifically proven to provide health benefits by enhancing the immune system's viral-fighting Natural Killer cells and Macrophages. Also, product website is making multiple curative claims.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/11/2014

Desc: COLD-FX
Notes: COLD-FX Label; Clinically proven to reduce FREQUENCY, SEVERITY, DURATION of cold and flu symptoms and CVT-E002 is scientifically proven to provide health benefits by enhancing the immune system's viral-fighting Natural Killer cells and Macrophages. Also; product website is making multiple curative claims.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/11/2014

Desc: COLD-FX
Notes: COLD-FX Label; Clinically proven to reduce FREQUENCY, SEVERITY, DURATION of cold and flu symptoms and CVT-E002 is scientifically proven to provide health benefits by enhancing the immune system?s viral-fighting Natural Killer cells and Macrophages. Also; product website is making multiple curative claims.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/11/2014

Desc: COLD-FX EXTRA
Notes: COLD-FX EXTRA Label; Clinically proven to reduce FREQUENCY, SEVERITY, DURATION of cold and flu symptoms and CVT-E002 is scientifically proven to provide health benefits by enhancing the immune system's viral-fighting Natural Killer cells and Macrophages. Also; product website is making multiple curative claims.

Vimex Pharma Inc
Date Published : 09/30/2009
21951 Vanneck Rd , Ilderton, ON CANADA
63 V - - 99 Depigmentor N.E.C.
Date Published: 09/30/2009

Notes: 3/13/2008                   Hiruval Cream 35

Virage Sante inc.
Date Published : 11/05/2019
690 Perreault St , ROMUALD , Levis, Quebec CANADA
31 - - - -- Coffee/Tea
Date Published: 11/05/2019

Desc: Lalma Easy Lax Tea Bags
Notes: The product appears to be an unapproved new drug as the product's promotional website and product labeling include claims such as: '...[H]erbal tea produces a laxative action...; ...[R]elieves constipation...'.

31 - - - -- Coffee/Tea
Date Published: 11/05/2019

Desc: Lalma Eliminante Easy Lax Tea Bags
Notes: The product appears to be an unapproved new drug as the product's promotional website and product labeling include claims such as: '...Herbal tea effectively and safely relieves constipation by exerting a laxative action of the intestinal tract...; ... Eliminante is a laxative herbal tea for people who do not have a regular intestinal transit...'.

31 - - - -- Coffee/Tea
Date Published: 11/05/2019

Desc: Lalma Easy Lax Max Tea Bags
Notes: The product appears to be an unapproved new drug as the product's promotional website and product labeling include claims such as: '...Is a laxative infusion that relieves constipation...; ...[R]elieves constipation...'.

31 - - - -- Coffee/Tea
Date Published: 11/05/2019

Desc: Lalma Digestive Tea Bags
Notes: The product appears to be an unapproved new drug as the product's promotional website and product labeling include claims such as: '...[H]elps relieve mild digestion disturbances (such as dyspepsia)...; ...helps relieve inflammatory conditions...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 11/05/2019

Desc: Lalma Easy Lax Tea Bags
Notes: The product appears to be an unapproved new drug as the product's promotional website and product labeling include claims such as: '...[H]erbal tea produces a laxative action...; ...[R]elieves constipation...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 11/05/2019

Desc: Lalma Easy Lax Max Tea Bags
Notes: The product appears to be an unapproved new drug as the product's promotional website and product labeling include claims such as: '...Is a laxative infusion that relieves constipation...; ...[R]elieves constipation...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 11/05/2019

Desc: Lalma Digestive Tea Bags
Notes: The product appears to be an unapproved new drug as the product's promotional website and product labeling include claims such as: '...[H]elps relieve mild digestion disturbances (such as dyspepsia)...; ...helps relieve inflammatory conditions...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 11/05/2019

Desc: Lalma Eliminante Easy Lax Tea Bags
Notes: The product appears to be an unapproved new drug as the product's promotional website and product labeling include claims such as: '...Herbal tea effectively and safely relieves constipation by exerting a laxative action of the intestinal tract...; ... Eliminante is a laxative herbal tea for people who do not have a regular intestinal transit...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/05/2019

Desc: Lalma Eliminante Easy Lax Tea Bags
Notes: The product appears to be an unapproved new drug as the product's promotional website and product labeling include claims such as: '...Herbal tea effectively and safely relieves constipation by exerting a laxative action of the intestinal tract...; ... Eliminante is a laxative herbal tea for people who do not have a regular intestinal transit...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/05/2019

Desc: Lalma Digestive Tea Bags
Notes: The product appears to be an unapproved new drug as the product's promotional website and product labeling include claims such as: '...[H]elps relieve mild digestion disturbances (such as dyspepsia)...; ...helps relieve inflammatory conditions...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/05/2019

Desc: Lalma Easy Lax Tea Bags
Notes: The product appears to be an unapproved new drug as the product's promotional website and product labeling include claims such as: '...[H]erbal tea produces a laxative action...; ...[R]elieves constipation...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/05/2019

Desc: Lalma Easy Lax Max Tea Bags
Notes: The product appears to be an unapproved new drug as the product's promotional website and product labeling include claims such as: '...Is a laxative infusion that relieves constipation...; ...[R]elieves constipation...'.

Viva Pharmaceutical Inc
Date Published : 05/10/2017
13880 Viking Pl , Richmond, British Columbia CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/10/2017

Desc: Puralor Ci Tablets
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'Puralor Ci' is…formulated to improve the nutritional status of patients with anemias of nutritional origin – specifically folate malabsorption as determined by a licensed medical practitioner, and is associated with metabolic imbalances in transformylation biochemistry. Particular emphasis is on hyperhomocysteinemia – with or without a primary disease state…; Folate is effective in the treatment of hyperhomocysteinemia and/or megaloblastic anemias (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, childhood or other related folate-malabsorption, complications of an inborn or environmental origin…'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/10/2017

Desc: Puralor Ci Tablets
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'Puralor Ci' is…formulated to improve the nutritional status of patients with anemias of nutritional origin – specifically folate malabsorption as determined by a licensed medical practitioner, and is associated with metabolic imbalances in transformylation biochemistry. Particular emphasis is on hyperhomocysteinemia – with or without a primary disease state…; Folate is effective in the treatment of hyperhomocysteinemia and/or megaloblastic anemias (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, childhood or other related folate-malabsorption, complications of an inborn or environmental origin…'.

Voyant Beauty, Inc.
Date Published : 12/09/2011
2000 Kipling Ave , Etobicoke, Ontario CANADA
62 M - - 99 Anti-Pruritic N.E.C.
Date Published: 12/09/2011

Desc: Cortaid (Poison Ivy Removal Scrub)
Notes: canada

WIN IN HEALTH
Date Published : 01/10/2017
224 Bellehumeur St , Gatineau, Quebec CANADA
53 L - - -- Skin Care Prep
Date Published: 01/10/2017

Desc: Solugel Fisiocrem

62 M - - 99 Anti-Pruritic N.E.C.
Date Published: 01/10/2017

Desc: Solugel Fisiocrem

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/10/2017

Desc: Solugel Fisiocrem

Wellness Pharmacy
Date Published : 08/09/2019
884 Portage Avenue , Winnipeg, MB CANADA
31 - - - -- Coffee/Tea
Date Published: 08/09/2019

Desc: Essiac

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/09/2019

Desc: Essiac

66 - - - -- Human and Animal Drugs
Date Published: 08/09/2019

Desc: Essiac

Whistler Naturals
Date Published : 05/16/2014
2122 Timber Ridge , Whistler, BC CANADA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 05/16/2014

Desc: Lemongrass Green Tea Tonic

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 05/16/2014

Desc: Coconut Lime Balancing Cleanser

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/19/2014

Desc: Mandarin & Organic Shea Revitalizing Body Lotion

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 05/16/2014

Desc: Sugar Apple Renewal Masque

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 05/19/2014

Desc: Hibiscus Miracle Eye Lift & Wrinkle Treatment

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/16/2014

Desc: Sugar Apple Renewal Masque

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/16/2014

Desc: Mandarin & Organic Shea Revitalizing Body Lotion

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/19/2014

Desc: Hibiscus Miracle Eye Lift & Wrinkle Treatment

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/16/2014

Desc: Lemongrass Green Tea Tonic

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/16/2014

Desc: Coconut Lime Balancing Cleanser

Wings International Marketing, Ltd.
Date Published : 09/30/2009
6595 Herry Road , Vernon, BC CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: Wings Heartdrop Furniture Herbal Tinture 9/30/2004

Wn Pharmaceuticals
Date Published : 02/24/2015
2000 Brigantine Dr , Coquitlam, British Columbia CANADA
54 A - - 99 Vitamin, N.E.C.
Date Published: 10/27/2015

Desc: Osteo Joint Ease
Notes: Product labels made medical claims.

54 Y - - 08 Coenzyme Q10 (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 02/24/2015

Desc: Omega -3 & CoQ10 with Plant Sterols

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/24/2015

Desc: Omega -3 & CoQ10 with Plant Sterols

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/21/2016

Desc: Glucosamine and Chondroitin Sulfate
Notes: Medical claims on product label/ website

55 P - - 01 Glucosamine (Pharmaceutic Necessity)
Date Published: 06/21/2016

Desc: Glucosamine and Chondroitin Sulfate
Notes: Medical claims on product label/ website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/21/2016

Desc: Glucosamine and Chondroitin Sulfate
Notes: Medical claims on product label/ website

Yung Sing Ent Ltd
Date Published : 09/30/2009
279 E Pender St , Richmond, BC CANADA
54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 03/16/2022

Desc: Gynostemma Pentaphylla And Evening Primrose Pills
Notes: 10/28/2005

54 H - - -- Fats and Lipid Substances
Date Published: 09/04/2019

Desc: Gynostemma Pentaphylla And Evening Primrose Pills
Notes: 10/28/2005

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 09/04/2019

Desc: Gynostemma Pentaphylla And Evening Primrose Pills
Notes: 10/28/2005

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/04/2019

Notes: Gynostemma Pentaphylla And Evening Primrose Pills ; 10/28/2005

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Gynostemma Pentaphylla And Evening Primrose Pills ; 10/28/2005

61 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Gynostemma Pentaphylla And Evening Primrose Pills ; 10/28/2005

62 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Gynostemma Pentaphylla And Evening Primrose Pills ; 10/28/2005

63 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Gynostemma Pentaphylla And Evening Primrose Pills ; 10/28/2005

64 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Gynostemma Pentaphylla And Evening Primrose Pills ; 10/28/2005

65 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Gynostemma Pentaphylla And Evening Primrose Pills ; 10/28/2005

66 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Gynostemma Pentaphylla And Evening Primrose Pills ; 10/28/2005

Zibadel Creations Inc.
Date Published : 07/20/2016
603-1550 Duchess Ave , West Vancouver, British Columbia CANADA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/20/2016

Desc: Organic Manuka Honey Skin Cream
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'For centuries honey has been used to treat variety of ailments through topical application'. In addition, websites associated with the product include claims such as: www.zibadel.com, 'Honey is one of nature's oldest folk remedies …'; and www.eczemacompany.com, 'Manuka Honey Skin Cream … creates a barrier, reduces inflammation, and fights bacteria …', 'Manuka [oil][an ingredient] and tea tree oil are praised world wide for their ability to naturally treat infections …', 'Naturally anti- inflammatory, anti-bacterial, anti-viral, and anti-septic', 'Great for eczema, psoriasis and rosacea as well as wounds, cuts, scrapes, and more', 'Helps heal and prevent bacterial infections on the skin'.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/20/2016

Desc: Organic Manuka Honey Skin Cream
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'For centuries honey has been used to treat variety of ailments through topical application'. In addition, websites associated with the product include claims such as: www.zibadel.com, 'Honey is one of nature's oldest folk remedies …'; and www.eczemacompany.com, 'Manuka Honey Skin Cream … creates a barrier, reduces inflammation, and fights bacteria …', 'Manuka [oil][an ingredient] and tea tree oil are praised world wide for their ability to naturally treat infections …', 'Naturally anti- inflammatory, anti-bacterial, anti-viral, and anti-septic', 'Great for eczema, psoriasis and rosacea as well as wounds, cuts, scrapes, and more', 'Helps heal and prevent bacterial infections on the skin'.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/20/2016

Desc: Organic Manuka Honey Skin Cream
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'For centuries honey has been used to treat variety of ailments through topical application'. In addition, websites associated with the product include claims such as: www.zibadel.com, 'Honey is one of nature's oldest folk remedies …'; and www.eczemacompany.com, 'Manuka Honey Skin Cream … creates a barrier, reduces inflammation, and fights bacteria …', 'Manuka [oil][an ingredient] and tea tree oil are praised world wide for their ability to naturally treat infections …', 'Naturally anti- inflammatory, anti-bacterial, anti-viral, and anti-septic', 'Great for eczema, psoriasis and rosacea as well as wounds, cuts, scrapes, and more', 'Helps heal and prevent bacterial infections on the skin'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/20/2016

Desc: Organic Manuka Honey Skin Cream
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'For centuries honey has been used to treat variety of ailments through topical application'. In addition, websites associated with the product include claims such as: www.zibadel.com, 'Honey is one of nature's oldest folk remedies …'; and www.eczemacompany.com, 'Manuka Honey Skin Cream … creates a barrier, reduces inflammation, and fights bacteria …', 'Manuka [oil][an ingredient] and tea tree oil are praised world wide for their ability to naturally treat infections …', 'Naturally anti- inflammatory, anti-bacterial, anti-viral, and anti-septic', 'Great for eczema, psoriasis and rosacea as well as wounds, cuts, scrapes, and more', 'Helps heal and prevent bacterial infections on the skin'.


CHILE


Cosmetica Nacional Ltda.
Date Published : 03/11/2011
3830 Vargas Fontecilla , Santiago, CHILE
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/11/2011

Desc: Facial Wrinkle Treatment Elixir de Helix Aspersa Caracol
Notes: Chile

Cosmeticos Elicina LTDA.
Date Published : 03/04/2016
Padre Orellana 1319 , Santiago, CHILE
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/04/2016

Desc: ELICINA CREAM
Notes: Productlabels made medical and/or structure and functional claims.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/04/2016

Desc: ELINCINA EYE CREAM
Notes: Productlabels made medical and/or structure and functional claims.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/04/2016

Desc: ELINCINA EYE CREAM
Notes: Productlabels made medical and/or structure and functional claims.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/04/2016

Desc: ELICINA CREAM
Notes: Productlabels made medical and/or structure and functional claims.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 03/04/2016

Desc: ELICINA CREAM
Notes: Productlabels made medical and/or structure and functional claims.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 03/04/2016

Desc: ELINCINA EYE CREAM
Notes: Productlabels made medical and/or structure and functional claims.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 03/04/2016

Desc: ELINCINA EYE CREAM
Notes: Productlabels made medical and/or structure and functional claims.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 03/04/2016

Desc: ELICINA CREAM
Notes: Productlabels made medical and/or structure and functional claims.

Lacofar y CIA Ltda.
Date Published : 03/04/2016
Emiliano Figueroa 851 , Santiago, CHILE
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/04/2016

Desc: ELICINA CREAM
Notes: Product labels made medical and/or structure and functional claims.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/04/2016

Desc: ELINCINA EYE CREAM
Notes: Product labels made medical and/or structure and functional claims.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/04/2016

Desc: ELICINA CREAM
Notes: Product labels made medical and/or structure and functional claims.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/04/2016

Desc: ELINCINA EYE CREAM
Notes: Product labels made medical and/or structure and functional claims.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 03/04/2016

Desc: ELINCINA EYE CREAM
Notes: Product labels made medical and/or structure and functional claims.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 03/04/2016

Desc: ELICINA CREAM
Notes: Product labels made medical and/or structure and functional claims.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 03/04/2016

Desc: ELINCINA EYE CREAM
Notes: Product labels made medical and/or structure and functional claims.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 03/04/2016

Desc: ELICINA CREAM
Notes: Product labels made medical and/or structure and functional claims.


CHINA


AFRICAN DUORONZI MEDICINE NATIONS GROUP
Date Published : 06/30/2015
JIANSHE ROAD #168 AFFILIATOD #10 , NEIMENGGU CITY, CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/30/2015

Desc: African Superman Tablets
Notes: FDA analysis of product found product contains undeclared Sildenafil

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 06/30/2015

Desc: African Superman Tablets
Notes: FDA analysis of product found product contains undeclared Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/30/2015

Desc: African Superman Tablets
Notes: FDA analysis of product found product contains undeclared Sildenafil

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 06/30/2015

Desc: African Superman Tablets
Notes: FDA analysis of product found product contains undeclared Sildenafil

Ajiao Toothbrush Firm
Date Published : 03/27/2023
H1-0353 Shop, Huan Yuan Market , China Commodity City , Yiwu City, Zhejiang CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Cresent Cavity Fighting toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 10/09/2007

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: Cresent Cavity Fighting toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 10/09/2007

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: Cresent Cavity Fighting toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 10/09/2007

Anhui Santi Medical & Health Products
Date Published : 07/27/2015
118 Mengbanglu , Mengcheng, Anhui Province, CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/27/2015

Desc: Santi Scalper Penis Erection Capsule

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 07/27/2015

Desc: Santi Scalper Penis Erection Capsule

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/27/2015

Desc: Santi Scalper Penis Erection Capsule

BATH CONCEPT COSMETICS (DONGGUAN
Date Published : 10/23/2023
No. 20 Dushang North Ro , District, Do , Wanjiang, CHINA
60 Q - - 99 Anesthetic, N.E.C.
Date Published: 10/23/2023

Desc: Hero Climax Control Gel

60 Q - - 99 Anesthetic, N.E.C.
Date Published: 10/23/2023

Desc: Pro Delay Gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/23/2023

Desc: Hero Climax Control Gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/23/2023

Desc: Pro Delay Gel

BEIJING LIDAMEIZI S&T DEVELOPMENT CO., LTD
Date Published : 09/30/2009
Room1001, Building D, YONGHE plaza, 28 , East street, Andingmen, Dongcheng Distri , Beijing, Beijingshi CHINA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/13/2019

Notes: Slimming Capsules 2/18/09

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: Slimming Capsules 2/18/09

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: Slimming Capsules 2/18/09

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: Slimming Capsules 2/18/09

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: Slimming Capsules 2/18/09

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: Slimming Capsules 2/18/09

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: Slimming Capsules 2/18/09

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: Slimming Capsules 2/18/09

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: Slimming Capsules 2/18/09

BILL YUAN
Date Published : 01/27/2017
Tangdong Hongyi Buniess , Tianhe Guangchang , Guangzhou, Guangdong CHINA
53 - - - -- Cosmetics
Date Published: 01/27/2017

Desc: L'VANAH NATURALS Essential Oil
Notes: The product contains six types of essential oils. DWPE under this listing applies to the following five essential oils: Lemongrass, Peppermint, Eucalyptus, Lavender, and Tea Tree. The Sweet Orange essential oil included in the product is not subject to DWPE under this listing.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/27/2017

Desc: L'VANAH NATURALS Essential Oil
Notes: The product contains six types of essential oils. DWPE under this listing applies to the following five essential oils: Lemongrass, Peppermint, Eucalyptus, Lavender, and Tea Tree. The Sweet Orange essential oil included in the product is not subject to DWPE under this listing.

BINGO HAIR COSMETICS MANUFACTURE LTD
Date Published : 10/27/2016
Hengkeng Ind Park NO 15 , Xiusheng Rd , Guangzhou, Guangdong CHINA
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 12/23/2016

Desc: Liquid Diamond Hair Regrowth

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 02/26/2018

Desc: Bingo Care Mineral Revitalizing Hair Masque

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 02/26/2018

Desc: Bingo Care Botanical Hair Treatment

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 02/26/2018

Desc: Antihair Loss Shampoo Chinese Herb Essence For Men

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 02/26/2018

Desc: Antidandruff Shampoo Chinese Herb Essence For Women

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 03/21/2020

Desc: Ultra Rich Care Sulfate Free Argan Oil Shampoo
Notes: The product appears to be an unapproved new drug, as defined in section 201(p) of the Act, for making representations that they are intended for use in the cure, mitigation, treatment, or prevention of disease or is intended to affect the structure or function of the body without having an effective new drug application. Statements of intended use meeting the definition of a drug that are identified in product labeling include, but are not limited to: "Control the production of dandruff and itchy scalp before symptoms appear" and "Good for: dry, dandruff, itchy and oily scalp problems". The product appears to be a new drug, as defined in section 201(p) of the Act, without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 10/17/2019

Desc: Delino Hair Thickening Shampoo
Notes: The product appears to be an unapproved new drug as the product's promotional website includes the following claims: '...[S]trength [sic] the hair follicle while naturally promote blood circulation and hair growth. It is also, specially formulated to rejuvenate the hair shaft...'.

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 02/26/2018

Desc: Antihair Loss Shampoo Chinese Herb Essence For Women

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 03/21/2020

Desc: Sulfate Free Argan Oil Shampoo
Notes: The product appears to be an unapproved new drug, as defined in section 201(p) of the Act, for making representations that they are intended for use in the cure, mitigation, treatment, or prevention of disease or is intended to affect the structure or function of the body without having an effective new drug application. Statements of intended use meeting the definition of a drug that are identified in product labeling include, but are not limited to: "Sebamed agent is an antiseptic and treats oily scalps with scales and bacteria". The product appears to be a new drug, as defined in section 201(p) of the Act, ) without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 03/21/2020

Desc: Sulfate Free Shampoo
Notes: The product appears to be an unapproved new drug, as defined in section 201(p) of the Act, for making representations that they are intended for use in the cure, mitigation, treatment, or prevention of disease or is intended to affect the structure or function of the body without having an effective new drug application. Statements of intended use meeting the definition of a drug that are identified in product labeling include, but are not limited to: "Sebamed agent is an antiseptic and treats oily scalps with scales and bacteria". The product appears to be a new drug, as defined in section 201(p) of the Act, ) without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 02/26/2018

Desc: Bingo Care Botanical Hair Treatment

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 02/26/2018

Desc: Bingo Care Mineral Revitalizing Hair Masque

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 02/26/2018

Desc: Antihair Loss Shampoo Chinese Herb Essence For Men

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 02/26/2018

Desc: Antidandruff Shampoo Chinese Herb Essence For Women

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 12/23/2016

Desc: Liquid Diamond Hair Regrowth

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 02/26/2018

Desc: Antihair Loss Shampoo Chinese Herb Essence For Women

53 E - - -- Hair Preps(Non-Coloring)
Date Published: 10/27/2016

Desc: Delino Follicle Regenerator Shampoo
Notes: The product appears to be an unapproved new drug as the product labeling and firm's website include claims such as: (PRODUCT LABEL) 'Follicle Regenerator Shampoo', 'Created for Hair Loss and Botanical Regrowth', and 'Only by using it chronically can the proper curative effect be obtained'; and (PRODUCT WEBSITE) '[P]romotes blood circulation and hair growth'.

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 10/27/2016

Desc: Delino Follicle Regenerator Shampoo
Notes: The product appears to be an unapproved new drug as the product labeling and firm's website include claims such as: (PRODUCT LABEL) 'Follicle Regenerator Shampoo', 'Created for Hair Loss and Botanical Regrowth', and 'Only by using it chronically can the proper curative effect be obtained'; and (PRODUCT WEBSITE) '[P]romotes blood circulation and hair growth'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/23/2016

Desc: Liquid Diamond Hair Regrowth

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/26/2018

Desc: Antihair Loss Shampoo Chinese Herb Essence For Men

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/26/2018

Desc: Antidandruff Shampoo Chinese Herb Essence For Women

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/21/2020

Desc: Sulfate Free Shampoo
Notes: The product appears to be an unapproved new drug, as defined in section 201(p) of the Act, for making representations that they are intended for use in the cure, mitigation, treatment, or prevention of disease or is intended to affect the structure or function of the body without having an effective new drug application. Statements of intended use meeting the definition of a drug that are identified in product labeling include, but are not limited to: "Sebamed agent is an antiseptic and treats oily scalps with scales and bacteria". The product appears to be a new drug, as defined in section 201(p) of the Act, ) without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/27/2016

Desc: Delino Follicle Regenerator Shampoo
Notes: The product appears to be an unapproved new drug as the product labeling and firm's website include claims such as: (PRODUCT LABEL) 'Follicle Regenerator Shampoo', 'Created for Hair Loss and Botanical Regrowth', and 'Only by using it chronically can the proper curative effect be obtained'; and (PRODUCT WEBSITE) '[P]romotes blood circulation and hair growth'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/17/2019

Desc: Delino Hair Thickening Shampoo
Notes: The product appears to be an unapproved new drug as the product's promotional website includes the following claims: '...[S]trength [sic] the hair follicle while naturally promote blood circulation and hair growth. It is also, specially formulated to rejuvenate the hair shaft...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/21/2020

Desc: Sulfate Free Argan Oil Shampoo
Notes: The product appears to be an unapproved new drug, as defined in section 201(p) of the Act, for making representations that they are intended for use in the cure, mitigation, treatment, or prevention of disease or is intended to affect the structure or function of the body without having an effective new drug application. Statements of intended use meeting the definition of a drug that are identified in product labeling include, but are not limited to: "Sebamed agent is an antiseptic and treats oily scalps with scales and bacteria". The product appears to be a new drug, as defined in section 201(p) of the Act, ) without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/26/2018

Desc: Bingo Care Mineral Revitalizing Hair Masque

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/26/2018

Desc: Bingo Care Botanical Hair Treatment

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/21/2020

Desc: Ultra Rich Care Sulfate Free Argan Oil Shampoo
Notes: The product appears to be an unapproved new drug, as defined in section 201(p) of the Act, for making representations that they are intended for use in the cure, mitigation, treatment, or prevention of disease or is intended to affect the structure or function of the body without having an effective new drug application. Statements of intended use meeting the definition of a drug that are identified in product labeling include, but are not limited to: "Control the production of dandruff and itchy scalp before symptoms appear" and "Good for: dry, dandruff, itchy and oily scalp problems". The product appears to be a new drug, as defined in section 201(p) of the Act, without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/26/2018

Desc: Antihair Loss Shampoo Chinese Herb Essence For Women

Bath Concept Cosmetics (DongGuan) Co., Ltd.
Date Published : 10/23/2023
No. 1 Nange 5th Road, Daojiao Town , Dongguan, Guangdong CHINA
60 Q - - 99 Anesthetic, N.E.C.
Date Published: 10/23/2023

Desc: Hero Climax Control Gel

60 Q - - 99 Anesthetic, N.E.C.
Date Published: 10/23/2023

Desc: Pro Delay Gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/23/2023

Desc: Hero Climax Control Gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/23/2023

Desc: Pro Delay Gel

Beijing Golden Herb & Health Co., Ltd.
Date Published : 09/30/2009
Beijing Chemical Technology University , 15 Beisanhuan East Road Rm.205 Huaxin Bl , Beijing, CHINA
53 - - - -- Cosmetics
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                              declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

73 - - - -- Anesthesiology
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

74 - - - -- Cardiovascular
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

76 - - - -- Dental
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

77 - - - -- Ear,Nose And Throat
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

78 - - - -- Gastroenterological & Urological
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

79 - - - -- General & Plastic Surgery
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

80 - - - -- General Hospital/Personal Use
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

84 - - - -- Neurological
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

85 - - - -- Obstetrical & Gynecological
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

86 - - - -- Ophthalmic
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

87 - - - -- Orthopedic
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

89 - - - -- Physical Medicine
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

90 - - - -- Radiology
Date Published: 09/30/2009

Notes: The product is a combination product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and the ingredients absorbed into the pad make up the drug portion). The product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and as promoted on the product's website,                               declares Bamboo Crystal Foot Plaster helps with constipation, eliminates swollen veins, helps with menstrual cramps, reduces joint pain, reduces swelling, helps with fatigue, enhances sleep as well as aid in the release of toxins through the skin.

Beijing HuaDa Indistry & Trade Co. Ltd.
Date Published : 06/18/2012
Unknown , Beijing, unknown CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/18/2012

Desc: Dream Body Slimming Capsules
Notes: China

Beijing Kowloon Pharmaceutical Factory
Date Published : 09/30/2009
No 1200 Diyang Bldg , Beijing, CHINA
66 S - - 51 Tadalafil
Date Published: 06/29/2015

Desc: Stamax Sexual Stimulant Dietary Supplement
Notes: 5/16/2005

Beijing Yasi Scientific & Technology Co., Ltd.
Date Published : 04/23/2020
Unknown , Beijing, CHINA
53 - - - -- Cosmetics
Date Published: 04/23/2020

Desc: Botulinum Toxin Types A & B

65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Botulinum Toxin Types A & B

65 Q - - 07 Myobloc
Date Published: 04/23/2020

Desc: Botulinum Toxin Types A & B

Beijing Zhangguang 101 Group
Date Published : 06/11/2013
Rm 1701 HanWei Plaza, No.7 Guanghua Road , Chaoyang District , Beijing, CHINA
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 06/11/2013

Desc: Zhangguang 101F Hair Tonic
Notes: NOTE; Beijing Zhangguang 101; Beijing; China is the manufacturer per product labels. ;

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 06/11/2013

Desc: Zhangguang 101B Formula
Notes: NOTE; Beijing Zhangguang 101; Beijing; China is the manufacturer per product labels.

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 06/11/2013

Desc: Zhangguang 101G Hair Tonic
Notes: NOTE; Beijing Zhangguang 101; Beijing; China is the manufacturer per product labels

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 06/11/2013

Desc: Zhangguang 101F Hair Tonic
Notes: NOTE; Beijing Zhangguang 101; Beijing; China is the manufacturer per product labels

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 06/11/2013

Desc: Zhangguang 101B Formula
Notes: NOTE; Beijing Zhangguang 101; Beijing; China is the manufacturer per product labels

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 06/11/2013

Desc: Zhangguang 101G Hair Tonic
Notes: NOTE; Beijing Zhangguang 101; Beijing; China is the manufacturer per product labels

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 06/11/2013

Desc: Zhangguang 101B Formula
Notes: NOTE; Beijing Zhangguang 101; Beijing; China is the manufacturer per product labels

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 06/11/2013

Desc: Zhangguang 101G Hair Tonic
Notes: NOTE; Beijing Zhangguang 101; Beijing; China is the manufacturer per product labels

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 06/11/2013

Desc: Zhangguang 101F Hair Tonic
Notes: NOTE; Beijing Zhangguang 101; Beijing; China is the manufacturer per product labels

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 06/11/2013

Desc: Zhangguang 101G Hair Tonic
Notes: NOTE; Beijing Zhangguang 101; Beijing; China is the manufacturer per product labels

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 06/11/2013

Desc: Zhangguang 101F Hair Tonic
Notes: NOTE; Beijing Zhangguang 101; Beijing; China is the manufacturer per product labels. ;

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 06/11/2013

Desc: Zhangguang 101B Formula
Notes: NOTE; Beijing Zhangguang 101; Beijing; China is the manufacturer per product labels.

Beijing yin han health products manufactory Inc
Date Published : 09/13/2019
Hao 29 Wang Xin Zhuang Zhen Le Yuan Lu , Ping Gu District , Beijing, Beijing CHINA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/13/2019

Notes: CiCi Natural Herbal Capsules 11/12/2008

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: CiCi Natural Herbal Capsules 11/12/2008

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: CiCi Natural Herbal Capsules 11/12/2008

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: CiCi Natural Herbal Capsules 11/12/2008

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: CiCi Natural Herbal Capsules 11/12/2008

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: CiCi Natural Herbal Capsules 11/12/2008

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: CiCi Natural Herbal Capsules 11/12/2008

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: CiCi Natural Herbal Capsules 11/12/2008

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: CiCi Natural Herbal Capsules 11/12/2008

Brilliant Pharma Co Ltd, ChengDu
Date Published : 05/28/2020
No. 1166 Konggang 4th Road , Chengdu, Sichuan CHINA
54 A - - 99 Vitamin, N.E.C.
Date Published: 05/28/2020

Desc: Gludin Forte- Glutathione Complex

54 A - - 99 Vitamin, N.E.C.
Date Published: 05/28/2020

Desc: L-Car Magic

54 H - - -- Fats and Lipid Substances
Date Published: 05/28/2020

Desc: Lecithin Magic

54 Y - - 02 Carnitine, Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, n.e.c.)
Date Published: 05/28/2020

Desc: L-Car Magic

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/28/2020

Desc: Gludin Forte- Glutathione Complex

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/28/2020

Desc: L-Car Magic

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/28/2020

Desc: Gludin Forte- Glutathione Complex

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/28/2020

Desc: Lecithin Magic

CHANGZHOU KAKOO TEA FOODSTUFF CO.,LTD
Date Published : 03/20/2012
Xin Zha Street Xinchang Road , Zhonglou , Changzhou, Jiangsu CHINA
31 K - - 02 Tea, Green
Date Published: 03/20/2012

Desc: Green Tea
Notes: China

CHANGZHOU KAKOO TEA FOODSTUFF CO.,LTD
Date Published : 03/20/2012
Xin Zha Street Xinchang Road , Zhonglou , Changzhou, Jiangsu CHINA
31 K - - 02 Tea, Green
Date Published: 03/20/2012

Desc: Green Tea
Notes: China

CHENGDU SANHERB BIOSCIENCE CO.,LTD
Date Published : 07/27/2016
B4-201 , NO. 88 Keyuannanlu; Wuhou , Chengdou, Sichuan CHINA
31 P - - 99 Tea Substitutes, N.E.C.
Date Published: 07/27/2016

Desc: 5HTP/5-Hydroxytryptophan (Griffonia Seed Extract)

54 A - - 99 Vitamin, N.E.C.
Date Published: 07/27/2016

Desc: 5HTP/5-Hydroxytryptophan (Griffonia Seed Extract)

54 C - - 20 L-Tryptophan (Protein)
Date Published: 07/27/2016

Desc: 5HTP/5-Hydroxytryptophan (Griffonia Seed Extract)

54 F - - 29 Yohimbe (Herbal & Botanicals, not Teas)
Date Published: 07/27/2016

Desc: Yohimbe Bark Powder (Yohimbine Hydrochloride)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/27/2016

Desc: 5HTP/5-Hydroxytryptophan (Griffonia Seed Extract)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/27/2016

Desc: 5HTP/5-Hydroxytryptophan (Griffonia Seed Extract)

Changchun Banger Bio-engineering Co., Ltd.
Date Published : 11/10/2014
Weizigou Industrial Park of Changchun , Economic Development Zone , Changchun, CHINA
60 L - - 99 Analgesic, N.E.C.
Date Published: 11/10/2014

Desc: Banger Pain-Relieving Plaster

Changzhou Meiang International Trade Co.,Ltd
Date Published : 03/11/2011
2620 15 Huangshan Rd , Changzhou, Jiangsu CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/11/2011

Desc: Rutaecarpine Root Extract Powder
Notes: China

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/11/2011

Desc: Rutaecarpine Root Extract Powder
Notes: China

55 R - - 99 Pharmaceutic Necessities, N.E.C.
Date Published: 03/11/2011

Desc: Rutaecarpine Root Extract Powder
Notes: China

Chengdu Yong Kang Pharmacy Co Lt
Date Published : 10/23/2014
118 Wing Hong Rd , Chengdu, CHINA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 10/23/2014

Desc: Strobilanthes Flaccidifolius Compound Tablets (Pre-Cold Immune Enhancement Formula)

60 - - - -- Human and Animal Drugs
Date Published: 10/23/2014

Desc: Strobilanthes Flaccidifolius Compound Tablets (Pre-Cold Immune Enhancement Formula)

62 U - - 99 Anti-Tussive/Cold N.E.C.
Date Published: 10/23/2014

Desc: Strobilanthes Flaccidifolius Compound Tablets (Pre-Cold Immune Enhancement Formula) ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/23/2014

Desc: Strobilanthes Flaccidifolius Compound Tablets (Pre-Cold Immune Enhancement Formula) ;

China National Chemicals Import & Export
Date Published : 09/30/2009
27 Chungshan Rd , Shanghai, CHINA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/13/2019

Notes: Ancom Tablets 2/12/2003

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: Ancom Tablets 2/12/2003

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets 2/12/2003

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets 2/12/2003

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets 2/12/2003

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets 2/12/2003

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets 2/12/2003

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets 2/12/2003

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets 2/12/2003

Cinogen Cosmetics (zhaoqing), Ltd.
Date Published : 01/29/2010
Shahu Road, Huanggang Town , First Duanzhou Road , Zhaoqing, Guangdong, CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/29/2010

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 01/29/2010

61 - - - -- Human and Animal Drugs
Date Published: 01/29/2010

62 - - - -- Human and Animal Drugs
Date Published: 01/29/2010

63 - - - -- Human and Animal Drugs
Date Published: 01/29/2010

64 - - - -- Human and Animal Drugs
Date Published: 01/29/2010

65 - - - -- Human and Animal Drugs
Date Published: 01/29/2010

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/29/2010

Desc: Quick Gel Hand Sanitizer

66 - - - -- Human and Animal Drugs
Date Published: 01/29/2010

Classic Import&Export
Date Published : 09/05/2014
No 1 Industrial Zone , Dongguan, CHINA
54 F - - 12 Ginseng (Herbal & Botanicals, not Teas)
Date Published: 09/05/2014

Desc: Prolongz
Notes:                                                                                                                                                                                                                                                                          

54 Y - - 04 Ginseng Unconventional Dietary Speciality for Humans or Animals
Date Published: 09/05/2014

Desc: Prolongz
Notes:                                                                                                                                                                                                                                                                              

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/05/2014

Desc: Prolongz
Notes:                                                                                                                                                                                                                                                                              

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/05/2014

Desc: Prolongz
Notes:                                                                                                                                                                                                                                                                              

DONG TIAN YANG INDUSTRIAL CO., LTD
Date Published : 01/29/2020
Lishui , Dachong Industrial District Town, Nanhai , Foshan, Guangdong CHINA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/11/2020

Desc: Whitening Mask
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.'

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/11/2020

Desc: Aloe Mask
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.'

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 05/11/2020

Desc: Aloe Mask
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.'

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 05/11/2020

Desc: Whitening Mask
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.'

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 01/29/2020

Desc: Powder Soft Mask Vitamin C Whitening
Notes: The product appears to be an unapproved new drug and is promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetics Act (FD&C Act or the Act) in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Therefore, the product must meet the regulatory requirements of both a cosmetic and a drug. The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. The product appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. Powder Soft Mask Vitamin C Whitening is subject to DWPE under Import Alert # 66-41. Shipments of this product appear to have been transmitted under various product codes to FDA; therefore, please verify the true identity of product shipments from this firm offered for entry into the US.

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 01/29/2020

Desc: Powder Soft Mask Vitamin C Whitening
Notes: The product appears to be an unapproved new drug and is promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetics Act (FD&C Act or the Act) in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Therefore, the product must meet the regulatory requirements of both a cosmetic and a drug. The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. The product appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. Powder Soft Mask Vitamin C Whitening is subject to DWPE under Import Alert # 66-41. Shipments of this product appear to have been transmitted under various product codes to FDA; therefore, please verify the true identity of product shipments from this firm offered for entry into the US.

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 05/11/2020

Desc: Whitening Mask
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.'

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 05/11/2020

Desc: Aloe Mask
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.'

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/11/2020

Desc: Whitening Mask
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.'

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 01/29/2020

Desc: Powder Soft Mask Vitamin C Whitening
Notes: The product appears to be an unapproved new drug and is promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetics Act (FD&C Act or the Act) in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Therefore, the product must meet the regulatory requirements of both a cosmetic and a drug. The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. The product appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. Powder Soft Mask Vitamin C Whitening is subject to DWPE under Import Alert # 66-41. Shipments of this product appear to have been transmitted under various product codes to FDA; therefore, please verify the true identity of product shipments from this firm offered for entry into the US.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/11/2020

Desc: Aloe Mask
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/11/2020

Desc: Whitening Mask
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/11/2020

Desc: Aloe Mask
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.'

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 01/29/2020

Desc: Powder Soft Mask Vitamin C Whitening
Notes: The product appears to be an unapproved new drug and is promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetics Act (FD&C Act or the Act) in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Therefore, the product must meet the regulatory requirements of both a cosmetic and a drug. The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. The product appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. Powder Soft Mask Vitamin C Whitening is subject to DWPE under Import Alert # 66-41. Shipments of this product appear to have been transmitted under various product codes to FDA; therefore, please verify the true identity of product shipments from this firm offered for entry into the US.

Desonic Industrial
Date Published : 09/30/2009
11 Bl Shiao 2nd In , Shenzhen, CHINA
66 B - - 44 Nicotine Delivery System
Date Published: 09/30/2009

Desc: Electronic Cigarettes and Electronic Cigarette Components
Notes: 4/6/09

66 B - - 99 Stimulant N.E.C.
Date Published: 09/30/2009

Desc: Electronic Cigarettes and Electronic Cigarette Components
Notes: 4/6/09

77 E - - PN Pump, Nebulizer, Manual
Date Published: 09/30/2009

Desc: Electronic Cigarettes and Electronic Cigarette Components
Notes: 4/6/09

77 K - - CO Inhaler, Nasal
Date Published: 09/30/2009

Desc: Electronic Cigarettes and Electronic Cigarette Components
Notes: 4/6/09

89 M - - ZX Stimulator, Electrical for smoking cessation
Date Published: 09/30/2009

Desc: Electronic Cigarettes and Electronic Cigarette Components
Notes: 4/6/09

91 D - - LC Atomizer, Tlc
Date Published: 09/30/2009

Desc: Electronic Cigarettes and Electronic Cigarette Components
Notes: 4/6/09

Fu Sung Pharmaceutaical Works
Date Published : 08/30/2021
unknown , Unknown, CHINA
66 - - - -- Human and Animal Drugs
Date Published: 08/30/2021

Desc: Huku Wan
Notes:                                                                                                                                                         

Fuzhou Cheer Trading Co. Ltd.
Date Published : 10/13/2010
Zhongshan Building , Gulow District , Fuzhou, Fujian CHINA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 10/13/2010

Desc: Playboy Viagra (Blood Tonic)
Notes: China

GL Biochem (Shanghai) Ltd
Date Published : 10/08/2013
D Shanghai 200241 China , Shanghai, Shanghai CHINA
53 - - - -- Cosmetics
Date Published: 10/08/2013

Notes: Peptide (Triptorelin) FDA analysis found undeclared Triptorelin in product

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 10/08/2013

Notes: Peptide (Triptorelin) FDA analysis found undeclared Triptorelin in product

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 10/08/2013

Notes: Peptide (Triptorelin) FDA analysis found undeclared Triptorelin in product

56 F - - 99 Peptide N.E.C.
Date Published: 09/18/2019

Desc: Melanotan (I and II)
Notes: The product is imported as non-human reseach purposes only and then the unapproved new drug is sold on internet; 4/09/2010

56 F - - 99 Peptide N.E.C.
Date Published: 09/18/2019

Desc: Dermorphin aka Chemically Synthesized Peptide -CAS # 77614-16-5
Notes: Unapproved New Drug; Misbranded; 9/16/2014

56 - - - -- Antibiotics (Human/Animal)
Date Published: 10/08/2013

Notes: Peptide (Triptorelin) FDA analysis found undeclared Triptorelin in product

57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 10/08/2013

Notes: Peptide (Triptorelin) FDA analysis found undeclared Triptorelin in product

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 10/08/2013

Notes: Peptide (Triptorelin) FDA analysis found undeclared Triptorelin in product

61 - - - -- Human and Animal Drugs
Date Published: 10/08/2013

Notes: Peptide (Triptorelin) FDA analysis found undeclared Triptorelin in product

62 - - - -- Human and Animal Drugs
Date Published: 10/08/2013

Notes: Peptide (Triptorelin) FDA analysis found undeclared Triptorelin in product

63 - - - -- Human and Animal Drugs
Date Published: 10/08/2013

Notes: Peptide (Triptorelin) FDA analysis found undeclared Triptorelin in product

64 R - - 99 Hormone N.E.C.
Date Published: 09/18/2019

Desc: Melanotan (I and II)
Notes: The product is imported as non-human research purposes only and then the unapproved new drug is sold on internet; 4/09/2010

64 - - - -- Human and Animal Drugs
Date Published: 10/08/2013

Notes: Peptide (Triptorelin) FDA analysis found undeclared Triptorelin in product

65 - - - -- Human and Animal Drugs
Date Published: 10/08/2013

Notes: Peptide (Triptorelin) FDA analysis found undeclared Triptorelin in product

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/18/2019

Desc: Dermorphin aka Chemically Synthesized Peptide -CAS # 77614-16-5
Notes: Unapproved New Drug; Misbranded; 9/16/2014

66 - - - -- Human and Animal Drugs
Date Published: 10/08/2013

Notes: Peptide (Triptorelin) FDA analysis found undeclared Triptorelin in product

68 - - - -- Animal Devices and Diagnostic Products
Date Published: 10/08/2013

Notes: Peptide (Triptorelin) FDA analysis found undeclared Triptorelin in product

75 - - - -- Chemistry
Date Published: 10/08/2013

Notes: Peptide (Triptorelin) FDA analysis found undeclared Triptorelin in product

81 - - - -- Hematology
Date Published: 10/08/2013

Notes: Peptide (Triptorelin) FDA analysis found undeclared Triptorelin in product

82 - - - -- Immunology
Date Published: 10/08/2013

Notes: Peptide (Triptorelin) FDA analysis found undeclared Triptorelin in product

83 - - - -- Microbiology
Date Published: 10/08/2013

Notes: Peptide (Triptorelin) FDA analysis found undeclared Triptorelin in product

87 - - - -- Orthopedic
Date Published: 10/08/2013

Notes: Peptide (Triptorelin) FDA analysis found undeclared Triptorelin in product

88 - - - -- Pathology
Date Published: 10/08/2013

Notes: Peptide (Triptorelin) FDA analysis found undeclared Triptorelin in product

91 - - - -- Toxicology
Date Published: 10/08/2013

Notes: Peptide (Triptorelin) FDA analysis found undeclared Triptorelin in product

GOLDCREDIT INTERNATIONAL ENTERPRISES LTD
Date Published : 03/27/2023
9/F,Wuxi National Industry Design , Liyuan Economic Dvp Zone; District , Wuxi, Jiangsu CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Cooldent fluoride/spearmint/ICE; Dr. Cool; Everfresh; Superdent toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 05/31/2007

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: Cooldent fluoride/spearmint/ICE; Dr. Cool; Everfresh; Superdent toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 05/31/2007

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: Cooldent fluoride/spearmint/ICE; Dr. Cool; Everfresh; Superdent toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 05/31/2007

GOLDCREDIT INTERNATIONAL TRADING CO., LTD.
Date Published : 03/27/2023
8-801 Haoyuan Bldg., Taihu Square , Wuxi, Jiangsu CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Clean Rite; Oralmax Extreme Action; Oral Bright spearmint; Bright Max peppermint Brand toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 05/31/2007

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: Clean Rite; Oralmax Extreme Action; Oral Bright spearmint; Bright Max peppermint Brand toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 05/31/2007

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: Clean Rite; Oralmax Extreme Action; Oral Bright spearmint; Bright Max peppermint Brand toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 05/31/2007

General Factory of Beijing Zhangguang Hair Regrowth Liniment
Date Published : 09/30/2009
725 Area 7 Jim Song Xi , Chagyang, Beijing CHINA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/27/2019

Desc: Hair Regrowth Liniment (AKA Formula 101)

Global Hotel Necessities Co., Ltd.
Date Published : 03/27/2023
Zhennan Industrial Area, , Jiujiang Town , Nanhai District Guangdong, CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Toothpaste Dental Kits
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 09/12/2007

63 R - - -- Dental Caries Prophyl
Date Published: 01/03/2024

Desc: Toothpaste Dental Kits
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 09/12/2007

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: Toothpaste Dental Kits
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 09/12/2007

Goldcredit International Enterprises
Date Published : 03/27/2023
Jincheng Road , 151 Lakebank Elegeant Gardenwest , Wuxi, Jiangsu CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Cooldent fluoride/spearmint/ICE; Dr. Cool; Everfresh; Superdent brands
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 05/31/2007

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: Cooldent fluoride/spearmint/ICE; Dr. Cool; Everfresh; Superdent brands
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 05/31/2007

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: Cooldent fluoride/spearmint/ICE; Dr. Cool; Everfresh; Superdent brands
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 05/31/2007

Goldcredit International Enterprises Ltd.
Date Published : 03/27/2023
NO. 666 Shuguang bei Road , Hangji Town , Jiangsu, CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Cooldent fluoride/spearmint/ICE; Dr. Cool; Everfresh; Superdent brands
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 05/31/2007

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: Cooldent fluoride/spearmint/ICE; Dr. Cool; Everfresh; Superdent brands
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 05/31/2007

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: Cooldent fluoride/spearmint/ICE; Dr. Cool; Everfresh; Superdent brands
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 05/31/2007

Goldendays Eco Naturalcare Pte Ltd
Date Published : 12/05/2014
N. 82, Playfair Road , #14-01, D' Lithium , Singapore, CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)- V. TAPADradiance
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)-V. TAPADmed ;
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)-V. TAPADmenstrua
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)- V. GOPAD
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)- V. TAPAD
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)-; V. TAPAD Meno
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

60 J - - 99 Ammonia Detoxicant, N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)-V. TAPADmed ;
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

60 J - - 99 Ammonia Detoxicant, N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)-V. TAPADmenstrua
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

60 J - - 99 Ammonia Detoxicant, N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)- V. GOPAD
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

60 J - - 99 Ammonia Detoxicant, N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)-; V. TAPAD Meno
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

60 J - - 99 Ammonia Detoxicant, N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)- V. TAPAD
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

60 J - - 99 Ammonia Detoxicant, N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)- V. TAPADradiance
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)-; V. TAPAD Meno
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)-V. TAPADmed ;
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)- V. GOPAD
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)-V. TAPADmenstrua
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)- V. TAPADradiance
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)- V. TAPAD
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

Guangdong Classic Health-Care Products Co. Ltd.
Date Published : 09/05/2014
XingJiang 3rd Road , Heyuan, Guangzhou CHINA
54 F - - 12 Ginseng (Herbal & Botanicals, not Teas)
Date Published: 09/05/2014

Desc: Prolongz
Notes: The referenced Prolongz product appears to be an unapproved new drug as the product labeling; insert; brochure; and corresponding websites (www.prolongz.com; www.prolongz.org; and www.amilonger.com) make claims such as; increase ejaculatory control?; for sexual dysfunction in men; longer lasting erections.

54 Y - - 04 Ginseng Unconventional Dietary Speciality for Humans or Animals
Date Published: 09/05/2014

Desc: Prolongz
Notes: The referenced Prolongz product appears to be an unapproved new drug as the product labeling; insert; brochure; and corresponding websites (www.prolongz.com; www.prolongz.org; and www.amilonger.com) make claims such as; increase ejaculatory control; for sexual dysfunction in men; longer lasting erections.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/05/2014

Desc: Prolongz
Notes: The referenced Prolongz product appears to be an unapproved new drug as the product labeling; insert; brochure; and corresponding websites (www.prolongz.com; www.prolongz.org; and www.amilonger.com) make claims such as; increase ejaculatory control; for sexual dysfunction in men; longer lasting erections.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/05/2014

Desc: Prolongz
Notes: The referenced Prolongz product appears to be an unapproved new drug as the product labeling; insert; brochure; and corresponding websites (www.prolongz.com; www.prolongz.org; and www.amilonger.com) make claims such as; increase ejaculatory control; for sexual dysfunction in men; longer lasting erections.

Guangdong T&K Pharmaceutical Factory Co., Ltd.
Date Published : 09/30/2009
48 Pujianglu , Longhu , Shantou, Guangdong CHINA
60 L - - 99 Analgesic, N.E.C.
Date Published: 09/30/2009

Notes: 9/3/2008. PainNot Patch. Claims of "Pain Relieving Patch...for temporary relief of minor aches and pains...works in 10 minutes to relieve pain..." and "relieves pain from arthritus; back; bursitus; carpal tunnel; tendonitis; sprains; strains; and more..." were during the review of labeling for the product and the internet website for the intitial distributor; Suarez Corporation. Also; review of the formulation found that it did not match the Tentative Final Monogrpah for OTC External Analgesics.

Guangdong Wellknown Ceramics Co
Date Published : 03/27/2023
Rm 917-919 Golden Eagle Bldg , Guangzhou, CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Tian Qi Toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 06/20/2007

63 R - - -- Dental Caries Prophyl
Date Published: 01/03/2024

Desc: Tian Qi Toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 06/20/2007

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: Tian Qi Toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 06/20/2007

Guangdong Wellknown Ceramics Co. Lt
Date Published : 03/27/2023
Ceramics Building No 268 Huan- , Guangzhou, CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Tian Qi Toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 06/20/2007

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: Tian Qi Toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 06/20/2007

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: Tian Qi Toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 06/20/2007

Guangzhou Biying Cosmetics Co., Ltd.
Date Published : 04/12/2022
68 Liangshazhong Road, 23 Liangshan Village , Zhong Laotan, Baiyun District , Guangzhou, Guangdong CHINA
53 D - - 02 Perfumes (Fragrance Preparations)
Date Published: 04/12/2022

Desc: Aloe Vera Gel (Republic Cosmetics)
Notes: The product appears to be an unapproved new drug as the product’s label/website include statements such as (not an all-inclusive list): ‘Sunburn skin; Antiseptic; Acne control; ORGANIC Aloe vera gel that helps to… control acne, sunburn, irritated skin and insect bites. ’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 04/12/2022

Desc: Aloe Vera Gel (Republic Cosmetics)
Notes: The product appears to be an unapproved new drug as the product’s label/website include statements such as (not an all-inclusive list): ‘Sunburn skin; Antiseptic; Acne control; ORGANIC Aloe vera gel that helps to… control acne, sunburn, irritated skin and insect bites. ’.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/12/2022

Desc: Aloe Vera Gel (Republic Cosmetics)
Notes: The product appears to be an unapproved new drug as the product’s label/website include statements such as (not an all-inclusive list): ‘Sunburn skin; Antiseptic; Acne control; ORGANIC Aloe vera gel that helps to… control acne, sunburn, irritated skin and insect bites. ’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/12/2022

Desc: Aloe Vera Gel (Republic Cosmetics)
Notes: The product appears to be an unapproved new drug as the product’s label/website include statements such as (not an all-inclusive list): ‘Sunburn skin; Antiseptic; Acne control; ORGANIC Aloe vera gel that helps to… control acne, sunburn, irritated skin and insect bites. ’.

Guangzhou Chuyu Cosmetics Co., Ltd.
Date Published : 10/25/2021
Area B, Floor No.16-14 Self-Numbered , uaxing M. Road, Xinya Street , Guangzhou, Guangdong CHINA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Bio Brightening Intensive Cream Complex
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [A]ddresses skin discoloration from age spots, freckles, melasma and other hyperpigmentation symptoms; [H]elps problem areas by diminishing the appearance of existing dark/age spots; It is formulated to delve deep into the skin’s pigment producing region, which allows it to continue to stabilize skin color; Reduce wrinkles, fine lines & aging spots; Defense barrier against oxidative stress; Improving discolorations …’.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Rejuvenating Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[A] powerful anti-wrinkles action. . . its natural main actives boost the cell synchronization in all epidermis layers…’.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Skin Rejuvenating Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[A] powerful anti wrinkles action. . .boost the cell synchronization in all epidermis layers; [F]ights the deep expression wrinkles and under-eye, puffiness…’.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Skin Collagen Transformation Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Using antiseptic proper-ties. . .removes impurities from pores…gently draws out toxins; Cell renewing; Promotes Collagen Production; [H]ealing; Draws out toxins & impurities…’.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Black Orchid Transformation Skin Collection
Notes: The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Black Orchid 24 Hour Moisturizer; Black Orchid Skin Concentrate Finishing Layer Mask; Black Orchid 50X Premium Serum – Multivitamin A C & E Age Defying 24K Gold Serum; Black Orchid 50X Premium Serum Vitamin C Whitening Serum; Black Orchid 50X Premium Serum Vitamin A Retinal Anti-Wrinkle Serum.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Argan Oil Facial Peeling Gel
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [A]s a detoxifying peel to penetrate deep into skin for in-depth exfoliation; [H]elping to promote skin cell growth, repair sun damaged skin, and assist in protecting your skin from cancer causing ultraviolet rays; Contain Anti-Bacterial and Antiseptic properties that help the treatment of chronic skin diseases such as psoriasis, hidradenitis suppurativa, and eczema of a sub-acute character; Protects cells against injury due to oxidation to shield the skins surface, creating a protective defense barrier against oxidative stress, cancer; Helps to demolish acne and eczema, as well as improving discolorations and wrinkles from sun damage …’.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Black Orchid Peptide Amino Acid Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… Working on a molecular level, assisting the skin cell retinoid receptors that regulate certain skin functions; [S]peeding up skin cell rejuvenation; [H]elps to repair damaged. . . skin; [D]esigned to encourage intensive cell rejuvenation, reduce dark spots, help to minimize problematic blackheads. . . help to protect and repair your skin…; Tighten, Firm, Diminish Stretch Marks …’.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Triple Acting Facial Cleansing Scrub
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Fight acne…’.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Black Orchid Peptide Resurfacing Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [M]aintains a barrier on the skin; [T]he skin gradually arms itself against external aggressions becoming stronger, and more resistant …’.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Skin Tightening Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Formulated to lighten, lift, and firm the skin; [D]iminishes Fine Lines & Wrinkles; [I]mprove skin tone/color…’.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Skin Concentrate Finishing Layering Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[R]epair and solve pores problems; [P]revent premature skin aging…’.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Age Defying Collection
Notes: The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Snail Skin Concentrate Finishing Layer Mask; Snail Vitamin C, A & E Booster Serum Treatment; Snail Miracle Cloud Correction Mask.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Red Wine Intensive Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…This cream will help reduce wrinkles, uneven skin tone and even those embarrassing acne scars; Corrects Uneven Skin Tone; Heals Acne Scars; Improves Skin Texture; Protects From Free Radicals; Revitalizes the layers of the skin…’.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Secret Collagen Age Defying Instant Wrinkle Killer
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[R]estores the skin renewal process by stimulating facial cells, and promotes the tightening, lifting and firming of the skin; [E]nergize the layers of the skin on a molecular level; [H]elping to revive the skin. . . diminishing fine lines and wrinkles; [D]esigned to encourage intensive cell rejuvenation, reduce dark spots, help to minimize problematic blackheads…’.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Caviar Hyaluronic Acid Age Defying Collection
Notes: The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Caviar Hyaluronic Acid Renewal Finishing Cream; Caviar Hyaluronic Acid 24 Hour Moisturizer; Caviar Hyaluronic Acid Age-Defying Serum Treatment; Caviar Hyaluronic Acid Skin Concentrate Finishing Layer Mask.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Daily Hydrating Moisturizer
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [P]rotects against…UV light; [R]educes small wrinkles and reduces inflammation and skin irritation; [D]esigned to accelerate cell surface regeneration; [H]elp the skin heal and rejuvenate; Healing …’.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Bio Brightening Dark Spot Solution
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… Lighten freckles, age spots and dark pigmentation areas on the skin; It promotes cell regeneration, maintains collagen; Reduce wrinkles, fine lines & aging spots; Defense barrier against oxidative stress; Improving discolorations …’.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Black Orchid Peptide Age Defying Skin Firming Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… Formulated…combined with the restoring properties of resurgent stems cells …’.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Rapid Renewal Repair Set
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Ideal for: Cell Regenerating… Minimizing Fine Lines & Wrinkles…Improve Collagen Production…’. The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Skin Tightening Wrinkle Cream; Age Defying Instant Wrinkle Cream Eraser with Vitamins E & A.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Everyday Care Finishing Layer Mask with Wrinkle Vanisher Device
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[W]rinkle reducer; [H]elps to repair and solve your deep troubling pores. . .prevent premature skin aging; [H]elping with blood circulation. . .helps to reduce wrinkles. . .helping to … heal; Healing; Accelerates Cell Renewal; Improving discolorations and wrinkles from sun damage; Hydrates quickly and protects against dryness; Helps to demolish acne and eczema…’.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Golden Magnetic Mud Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[R]evives your skin through the power of magnetism. As you run the magnet over your face, the iron powder in the mask is magnetized and lifted, which increases blood flow, boosts oxygen production and expels impurities. The natural oils in this mask accelerate collagen production; Stimulating new collagen and healthy skin cell growth; Helping to clear up breakouts; Improving the skin’s color, clarity, tone and texture; Removing black heads; Reducing discoloration caused by sun damage…’.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Skin Cell Renewal Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[T]he most secret weapon against. . .anti-wrinkle, face restoration, reduces. . .dark circles under eyes; [P]rotects. . .against bacteria, cuts, and UV Rays; [T]ighten the skin…smooth wrinkles, and fix sun damage; Cares for Damaged Skin; Improve Skin Defense…’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Rapid Renewal Repair Set
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Ideal for: Cell Regenerating… Minimizing Fine Lines & Wrinkles…Improve Collagen Production…’. The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Skin Tightening Wrinkle Cream; Age Defying Instant Wrinkle Cream Eraser with Vitamins E & A.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Rejuvenating Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[A] powerful anti-wrinkles action. . . its natural main actives boost the cell synchronization in all epidermis layers…’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Black Orchid Peptide Resurfacing Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [M]aintains a barrier on the skin; [T]he skin gradually arms itself against external aggressions becoming stronger, and more resistant …’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Black Orchid Peptide Age Defying Skin Firming Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… Formulated…combined with the restoring properties of resurgent stems cells …’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Skin Concentrate Finishing Layering Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[R]epair and solve pores problems; [P]revent premature skin aging…’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Bio Brightening Dark Spot Solution
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… Lighten freckles, age spots and dark pigmentation areas on the skin; It promotes cell regeneration, maintains collagen; Reduce wrinkles, fine lines & aging spots; Defense barrier against oxidative stress; Improving discolorations …’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Black Orchid Transformation Skin Collection
Notes: The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Black Orchid 24 Hour Moisturizer; Black Orchid Skin Concentrate Finishing Layer Mask; Black Orchid 50X Premium Serum – Multivitamin A C & E Age Defying 24K Gold Serum; Black Orchid 50X Premium Serum Vitamin C Whitening Serum; Black Orchid 50X Premium Serum Vitamin A Retinal Anti-Wrinkle Serum.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Secret Collagen Age Defying Instant Wrinkle Killer
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[R]estores the skin renewal process by stimulating facial cells, and promotes the tightening, lifting and firming of the skin; [E]nergize the layers of the skin on a molecular level; [H]elping to revive the skin. . . diminishing fine lines and wrinkles; [D]esigned to encourage intensive cell rejuvenation, reduce dark spots, help to minimize problematic blackheads…’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Triple Acting Facial Cleansing Scrub
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Fight acne…’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Caviar Hyaluronic Acid Age Defying Collection
Notes: The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Caviar Hyaluronic Acid Renewal Finishing Cream; Caviar Hyaluronic Acid 24 Hour Moisturizer; Caviar Hyaluronic Acid Age-Defying Serum Treatment; Caviar Hyaluronic Acid Skin Concentrate Finishing Layer Mask.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Argan Oil Facial Peeling Gel
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [A]s a detoxifying peel to penetrate deep into skin for in-depth exfoliation; [H]elping to promote skin cell growth, repair sun damaged skin, and assist in protecting your skin from cancer causing ultraviolet rays; Contain Anti-Bacterial and Antiseptic properties that help the treatment of chronic skin diseases such as psoriasis, hidradenitis suppurativa, and eczema of a sub-acute character; Protects cells against injury due to oxidation to shield the skins surface, creating a protective defense barrier against oxidative stress, cancer; Helps to demolish acne and eczema, as well as improving discolorations and wrinkles from sun damage …’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Bio Brightening Intensive Cream Complex
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [A]ddresses skin discoloration from age spots, freckles, melasma and other hyperpigmentation symptoms; [H]elps problem areas by diminishing the appearance of existing dark/age spots; It is formulated to delve deep into the skin’s pigment producing region, which allows it to continue to stabilize skin color; Reduce wrinkles, fine lines & aging spots; Defense barrier against oxidative stress; Improving discolorations …’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Age Defying Collection
Notes: The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Snail Skin Concentrate Finishing Layer Mask; Snail Vitamin C, A & E Booster Serum Treatment; Snail Miracle Cloud Correction Mask.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Skin Collagen Transformation Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Using antiseptic proper-ties. . .removes impurities from pores…gently draws out toxins; Cell renewing; Promotes Collagen Production; [H]ealing; Draws out toxins & impurities…’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Black Orchid Peptide Amino Acid Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… Working on a molecular level, assisting the skin cell retinoid receptors that regulate certain skin functions; [S]peeding up skin cell rejuvenation; [H]elps to repair damaged. . . skin; [D]esigned to encourage intensive cell rejuvenation, reduce dark spots, help to minimize problematic blackheads. . . help to protect and repair your skin…; Tighten, Firm, Diminish Stretch Marks …’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Skin Rejuvenating Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[A] powerful anti wrinkles action. . .boost the cell synchronization in all epidermis layers; [F]ights the deep expression wrinkles and under-eye, puffiness…’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Skin Cell Renewal Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[T]he most secret weapon against. . .anti-wrinkle, face restoration, reduces. . .dark circles under eyes; [P]rotects. . .against bacteria, cuts, and UV Rays; [T]ighten the skin…smooth wrinkles, and fix sun damage; Cares for Damaged Skin; Improve Skin Defense…’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Red Wine Intensive Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…This cream will help reduce wrinkles, uneven skin tone and even those embarrassing acne scars; Corrects Uneven Skin Tone; Heals Acne Scars; Improves Skin Texture; Protects From Free Radicals; Revitalizes the layers of the skin…’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Skin Tightening Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Formulated to lighten, lift, and firm the skin; [D]iminishes Fine Lines & Wrinkles; [I]mprove skin tone/color…’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Everyday Care Finishing Layer Mask with Wrinkle Vanisher Device
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[W]rinkle reducer; [H]elps to repair and solve your deep troubling pores. . .prevent premature skin aging; [H]elping with blood circulation. . .helps to reduce wrinkles. . .helping to … heal; Healing; Accelerates Cell Renewal; Improving discolorations and wrinkles from sun damage; Hydrates quickly and protects against dryness; Helps to demolish acne and eczema…’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Daily Hydrating Moisturizer
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [P]rotects against…UV light; [R]educes small wrinkles and reduces inflammation and skin irritation; [D]esigned to accelerate cell surface regeneration; [H]elp the skin heal and rejuvenate; Healing …’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Golden Magnetic Mud Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[R]evives your skin through the power of magnetism. As you run the magnet over your face, the iron powder in the mask is magnetized and lifted, which increases blood flow, boosts oxygen production and expels impurities. The natural oils in this mask accelerate collagen production; Stimulating new collagen and healthy skin cell growth; Helping to clear up breakouts; Improving the skin’s color, clarity, tone and texture; Removing black heads; Reducing discoloration caused by sun damage…’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Secret Collagen Age Defying Instant Wrinkle Killer
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[R]estores the skin renewal process by stimulating facial cells, and promotes the tightening, lifting and firming of the skin; [E]nergize the layers of the skin on a molecular level; [H]elping to revive the skin. . . diminishing fine lines and wrinkles; [D]esigned to encourage intensive cell rejuvenation, reduce dark spots, help to minimize problematic blackheads…’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Rejuvenating Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[A] powerful anti-wrinkles action. . . its natural main actives boost the cell synchronization in all epidermis layers…’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Skin Collagen Transformation Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Using antiseptic proper-ties. . .removes impurities from pores…gently draws out toxins; Cell renewing; Promotes Collagen Production; [H]ealing; Draws out toxins & impurities…’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Skin Cell Renewal Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[T]he most secret weapon against. . .anti-wrinkle, face restoration, reduces. . .dark circles under eyes; [P]rotects. . .against bacteria, cuts, and UV Rays; [T]ighten the skin…smooth wrinkles, and fix sun damage; Cares for Damaged Skin; Improve Skin Defense…’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Age Defying Collection
Notes: The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Snail Skin Concentrate Finishing Layer Mask; Snail Vitamin C, A & E Booster Serum Treatment; Snail Miracle Cloud Correction Mask.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Triple Acting Facial Cleansing Scrub
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Fight acne…’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Skin Tightening Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Formulated to lighten, lift, and firm the skin; [D]iminishes Fine Lines & Wrinkles; [I]mprove skin tone/color…’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Skin Rejuvenating Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[A] powerful anti wrinkles action. . .boost the cell synchronization in all epidermis layers; [F]ights the deep expression wrinkles and under-eye, puffiness…’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Rapid Renewal Repair Set
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Ideal for: Cell Regenerating… Minimizing Fine Lines & Wrinkles…Improve Collagen Production…’. The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Skin Tightening Wrinkle Cream; Age Defying Instant Wrinkle Cream Eraser with Vitamins E & A.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Black Orchid Peptide Amino Acid Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… Working on a molecular level, assisting the skin cell retinoid receptors that regulate certain skin functions; [S]peeding up skin cell rejuvenation; [H]elps to repair damaged. . . skin; [D]esigned to encourage intensive cell rejuvenation, reduce dark spots, help to minimize problematic blackheads. . . help to protect and repair your skin…; Tighten, Firm, Diminish Stretch Marks …’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Bio Brightening Dark Spot Solution
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… Lighten freckles, age spots and dark pigmentation areas on the skin; It promotes cell regeneration, maintains collagen; Reduce wrinkles, fine lines & aging spots; Defense barrier against oxidative stress; Improving discolorations …’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Black Orchid Peptide Resurfacing Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [M]aintains a barrier on the skin; [T]he skin gradually arms itself against external aggressions becoming stronger, and more resistant …’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Daily Hydrating Moisturizer
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [P]rotects against…UV light; [R]educes small wrinkles and reduces inflammation and skin irritation; [D]esigned to accelerate cell surface regeneration; [H]elp the skin heal and rejuvenate; Healing …’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Bio Brightening Intensive Cream Complex
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [A]ddresses skin discoloration from age spots, freckles, melasma and other hyperpigmentation symptoms; [H]elps problem areas by diminishing the appearance of existing dark/age spots; It is formulated to delve deep into the skin’s pigment producing region, which allows it to continue to stabilize skin color; Reduce wrinkles, fine lines & aging spots; Defense barrier against oxidative stress; Improving discolorations …’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Red Wine Intensive Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…This cream will help reduce wrinkles, uneven skin tone and even those embarrassing acne scars; Corrects Uneven Skin Tone; Heals Acne Scars; Improves Skin Texture; Protects From Free Radicals; Revitalizes the layers of the skin…’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Caviar Hyaluronic Acid Age Defying Collection
Notes: The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Caviar Hyaluronic Acid Renewal Finishing Cream; Caviar Hyaluronic Acid 24 Hour Moisturizer; Caviar Hyaluronic Acid Age-Defying Serum Treatment; Caviar Hyaluronic Acid Skin Concentrate Finishing Layer Mask.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Black Orchid Peptide Age Defying Skin Firming Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… Formulated…combined with the restoring properties of resurgent stems cells …’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Argan Oil Facial Peeling Gel
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [A]s a detoxifying peel to penetrate deep into skin for in-depth exfoliation; [H]elping to promote skin cell growth, repair sun damaged skin, and assist in protecting your skin from cancer causing ultraviolet rays; Contain Anti-Bacterial and Antiseptic properties that help the treatment of chronic skin diseases such as psoriasis, hidradenitis suppurativa, and eczema of a sub-acute character; Protects cells against injury due to oxidation to shield the skins surface, creating a protective defense barrier against oxidative stress, cancer; Helps to demolish acne and eczema, as well as improving discolorations and wrinkles from sun damage …’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Golden Magnetic Mud Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[R]evives your skin through the power of magnetism. As you run the magnet over your face, the iron powder in the mask is magnetized and lifted, which increases blood flow, boosts oxygen production and expels impurities. The natural oils in this mask accelerate collagen production; Stimulating new collagen and healthy skin cell growth; Helping to clear up breakouts; Improving the skin’s color, clarity, tone and texture; Removing black heads; Reducing discoloration caused by sun damage…’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Everyday Care Finishing Layer Mask with Wrinkle Vanisher Device
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[W]rinkle reducer; [H]elps to repair and solve your deep troubling pores. . .prevent premature skin aging; [H]elping with blood circulation. . .helps to reduce wrinkles. . .helping to … heal; Healing; Accelerates Cell Renewal; Improving discolorations and wrinkles from sun damage; Hydrates quickly and protects against dryness; Helps to demolish acne and eczema…’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Black Orchid Transformation Skin Collection
Notes: The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Black Orchid 24 Hour Moisturizer; Black Orchid Skin Concentrate Finishing Layer Mask; Black Orchid 50X Premium Serum – Multivitamin A C & E Age Defying 24K Gold Serum; Black Orchid 50X Premium Serum Vitamin C Whitening Serum; Black Orchid 50X Premium Serum Vitamin A Retinal Anti-Wrinkle Serum.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Skin Concentrate Finishing Layering Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[R]epair and solve pores problems; [P]revent premature skin aging…’.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Caviar Hyaluronic Acid Age Defying Collection
Notes: The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Caviar Hyaluronic Acid Renewal Finishing Cream; Caviar Hyaluronic Acid 24 Hour Moisturizer; Caviar Hyaluronic Acid Age-Defying Serum Treatment; Caviar Hyaluronic Acid Skin Concentrate Finishing Layer Mask.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Black Orchid Peptide Resurfacing Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [M]aintains a barrier on the skin; [T]he skin gradually arms itself against external aggressions becoming stronger, and more resistant …’.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Triple Acting Facial Cleansing Scrub
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Fight acne…’.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Black Orchid Peptide Age Defying Skin Firming Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… Formulated…combined with the restoring properties of resurgent stems cells …’.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Skin Rejuvenating Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[A] powerful anti wrinkles action. . .boost the cell synchronization in all epidermis layers; [F]ights the deep expression wrinkles and under-eye, puffiness…’.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Bio Brightening Intensive Cream Complex
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [A]ddresses skin discoloration from age spots, freckles, melasma and other hyperpigmentation symptoms; [H]elps problem areas by diminishing the appearance of existing dark/age spots; It is formulated to delve deep into the skin’s pigment producing region, which allows it to continue to stabilize skin color; Reduce wrinkles, fine lines & aging spots; Defense barrier against oxidative stress; Improving discolorations …’.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Skin Tightening Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Formulated to lighten, lift, and firm the skin; [D]iminishes Fine Lines & Wrinkles; [I]mprove skin tone/color…’.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Skin Concentrate Finishing Layering Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[R]epair and solve pores problems; [P]revent premature skin aging…’.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Rejuvenating Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[A] powerful anti-wrinkles action. . . its natural main actives boost the cell synchronization in all epidermis layers…’.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Black Orchid Peptide Amino Acid Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… Working on a molecular level, assisting the skin cell retinoid receptors that regulate certain skin functions; [S]peeding up skin cell rejuvenation; [H]elps to repair damaged. . . skin; [D]esigned to encourage intensive cell rejuvenation, reduce dark spots, help to minimize problematic blackheads. . . help to protect and repair your skin…; Tighten, Firm, Diminish Stretch Marks …’.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Age Defying Collection
Notes: The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Snail Skin Concentrate Finishing Layer Mask; Snail Vitamin C, A & E Booster Serum Treatment; Snail Miracle Cloud Correction Mask.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Skin Collagen Transformation Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Using antiseptic proper-ties. . .removes impurities from pores…gently draws out toxins; Cell renewing; Promotes Collagen Production; [H]ealing; Draws out toxins & impurities…’.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Daily Hydrating Moisturizer
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [P]rotects against…UV light; [R]educes small wrinkles and reduces inflammation and skin irritation; [D]esigned to accelerate cell surface regeneration; [H]elp the skin heal and rejuvenate; Healing …’.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Everyday Care Finishing Layer Mask with Wrinkle Vanisher Device
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[W]rinkle reducer; [H]elps to repair and solve your deep troubling pores. . .prevent premature skin aging; [H]elping with blood circulation. . .helps to reduce wrinkles. . .helping to … heal; Healing; Accelerates Cell Renewal; Improving discolorations and wrinkles from sun damage; Hydrates quickly and protects against dryness; Helps to demolish acne and eczema…’.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Rapid Renewal Repair Set
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Ideal for: Cell Regenerating… Minimizing Fine Lines & Wrinkles…Improve Collagen Production…’. The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Skin Tightening Wrinkle Cream; Age Defying Instant Wrinkle Cream Eraser with Vitamins E & A.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Black Orchid Transformation Skin Collection
Notes: The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Black Orchid 24 Hour Moisturizer; Black Orchid Skin Concentrate Finishing Layer Mask; Black Orchid 50X Premium Serum – Multivitamin A C & E Age Defying 24K Gold Serum; Black Orchid 50X Premium Serum Vitamin C Whitening Serum; Black Orchid 50X Premium Serum Vitamin A Retinal Anti-Wrinkle Serum.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Bio Brightening Dark Spot Solution
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… Lighten freckles, age spots and dark pigmentation areas on the skin; It promotes cell regeneration, maintains collagen; Reduce wrinkles, fine lines & aging spots; Defense barrier against oxidative stress; Improving discolorations …’.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Golden Magnetic Mud Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[R]evives your skin through the power of magnetism. As you run the magnet over your face, the iron powder in the mask is magnetized and lifted, which increases blood flow, boosts oxygen production and expels impurities. The natural oils in this mask accelerate collagen production; Stimulating new collagen and healthy skin cell growth; Helping to clear up breakouts; Improving the skin’s color, clarity, tone and texture; Removing black heads; Reducing discoloration caused by sun damage…’.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Secret Collagen Age Defying Instant Wrinkle Killer
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[R]estores the skin renewal process by stimulating facial cells, and promotes the tightening, lifting and firming of the skin; [E]nergize the layers of the skin on a molecular level; [H]elping to revive the skin. . . diminishing fine lines and wrinkles; [D]esigned to encourage intensive cell rejuvenation, reduce dark spots, help to minimize problematic blackheads…’.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Argan Oil Facial Peeling Gel
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [A]s a detoxifying peel to penetrate deep into skin for in-depth exfoliation; [H]elping to promote skin cell growth, repair sun damaged skin, and assist in protecting your skin from cancer causing ultraviolet rays; Contain Anti-Bacterial and Antiseptic properties that help the treatment of chronic skin diseases such as psoriasis, hidradenitis suppurativa, and eczema of a sub-acute character; Protects cells against injury due to oxidation to shield the skins surface, creating a protective defense barrier against oxidative stress, cancer; Helps to demolish acne and eczema, as well as improving discolorations and wrinkles from sun damage …’.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Red Wine Intensive Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…This cream will help reduce wrinkles, uneven skin tone and even those embarrassing acne scars; Corrects Uneven Skin Tone; Heals Acne Scars; Improves Skin Texture; Protects From Free Radicals; Revitalizes the layers of the skin…’.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Skin Cell Renewal Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[T]he most secret weapon against. . .anti-wrinkle, face restoration, reduces. . .dark circles under eyes; [P]rotects. . .against bacteria, cuts, and UV Rays; [T]ighten the skin…smooth wrinkles, and fix sun damage; Cares for Damaged Skin; Improve Skin Defense…’.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Black Orchid Peptide Age Defying Skin Firming Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… Formulated…combined with the restoring properties of resurgent stems cells …’.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Red Wine Intensive Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…This cream will help reduce wrinkles, uneven skin tone and even those embarrassing acne scars; Corrects Uneven Skin Tone; Heals Acne Scars; Improves Skin Texture; Protects From Free Radicals; Revitalizes the layers of the skin…’.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Golden Magnetic Mud Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[R]evives your skin through the power of magnetism. As you run the magnet over your face, the iron powder in the mask is magnetized and lifted, which increases blood flow, boosts oxygen production and expels impurities. The natural oils in this mask accelerate collagen production; Stimulating new collagen and healthy skin cell growth; Helping to clear up breakouts; Improving the skin’s color, clarity, tone and texture; Removing black heads; Reducing discoloration caused by sun damage…’.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Daily Hydrating Moisturizer
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [P]rotects against…UV light; [R]educes small wrinkles and reduces inflammation and skin irritation; [D]esigned to accelerate cell surface regeneration; [H]elp the skin heal and rejuvenate; Healing …’.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Skin Rejuvenating Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[A] powerful anti wrinkles action. . .boost the cell synchronization in all epidermis layers; [F]ights the deep expression wrinkles and under-eye, puffiness…’.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Skin Collagen Transformation Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Using antiseptic proper-ties. . .removes impurities from pores…gently draws out toxins; Cell renewing; Promotes Collagen Production; [H]ealing; Draws out toxins & impurities…’.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Skin Cell Renewal Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[T]he most secret weapon against. . .anti-wrinkle, face restoration, reduces. . .dark circles under eyes; [P]rotects. . .against bacteria, cuts, and UV Rays; [T]ighten the skin…smooth wrinkles, and fix sun damage; Cares for Damaged Skin; Improve Skin Defense…’.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Black Orchid Transformation Skin Collection
Notes: The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Black Orchid 24 Hour Moisturizer; Black Orchid Skin Concentrate Finishing Layer Mask; Black Orchid 50X Premium Serum – Multivitamin A C & E Age Defying 24K Gold Serum; Black Orchid 50X Premium Serum Vitamin C Whitening Serum; Black Orchid 50X Premium Serum Vitamin A Retinal Anti-Wrinkle Serum.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Rejuvenating Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[A] powerful anti-wrinkles action. . . its natural main actives boost the cell synchronization in all epidermis layers…’.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Black Orchid Peptide Amino Acid Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… Working on a molecular level, assisting the skin cell retinoid receptors that regulate certain skin functions; [S]peeding up skin cell rejuvenation; [H]elps to repair damaged. . . skin; [D]esigned to encourage intensive cell rejuvenation, reduce dark spots, help to minimize problematic blackheads. . . help to protect and repair your skin…; Tighten, Firm, Diminish Stretch Marks …’.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Rapid Renewal Repair Set
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Ideal for: Cell Regenerating… Minimizing Fine Lines & Wrinkles…Improve Collagen Production…’. The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Skin Tightening Wrinkle Cream; Age Defying Instant Wrinkle Cream Eraser with Vitamins E & A.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Age Defying Collection
Notes: The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Snail Skin Concentrate Finishing Layer Mask; Snail Vitamin C, A & E Booster Serum Treatment; Snail Miracle Cloud Correction Mask.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Snail Skin Concentrate Finishing Layering Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[R]epair and solve pores problems; [P]revent premature skin aging…’.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Triple Acting Facial Cleansing Scrub
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Fight acne…’.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Black Orchid Peptide Resurfacing Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [M]aintains a barrier on the skin; [T]he skin gradually arms itself against external aggressions becoming stronger, and more resistant …’.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Bio Brightening Intensive Cream Complex
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [A]ddresses skin discoloration from age spots, freckles, melasma and other hyperpigmentation symptoms; [H]elps problem areas by diminishing the appearance of existing dark/age spots; It is formulated to delve deep into the skin’s pigment producing region, which allows it to continue to stabilize skin color; Reduce wrinkles, fine lines & aging spots; Defense barrier against oxidative stress; Improving discolorations …’.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Bio Brightening Dark Spot Solution
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… Lighten freckles, age spots and dark pigmentation areas on the skin; It promotes cell regeneration, maintains collagen; Reduce wrinkles, fine lines & aging spots; Defense barrier against oxidative stress; Improving discolorations …’.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Secret Collagen Age Defying Instant Wrinkle Killer
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[R]estores the skin renewal process by stimulating facial cells, and promotes the tightening, lifting and firming of the skin; [E]nergize the layers of the skin on a molecular level; [H]elping to revive the skin. . . diminishing fine lines and wrinkles; [D]esigned to encourage intensive cell rejuvenation, reduce dark spots, help to minimize problematic blackheads…’.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Skin Tightening Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Formulated to lighten, lift, and firm the skin; [D]iminishes Fine Lines & Wrinkles; [I]mprove skin tone/color…’.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Caviar Hyaluronic Acid Age Defying Collection
Notes: The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Caviar Hyaluronic Acid Renewal Finishing Cream; Caviar Hyaluronic Acid 24 Hour Moisturizer; Caviar Hyaluronic Acid Age-Defying Serum Treatment; Caviar Hyaluronic Acid Skin Concentrate Finishing Layer Mask.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Argan Oil Facial Peeling Gel
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [A]s a detoxifying peel to penetrate deep into skin for in-depth exfoliation; [H]elping to promote skin cell growth, repair sun damaged skin, and assist in protecting your skin from cancer causing ultraviolet rays; Contain Anti-Bacterial and Antiseptic properties that help the treatment of chronic skin diseases such as psoriasis, hidradenitis suppurativa, and eczema of a sub-acute character; Protects cells against injury due to oxidation to shield the skins surface, creating a protective defense barrier against oxidative stress, cancer; Helps to demolish acne and eczema, as well as improving discolorations and wrinkles from sun damage …’.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/26/2021

Desc: Everyday Care Finishing Layer Mask with Wrinkle Vanisher Device
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[W]rinkle reducer; [H]elps to repair and solve your deep troubling pores. . .prevent premature skin aging; [H]elping with blood circulation. . .helps to reduce wrinkles. . .helping to … heal; Healing; Accelerates Cell Renewal; Improving discolorations and wrinkles from sun damage; Hydrates quickly and protects against dryness; Helps to demolish acne and eczema…’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/26/2021

Desc: Golden Magnetic Mud Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[R]evives your skin through the power of magnetism. As you run the magnet over your face, the iron powder in the mask is magnetized and lifted, which increases blood flow, boosts oxygen production and expels impurities. The natural oils in this mask accelerate collagen production; Stimulating new collagen and healthy skin cell growth; Helping to clear up breakouts; Improving the skin’s color, clarity, tone and texture; Removing black heads; Reducing discoloration caused by sun damage…’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/25/2021

Desc: Bio Brightening Dark Spot Solution
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… Lighten freckles, age spots and dark pigmentation areas on the skin; It promotes cell regeneration, maintains collagen; Reduce wrinkles, fine lines & aging spots; Defense barrier against oxidative stress; Improving discolorations …’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/26/2021

Desc: Snail Skin Rejuvenating Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[A] powerful anti wrinkles action. . .boost the cell synchronization in all epidermis layers; [F]ights the deep expression wrinkles and under-eye, puffiness…’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/25/2021

Desc: Argan Oil Facial Peeling Gel
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [A]s a detoxifying peel to penetrate deep into skin for in-depth exfoliation; [H]elping to promote skin cell growth, repair sun damaged skin, and assist in protecting your skin from cancer causing ultraviolet rays; Contain Anti-Bacterial and Antiseptic properties that help the treatment of chronic skin diseases such as psoriasis, hidradenitis suppurativa, and eczema of a sub-acute character; Protects cells against injury due to oxidation to shield the skins surface, creating a protective defense barrier against oxidative stress, cancer; Helps to demolish acne and eczema, as well as improving discolorations and wrinkles from sun damage …’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/26/2021

Desc: Secret Collagen Age Defying Instant Wrinkle Killer
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[R]estores the skin renewal process by stimulating facial cells, and promotes the tightening, lifting and firming of the skin; [E]nergize the layers of the skin on a molecular level; [H]elping to revive the skin. . . diminishing fine lines and wrinkles; [D]esigned to encourage intensive cell rejuvenation, reduce dark spots, help to minimize problematic blackheads…’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/25/2021

Desc: Daily Hydrating Moisturizer
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [P]rotects against…UV light; [R]educes small wrinkles and reduces inflammation and skin irritation; [D]esigned to accelerate cell surface regeneration; [H]elp the skin heal and rejuvenate; Healing …’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/26/2021

Desc: Snail Age Defying Collection
Notes: The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Snail Skin Concentrate Finishing Layer Mask; Snail Vitamin C, A & E Booster Serum Treatment; Snail Miracle Cloud Correction Mask.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/26/2021

Desc: Snail Skin Cell Renewal Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[T]he most secret weapon against. . .anti-wrinkle, face restoration, reduces. . .dark circles under eyes; [P]rotects. . .against bacteria, cuts, and UV Rays; [T]ighten the skin…smooth wrinkles, and fix sun damage; Cares for Damaged Skin; Improve Skin Defense…’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/25/2021

Desc: Black Orchid Peptide Amino Acid Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… Working on a molecular level, assisting the skin cell retinoid receptors that regulate certain skin functions; [S]peeding up skin cell rejuvenation; [H]elps to repair damaged. . . skin; [D]esigned to encourage intensive cell rejuvenation, reduce dark spots, help to minimize problematic blackheads. . . help to protect and repair your skin…; Tighten, Firm, Diminish Stretch Marks …’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/25/2021

Desc: Black Orchid Peptide Age Defying Skin Firming Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… Formulated…combined with the restoring properties of resurgent stems cells …’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/25/2021

Desc: Red Wine Intensive Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…This cream will help reduce wrinkles, uneven skin tone and even those embarrassing acne scars; Corrects Uneven Skin Tone; Heals Acne Scars; Improves Skin Texture; Protects From Free Radicals; Revitalizes the layers of the skin…’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/26/2021

Desc: Rapid Renewal Repair Set
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Ideal for: Cell Regenerating… Minimizing Fine Lines & Wrinkles…Improve Collagen Production…’. The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Skin Tightening Wrinkle Cream; Age Defying Instant Wrinkle Cream Eraser with Vitamins E & A.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/25/2021

Desc: Black Orchid Peptide Resurfacing Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [M]aintains a barrier on the skin; [T]he skin gradually arms itself against external aggressions becoming stronger, and more resistant …’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/26/2021

Desc: Snail Skin Concentrate Finishing Layering Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[R]epair and solve pores problems; [P]revent premature skin aging…’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/26/2021

Desc: Snail Rejuvenating Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[A] powerful anti-wrinkles action. . . its natural main actives boost the cell synchronization in all epidermis layers…’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/25/2021

Desc: Caviar Hyaluronic Acid Age Defying Collection
Notes: The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Caviar Hyaluronic Acid Renewal Finishing Cream; Caviar Hyaluronic Acid 24 Hour Moisturizer; Caviar Hyaluronic Acid Age-Defying Serum Treatment; Caviar Hyaluronic Acid Skin Concentrate Finishing Layer Mask.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/26/2021

Desc: Everyday Care Finishing Layer Mask with Wrinkle Vanisher Device
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…[W]rinkle reducer; [H]elps to repair and solve your deep troubling pores. . .prevent premature skin aging; [H]elping with blood circulation. . .helps to reduce wrinkles. . .helping to … heal; Healing; Accelerates Cell Renewal; Improving discolorations and wrinkles from sun damage; Hydrates quickly and protects against dryness; Helps to demolish acne and eczema…’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/26/2021

Desc: Triple Acting Facial Cleansing Scrub
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Fight acne…’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/25/2021

Desc: Black Orchid Transformation Skin Collection
Notes: The product is a collection of products. The following products within the collection appear to be unapproved new drugs: Black Orchid 24 Hour Moisturizer; Black Orchid Skin Concentrate Finishing Layer Mask; Black Orchid 50X Premium Serum – Multivitamin A C & E Age Defying 24K Gold Serum; Black Orchid 50X Premium Serum Vitamin C Whitening Serum; Black Orchid 50X Premium Serum Vitamin A Retinal Anti-Wrinkle Serum.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/25/2021

Desc: Bio Brightening Intensive Cream Complex
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘… [A]ddresses skin discoloration from age spots, freckles, melasma and other hyperpigmentation symptoms; [H]elps problem areas by diminishing the appearance of existing dark/age spots; It is formulated to delve deep into the skin’s pigment producing region, which allows it to continue to stabilize skin color; Reduce wrinkles, fine lines & aging spots; Defense barrier against oxidative stress; Improving discolorations …’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/26/2021

Desc: Skin Tightening Serum
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Formulated to lighten, lift, and firm the skin; [D]iminishes Fine Lines & Wrinkles; [I]mprove skin tone/color…’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/26/2021

Desc: Skin Collagen Transformation Mask
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…Using antiseptic proper-ties. . .removes impurities from pores…gently draws out toxins; Cell renewing; Promotes Collagen Production; [H]ealing; Draws out toxins & impurities…’.

Guangzhou Fu Bao Daily Chemical Co.,Ltd.
Date Published : 11/15/2016
B Building , 51 North Zhenhua Road; Shenshan Industrial Estate , Guangzhou, Guangdong CHINA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 11/15/2016

Desc: Latoja Lotion (body firming cream)

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 11/15/2016

Desc: Latoja Lotion (body firming cream)

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 11/15/2016

Desc: Suikan Hada Facial Mask

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/15/2016

Desc: Suikan Hada Facial Mask

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/15/2016

Desc: Latoja Lotion (body firming cream)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/15/2016

Desc: Suikan Hada Facial Mask

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/15/2016

Desc: Latoja Lotion (body firming cream)

Guangzhou JiuTai Bio-technology Co., Ltd.
Date Published : 07/06/2020
2 Huonanzhuang, Nancun Village , Baiyun District, Taihe , Guangzhou, Guangdong CHINA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 07/06/2020

Desc: Liyalan Instant Hand Sanitizer

62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 07/06/2020

Desc: Liyalan Instant Hand Sanitizer

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 07/06/2020

Desc: Liyalan Instant Hand Sanitizer

Guangzhou Joy Claire Technology Co., Ltd
Date Published : 11/04/2020
Building 8 Room 1601-1608 1614 , No. 50 Juyuan Street, Shijing Street, Baiyun District , Guangzhou, Guangdong CHINA
62 H - - 99 Anti-Microbial N.E.C.
Date Published: 11/04/2020

Desc: Lifecare Moisturizing Anti-bacterial Hand Sanitizer Gel

Guangzhou Wantang Co.,Ltd
Date Published : 04/23/2020
Xi Yayuan Room 1006 , Rict , Guangzhou, Guangdong CHINA
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/23/2020

Desc: Otesaly Botulinum Toxin Type A

65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Otesaly Botulinum Toxin Type A

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 04/23/2020

Desc: Otesaly Botulinum Toxin Type A

Guangzhou Xingqun Pharmaceutical Co Ltd
Date Published : 09/25/2012
No. 252 Rengmin Road Central , Guangzhou, Guangdong, CHINA
31 K - - 99 Tea, N.E.C.
Date Published: 09/25/2012

Desc: Xiasangju Chong Ji Herbal Tea

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/25/2012

Desc: Xiasangju Chong Ji Herbal Tea

Guangzhou Xiubo Medical Equipment Co. Ltd
Date Published : 04/23/2020
No. 22 Tian Yuan Road, Baiyun District , Guangzhou, Guangdong CHINA
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/23/2020

Desc: Otesaly Botulinum Toxin Type A

65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Otesaly Botulinum Toxin Type A

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 04/23/2020

Desc: Otesaly Botulinum Toxin Type A

Guangzhou Yanxiang Biology Development Co., Ltd.
Date Published : 01/10/2011
105 Avenue North , Guangzhou D Doa Bei, CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/10/2011

Notes: Dietary Supplements AKA Reduce Weight Fruta Planta or Reduce Wieght Fruta Planta; China

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 05/29/2012

Desc: Slim Tea Pao You Guo
Notes: China

60 - - - -- Human and Animal Drugs
Date Published: 01/10/2011

Notes: Dietary Supplements AKA Reduce Weight Fruta Planta or Reduce Wieght Fruta Planta; China

61 - - - -- Human and Animal Drugs
Date Published: 01/10/2011

Notes: Dietary Supplements AKA Reduce Weight Fruta Planta or Reduce Wieght Fruta Planta; China

62 - - - -- Human and Animal Drugs
Date Published: 01/10/2011

Notes: Dietary Supplements AKA Reduce Weight Fruta Planta or Reduce Wieght Fruta Planta; China

63 - - - -- Human and Animal Drugs
Date Published: 01/10/2011

Notes: Dietary Supplements AKA Reduce Weight Fruta Planta or Reduce Wieght Fruta Planta; China

64 - - - -- Human and Animal Drugs
Date Published: 01/10/2011

Notes: Dietary Supplements AKA Reduce Weight Fruta Planta or Reduce Wieght Fruta Planta; China

65 - - - -- Human and Animal Drugs
Date Published: 01/10/2011

Notes: Dietary Supplements AKA Reduce Weight Fruta Planta or Reduce Wieght Fruta Planta; China

66 - - - -- Human and Animal Drugs
Date Published: 01/10/2011

Notes: Dietary Supplements AKA Reduce Weight Fruta Planta or Reduce Wieght Fruta Planta; China

Guangzhou Youxi Cosmetics Co., Ltd.
Date Published : 01/19/2012
Xinshi Road , Workshop 19 , Gangzhou, Guangdong CHINA
53 - - - -- Cosmetics
Date Published: 01/19/2012

Notes: Lulanjina Skin Cream

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/19/2012

Notes: Lulanjina Skin Cream

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Lulanjina Skin Cream

61 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Lulanjina Skin Cream

62 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Lulanjina Skin Cream

63 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Lulanjina Skin Cream

64 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Lulanjina Skin Cream

65 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Lulanjina Skin Cream

66 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Lulanjina Skin Cream

Guangzhou Zai Gao Co Ltd
Date Published : 09/04/2013
Guanghua Road , Guangzhou Baiyun District , Shisheng, CHINA
65 Q - - 02 Botox
Date Published: 09/04/2013

Desc: Botulinum Toxin type A

75 C - - EP Radioimmunoassay, Luteinizing Hormone
Date Published: 09/04/2013

Desc: Luteinizing Hormone Hardening Agent

Guangzhou Zi Xiu Tang Biotechnology, Co LTD
Date Published : 10/10/2013
11 Fuli Building, Pearl River , New , Town Guangzhou City, Guangdong CHINA
54 Y - - 06 Bee Pollen (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 10/10/2013

Desc: Zi Xiu Tang
Notes: "Classic" Bee Pollen Capsules; FDA analysis found Sibutramine in product.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/10/2013

Notes: Zi Xiu Tang "Classic" Bee Pollen Capsules; FDA analysis found Sibutramine in product.

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 10/10/2013

Notes: Zi Xiu Tang "Classic" Bee Pollen Capsules; FDA analysis found Sibutramine in product.

Guangzhou Zilin Cosmetic Co., Ltd.
Date Published : 08/15/2013
8 Zibian Mulongtan St. , The Fourth Community, Xiushui , Baiyun, Guangzhou CHINA
53 G - - 01 Blushers (all Types) (Makeup Preparations, not for Eyes)
Date Published: 08/15/2013

Desc: Mineralized Loose Powder SPF15
Notes: China

53 G - - 01 Blushers (all Types) (Makeup Preparations, not for Eyes)
Date Published: 08/15/2013

Desc: Loose Powder for Face
Notes: China

53 G - - 02 Face Powders (Makeup Preparations, not for Eyes)
Date Published: 08/15/2013

Desc: Mineralized Loose Powder SPF15
Notes: China

53 G - - 02 Face Powders (Makeup Preparations, not for Eyes)
Date Published: 08/15/2013

Desc: Loose Powder for Face
Notes: China

H & L Industrial
Date Published : 03/27/2023
Rm 2405 Sunwise Ind. Centre16-26 Wang Wo , Tsuen Wan, CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Amerfresh toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 09/12/2007

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: Amerfresh toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 09/12/2007

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: Amerfresh toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 09/12/2007

H & S GMP Factory
Date Published : 05/31/2011
No. 125, High Technology & Development , Kunming, Yunnan CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/31/2011

Desc: Celerite Slimming Capsules
Notes: China

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/31/2011

Desc: Celerite Slimming Tea
Notes: China

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/22/2012

Desc: A-Slim 100 Natural Slimming Caps
Notes: Note; Analytical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein.

HANGZHOU FASHIONCITY HOMETEXTILECO
Date Published : 09/06/2018
No 149 Yuansha Village,Xinjie Twon , Xianshan District , Hangzhou, CHINA
53 L - - -- Skin Care Prep
Date Published: 09/06/2018

Desc: Natural Active Slimming Cream (AGOL Body Lab)
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; '... Anti-Cellulite ... Slimming Cream ... Effectively dispel abdominal obesity; striae gravidarum and sagging skin ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/06/2018

Desc: Natural Active Slimming Cream (AGOL Body Lab)
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; '... Anti-Cellulite ... Slimming Cream ... Effectively dispel abdominal obesity; striae gravidarum and sagging skin ...'.

HEBEI JIA ZI BIOLOGIAL TECHNOLOG
Date Published : 01/25/2017
9-903 No 266 Tiamshin S , Shijiazhuang, CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/25/2017

Desc: EZ Slimming Patch
Notes: Medical claims made on product label

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2017

Desc: EZ Slimming Patch
Notes: Medical claims made on product label

79 K - - GX Tape And Bandage, Adhesive
Date Published: 01/25/2017

Desc: EZ Slimming Patch
Notes: Medical claims made on product label

HENAN EXTEND TRADING CO
Date Published : 04/14/2017
30 E OF HANGHI RD , HENAN, CHINA
45 C - - 99 Antioxidants (Food Additives for Human Use)
Date Published: 04/14/2017

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone

54 C - - 01 L-Alanine (Protein)
Date Published: 04/14/2017

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone

54 C - - 99 Protein N.E.C.
Date Published: 04/14/2017

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone

56 F - - 99 Peptide N.E.C.
Date Published: 04/14/2017

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone

64 R - - 18 Human Growth Hormone (Hormone)
Date Published: 04/14/2017

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone

64 R - - 99 Hormone N.E.C.
Date Published: 04/14/2017

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/14/2017

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone

HENAN EXTEND TRADING COMPANY
Date Published : 04/14/2017
860 Weilai Rd , Zhengzhou, CHINA
45 C - - 99 Antioxidants (Food Additives for Human Use)
Date Published: 04/14/2017

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone

54 C - - 01 L-Alanine (Protein)
Date Published: 04/14/2017

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone

54 C - - 99 Protein N.E.C.
Date Published: 04/14/2017

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone

56 F - - 99 Peptide N.E.C.
Date Published: 04/14/2017

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.

64 R - - 18 Human Growth Hormone (Hormone)
Date Published: 04/14/2017

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone

64 R - - 99 Hormone N.E.C.
Date Published: 04/14/2017

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/14/2017

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone

HENAN FENGTAI INDUSTRY&COMMERCE LTD.
Date Published : 08/25/2010
Mazhai Industrial Park. , No. 20 Xianfeng Road , Zhengzhou, Henan CHINA
02 - - - -- Whole Grains/Milled Grain Products/Starches
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

04 - - - -- Macaroni/Noodle Products
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

05 - - - -- Cereal Preparations/Breakfast Foods
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

07 - - - -- Snack Food Items
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

09 - - - -- Milk/Butter/Dried Milk Products
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

12 - - - -- Cheese/Cheese Products
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

13 - - - -- Ice Cream and related Products
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

14 - - - -- Filled Milk/Imitation Milk Products
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

15 - - - -- Eggs/Egg Products
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

16 - - - -- Fishery/Seafood Products
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

17 - - - -- Meats, Meat Products and Poultry
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

18 - - - -- Vegetable Protein Products
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

20 - - - -- Fruit/Fruit Products
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

21 - - - -- Fruit/Fruit Products
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

22 - - - -- Fruit/Fruit Products
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

23 - - - -- Nuts/Edible Seeds
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

24 - - - -- Vegetables/Vegetable Products
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

25 - - - -- Vegetables/Vegetable Products
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

26 - - - -- Vegetable Oils
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

27 - - - -- Dressing/Condiments
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

28 - - - -- Spices, Flavors And Salts
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

29 - - - -- Soft Drinks/Water
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

31 - - - -- Coffee/Tea
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

32 - - - -- Alcoholic Beverages
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

38 - - - -- Soups
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

39 - - - -- Prepared Salad Products
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

40 A - - -- Baked Goods (Baby)
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

40 B - - -- Cereal (Baby)
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

40 D - - -- Veg (Baby)
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

40 J - - -- Egg Prod (Baby)
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

40 K - - -- Pudding/Custard (Baby)
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

40 L - - -- Soups/Soup Mix (Baby)
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

40 X - - -- Market Basket Sampling
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

40 Y - - -- Baby Food N.E.C.
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 08/25/2010

52 B - - 06 Corn Husks (Food Related)
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

52 B - - 07 Snail Shells (Food Related)
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

52 D - - -- Live Animals
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

61 - - - -- Human and Animal Drugs
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

62 - - - -- Human and Animal Drugs
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

63 - - - -- Human and Animal Drugs
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

64 - - - -- Human and Animal Drugs
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

65 - - - -- Human and Animal Drugs
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

66 - - - -- Human and Animal Drugs
Date Published: 08/25/2010

Notes: YongGang Food Supplement; Country-China

HONG HUI DAILY APPLIANCE CO LTD
Date Published : 11/06/2017
2nd F. Baiyunhui Group , No. 88 Huangshi East Rd; Baiyun Dist , Guangzhou, Guangdong CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 11/06/2017

Desc: Miracle Charcoil Toothpaste
Notes: The statement on label referring specifically to product "Whitens; Kill germs and freshens breath

Hainan Fuwang Industrial Co., Ltd.
Date Published : 03/29/2017
Room 9b , Beijing Bldg A6 Garden Financial; Haikou , Hainansheng, Hainan CHINA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 03/29/2017

Desc: Peppermint Scrub
Notes: The product appears to be an unapproved new drug as the product labeling and firm's website contain claims that indicate drug uses for the product including; "[W]ith regular use will target cellulite"; "Caffeine will stimulate blood flow"; and "removing ... acne; whiteheads; blackheads; breakouts and other skin blemishes".

Hainan Resurgence Natural Healthy F
Date Published : 08/14/2012
105 Numbersof , Guangzhou Cityguangzhou City, CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/14/2012

Desc: Fruta Bio Dietary Supplement
Notes: China

Hangzhou Beja Commodity Co., Ltd.
Date Published : 07/21/2014
288, Xiufeng Road , Yuzhao Village, Fuchunjiang Town, Tonglu County , Hangzhou, Zhejiang CHINA
64 X - - 06 Salicylic Acid (Keratolytic)
Date Published: 07/21/2014

Desc: Acne Wipes (Salicylic Acid Acne Treatment)
Notes: Product does not contain Salicylic Acid and is misbranded.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/21/2014

Desc: Acne Wipes (Salicylic Acid Acne Treatment)
Notes: Product does not contain Salicylic Acid and is misbranded.

79 O - - ZC Over the counter acne treatment
Date Published: 07/21/2014

Desc: Acne Wipes (Salicylic Acid Acne Treatment)
Notes: Product does not contain Salicylic Acid and is misbranded.

Hangzhou Huajin Pharmaceutical Co., Litd.
Date Published : 10/20/2016
No. 156 Guagangyi Road , Hangzhou, Zhejiang CHINA
17 M - - 11 Pork, Extract
Date Published: 10/20/2016

Desc: Hepatohydrolysate

54 G - - 03 Porcine (Pig, Etc.) (Animal By-Products and Extracts)
Date Published: 10/20/2016

Desc: Hepatohydrolysate

Hangzhou Johncan Mushroom Bio-technology Co.,Ltd
Date Published : 08/01/2019
No.892,East ChangHong Street , DeQing , Hangzhou, Zhejiang CHINA
28 C - - 99 Natural Extract or Flavor, N.E.C.
Date Published: 08/01/2019

Desc: 4 Mushrooms Emperor?s Blend Powder
Notes:                                               The product appears to be an unapproved new drug as the product's label and website include disease claims such as (not an all-inclusive list): '...Formulated with 4 of our most legendary and effective traditional medicinal mushrooms...; ...See our FAQ section for an in-depth understanding of Medicinal Mushrooms, how they work and how to select the right ones for you*...; ...[A]ntiviral, Anti-Inflammatory, Anti-Allergy,...; ...Helps Prevent Cancers and Slow Tumor Growth...'

46 Y - - 99 Food Additives For Human Use, N.E.C.
Date Published: 08/01/2019

Desc: 4 Mushrooms Emperor?s Blend Powder
Notes:                                               The product appears to be an unapproved new drug as the product's label and website include disease claims such as (not an all-inclusive list): '...Formulated with 4 of our most legendary and effective traditional medicinal mushrooms...; ...See our FAQ section for an in-depth understanding of Medicinal Mushrooms, how they work and how to select the right ones for you*...; ...[A]ntiviral, Anti-Inflammatory, Anti-Allergy,...; ...Helps Prevent Cancers and Slow Tumor Growth...'

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/01/2019

Desc: 4 Mushrooms Emperor?s Blend Powder
Notes:                                               The product appears to be an unapproved new drug as the product's label and website include disease claims such as (not an all-inclusive list): '...Formulated with 4 of our most legendary and effective traditional medicinal mushrooms...; ...See our FAQ section for an in-depth understanding of Medicinal Mushrooms, how they work and how to select the right ones for you*...; ...[A]ntiviral, Anti-Inflammatory, Anti-Allergy,...; ...Helps Prevent Cancers and Slow Tumor Growth...'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/01/2019

Desc: 4 Mushrooms Emperor?s Blend Powder
Notes:                                               The product appears to be an unapproved new drug as the product's label and website include disease claims such as (not an all-inclusive list): '...Formulated with 4 of our most legendary and effective traditional medicinal mushrooms...; ...See our FAQ section for an in-depth understanding of Medicinal Mushrooms, how they work and how to select the right ones for you*...; ...[A]ntiviral, Anti-Inflammatory, Anti-Allergy,...; ...Helps Prevent Cancers and Slow Tumor Growth...'

Hangzhou Vet & Pet Supplies Co Ltd
Date Published : 03/27/2023
F 14 , NO 229 Tiyunchang Road , Hangzhou, Zhejiang CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Pro Dental Mint Flavored toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 10/09/2007

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: Pro Dental Mint Flavored toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 10/09/2007

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: Pro Dental Mint Flavored toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 10/09/2007

Harbin Gelidia Cosmetics Co Ltd
Date Published : 09/30/2009
69 Erdao St , Nanyuan, CHINA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/30/2009

Notes: 9/14/2007. Jiaoli Miraculous Cream Day and Night Whitening.                        Product has been found to contain mercury, which is a health hazard. Additionally, the website promotes and sells this product for drug use. There is no substantial scientific evidence that this product is generally recognized as safe and effective for the conditions recommended or suggested in its labeling.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/30/2009

Notes: 9/14/2007.Jiaoli Miraculous Cream Day and Night Whitening.                        Product has been found to contain mercury, which is a health hazard. Additionally, the website promotes and sells this product for drug use. There is no substantial scientific evidence that this product is generally recognized as safe and effective for the conditions recommended or suggested in its labeling.

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: 9/14/2007. Jiaoli Miraculous Cream Day and Night Whitening.                        Product has been found to contain mercury, which is a health hazard. Additionally, the website promotes and sells this product for drug use. There is no substantial scientific evidence that this product is generally recognized as safe and effective for the conditions recommended or suggested in its labeling.

Harbin Zhongshan Diabetes Research Institute
Date Published : 09/30/2009
Unknown Street , Harbin, CHINA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/28/2019

Notes: All products; 6/6/2000

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All products; 6/6/2000

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products; 6/6/2000

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products; 6/6/2000

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products; 6/6/2000

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products; 6/6/2000

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products; 6/6/2000

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products; 6/6/2000

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products; 6/6/2000

Heilongjiang Provincial Hechang Import & Export Co. Ltd.
Date Published : 08/29/2019
Unknown Street , Harbin, CHINA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/29/2019

Notes: All Products; 6/6/2000

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/29/2019

Notes: All Products; 6/6/2000

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 08/29/2019

Notes: All Products; 6/6/2000

61 - - - -- Human and Animal Drugs
Date Published: 08/29/2019

Notes: All Products; 6/6/2000

62 - - - -- Human and Animal Drugs
Date Published: 08/29/2019

Notes: All Products; 6/6/2000

63 - - - -- Human and Animal Drugs
Date Published: 08/29/2019

Notes: All Products; 6/6/2000

64 - - - -- Human and Animal Drugs
Date Published: 08/29/2019

Notes: All Products; 6/6/2000

65 - - - -- Human and Animal Drugs
Date Published: 08/29/2019

Notes: All Products; 6/6/2000

66 - - - -- Human and Animal Drugs
Date Published: 08/29/2019

Notes: All Products; 6/6/2000

Henan Kangdi Medical Devices Co. Ltd
Date Published : 06/08/2012
Sme Pioneer Park , No. 4 2nd Area , Zhoukou, Henan CHINA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 06/06/2017

Desc: FitTea Wraps (Gel patch)
Notes: Drug claims made in product labels and websites

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 06/06/2017

Desc: FitTea Wraps (Gel patch)
Notes: Drug claims made in product labels and websites

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2012

Desc: Foot Relief Patch
Notes: China

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/06/2017

Desc: FitTea Wraps (Gel patch)
Notes: Drug claims made in product labels and websites

Henan New Sensation Chemical Co Ltd
Date Published : 11/01/2016
No 861 Huanghe East Rd , Jingjijizhukaifa Guanchenghuizu , Zhengzhou, Henan CHINA
45 C - - 99 Antioxidants (Food Additives for Human Use)
Date Published: 11/01/2016

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone

45 C - - 99 Antioxidants (Food Additives for Human Use)
Date Published: 01/13/2017

Desc: Aspartic Acid (cosmetic raw material)
Notes: Product was manifested as Aspartic Acid, however it was found to contain undeclared Ipamorelin, a Human Growth Hormone.

45 C - - 99 Antioxidants (Food Additives for Human Use)
Date Published: 11/07/2016

Desc: Glutathione
Notes: Product was manifested as Glutathione; however it was found to contain undeclared Human Growth Hormone.

53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 01/13/2017

Desc: Aspartic Acid (cosmetic raw material)
Notes: Product was manifested as Aspartic Acid, however it was found to contain undeclared Ipamorelin, a Human Growth Hormone.

53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 07/28/2017

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.

54 C - - 01 L-Alanine (Protein)
Date Published: 07/28/2017

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.

54 C - - 08 L-Glutamine (Protein)
Date Published: 11/07/2016

Desc: Glutathione
Notes: Product was manifested as Glutathione; however it was found to contain undeclared Human Growth Hormone.

54 C - - 99 Protein N.E.C.
Date Published: 11/07/2016

Desc: Glutathione
Notes: Product was manifested as Glutathione; however it was found to contain undeclared Human Growth Hormone.

54 C - - 99 Protein N.E.C.
Date Published: 11/01/2016

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.

56 F - - 99 Peptide N.E.C.
Date Published: 11/01/2016

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.

56 F - - 99 Peptide N.E.C.
Date Published: 11/07/2016

Desc: Glutathione
Notes: Product was manifested as Glutathione; however it was found to contain undeclared Human Growth Hormone.

64 R - - 18 Human Growth Hormone (Hormone)
Date Published: 11/07/2016

Desc: Glutathione
Notes: Product was manifested as Glutathione; however it was found to contain undeclared Human Growth Hormone.

64 R - - 18 Human Growth Hormone (Hormone)
Date Published: 11/01/2016

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone

64 R - - 18 Human Growth Hormone (Hormone)
Date Published: 01/13/2017

Desc: Aspartic Acid (cosmetic raw material)
Notes: Product was manifested as Aspartic Acid, however it was found to contain undeclared Ipamorelin, a Human Growth Hormone.

64 R - - 99 Hormone N.E.C.
Date Published: 11/01/2016

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.

64 R - - 99 Hormone N.E.C.
Date Published: 01/13/2017

Desc: Aspartic Acid (cosmetic raw material)
Notes: Product was manifested as Aspartic Acid, however it was found to contain undeclared Ipamorelin, a Human Growth Hormone.

64 R - - 99 Hormone N.E.C.
Date Published: 11/07/2016

Desc: Glutathione
Notes: Product was manifested as Glutathione; however it was found to contain undeclared Human Growth Hormone.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/01/2016

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/07/2016

Desc: Glutathione
Notes: Product was manifested as Glutathione; however it was found to contain undeclared Human Growth Hormone.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/13/2017

Desc: Aspartic Acid (cosmetic raw material)
Notes: Product was manifested as Aspartic Acid, however it was found to contain undeclared Ipamorelin, a Human Growth Hormone.

75 O - - TV Research use only/clinical chemistry devices
Date Published: 01/13/2017

Desc: Aspartic Acid (cosmetic raw material)
Notes: Product was manifested as Aspartic Acid, however it was found to contain undeclared Ipamorelin, a Human Growth Hormone.

88 L - - DT Reagent, General Purpose
Date Published: 11/07/2016

Desc: Glutathione
Notes: Product was manifested as Glutathione; however it was found to contain undeclared Human Growth Hormone.

88 L - - DT Reagent, General Purpose
Date Published: 11/01/2016

Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone

Hong Kong Asia-Pacific Biotechnology Ltd
Date Published : 03/17/2017
Tsim Sha Tsui East , Kowloon , Hong Kong, CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/17/2017

Desc: Street Overlord Capsules
Notes: Product was found to contain undeclared Sildenafil

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 03/17/2017

Desc: Street Overlord Capsules
Notes: Product was found to contain undeclared Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/17/2017

Desc: Street Overlord Capsules
Notes: Product was found to contain undeclared Sildenafil

Hubei Minkang Pharmaceutical Co., Ltd.
Date Published : 04/24/2017
NO. 50 Xiba Road , Yichang, Hubei CHINA
54 E - - -- Herbal and Botanical
Date Published: 04/24/2017

Desc: Hawthorn Fruit Combo Tea Extract (Jiang Zhi Wan)

54 E - - -- Herbal and Botanical
Date Published: 04/24/2017

Desc: Huang Lian Su Herbal Supplement Tablets

54 E - - -- Herbal and Botanical
Date Published: 04/24/2017

Desc: Fructus Sophorae Concentrated (Huai Jiao Wan)

54 E - - -- Herbal and Botanical
Date Published: 04/24/2017

Desc: Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement Tablets

54 E - - -- Herbal and Botanical
Date Published: 04/24/2017

Desc: Mulberry Twig Combo Tea Extract (Guan Jie Bi Tong Wan)

54 E - - -- Herbal and Botanical
Date Published: 04/24/2017

Desc: Magnolia Combo Extract Concentrated (Bi Yuan Wan)

54 E - - -- Herbal and Botanical
Date Published: 04/24/2017

Desc: Angelica Combination Tea Extract (Du Huo Ji Shang)

54 E - - -- Herbal and Botanical
Date Published: 04/24/2017

Desc: Circulex Dietary Supplement

54 E - - -- Herbal and Botanical
Date Published: 04/24/2017

Desc: Rehmannia Root Combo Tea Extract (Xiao Feng Wan)

54 E - - -- Herbal and Botanical
Date Published: 04/24/2017

Desc: Auricularex (Er Ming Wan)

54 F - - 03 Angelica (Herbal & Botanicals, not Teas)
Date Published: 04/24/2017

Desc: Angelica Combination Tea Extract (Du Huo Ji Shang)

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 04/24/2017

Desc: Auricularex (Er Ming Wan)

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 04/24/2017

Desc: Fructus Sophorae Concentrated (Huai Jiao Wan)

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 04/24/2017

Desc: Circulex Dietary Supplement

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 04/24/2017

Desc: Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement Tablets

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 04/24/2017

Desc: Magnolia Combo Extract Concentrated (Bi Yuan Wan)

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 04/24/2017

Desc: Angelica Combination Tea Extract (Du Huo Ji Shang)

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 04/24/2017

Desc: Huang Lian Su Herbal Supplement Tablets

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 04/24/2017

Desc: Rehmannia Root Combo Tea Extract (Xiao Feng Wan)

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 04/24/2017

Desc: Mulberry Twig Combo Tea Extract (Guan Jie Bi Tong Wan)

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 04/24/2017

Desc: Hawthorn Fruit Combo Tea Extract (Jiang Zhi Wan)

54 J - - -- Herbal and Botanical II
Date Published: 04/24/2017

Desc: Magnolia Combo Extract Concentrated (Bi Yuan Wan)

54 J - - -- Herbal and Botanical II
Date Published: 04/24/2017

Desc: Fructus Sophorae Concentrated (Huai Jiao Wan)

54 J - - -- Herbal and Botanical II
Date Published: 04/24/2017

Desc: Hawthorn Fruit Combo Tea Extract (Jiang Zhi Wan)

54 J - - -- Herbal and Botanical II
Date Published: 04/24/2017

Desc: Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement Tablets

54 J - - -- Herbal and Botanical II
Date Published: 04/24/2017

Desc: Huang Lian Su Herbal Supplement Tablets

54 J - - -- Herbal and Botanical II
Date Published: 04/24/2017

Desc: Auricularex (Er Ming Wan)

54 J - - -- Herbal and Botanical II
Date Published: 04/24/2017

Desc: Circulex Dietary Supplement

54 J - - -- Herbal and Botanical II
Date Published: 04/24/2017

Desc: Mulberry Twig Combo Tea Extract (Guan Jie Bi Tong Wan)

54 J - - -- Herbal and Botanical II
Date Published: 04/24/2017

Desc: Angelica Combination Tea Extract (Du Huo Ji Shang)

54 J - - -- Herbal and Botanical II
Date Published: 04/24/2017

Desc: Rehmannia Root Combo Tea Extract (Xiao Feng Wan)

54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 04/24/2017

Desc: Huang Lian Su Herbal Supplement Tablets

54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 04/24/2017

Desc: Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement Tablets

54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 04/24/2017

Desc: Angelica Combination Tea Extract (Du Huo Ji Shang)

54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 04/24/2017

Desc: Fructus Sophorae Concentrated (Huai Jiao Wan)

54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 04/24/2017

Desc: Rehmannia Root Combo Tea Extract (Xiao Feng Wan)

54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 04/24/2017

Desc: Circulex Dietary Supplement

54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 04/24/2017

Desc: Mulberry Twig Combo Tea Extract (Guan Jie Bi Tong Wan)

54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 04/24/2017

Desc: Magnolia Combo Extract Concentrated (Bi Yuan Wan)

54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 04/24/2017

Desc: Auricularex (Er Ming Wan)

54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 04/24/2017

Desc: Hawthorn Fruit Combo Tea Extract (Jiang Zhi Wan)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2017

Desc: Rehmannia Root Combo Tea Extract (Xiao Feng Wan)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2017

Desc: Hawthorn Fruit Combo Tea Extract (Jiang Zhi Wan)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2017

Desc: Angelica Combination Tea Extract (Du Huo Ji Shang)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2017

Desc: Mulberry Twig Combo Tea Extract (Guan Jie Bi Tong Wan)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2017

Desc: Auricularex (Er Ming Wan)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2017

Desc: Huang Lian Su Herbal Supplement Tablets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2017

Desc: Circulex Dietary Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2017

Desc: Magnolia Combo Extract Concentrated (Bi Yuan Wan)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2017

Desc: Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement Tablets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2017

Desc: Fructus Sophorae Concentrated (Huai Jiao Wan)

Huikng Pharmaceutical
Date Published : 08/24/2012
Unknown , Unknown, CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/04/2019

Desc: P57 Hoodia Cactus Slimming Caps
Notes: 8/24/2012; Analytical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein

Huzhou Guoneng New Material Co., Ltd.
Date Published : 08/11/2020
Building 1 Floor 4 , 1518 Mengxi Road; Shanlianzhen Nanxun , Huzhou, Zhejiang CHINA
62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 08/11/2020

Desc: VISBELLA INSTANT HAND SANITIZER

Imam International Group Co., Limited
Date Published : 03/12/2014
901 , # 1-4 Qin Fang Li, Liu Jia Fang Zi; Bei Chen District , Hongqiao, Tianjin CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/12/2014

Desc: Gut-Be-Gone
Notes: country; China

JIANGXI GAOAN TEA CO., LTD.
Date Published : 09/30/2009
Fuqiaocun , Yichunshi, Jiangxisheng CHINA
31 K - - 99 Tea, N.E.C.
Date Published: 09/30/2009

Notes: 9/24/2008. Healing Collection 4 Tea. Also diabetic choice tea. Labeling of this herbal product makes drug claims related to the mitigation of cholesterol; diabetes; and high blood pressure thus causing the product to be a new drug; for which no approval is in effect. The product may be entering as a dietary supplement; therefore we have included various product codes.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 09/30/2009

Notes: 9/24/2008. Healing Collection 4 Tea. Labeling of this herbal product makes drug claims related to the mitigation of cholesterol; diabetes; and high blood pressure thus causing the product to be a new drug; for which no approval is in effect. The product may be entering as a dietary supplement; therefore we have included various product codes.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 9/24/2008. Healing Collection 4 Tea. Labeling of this herbal product makes drug claims related to the mitigation of cholesterol; diabetes; and high blood pressure thus causing the product to be a new drug; for which no approval is in effect. The product may be entering as a dietary supplement; therefore we have included various product codes.

JIANGXI JIANYUAN BIOLOGICAL TECHNOLOGY CO LTD
Date Published : 06/23/2010
Liangfu Gongyeyuan , Dingnanxian , Ganzhou, Jiangxi CHINA
31 A - - 03 Coffee, Instant
Date Published: 06/23/2010

Desc: Magic Power Coffee
Notes: China; Analytical testing by FDA¿s Forensic Chemistry Center reveals the product contains hydroxythiohomosildenafil, an analogue of sildenafil, the active pharmaceutical ingredient in Viagra. The product is labeled as a dietary supplement.

31 A - - 99 Coffee, N.E.C.
Date Published: 06/23/2010

Desc: Magic Power Coffee
Notes: China; Analytical testing by FDA¿s Forensic Chemistry Center reveals the product contains hydroxythiohomosildenafil, an analogue of sildenafil, the active pharmaceutical ingredient in Viagra. The product is labeled as a dietary supplement.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/23/2010

Desc: Magic Power Coffee
Notes: China; Analytical testing by FDA¿s Forensic Chemistry Center reveals the product contains hydroxythiohomosildenafil, an analogue of sildenafil, the active pharmaceutical ingredient in Viagra. The product is labeled as a dietary supplement.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/23/2010

Desc: Magic Power Coffee
Notes: China; Analytical testing by FDA¿s Forensic Chemistry Center reveals the product contains hydroxythiohomosildenafil, an analogue of sildenafil, the active pharmaceutical ingredient in Viagra. The product is labeled as a dietary supplement.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/23/2010

Desc: Magic Power Coffee
Notes: China; Analytical testing by FDA¿s Forensic Chemistry Center reveals the product contains hydroxythiohomosildenafil, an analogue of sildenafil, the active pharmaceutical ingredient in Viagra. The product is labeled as a dietary supplement.

Jiangsu Longliqi Bioscience Co Ltd.
Date Published : 07/30/2010
Longliqi Biological Ind. Park , Changnan Village, Xinzhuang , Changshu, CHINA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 07/30/2010

Desc: Germinator Hand Sanitizer
Notes: China

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 07/30/2010

Desc: Germinator Hand Sanitizer
Notes: China

Jiangsu Longliqi Leather Co Ltd South Xingzipuang Changsu
Date Published : 07/30/2010
Unknown Street , Jiangsu, CHINA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 07/30/2010

Desc: Germinator Hand Sanitizer
Notes: China

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 07/30/2010

Desc: Germinator Hand Sanitizer
Notes: China

Jiangsu Soho Int'L Gp Yangzhou Co.
Date Published : 03/27/2023
No.628 Yangzijiang Middle Roadyangzhou , Jiangsu, CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Flora Fresh toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 07/13/2007

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: Flora Fresh toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 07/13/2007

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: Flora Fresh toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 07/13/2007

Jianhe Medical Articles Company Ltd
Date Published : 01/19/2018
86 Suli Road , Changqiaozhen Wuzhong , Suzhou, Jiangsu CHINA
60 L - - 99 Analgesic, N.E.C.
Date Published: 01/19/2018

Desc: Mundicare Burnaid Hydrogel-First Aid Burn Treatment

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/19/2018

Desc: Mundicare Burnaid Hydrogel-First Aid Burn Treatment

79 M - - GQ Dressing, Wound And Burn, Hydrogel
Date Published: 01/19/2018

Desc: Mundicare Burnaid Hydrogel-First Aid Burn Treatment

Jinan Felicity Biotechnology Co.,Ltd
Date Published : 06/13/2018
1 Huayang Road , Lixia District , Jinan, CHINA
26 B - - 10 Flaxseed/Linseed Oil Seed Stock
Date Published: 06/13/2018

Desc: CBD2 Dietary Supplement (Hemp Oil)
Notes: Product was misdeclared as Flaxseed oil (26B[][]10)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/13/2018

Desc: CBD2 Dietary Supplement (Hemp Oil)
Notes: Product was misdeclared as Flaxseed oil (26B[][]10)

Jk Tea Co., Ltd
Date Published : 11/10/2020
No.3 Chun Hong Room 2ST , 803 Baiyundadao; Baiyun , Guangzhou, Guangdong CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/10/2020

Desc: IMMORTALITEA JIAOGULAN LEAF Capsules
Notes: The product appears to be an unapproved new drug as the product's promotional material includes claims such as (not an all-inclusive list): 'The Health Benefits of [ingredient in the product] Gynostemma: The Herb of Immortality'; 'What if you could gain those health benefits while preventing most of the chronic diseases that plague our modern society?...Well, that's what Jiaogulan (Gynestemma Pentaphyllum) can do for you'; 'The Heart Healer . . . Gynostemma . . . may reduce the chance of heart disease'; 'Gynostemma can help manage cholesterol level the body [sic]. This support [six] blood circulation, ensuring that the arteries are free from toxins, which could lead to a stroke or a heart attack. Overall, this herb may be very beneficial to your ticker, especially if you have a family history of heart problems'.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/10/2020

Desc: IMMORTALITEA JIAOGULAN LEAF Capsules
Notes: The product appears to be an unapproved new drug as the product's promotional material includes claims such as (not an all-inclusive list): 'The Health Benefits of [ingredient in the product] Gynostemma: The Herb of Immortality'; 'What if you could gain those health benefits while preventing most of the chronic diseases that plague our modern society?...Well, that's what Jiaogulan (Gynestemma Pentaphyllum) can do for you'; 'The Heart Healer . . . Gynostemma . . . may reduce the chance of heart disease'; 'Gynostemma can help manage cholesterol level the body [sic]. This support [six] blood circulation, ensuring that the arteries are free from toxins, which could lead to a stroke or a heart attack. Overall, this herb may be very beneficial to your ticker, especially if you have a family history of heart problems'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/10/2020

Desc: IMMORTALITEA JIAOGULAN LEAF Capsules
Notes: The product appears to be an unapproved new drug as the product's promotional material includes claims such as (not an all-inclusive list): 'The Health Benefits of [ingredient in the product] Gynostemma: The Herb of Immortality'; 'What if you could gain those health benefits while preventing most of the chronic diseases that plague our modern society?...Well, that's what Jiaogulan (Gynestemma Pentaphyllum) can do for you'; 'The Heart Healer . . . Gynostemma . . . may reduce the chance of heart disease'; 'Gynostemma can help manage cholesterol level the body [sic]. This support [six] blood circulation, ensuring that the arteries are free from toxins, which could lead to a stroke or a heart attack. Overall, this herb may be very beneficial to your ticker, especially if you have a family history of heart problems'.

Kathan Trading Co.
Date Published : 11/06/2012
10F tech bldg East Heping Road , Longhua St. Baoan District, , Shenzhen Guangdong, CHINA
31 E - - 06 Herbal Coffee (Blend of herbs, grains, fruits and nuts)
Date Published: 11/06/2012

Desc: Brazilian Slimming Coffee
Notes: Note; Analytical testing by FDA revealed these products contain undeclared Sibutramine and Phenolphthalein.

31 E - - 06 Herbal Coffee (Blend of herbs, grains, fruits and nuts)
Date Published: 11/06/2012

Desc: Vitaccino
Notes: Note; Analytical testing by FDA revealed these products contain undeclared Sibutramine and Phenolphthalein.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/06/2012

Desc: Green Slimming
Notes: Note; Analytical testing by FDA revealed these products contain undeclared Sibutramine and Phenolphthalein

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/06/2012

Desc: Brazilian Slimming Coffee
Notes: Note; Analytical testing by FDA revealed these products contain undeclared Sibutramine and Phenolphthalein.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/06/2012

Desc: Vitaccino
Notes: Note; Analytical testing by FDA revealed these products contain undeclared Sibutramine and Phenolphthalein.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/06/2012

Desc: Brazilian Slimming Coffee
Notes: Note; Analytical testing by FDA revealed these products contain undeclared Sibutramine and Phenolphthalein.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/06/2012

Desc: Vitaccino
Notes: Note; Analytical testing by FDA revealed these products contain undeclared Sibutramine and Phenolphthalein

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/06/2012

Desc: Green Slimming
Notes: Note; Analytical testing by FDA revealed these products contain undeclared Sibutramine and Phenolphthalein

Komar Cosmetics (Guangzhou) Ltd
Date Published : 09/06/2012
48 Hongmian Road, Huadu Xinhua Town , Guangzhou, Guangdong CHINA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/06/2012

Desc: Toy and Body Cleaner

Kunming Bi Xing
Date Published : 12/23/2013
Unknown , Kunming-Eastern Border Of Xian, CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/23/2013

Desc: Xiyouji Qingzhi
Notes: Note; Analytical testing by FDA revealed these products contain undeclared Sibutramine.

Kunming DaLi Industry & Trade Co., Ltd
Date Published : 09/13/2019
372 Ren Min West Rd , Xishan , Kunming, Yunnan CHINA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/13/2019

Notes: 12/1/2008; Li Da Dai Dai Hua Slimming Capsules

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: 12/1/2008; Li Da Dai Dai Hua Slimming Capsules

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 12/1/2008; Li Da Dai Dai Hua Slimming Capsules

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 12/1/2008; Li Da Dai Dai Hua Slimming Capsules

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 12/1/2008; Li Da Dai Dai Hua Slimming Capsules

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 12/1/2008; Li Da Dai Dai Hua Slimming Capsules

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 12/1/2008; Li Da Dai Dai Hua Slimming Capsules

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 12/1/2008; Li Da Dai Dai Hua Slimming Capsules

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: 12/1/2008; Li Da Dai Dai Hua Slimming Capsules

Kunming Dali Industry & Trade Co, LTD
Date Published : 05/10/2012
Citgroup Tower No. 33 , Lu Jia Zui Finance; Qia Trade Zone , Shanghai, Shanghai CHINA
54 F - - 83 Citrus Aurantium ( Herbal & Botanical other than Teas)
Date Published: 05/10/2012

Desc: SlimXtreme Herbal Slimming Capsules
Notes: china

54 F - - 83 Citrus Aurantium ( Herbal & Botanical other than Teas)
Date Published: 05/10/2012

Desc: ViaXtreme Ultimate Sexual Enhancer Dietary Supplement for Men
Notes: china

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/13/2019

Desc: ViaXtreme Ultimate Sexual Enhancer Dietary Supplement for Men
Notes: 5/10/2012; China

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/10/2012

Desc: SlimXtreme Herbal Slimming Capsules
Notes: China

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/10/2012

Desc: SlimXtreme Herbal Slimming Capsules
Notes: China

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/10/2012

Desc: ViaXtreme Ultimate Sexual Enhancer Dietary Supplement for Men
Notes: china

LMZ
Date Published : 09/29/2017
282 East Ring Rd , Liuzhou, Guangxizhuangzuzizhiqu CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 09/29/2017

Desc: LMZ Herbal Toothpaste
Notes: LMZ Int'l Ltd. (FEI # 3010414385) is the Headquarters of Liuzhou LMZ Co. Ltd.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2017

Desc: LMZ Herbal Toothpaste
Notes: LMZ Int'l Ltd. (FEI # 3010414385) is the Headquarters of Liuzhou LMZ Co. Ltd.

LMZ
Date Published : 09/29/2017
282 East Ring Rd , Liuzhou, Guangxizhuangzuzizhiqu CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 09/29/2017

Desc: LMZ Herbal Toothpaste
Notes: LMZ Intl Ltd. (FEI # 3010414385) is the Headquarters of Liuzhou LMZ Co. Ltd.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2017

Desc: LMZ Herbal Toothpaste
Notes: LMZ Intl Ltd. (FEI # 3010414385) is the Headquarters of Liuzhou LMZ Co. Ltd.

LMZ INTERNATIONAL LTD
Date Published : 09/29/2017
NO 2 Changfeng Road Liuzhou Guangxi , Liuzhou, Guangxi CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 09/29/2017

Desc: LMZ Herbal Toothpaste
Notes: LMZ Intl Ltd. (FEI # 3010414385) is the Headquarters of Liuzhou LMZ Co. Ltd.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2017

Desc: LMZ Herbal Toothpaste
Notes: LMZ Intl Ltd. (FEI # 3010414385) is the Headquarters of Liuzhou LMZ Co. Ltd.

Lanzhou Foci Pharmaceutical Co., Ltd.
Date Published : 08/30/2021
No 2289 Huashan Rd , Lanzhou New Area , Lanzhou, Gansu CHINA
66 - - - -- Human and Animal Drugs
Date Published: 08/30/2021

Desc: Lycium-Rehmannia Pills
Notes:                                                                                                                                                         

66 - - - -- Human and Animal Drugs
Date Published: 08/30/2021

Desc: Fructus Persica Compound Pills
Notes:                                                                                                                        

Lanzhou Institute of Biological Products
Date Published : 04/23/2020
178 Yanchanglu , Lanzhoushi, Gansusheng CHINA
53 - - - -- Cosmetics
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 07 Myobloc
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

Lanzhou Taibao Pharmaceutical Company, LLC
Date Published : 02/26/2013
No. 85 Jian West West Rd , Lanzhou, Gansu CHINA
53 E - - -- Hair Preps(Non-Coloring)
Date Published: 02/26/2013

Desc: Li Dan Hua Shi Wan Herbal Dietary Supplement
Notes: NOTE: Gansu Medicine is the OASIS declared manufacturer and Lanzhou Taibao Pharmaceutical Co. Ltd. is the manufacturer per product label.

53 E - - -- Hair Preps(Non-Coloring)
Date Published: 02/26/2013

Desc: Ban Xia Bai Zhu Tian Ma Wan Herbal Dietary Supplement
Notes: NOTE: Gansu Medicine is the OASIS declared manufacturer and Lanzhou Taibao Pharmaceutical Co. Ltd. is the manufacturer per product label.

53 E - - -- Hair Preps(Non-Coloring)
Date Published: 02/26/2013

Desc: Zuo Gu Shen Jing Tong Wan Herbal Dietary Supplement
Notes: NOTE: Gansu Medicine is the OASIS declared manufacturer and Lanzhou Taibao Pharmaceutical Co. Ltd. is the manufacturer per product label.

53 E - - -- Hair Preps(Non-Coloring)
Date Published: 02/26/2013

Desc: Xiang Sha Liu Jun Wan Herbal Dietary Supplement
Notes: NOTE: Gansu Medicine is the OASIS declared manufacturer and Lanzhou Taibao Pharmaceutical Co. Ltd. is the manufacturer per product label.

53 E - - -- Hair Preps(Non-Coloring)
Date Published: 02/26/2013

Desc: Jin Gu Die Da Wan Herbal Dietary Supplement
Notes: NOTE: Gansu Medicine is the OASIS declared manufacturer and Lanzhou Taibao Pharmaceutical Co. Ltd. is the manufacturer per product label.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/26/2013

Desc: Zuo Gu Shen Jing Tong Wan Herbal Dietary Supplement
Notes: NOTE: Gansu Medicine is the OASIS declared manufacturer and Lanzhou Taibao Pharmaceutical Co. Ltd. is the manufacturer per product label.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/26/2013

Desc: Li Dan Hua Shi Wan Herbal Dietary Supplement
Notes: NOTE: Gansu Medicine is the OASIS declared manufacturer and Lanzhou Taibao Pharmaceutical Co. Ltd. is the manufacturer per product label.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/26/2013

Desc: Jin Gu Die Da Wan Herbal Dietary Supplement
Notes: NOTE: Gansu Medicine is the OASIS declared manufacturer and Lanzhou Taibao Pharmaceutical Co. Ltd. is the manufacturer per product label.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/26/2013

Desc: Ban Xia Bai Zhu Tian Ma Wan Herbal Dietary Supplement
Notes: NOTE: Gansu Medicine is the OASIS declared manufacturer and Lanzhou Taibao Pharmaceutical Co. Ltd. is the manufacturer per product label.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/26/2013

Desc: Xiang Sha Liu Jun Wan Herbal Dietary Supplement
Notes: NOTE: Gansu Medicine is the OASIS declared manufacturer and Lanzhou Taibao Pharmaceutical Co. Ltd. is the manufacturer per product label.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/26/2013

Desc: Jin Gu Die Da Wan Herbal Dietary Supplement
Notes: NOTE: Gansu Medicine is the OASIS declared manufacturer and Lanzhou Taibao Pharmaceutical Co. Ltd. is the manufacturer per product label.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/26/2013

Desc: Xiang Sha Liu Jun Wan Herbal Dietary Supplement
Notes: NOTE: Gansu Medicine is the OASIS declared manufacturer and Lanzhou Taibao Pharmaceutical Co. Ltd. is the manufacturer per product label.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/26/2013

Desc: Zuo Gu Shen Jing Tong Wan Herbal Dietary Supplement
Notes: NOTE: Gansu Medicine is the OASIS declared manufacturer and Lanzhou Taibao Pharmaceutical Co. Ltd. is the manufacturer per product label.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/26/2013

Desc: Ban Xia Bai Zhu Tian Ma Wan Herbal Dietary Supplement
Notes: NOTE: Gansu Medicine is the OASIS declared manufacturer and Lanzhou Taibao Pharmaceutical Co. Ltd. is the manufacturer per product label.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/26/2013

Desc: Li Dan Hua Shi Wan Herbal Dietary Supplement
Notes: NOTE: Gansu Medicine is the OASIS declared manufacturer and Lanzhou Taibao Pharmaceutical Co. Ltd. is the manufacturer per product label.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/26/2013

Desc: Jin Gu Die Da Wan Herbal Dietary Supplement
Notes: NOTE: Gansu Medicine is the OASIS declared manufacturer and Lanzhou Taibao Pharmaceutical Co. Ltd. is the manufacturer per product label.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/26/2013

Desc: Ban Xia Bai Zhu Tian Ma Wan Herbal Dietary Supplement
Notes: NOTE: Gansu Medicine is the OASIS declared manufacturer and Lanzhou Taibao Pharmaceutical Co. Ltd. is the manufacturer per product label.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/26/2013

Desc: Zuo Gu Shen Jing Tong Wan Herbal Dietary Supplement
Notes: NOTE: Gansu Medicine is the OASIS declared manufacturer and Lanzhou Taibao Pharmaceutical Co. Ltd. is the manufacturer per product label.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/26/2013

Desc: Li Dan Hua Shi Wan Herbal Dietary Supplement
Notes: NOTE: Gansu Medicine is the OASIS declared manufacturer and Lanzhou Taibao Pharmaceutical Co. Ltd. is the manufacturer per product label.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/26/2013

Desc: Xiang Sha Liu Jun Wan Herbal Dietary Supplement
Notes: NOTE: Gansu Medicine is the OASIS declared manufacturer and Lanzhou Taibao Pharmaceutical Co. Ltd. is the manufacturer per product label.

Li Zhao Lun
Date Published : 07/17/2014
Baiyun Road , Jiangxi Huangshi , Guangzhou, Guangdong CHINA
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 07/17/2014

Desc: Bichunyuan Tablets
Notes: FDA analysis found Sildenafil in product

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/17/2014

Desc: Bichunyuan Tablets
Notes: FDA analysis found Sildenafil in product

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/17/2014

Desc: Bichunyuan Tablets
Notes: FDA analysis found Sildenafil in product

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/17/2014

Desc: Bichunyuan Tablets
Notes: FDA analysis found Sildenafil in product

Liuzhou Liangmianzhen Co
Date Published : 09/29/2017
2 Changfeng Rd. , Luizhou, Guangxi CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 09/29/2017

Desc: LMZ Herbal Toothpaste
Notes: LMZ Intl Ltd. (FEI # 3010414385) is the Headquarters of Liuzhou LMZ Co. Ltd.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2017

Desc: LMZ Herbal Toothpaste
Notes: LMZ Intl Ltd. (FEI # 3010414385) is the Headquarters of Liuzhou LMZ Co. Ltd.

Long Zhu
Date Published : 09/13/2019
No 18 South District , Jiangchuan Second Village , Songjiang District, Shanghai CHINA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/13/2019

Desc: 3X Slimming Power

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 09/13/2019

Desc: 3X Slimming Power

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/13/2019

Desc: 3X Slimming Power

Loongtotem Science And Technology Co., Ltd.
Date Published : 09/30/2009
2f Pingan Bldg Gangkou Road 1 , Guangdong, CHINA
66 B - - 44 Nicotine Delivery System
Date Published: 09/30/2009

Desc: Electronic Cigarettes and Electronic Cigarette Components
Notes: 4/6/09

66 B - - 99 Stimulant N.E.C.
Date Published: 09/30/2009

Desc: Electronic Cigarettes and Electronic Cigarette Components
Notes: 4/6/09

77 E - - PN Pump, Nebulizer, Manual
Date Published: 09/30/2009

Desc: Electronic Cigarettes and Electronic Cigarette Components
Notes: 4/6/09

77 K - - CO Inhaler, Nasal
Date Published: 09/30/2009

Desc: Electronic Cigarettes and Electronic Cigarette Components
Notes: 4/6/09

89 M - - ZX Stimulator, Electrical for smoking cessation
Date Published: 09/30/2009

Desc: Electronic Cigarettes and Electronic Cigarette Components
Notes: 4/6/09

91 D - - LC Atomizer, Tlc
Date Published: 03/16/2022

Desc: Electronic Cigarettes and Electronic Cigarette Components
Notes: 4/6/09

Mayinglong Pharmaceutical Group Co Ltd
Date Published : 01/19/2016
100 Zhoujiawan , Wuhan, Hubei CHINA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/19/2016

Desc: Licorice Coughing Liquid
Notes: The only product currently subject to the guidance outlined in this import alert is Licorice Coughing Liquid;Problem(s); Unapproved new drug

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/19/2016

Notes: Licorice Coughing Liquid;Problem(s):Unapproved new drug;The only product currently subject to the guidance outlined in this import alert is Licorice Coughing Liquid.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 01/19/2016

Notes: Licorice Coughing Liquid;Problem(s):Unapproved new drug;The only product currently subject to the guidance outlined in this import alert is Licorice Coughing Liquid.

61 - - - -- Human and Animal Drugs
Date Published: 01/19/2016

Notes: Licorice Coughing Liquid;Problem(s):Unapproved new drug;The only product currently subject to the guidance outlined in this import alert is Licorice Coughing Liquid.

62 - - - -- Human and Animal Drugs
Date Published: 01/19/2016

Notes: Licorice Coughing Liquid;Problem(s):Unapproved new drug;The only product currently subject to the guidance outlined in this import alert is Licorice Coughing Liquid.

63 - - - -- Human and Animal Drugs
Date Published: 01/19/2016

Notes: Licorice Coughing Liquid;Problem(s):Unapproved new drug;The only product currently subject to the guidance outlined in this import alert is Licorice Coughing Liquid.

64 - - - -- Human and Animal Drugs
Date Published: 01/19/2016

Notes: Licorice Coughing Liquid;Problem(s):Unapproved new drug;The only product currently subject to the guidance outlined in this import alert is Licorice Coughing Liquid.

65 - - - -- Human and Animal Drugs
Date Published: 01/19/2016

Notes: Licorice Coughing Liquid;Problem(s):Unapproved new drug;The only product currently subject to the guidance outlined in this import alert is Licorice Coughing Liquid.

66 - - - -- Human and Animal Drugs
Date Published: 01/19/2016

Notes: Licorice Coughing Liquid;Problem(s):Unapproved new drug;The only product currently subject to the guidance outlined in this import alert is Licorice Coughing Liquid.

Meili Zhang Huanghuajingtonggongsi
Date Published : 11/28/2012
economic and technologic development zon , huangha hebei, CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/28/2012

Desc: Unmarked Green
Notes: china; Note: Analytical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein.

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 11/28/2012

Desc: Unmarked Green & White Caps
Notes: china ; Note; Analytical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein.

Meng Tao
Date Published : 10/22/2012
West Street Anding Square , Xian City , Xian Province, CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/22/2012

Desc: Sheng Yuan Fang Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/22/2012

Desc: Sheng Yuan Fang Capsules

Mester Trading Co., Ltd.
Date Published : 05/11/2012
10F Tech Building East Heping Rd , Longhua st. Baoan District , Shenzhen Guangdong, CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/11/2012

Desc: Slender Slim 11
Notes: china

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/17/2012

Desc: Best Slim Capsules
Notes: china;Note; This product was tested and found to contain the active pharmaceutical ingredient sibutramine.

NINGBO LONGWELL BABY PRODUCTS CO LTD
Date Published : 03/09/2018
Lane 520 , 77 Tongning Road , Ningbo, Zhejiang CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/09/2018

Desc: Nuby All Natural Teething Gel with Gum-eez Teether

53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/09/2018

Desc: Nuby All Natural Teething Gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/09/2018

Desc: Nuby All Natural Teething Gel with Gum-eez Teether

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/09/2018

Desc: Nuby All Natural Teething Gel

76 K - - KO Ring, Teething, Fluid-Filled
Date Published: 03/09/2018

Desc: Nuby All Natural Teething Gel with Gum-eez Teether

NUSPOWER GREATSUN (GUANGDONG) BIOTECHNOLOGY CO., LTD
Date Published : 04/04/2018
Mingzhugongye Yuan , Conghua; Conghua , Guangzhou, Guangdong CHINA
54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 04/04/2018

Desc: Energy Power PLUS

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/04/2018

Desc: Energy Power PLUS

Nantong Shenmei Biologial Technology Co Ltd
Date Published : 05/20/2010
4918 Tongfu North Road , Jiangsu, CHINA
63 B - - 99 Bronchodilator N.E.C.
Date Published: 05/20/2010

Desc: Boom Boom Energy Inhaler
Notes: china

Nature Products
Date Published : 09/30/2009
Mekong Hill Garden , Jinghong, Yunnan, CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2009

Notes: 2/1/2006 This product is promoted to treat AIDS/HIV infection and other viral diseases on the firms website                       

62 V - - 99 Anti-Viral N.E.C.
Date Published: 09/30/2009

Notes: 2/1/2006

Ningbo Limited Group Import and Export Co. Ltd.
Date Published : 11/01/2016
Liyuanyandu No. 39 Rm. 1603 Suite B , 159 Lane , Ningbo, Zhejiang CHINA
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 11/01/2016

Desc: Assured Dandruff Shampoo Dry Scalp Care

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 11/01/2016

Desc: Assured Dandruff Shampoo Dry Scalp Care

61 H - - 05 Zinc Pyrithione (Anti-Bacterial)
Date Published: 11/01/2016

Desc: Assured Dandruff Shampoo Dry Scalp Care

62 S - - 99 Anti-Seborrheic N.E.C.
Date Published: 11/01/2016

Desc: Assured Dandruff Shampoo Dry Scalp Care

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/01/2016

Desc: Assured Dandruff Shampoo Dry Scalp Care

Ningbo Liyuan Daily Chemical Products Co.
Date Published : 07/08/2014
Waixiang Technology Park No 4 , Xiwu Street Shangqiao Road; Fenghua , Ningbo, Zhejiang CHINA
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 07/08/2014

Desc: Personal Care Brand; Shampoo Dry Scalp Care
Notes: Unapproved

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 07/08/2014

Desc: Personal Care Brand; Shampoo Basic Everyday Cleaning for Normal Hair
Notes: Unapproved

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2014

Desc: Personal Care Brand; Shampoo Dry Scalp Care
Notes: Unapproved

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2014

Desc: Personal Care Brand; Shampoo Basic Everyday Cleaning for Normal Hair
Notes: Unapproved

Ningbo Powerwell Fine Chemical Industrial Co., Ltd.
Date Published : 03/27/2023
Gao Qiao Industrial Development Zone, , Yinzhou District , Ningbo, CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Healing Care toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 07/13/2007

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: Healing Care toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 07/13/2007

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: Healing Care toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 07/13/2007

No. 8 IIAlley
Date Published : 11/02/2012
xia shi wei district , hu yong town baon district , guangdong, CHINA
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 11/02/2012

Desc: Magic Slim
Notes: Note; Analytical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/02/2012

Desc: Body Envy Slimming Capsules
Notes: Analytical testing by FDA revealed the product contains undeclared sibutramine and phenolophthalein

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/02/2012

Desc: Magic Slim
Notes: Note; Analytical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/02/2012

Desc: Body Envy Slimming Capsules
Notes: Analytical testing by FDA revealed the product contains undeclared sibutramine and phenolophthalein

Oi Ming Guangzhou Foreign Trade Co
Date Published : 11/04/2013
62 Corporal Fuyong , Guangzhou, CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/04/2013

Desc: Triple ExtenZEn

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 11/04/2013

Desc: Triple ExtenZEn

65 P - - 99 Regulator N.E.C.
Date Published: 11/04/2013

Desc: Triple ExtenZEn

P&C (Shanghai) Perfumes and Cosmetics Co., Ltd.
Date Published : 03/27/2013
No. 1189 Chuanqiao Road , Shanghai, Shanghai CHINA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/27/2013

Desc: Fresh Umbrian Clay Mattifying Serum
Notes: NOTE: Fresh Black Tea Age-Delay Serum- claims for restoring and boosting collagen; Fresh Peony Whitening Essence- claims to inhibit the production of melanin; Fresh Umbrian Clay Mattifying Serum- claims to control oil production and regulate excess sebum production.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/27/2013

Desc: Fresh Black Tea Age-Delay Serum
Notes: NOTE: Fresh Black Tea Age-Delay Serum- claims for restoring and boosting collagen; Fresh Peony Whitening Essence- claims to inhibit the production of melanin; Fresh Umbrian Clay Mattifying Serum- claims to control oil production and regulate excess sebum production.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/27/2013

Desc: Fresh Peony Whitening Essence
Notes: NOTE: Fresh Black Tea Age-Delay Serum- claims for restoring and boosting collagen; Fresh Peony Whitening Essence- claims to inhibit the production of melanin; Fresh Umbrian Clay Mattifying Serum- claims to control oil production and regulate excess sebum production.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 03/27/2013

Desc: Fresh Black Tea Age-Delay Serum
Notes: NOTE: Fresh Black Tea Age-Delay Serum- claims for restoring and boosting collagen; Fresh Peony Whitening Essence- claims to inhibit the production of melanin; Fresh Umbrian Clay Mattifying Serum- claims to control oil production and regulate excess sebum production.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 03/27/2013

Desc: Fresh Peony Whitening Essence
Notes: NOTE: Fresh Black Tea Age-Delay Serum- claims for restoring and boosting collagen; Fresh Peony Whitening Essence- claims to inhibit the production of melanin; Fresh Umbrian Clay Mattifying Serum- claims to control oil production and regulate excess sebum production.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 03/27/2013

Desc: Fresh Umbrian Clay Mattifying Serum
Notes: NOTE: Fresh Black Tea Age-Delay Serum- claims for restoring and boosting collagen; Fresh Peony Whitening Essence- claims to inhibit the production of melanin; Fresh Umbrian Clay Mattifying Serum- claims to control oil production and regulate excess sebum production.

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 03/27/2013

Desc: Fresh Black Tea Age-Delay Serum
Notes: NOTE: Fresh Black Tea Age-Delay Serum- claims for restoring and boosting collagen; Fresh Peony Whitening Essence- claims to inhibit the production of melanin; Fresh Umbrian Clay Mattifying Serum- claims to control oil production and regulate excess sebum production.

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 03/27/2013

Desc: Fresh Peony Whitening Essence
Notes: NOTE: Fresh Black Tea Age-Delay Serum- claims for restoring and boosting collagen; Fresh Peony Whitening Essence- claims to inhibit the production of melanin; Fresh Umbrian Clay Mattifying Serum- claims to control oil production and regulate excess sebum production.

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 03/27/2013

Desc: Fresh Umbrian Clay Mattifying Serum
Notes: NOTE: Fresh Black Tea Age-Delay Serum- claims for restoring and boosting collagen; Fresh Peony Whitening Essence- claims to inhibit the production of melanin; Fresh Umbrian Clay Mattifying Serum- claims to control oil production and regulate excess sebum production.

Paragom Metal Inc
Date Published : 09/30/2009
69 Dengfang Road , Tower A Etan Plaza Pudong , Shanghai, CHINA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/30/2009

Notes: This product is promoted on the Internet and sold at retail as a dietary supplement for natural male enhancement. FDA analysis found tadalafil in this product. Tadalafil is the active ingredient in the FDA approved drug Cialis. 2/10/09

Pepsico International (Hong Kong) Ltd.
Date Published : 03/27/2023
Unit 2E, 2?F,Right Emperor Comrcial Bldg , 122-126 Wellington Street , Hong Kong, CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Toothpaste (Pepei)
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 03/20/2009

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: Toothpaste (Pepei)
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 03/20/2009

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: Toothpaste (Pepei)
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 03/20/2009

Pharmatech Asia Group Ltd.
Date Published : 06/13/2019
Vanke Star Online Unit 138 , No. 2 Wuhe South Road, Bantian , Shenzhen, Guangdong CHINA
54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 06/13/2019

Desc: BARI STIX Multivitamin Powder
Notes: The product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): 'After you've received a Gastric Band, Sleeve, or Bypass, your gastrointestinal tract is altered. As a result, bariatric patients are at an increased risk of forming gastric ulcers. Moreover, several pills are known to cause increased irritation and occasional formation of gastric ulcers. When pills are absorbed, many remain in the stomach for a prolonged period of time and can erode the protective mucosal lining. Over time, this repetitive damage manifests as a gastric ulcer. For this reason, we have developed a unique, great tasting, powder formula. Ask your medical professional if this product is right for you.'

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/13/2019

Desc: BARI STIX Multivitamin Powder
Notes: The product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): 'After you've received a Gastric Band, Sleeve, or Bypass, your gastrointestinal tract is altered. As a result, bariatric patients are at an increased risk of forming gastric ulcers. Moreover, several pills are known to cause increased irritation and occasional formation of gastric ulcers. When pills are absorbed, many remain in the stomach for a prolonged period of time and can erode the protective mucosal lining. Over time, this repetitive damage manifests as a gastric ulcer. For this reason, we have developed a unique, great tasting, powder formula. Ask your medical professional if this product is right for you.'

QINGDAO GOODAYMART
Date Published : 04/23/2020
Haier Road 1 Haier Indu , Laoshan, CHINA
53 - - - -- Cosmetics
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 07 Myobloc
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

Qin Huang Dao
Date Published : 07/10/2012
Shi Bei Huan Lu 25 2hao , Unknown, CHINA
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 07/10/2012

Desc: Unmarked White Capsules In unmarked White Bottle
Notes: Note; The product was found to have Sibutramine as an API.; China

Qinghai Baojiantang Pharmaceutical Co., Ltd
Date Published : 07/15/2015
People¿¿¿s Road 168 , Qinghai, CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/17/2015

Desc: Herb Viagra Male Sexual Stimulant Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/15/2015

Desc: Bulls Genitals Tablets
Notes: Contains undeclared Sildenafil

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/10/2015

Desc: Real Skill Male Sexual Stimulant capsules
Notes: Product contains undeclared Sildenafil.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/24/2015

Desc: Stree Overlord Tablets
Notes: Contains undeclared Sildenafil

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/30/2015

Desc: Black Ant Strong Tablets
Notes: There are drug claims on the product label.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/15/2015

Desc: Bulls Genitals Tablets
Notes: Contains undeclared Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/24/2015

Desc: Stree Overlord Tablets
Notes: Contains undeclared Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/10/2015

Desc: Real Skill Male Sexual Stimulant capsules
Notes: Product contains undeclared Sildenafil.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/17/2015

Desc: Herb Viagra Male Sexual Stimulant Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/30/2015

Desc: Black Ant Strong Tablets
Notes: There are drug claims on the product label.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 11/10/2015

Desc: Real Skill Male Sexual Stimulant capsules
Notes: Product contains undeclared Sildenafil.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/24/2015

Desc: Stree Overlord Tablets
Notes: Contains undeclared Sildenafil

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 10/30/2015

Desc: Black Ant Strong Tablets
Notes: There are drug claims on the product label.

Qinghan Hongwei Bioengineering Company
Date Published : 06/04/2015
No 158, Renim Road , Xining City, CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/04/2015

Desc: African Black Ant Capsules
Notes: FDA analysis found undeclared sildenafil in product

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 06/04/2015

Desc: African Black Ant Capsules
Notes: FDA analysis found undeclared sildenafil in product

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/04/2015

Desc: African Black Ant Capsules
Notes: FDA analysis found undeclared sildenafil in product

Qinye Cosmetics Co Ltd
Date Published : 02/24/2015
Zhenxing Industrial Zone , Guangzhou, CHINA
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 02/24/2015

Desc: Tom kcuc Professional Olive Shampoo

62 S - - 99 Anti-Seborrheic N.E.C.
Date Published: 02/24/2015

Desc: Tom kcuc Professional Olive Shampoo

Qufu Zhenmei Biotechnology Co Ltd
Date Published : 04/23/2020
12 West Fuyuan 11th St , Shandong, CHINA
53 - - - -- Cosmetics
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 07 Myobloc
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

QuinghaiQingzang Resource Special Medical Co. Ltd
Date Published : 09/30/2009
unknown , unknown, CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: 4/26/2007. Zang Wang Shen Bao Capsules. This product is promoted on the internet and sold at retail as a dietary supplement for natural male enchancement. FDA analysis found tadalafil in this product. Tadalafil is the active ingrediant in the FDA approved drug Cialis.

RICHVIT NUTRACEUTICAL CO LTD
Date Published : 03/05/2024
J Blk 6 Lane 1288 Yecheng Rd , Shanghai, CHINA
54 H - - 05 Omega-3 (Fats and Lipid Substances)
Date Published: 03/05/2024

Desc: OMEGA-3 GOLD (OMEGA 3 DIETARY SUPPLEMENTS)
Notes: The product appears to be a new drug as the product label bears a claim: “helps to satisfy daily needs of useful essential fatty acids preventing cardiovascular diseases and joint inflammation."

RIGHTEOUS DRAGON MANAGEMENT GROU
Date Published : 08/14/2017
7F, KOWLOON BLDG, 555 N , HONG KONG, CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/14/2017

Desc: Life Minerals Liquid (Gold Edition)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/14/2017

Desc: Life Minerals Liquid (Gold Edition)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/14/2017

Desc: Life Minerals Liquid (Gold Edition)

Ruize Trading Co.
Date Published : 05/10/2012
10F Tech Building, East Heping Rd , Longhua St, Baoan District, , Shenzhen Guangdong , CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/10/2012

Desc: Leisure 18 Slimming Coffee
Notes: china

SHANGHAI LIGHT INDUSTRIAL PRODUCTS IMP.&EXP.CORP.LTD.
Date Published : 03/27/2023
Room 1605-1607 , No. 501 Wuning Road , Shanghai, Shanghai CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Freshh Spearmint Brand Toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 06/13/2007

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: Freshh Spearmint Brand Toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 06/13/2007

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: Freshh Spearmint Brand Toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 06/13/2007

SHENZHEN JIESHIBO TECHNOLOGY CO
Date Published : 01/11/2022
I , Third Alley , Shenzhen, Guangdong CHINA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/11/2022

Desc: B12 VITAMINVAPE

98 L - - -- Electronic Nicotine Delivery System
Date Published: 01/11/2022

Desc: B12 VITAMINVAPE

98 M - - -- Electronic Nicotine Delivery System Component/Part
Date Published: 01/11/2022

Desc: B12 VITAMINVAPE

SHENZHEN TWOSUCCESS ELECTRONICS
Date Published : 08/21/2017
Room 508 , Ruida Science , Shenzhen City, CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/21/2017

Notes: PhenRx Patches

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 08/21/2017

Notes: PhenRx Patches

61 - - - -- Human and Animal Drugs
Date Published: 08/21/2017

Notes: PhenRx Patches

62 - - - -- Human and Animal Drugs
Date Published: 08/21/2017

Notes: PhenRx Patches

63 - - - -- Human and Animal Drugs
Date Published: 08/21/2017

Notes: PhenRx Patches

64 - - - -- Human and Animal Drugs
Date Published: 08/21/2017

Notes: PhenRx Patches

65 - - - -- Human and Animal Drugs
Date Published: 08/21/2017

Notes: PhenRx Patches

66 - - - -- Human and Animal Drugs
Date Published: 08/21/2017

Notes: PhenRx Patches

SHIJIAZHUANG YAOCHI IMP&EXP CO
Date Published : 08/06/2022
Rm B2 102 , 13-4 Dongsanz , Shijiazhuanag, CHINA
53 - - - -- Cosmetics
Date Published: 08/06/2022

Desc: Slim Patch

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/06/2022

Desc: Slim Patch

SSG (CHINA)
Date Published : 08/14/2017
No. 26 Jianguomen Nei Da Jie , 5th Floor, Beijing News Plaza , Beijing, Tianjin CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/14/2017

Desc: Life Minerals Liquid (Gold Edition)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/14/2017

Desc: Life Minerals Liquid (Gold Edition)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/14/2017

Desc: Life Minerals Liquid (Gold Edition)

Sanjiu Enterprise Group
Date Published : 09/30/2009
1026 Beihuan Avenue , Shenzhen, Guangdong CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/16/2019

Desc: Fitness Essence 999
Notes: China; 5/27/2009

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/16/2019

Desc: Fitness Essence 999
Notes: China; 5/27/2009

Sanzi Cosmetics
Date Published : 09/16/2019
5 Pine Park , New City Guang Zhou, CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/16/2019

Notes: Detox Foot Patch; 11/18/2008

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Detox Foot Patch; 11/18/2008

61 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Detox Foot Patch; 11/18/2008

62 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Detox Foot Patch; 11/18/2008

63 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Detox Foot Patch; 11/18/2008

64 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Detox Foot Patch; 11/18/2008

65 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Detox Foot Patch; 11/18/2008

66 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Detox Foot Patch; 11/18/2008

Sbs Genetech
Date Published : 08/07/2012
No. 1 Shangdi 4th Street, , Room 202, Building 2 , Haidian District, Beijing, CHINA
56 F - - 99 Peptide N.E.C.
Date Published: 08/07/2012

Desc: GHRP6 (Growth Hormone Releasing Peptide)
Notes: China

56 F - - 99 Peptide N.E.C.
Date Published: 08/07/2012

Desc: Ipamorelin (Growth Hormone Releasing Peptide)
Notes: China

56 F - - 99 Peptide N.E.C.
Date Published: 08/07/2012

Desc: GHRP2 ('Growth Hormone Releasing Peptide)
Notes: China

56 F - - 99 Peptide N.E.C.
Date Published: 08/07/2012

Desc: Melanotan II
Notes: China

65 D - - 06 Oxytocin (Injection) (Oxytocic)
Date Published: 08/07/2012

Desc: Oxytocin
Notes: China

Shaanxi Wanan Pharmaceutical Co., Ltd
Date Published : 07/19/2012
F14, CITIC Mansion, No. 89 North Chang'a , Xi'an, Shaanxi CHINA
62 F - - 99 Anti-Infective, Topical N.E.C.
Date Published: 07/19/2012

Desc: Zimeishu Silver Iron Gynecological Pad
Notes: china

85 N - - UR Pad, Interlabial
Date Published: 07/19/2012

Desc: Zimeishu Silver Iron Gynecological Pad
Notes: China

Shandong Runxin Biotechnology Co., Ltd.
Date Published : 02/21/2024
Wucun Industrial Park No.8 , Qufu , Qufu, Shandong CHINA
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 02/21/2024

Desc:               NAD Nicotinamide Riboside & Resveratrol Capsules

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 02/21/2024

Desc:               Berberine Capsules

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 02/21/2024

Desc:               Testosterone Enhancement Capsules

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 02/21/2024

Desc:                   NAD Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/21/2024

Desc:               NAD Nicotinamide Riboside & Resveratrol Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/21/2024

Desc:               Testosterone Enhancement Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/21/2024

Desc:                   NAD Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/21/2024

Desc:               Berberine Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/21/2024

Desc:                   NAD Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/21/2024

Desc:               Berberine Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/21/2024

Desc:               NAD Nicotinamide Riboside & Resveratrol Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/21/2024

Desc:               Testosterone Enhancement Capsules

Shanghai Chinese Medical Works
Date Published : 06/11/2014
Unknown , Shanghai, Unknown CHINA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/11/2014

Desc: Silintan Capsules
Notes: Unapproved New Drug

61 X - - 08 Chlorpheniramine Maleate (Anti-Histaminic)
Date Published: 06/11/2014

Desc: Silintan Capsules
Notes: Unapproved New Drug

61 - - - -- Human and Animal Drugs
Date Published: 06/11/2014

Desc: Silintan Capsules
Notes: Unapproved New Drug

64 L - - 19 Dexamethasone (Glucocorticoid)
Date Published: 06/11/2014

Desc: Silintan Capsules
Notes: Unapproved New Drug

64 - - - -- Human and Animal Drugs
Date Published: 06/11/2014

Desc: Silintan Capsules
Notes: Unapproved New Drug

Shanghai Chinese Medicine Works
Date Published : 12/21/2011
No 1303 Laohumin Road , Shanghai, Shanghai CHINA
61 V - - 99 Anti-Flatulent N.E.C.
Date Published: 12/21/2011

Desc: Lu Shen Wan or Liu Shen Wan
Notes: china

Shanghai Jiankang Co., Ltd.
Date Published : 01/21/2011
Mishanlu , Baoshan , Shanghai, Shanghai CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/21/2011

Desc: Bombyx Mori Blend
Notes: China

Shanghai Pharmaceutical Industry Corp.
Date Published : 09/30/2009
27 Chungshan Road , Shanghai, CHINA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/16/2019

Notes: Ancom Tablets; 2/12/2003

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/16/2019

Notes: Ancom Tablets; 2/12/2003

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Ancom Tablets; 2/12/2003

61 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Ancom Tablets; 2/12/2003

62 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Ancom Tablets; 2/12/2003

63 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Ancom Tablets; 2/12/2003

64 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Ancom Tablets; 2/12/2003

65 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Ancom Tablets; 2/12/2003

66 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Ancom Tablets; 2/12/2003

Shanghai YongYi Biotechnology
Date Published : 10/04/2013
Xuhui , Building B Room 1604; No 391 Guiping Road , Shanghai, Shanghai CHINA
46 Y - - 99 Food Additives For Human Use, N.E.C.
Date Published: 10/04/2013

Desc: Tauroursodeoxycholic Acid TUDCA

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/04/2013

Desc: Tauroursodeoxycholic Acid TUDCA

Shenyang Chang Gang Yibao Alcohol Co., Ltd.
Date Published : 09/30/2009
126 Chang Bai Street , Dongling , Shenyang, Liaoning CHINA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/30/2009

Desc: Yilishen. Contains prescription strength sildenafil by FDA analysis.
Notes: 10/10/2004 Actra-RX; Other names

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/30/2009

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 09/30/2009

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 09/30/2009

Desc: Yilishen. Contains prescription strength sildenafil by FDA analysis.
Notes: 10/10/2004 Actra-RX; Other names

Shenzhen 999 Chinese Medicine Investment & Dev. Co., Ltd.
Date Published : 09/30/2009
1028 Beihuan Blvd. , Shenzhen, Guangdong CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: The product contains undeclared drug

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2009

Notes: The product contains undeclared drug

Shenzhen Boge Technology Co Ltd
Date Published : 03/22/2019
E2 No. 6 Dong Entrepreneurial Ind Garden , Shenzhen, CHINA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/22/2019

Desc: Nutrovape Diet
Notes: Previous shipments of Nutrovape product have been invoiced as 'atomizer'; 'atomizer parts'; 'ecig parts'; and 'metal tubes'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/22/2019

Desc: Nutrovape Relax
Notes: Previous shipments of Nutrovape product have been invoiced as 'atomizer'; 'atomizer parts'; 'ecig parts'; and 'metal tubes'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/22/2019

Desc: Nutrovape Energy
Notes: Previous shipments of Nutrovape product have been invoiced as 'atomizer'; 'atomizer parts'; 'ecig parts'; and 'metal tubes'.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 03/22/2019

Desc: Nutrovape Relax
Notes: Previous shipments of Nutrovape product have been invoiced as 'atomizer'; 'atomizer parts'; 'ecig parts'; and 'metal tubes'.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 03/22/2019

Desc: Nutrovape Energy
Notes: Previous shipments of Nutrovape product have been invoiced as 'atomizer'; 'atomizer parts'; 'ecig parts'; and 'metal tubes'.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 03/22/2019

Desc: Nutrovape Diet
Notes: Previous shipments of Nutrovape product have been invoiced as 'atomizer'; 'atomizer parts'; 'ecig parts'; and 'metal tubes'.

98 L - - 01 E-Cigarette
Date Published: 03/22/2019

Desc: Nutrovape Diet
Notes: Previous shipments of Nutrovape product have been invoiced as 'atomizer', 'atomizer parts', 'ecig parts', and 'metal tubes'.

98 L - - 01 E-Cigarette
Date Published: 03/22/2019

Desc: Nutrovape Energy
Notes: Previous shipments of Nutrovape product have been invoiced as 'atomizer', 'atomizer parts', 'ecig parts', and 'metal tubes'

98 L - - 01 E-Cigarette
Date Published: 03/22/2019

Desc: Nutrovape Relax
Notes: Previous shipments of Nutrovape product have been invoiced as 'atomizer'; 'atomizer parts'; 'ecig parts'; and 'metal tubes'.

98 L - - 02 E-Cigarette, Kit
Date Published: 03/22/2019

Desc: Nutrovape Diet
Notes: Previous shipments of Nutrovape product have been invoiced as 'atomizer', 'atomizer parts', 'ecig parts', and 'metal tubes'.

98 L - - 02 E-Cigarette, Kit
Date Published: 03/22/2019

Desc: Nutrovape Energy
Notes: Previous shipments of Nutrovape product have been invoiced as 'atomizer', 'atomizer parts', 'ecig parts', and 'metal tubes'

98 L - - 02 E-Cigarette, Kit
Date Published: 03/22/2019

Desc: Nutrovape Relax
Notes: Previous shipments of Nutrovape product have been invoiced as 'atomizer'; 'atomizer parts'; 'ecig parts'; and 'metal tubes'.

98 M - - 03 Ends Atomizer
Date Published: 03/22/2019

Desc: Nutrovape Energy
Notes: Previous shipments of Nutrovape product have been invoiced as 'atomizer', 'atomizer parts', 'ecig parts', and 'metal tubes'

98 M - - 03 Ends Atomizer
Date Published: 03/22/2019

Desc: Nutrovape Relax
Notes: Previous shipments of Nutrovape product have been invoiced as 'atomizer'; 'atomizer parts'; 'ecig parts'; and 'metal tubes'.

98 M - - 03 Ends Atomizer
Date Published: 03/22/2019

Desc: Nutrovape Diet
Notes: Previous shipments of Nutrovape product have been invoiced as 'atomizer', 'atomizer parts', 'ecig parts', and 'metal tubes'.

98 M - - 99 Electronic Nicotine Delivery System Component/Part, NEC
Date Published: 03/22/2019

Desc: Nutrovape Diet
Notes: Previous shipments of Nutrovape product have been invoiced as 'atomizer', 'atomizer parts', 'ecig parts', and 'metal tubes'.

98 M - - 99 Electronic Nicotine Delivery System Component/Part, NEC
Date Published: 03/22/2019

Desc: Nutrovape Energy
Notes: Previous shipments of Nutrovape product have been invoiced as 'atomizer', 'atomizer parts', 'ecig parts', and 'metal tubes'

98 M - - 99 Electronic Nicotine Delivery System Component/Part, NEC
Date Published: 03/22/2019

Desc: Nutrovape Relax
Notes: Previous shipments of Nutrovape product have been invoiced as 'atomizer'; 'atomizer parts'; 'ecig parts'; and 'metal tubes'.

Shenzhen Concinning Technology C
Date Published : 12/10/2009
Baoan District Bin Ye Bldg 620 R , Fu Yong Town, CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/10/2009

Notes: Black Ant Capsules Note: Analysis by the FCC lab found the product to contain undeclared Sildenafil, the active ingredient in Viagra. The product is being marketed at a number of websites including:

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

Notes: Black Ant Capsules Note: Analysis by the FCC lab found the product to contain undeclared Sildenafil, the active ingredient in Viagra. The product is being marketed at a number of websites including:

61 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

Notes: Black Ant Capsules Note: Analysis by the FCC lab found the product to contain undeclared Sildenafil, the active ingredient in Viagra. The product is being marketed at a number of websites including:

62 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

Notes: Black Ant Capsules Note: Analysis by the FCC lab found the product to contain undeclared Sildenafil, the active ingredient in Viagra. The product is being marketed at a number of websites including:

63 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

Notes: Black Ant Capsules Note: Analysis by the FCC lab found the product to contain undeclared Sildenafil, the active ingredient in Viagra. The product is being marketed at a number of websites including:

64 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

Notes: Black Ant Capsules Note: Analysis by the FCC lab found the product to contain undeclared Sildenafil, the active ingredient in Viagra. The product is being marketed at a number of websites including:

65 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

Notes: Black Ant Capsules Note: Analysis by the FCC lab found the product to contain undeclared Sildenafil, the active ingredient in Viagra. The product is being marketed at a number of websites including:

66 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

Notes: Black Ant Capsules Note: Analysis by the FCC lab found the product to contain undeclared Sildenafil, the active ingredient in Viagra. The product is being marketed at a number of websites including:

Shenzhen Itsuwa Technology Co., Ltd.
Date Published : 09/08/2022
Zone B, 3/F, Bldg.2&4/F, Bldg.6, Yangbei Industrial Zone Phase 3, Huangtian , Xixiang Street , Baoan, Shenzhen, Guangdong CHINA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/08/2022

Desc: Epothecary Calm
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "We use high quality herbs along with all natural flavors to deliver solutions that improve your … general health. Our Epothecary Clam personal diffusers are great to unwind after dinner or before bed.”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/08/2022

Desc: Epothecary Enhance
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "We use high quality herbs along with all natural flavors to deliver solutions that improve your … general health. Our Epothecary Enhance personal diffusers promote vitality and libido.”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/08/2022

Desc: Botanika Strawberry Shake
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "[L]ooking for a pick me up or simply craving something better.”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/08/2022

Desc: Botanika Lemon Meringue
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "[L]ooking for a pick me up or simply craving something better.”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/08/2022

Desc: Epothecary Bliss
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "We use high quality herbs along with all natural flavors to deliver solutions that improve your … general health. Our Epothecary Bliss personal diffusers promote energy …”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/08/2022

Desc: Botanika Toffee Custard
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "[H]elps you move away from smoking and nicotine the all natural way.”; “[L]ooking for a pick me up or simply craving something better!”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/08/2022

Desc: Botanika Tart Strawberry
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "[H]elp you move away from smoking and nicotine.”; “The All Natural Alternative For when you’re craving something better.”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/08/2022

Desc: Epothecary Awake
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "We use high quality herbs along with all natural flavors to deliver solutions that improve your … general health.”; “[F]or when you need a convenient pick me up.”.

98 M - - 03 Ends Atomizer
Date Published: 09/08/2022

Desc: Botanika Lemon Meringue
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "[L]ooking for a pick me up or simply craving something better.”.

98 M - - 03 Ends Atomizer
Date Published: 09/08/2022

Desc: Epothecary Awake
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "We use high quality herbs along with all natural flavors to deliver solutions that improve your … general health.”; “[F]or when you need a convenient pick me up.”.

98 M - - 03 Ends Atomizer
Date Published: 09/08/2022

Desc: Botanika Tart Strawberry
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "[H]elp you move away from smoking and nicotine.”; “The All Natural Alternative For when you’re craving something better.”.

98 M - - 03 Ends Atomizer
Date Published: 09/08/2022

Desc: Epothecary Calm
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "We use high quality herbs along with all natural flavors to deliver solutions that improve your … general health. Our Epothecary Clam personal diffusers are great to unwind after dinner or before bed.”.

98 M - - 03 Ends Atomizer
Date Published: 09/08/2022

Desc: Epothecary Bliss
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "We use high quality herbs along with all natural flavors to deliver solutions that improve your … general health. Our Epothecary Bliss personal diffusers promote energy …”.

98 M - - 03 Ends Atomizer
Date Published: 09/08/2022

Desc: Epothecary Enhance
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "We use high quality herbs along with all natural flavors to deliver solutions that improve your … general health. Our Epothecary Enhance personal diffusers promote vitality and libido.”.

98 M - - 03 Ends Atomizer
Date Published: 09/08/2022

Desc: Botanika Strawberry Shake
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "[L]ooking for a pick me up or simply craving something better.”.

98 M - - 03 Ends Atomizer
Date Published: 09/08/2022

Desc: Botanika Toffee Custard
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "[H]elps you move away from smoking and nicotine the all natural way.”; “[L]ooking for a pick me up or simply craving something better!”.

Shenzhen Keshangda Electronics Technology Co., Ltd.
Date Published : 08/21/2017
6 Bld, Shantang Industrial Park Paibang Village , Henggang Town Longgang Dist. , Shenzhen, Guangdong CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/21/2017

Notes: PhenRx Patches

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 08/21/2017

Notes: PhenRx Patches

61 - - - -- Human and Animal Drugs
Date Published: 08/21/2017

Notes: PhenRx Patches

62 - - - -- Human and Animal Drugs
Date Published: 08/21/2017

Notes: PhenRx Patches

63 - - - -- Human and Animal Drugs
Date Published: 08/21/2017

Notes: PhenRx Patches

64 - - - -- Human and Animal Drugs
Date Published: 08/21/2017

Notes: PhenRx Patches

65 - - - -- Human and Animal Drugs
Date Published: 08/21/2017

Notes: PhenRx Patches

66 - - - -- Human and Animal Drugs
Date Published: 08/21/2017

Notes: PhenRx Patches

Shenzhen Ocity Times Technology CO., LTD
Date Published : 09/05/2018
Mingyou Purchasing Centre Room B542 , No. 168 Baoyuan Road; Baoan , Shenzhen, Guangdong CHINA
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 09/05/2018

Desc: NUTROVAPE FOCUS INHALABLE SUPPLEMENT

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/10/2020

Desc: Cloudy Personal Diffuser
Notes: The product appears to be an unapproved new drug as the product's label and promotional website include drug claims.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/05/2018

Desc: NUTROVAPE FOCUS INHALABLE SUPPLEMENT

98 L - - 01 E-Cigarette
Date Published: 11/10/2020

Desc: Cloudy Personal Diffuser
Notes: The product appears to be an unapproved new drug as the product's label and promotional website include drug claims.

98 L - - 02 E-Cigarette, Kit
Date Published: 11/10/2020

Desc: Cloudy Personal Diffuser
Notes: The product appears to be an unapproved new drug as the product's label and promotional website include drug claims.

98 L - - 09 Advanced Personal Vaporizer
Date Published: 11/10/2020

Desc: Cloudy Personal Diffuser
Notes: The product appears to be an unapproved new drug as the product's label and promotional website include drug claims.

98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 11/10/2020

Desc: Cloudy Personal Diffuser
Notes: The product appears to be an unapproved new drug as the product's label and promotional website include drug claims.

98 M - - 03 Ends Atomizer
Date Published: 11/10/2020

Desc: Cloudy Personal Diffuser
Notes: The product appears to be an unapproved new drug as the product's label and promotional website include drug claims.

98 M - - 12 Ends Drip Tip
Date Published: 11/10/2020

Desc: Cloudy Personal Diffuser
Notes: The product appears to be an unapproved new drug as the product's label and promotional website include drug claims.

98 M - - 18 Ends Tank
Date Published: 11/10/2020

Desc: Cloudy Personal Diffuser
Notes: The product appears to be an unapproved new drug as the product's label and promotional website include drug claims.

98 M - - 99 Electronic Nicotine Delivery System Component/Part, NEC
Date Published: 11/10/2020

Desc: Cloudy Personal Diffuser
Notes: The product appears to be an unapproved new drug as the product's label and promotional website include drug claims.

98 O - - 05 Pipe Filter
Date Published: 11/10/2020

Desc: Cloudy Personal Diffuser
Notes: The product appears to be an unapproved new drug as the product's label and promotional website include drug claims.

Shenzhen Shenbao Huacheng Tech.Co.,Ltd.
Date Published : 04/26/2013
Jinyuanlu , Heaocun; Longgang , Shenzhen, Guangdong CHINA
53 Y Y - 99 Other Cosmetic and Cosmetic Products, N.E.C., Not Elsewhere Classified (NEC)
Date Published: 04/26/2013

Desc: Kiyome Kinoki Cleansing Detox Foot Pads
Notes: Note; Manuf per OASIS; China

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/26/2013

Desc: Kiyome Kinoki Cleansing Detox Foot Pads
Notes: Note; Manuf per OASIS; China

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/26/2013

Desc: Kiyome Kinoki Cleansing Detox Foot Pads
Notes: Note; Manuf per OASIS; China

80 F - - QM Bandage, Elastic
Date Published: 04/26/2013

Desc: Kiyome Kinoki Cleansing Detox Foot Pads
Notes: Note; Manuf per OASIS; China

80 K - - YS Insoles, Medical
Date Published: 04/26/2013

Desc: Kiyome Kinoki Cleansing Detox Foot Pads
Notes: Note; Manuf per OASIS; China

Shenzhen leader's international Agent Co., Ltd.
Date Published : 07/09/2012
1/F all Layers , 6# , FuYi Road, , FuYong BaoAn District , ShenZhen , CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/09/2012

Desc: Man King Dietary Supplement
Notes: Note; Analytical testing by FDA found undeclared Sildenafil; China

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/09/2012

Desc: Man King Dietary Supplement
Notes: Note; Analytical testing by FDA found undeclared Sildenafil; China

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/31/2012

Notes: All Drug & Dietary Supplement Products; China;Note: Analystical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/31/2012

Notes: All Drug & Dietary Supplement Products; China;Note: Analystical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 07/31/2012

Notes: All Drug & Dietary Supplement Products; China;Note: Analystical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein

61 - - - -- Human and Animal Drugs
Date Published: 07/31/2012

Notes: All Drug & Dietary Supplement Products; China;Note: Analystical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein

62 - - - -- Human and Animal Drugs
Date Published: 07/31/2012

Notes: All Drug & Dietary Supplement Products; China;Note: Analystical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein

63 - - - -- Human and Animal Drugs
Date Published: 07/31/2012

Notes: All Drug & Dietary Supplement Products; China;Note: Analystical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein

64 - - - -- Human and Animal Drugs
Date Published: 07/31/2012

Notes: All Drug & Dietary Supplement Products; China;Note: Analystical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein

65 - - - -- Human and Animal Drugs
Date Published: 07/31/2012

Notes: All Drug & Dietary Supplement Products; China;Note: Analystical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein

66 - - - -- Human and Animal Drugs
Date Published: 07/31/2012

Notes: All Drug & Dietary Supplement Products; China;Note: Analystical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein

Shijiazhuang Keqin Trading Co., Ltd.
Date Published : 09/01/2016
163 East Huaian Rd , 6 Floor, Jinming Building , Shijiazhuang, Hebei CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/25/2017

Desc: EZ Slimming Patch
Notes: Medical claims made on product label

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/01/2016

Desc: Magnetic Slim Patch
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'Filled with all natural ingredients SLIM PATCH has been proven to be a highly effective way to lose weight. It works with the bodies [sic] own ENDOCRINE system, which includes the glands that control the bodies [sic] metabolic rate, by increasing this rate the body burns up the fats, carbs, and sugars that cause excess weight. SLIM PATCH also actively blocks the uptake of further fats, increases blood circulation and removes the toxins that have built up in the body.'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2017

Desc: EZ Slimming Patch
Notes: Medical claims made on product label

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 09/01/2016

Desc: Magnetic Slim Patch
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'Filled with all natural ingredients SLIM PATCH has been proven to be a highly effective way to lose weight. It works with the bodies [sic] own ENDOCRINE system, which includes the glands that control the bodies [sic] metabolic rate, by increasing this rate the body burns up the fats, carbs, and sugars that cause excess weight. SLIM PATCH also actively blocks the uptake of further fats, increases blood circulation and removes the toxins that have built up in the body.'

79 K - - GX Tape And Bandage, Adhesive
Date Published: 09/01/2016

Desc: Magnetic Slim Patch
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'Filled with all natural ingredients SLIM PATCH has been proven to be a highly effective way to lose weight. It works with the bodies [sic] own ENDOCRINE system, which includes the glands that control the bodies [sic] metabolic rate, by increasing this rate the body burns up the fats, carbs, and sugars that cause excess weight. SLIM PATCH also actively blocks the uptake of further fats, increases blood circulation and removes the toxins that have built up in the body.'

79 K - - GX Tape And Bandage, Adhesive
Date Published: 01/25/2017

Desc: EZ Slimming Patch
Notes: Medical claims made on product label

Shijiazhuang Yiling Pharmaceutical Co., Ltd.
Date Published : 05/28/2020
No 238 Tianshan Main Street , Shijiazhuang, Hebei CHINA
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 05/28/2020

Desc: Lianhua Qingwen Jiaonang Capsules
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as (not an all-inclusive list): (translated label) 'Indications: detoxification, pulmonary fever'; 'Used for treatment of respiratory related influenza, fever, attack of lungs'; 'Symptom: Fever or high fever, aversion to cold, muscle ache, nasal congestion, runny nose, cough, headache, dry or sore throat, reddish, yellow tongue'; (website) multiple treatment claims made on website regarding influenza, coronavirus pneumonia, MER syndrome, Ebola.                                                                                                                                                                                        

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 05/28/2020

Desc: Lianhua Qingwen Jiaonang Capsules
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as (not an all-inclusive list): (translated label) 'Indications: detoxification, pulmonary fever'; 'Used for treatment of respiratory related influenza, fever, attack of lungs'; 'Symptom: Fever or high fever, aversion to cold, muscle ache, nasal congestion, runny nose, cough, headache, dry or sore throat, reddish, yellow tongue'; (website) multiple treatment claims made on website regarding influenza, coronavirus pneumonia, MER syndrome, Ebola.                                                                                                                                                                                        

55 Y - - 99 Pharmaceutic Necessities and Containers, N.E.C.
Date Published: 05/28/2020

Desc: Lianhua Qingwen Jiaonang Capsules
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as (not an all-inclusive list): (translated label) 'Indications: detoxification, pulmonary fever'; 'Used for treatment of respiratory related influenza, fever, attack of lungs'; 'Symptom: Fever or high fever, aversion to cold, muscle ache, nasal congestion, runny nose, cough, headache, dry or sore throat, reddish, yellow tongue'; (website) multiple treatment claims made on website regarding influenza, coronavirus pneumonia, MER syndrome, Ebola.                                                                                                                                                                                        

56 K - - 99 Miscellaneous Antibiotics, N.E.C.
Date Published: 05/28/2020

Desc: Lianhua Qingwen Jiaonang Capsules
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as (not an all-inclusive list): (translated label) 'Indications: detoxification, pulmonary fever'; 'Used for treatment of respiratory related influenza, fever, attack of lungs'; 'Symptom: Fever or high fever, aversion to cold, muscle ache, nasal congestion, runny nose, cough, headache, dry or sore throat, reddish, yellow tongue'; (website) multiple treatment claims made on website regarding influenza, coronavirus pneumonia, MER syndrome, Ebola.                                                                                                                                                                                        

56 Y - - 99 Antibiotic N.E.C.
Date Published: 05/28/2020

Desc: Lianhua Qingwen Jiaonang Capsules
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as (not an all-inclusive list): (translated label) 'Indications: detoxification, pulmonary fever'; 'Used for treatment of respiratory related influenza, fever, attack of lungs'; 'Symptom: Fever or high fever, aversion to cold, muscle ache, nasal congestion, runny nose, cough, headache, dry or sore throat, reddish, yellow tongue'; (website) multiple treatment claims made on website regarding influenza, coronavirus pneumonia, MER syndrome, Ebola.                                                                                                                                                                                        

60 C - - 22 Ephedrine HCl (Adrenergic)
Date Published: 05/28/2020

Desc: Lianhua Qingwen Jiaonang Capsules
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as (not an all-inclusive list): (translated label) 'Indications: detoxification, pulmonary fever'; 'Used for treatment of respiratory related influenza, fever, attack of lungs'; 'Symptom: Fever or high fever, aversion to cold, muscle ache, nasal congestion, runny nose, cough, headache, dry or sore throat, reddish, yellow tongue'; (website) multiple treatment claims made on website regarding influenza, coronavirus pneumonia, MER syndrome, Ebola.                                                                                                                                                                                        

60 L - - 99 Analgesic, N.E.C.
Date Published: 05/28/2020

Desc: Lianhua Qingwen Jiaonang Capsules
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as (not an all-inclusive list): (translated label) 'Indications: detoxification, pulmonary fever'; 'Used for treatment of respiratory related influenza, fever, attack of lungs'; 'Symptom: Fever or high fever, aversion to cold, muscle ache, nasal congestion, runny nose, cough, headache, dry or sore throat, reddish, yellow tongue'; (website) multiple treatment claims made on website regarding influenza, coronavirus pneumonia, MER syndrome, Ebola.                                                                                                                                                                                        

60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 05/28/2020

Desc: Lianhua Qingwen Jiaonang Capsules
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as (not an all-inclusive list): (translated label) 'Indications: detoxification, pulmonary fever'; 'Used for treatment of respiratory related influenza, fever, attack of lungs'; 'Symptom: Fever or high fever, aversion to cold, muscle ache, nasal congestion, runny nose, cough, headache, dry or sore throat, reddish, yellow tongue'; (website) multiple treatment claims made on website regarding influenza, coronavirus pneumonia, MER syndrome, Ebola.                                                                                                                                                                                        

61 I - - 99 Anti-Bacterial Enzyme, N.E.C.
Date Published: 05/28/2020

Desc: Lianhua Qingwen Jiaonang Capsules
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as (not an all-inclusive list): (translated label) 'Indications: detoxification, pulmonary fever'; 'Used for treatment of respiratory related influenza, fever, attack of lungs'; 'Symptom: Fever or high fever, aversion to cold, muscle ache, nasal congestion, runny nose, cough, headache, dry or sore throat, reddish, yellow tongue'; (website) multiple treatment claims made on website regarding influenza, coronavirus pneumonia, MER syndrome, Ebola.                                                                                                                                                                                        

62 - - - -- Human and Animal Drugs
Date Published: 05/28/2020

Desc: Lianhua Qingwen Jiaonang Capsules
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as (not an all-inclusive list): (translated label) 'Indications: detoxification, pulmonary fever'; 'Used for treatment of respiratory related influenza, fever, attack of lungs'; 'Symptom: Fever or high fever, aversion to cold, muscle ache, nasal congestion, runny nose, cough, headache, dry or sore throat, reddish, yellow tongue'; (website) multiple treatment claims made on website regarding influenza, coronavirus pneumonia, MER syndrome, Ebola.                                                                                                                                                                                        

64 H - - 99 Expectorant N.E.C.
Date Published: 05/28/2020

Desc: Lianhua Qingwen Jiaonang Capsules
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as (not an all-inclusive list): (translated label) 'Indications: detoxification, pulmonary fever'; 'Used for treatment of respiratory related influenza, fever, attack of lungs'; 'Symptom: Fever or high fever, aversion to cold, muscle ache, nasal congestion, runny nose, cough, headache, dry or sore throat, reddish, yellow tongue'; (website) multiple treatment claims made on website regarding influenza, coronavirus pneumonia, MER syndrome, Ebola.                                                                                                                                                                                        

65 C - - 99 Nutrient/Tonic N.E.C.
Date Published: 05/28/2020

Desc: Lianhua Qingwen Jiaonang Capsules
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as (not an all-inclusive list): (translated label) 'Indications: detoxification, pulmonary fever'; 'Used for treatment of respiratory related influenza, fever, attack of lungs'; 'Symptom: Fever or high fever, aversion to cold, muscle ache, nasal congestion, runny nose, cough, headache, dry or sore throat, reddish, yellow tongue'; (website) multiple treatment claims made on website regarding influenza, coronavirus pneumonia, MER syndrome, Ebola.                                                                                                                                                                                        

66 - - - -- Human and Animal Drugs
Date Published: 05/28/2020

Desc: Lianhua Qingwen Jiaonang Capsules
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as (not an all-inclusive list): (translated label) 'Indications: detoxification, pulmonary fever'; 'Used for treatment of respiratory related influenza, fever, attack of lungs'; 'Symptom: Fever or high fever, aversion to cold, muscle ache, nasal congestion, runny nose, cough, headache, dry or sore throat, reddish, yellow tongue'; (website) multiple treatment claims made on website regarding influenza, coronavirus pneumonia, MER syndrome, Ebola.                                                                                                                                                                                        

Shineway Pharmaceutical
Date Published : 12/01/2011
No. 168 Shiluan Street , Luancheng District , Shijiazhuang, Hebei CHINA
56 H - - 99 Antitumor N.E.C.
Date Published: 12/01/2011

Desc: Cholest Pure
Notes: China

Sichuan Chuan Wu Ji Biotech Co. Ltd
Date Published : 10/26/2012
33 Wuqing South Rd , Wuhou , Chengdu, Sichuan CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/26/2012

Desc: Tianji True Slim Herbal Supplement
Notes: Product contains undeclared sibutramine

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/26/2012

Desc: Tianji True Slim Herbal Supplement
Notes: Product contains undeclared sibutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/26/2012

Desc: Tianji True Slim Herbal Supplement
Notes: Product contains undeclared sibutramine

Sunan Trading Co. Ltd
Date Published : 09/23/2010
International Building 9th Floor , Taian Road , Rizhao, Shandong CHINA
02 - - - -- Whole Grains/Milled Grain Products/Starches
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

04 - - - -- Macaroni/Noodle Products
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

05 - - - -- Cereal Preparations/Breakfast Foods
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

07 - - - -- Snack Food Items
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

09 - - - -- Milk/Butter/Dried Milk Products
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

12 - - - -- Cheese/Cheese Products
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

13 - - - -- Ice Cream and related Products
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

14 - - - -- Filled Milk/Imitation Milk Products
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

15 - - - -- Eggs/Egg Products
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

16 - - - -- Fishery/Seafood Products
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

17 - - - -- Meats, Meat Products and Poultry
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

18 - - - -- Vegetable Protein Products
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

20 - - - -- Fruit/Fruit Products
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

21 - - - -- Fruit/Fruit Products
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

22 - - - -- Fruit/Fruit Products
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

23 - - - -- Nuts/Edible Seeds
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

24 - - - -- Vegetables/Vegetable Products
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

25 - - - -- Vegetables/Vegetable Products
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

26 - - - -- Vegetable Oils
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

27 - - - -- Dressing/Condiments
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

28 - - - -- Spices, Flavors And Salts
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

29 - - - -- Soft Drinks/Water
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

31 - - - -- Coffee/Tea
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

32 - - - -- Alcoholic Beverages
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

38 - - - -- Soups
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

39 - - - -- Prepared Salad Products
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

40 A - - -- Baked Goods (Baby)
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

40 B - - -- Cereal (Baby)
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

40 D - - -- Veg (Baby)
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

40 J - - -- Egg Prod (Baby)
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

40 K - - -- Pudding/Custard (Baby)
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

40 L - - -- Soups/Soup Mix (Baby)
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

40 X - - -- Market Basket Sampling
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

40 Y - - -- Baby Food N.E.C.
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

52 B - - 06 Corn Husks (Food Related)
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

52 B - - 07 Snail Shells (Food Related)
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

52 D - - -- Live Animals
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

61 - - - -- Human and Animal Drugs
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

62 - - - -- Human and Animal Drugs
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

63 - - - -- Human and Animal Drugs
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

64 - - - -- Human and Animal Drugs
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

65 - - - -- Human and Animal Drugs
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

66 - - - -- Human and Animal Drugs
Date Published: 09/23/2010

Notes: Ophioglossum Thermale Powder; aka Ophioglossum Polyphylous; aka Mao Dun-grass, extract; Country-China

Suzhou City Jinmao Daily Chemicals Co., Ltd.
Date Published : 03/27/2023
138 Wenpu Lu , Kunshan , Suzhou, Jiangsu CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Shir Fresh Mint Brand Flouride Paste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 05/31/2007

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: Shir Fresh Mint Brand Flouride Paste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 05/31/2007

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: Shir Fresh Mint Brand Flouride Paste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 05/31/2007

Suzhou Qing Xin Daily Chemical Co., Ltd
Date Published : 03/27/2023
158 Jingiang Rd. New Development , Suzhou, CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: All products
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 06/20/2007

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: All products
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 06/20/2007

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: All products
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 06/20/2007

TAIAN ZHONGXIN LINGZHI TECHNOLOGY AND DEVELOPMENT CO. LTD
Date Published : 09/30/2009
High And New , No. 5 North Of Road; Technology Development Zone , Taian, Shandong CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: 4/7/2008 Optimum Male Enhancer. These products are promoted as dietary supplements for the male and female sexual enchancement. FDA analyses found sildenafil in these products. Sildenfil is the active ingrediant in FDA approved drug Viagara.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2009

Notes: 4/7/2008 Optimum Male Enhancer. These products are promoted as dietary supplements for the male and female sexual enchancement. FDA analyses found sildenafil in these products. Sildenfil is the active ingrediant in FDA approved drug Viagara.

Taian Zhongxin Lingzhi Technology and Development Co. Ltd.
Date Published : 09/30/2009
Development Zone , Peitianmen Main Street; Gaoxin Jizhuchanye Kaifa , Taian, Shandong CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: 4/7/2008 KPC-25 Capsules Optimum Female Enhancer

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2009

Notes: 4/7/2008 KPC-25 Capsules Optimum Female Enhancer

Taishan AGHG Aloe Products Co.,LTD
Date Published : 08/25/2017
368 Sijiuwei , Taishan , Jiangmen, Guangdong CHINA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 08/25/2017

Desc: Aloe Acne Removing Deep Cleanser
Notes: Center review determined products contain drug claims on product labeling.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 08/25/2017

Desc: Aloe acne Prevention and Repair Toner
Notes: Center review determined products contain drug claims on product labeling.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 08/25/2017

Desc: Aloe Acne Repair Serum
Notes: Center review determined products contain drug claims on product labeling.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 08/25/2017

Desc: Aloe acne Prevention and Repair Toner
Notes: Center review determined products contain drug claims on product labeling.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 08/25/2017

Desc: Aloe Acne Removing Deep Cleanser
Notes: Center review determined products contain drug claims on product labeling.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 08/25/2017

Desc: Aloe Acne Repair Serum
Notes: Center review determined products contain drug claims on product labeling.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/25/2017

Desc: Aloe Acne Repair Serum
Notes: Center review determined products contain drug claims on product labeling.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/25/2017

Desc: Aloe acne Prevention and Repair Toner
Notes: Center review determined products contain drug claims on product labeling.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/25/2017

Desc: Aloe Acne Removing Deep Cleanser
Notes: Center review determined products contain drug claims on product labeling.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/25/2017

Desc: Aloe Acne Repair Serum
Notes: Center review determined products contain drug claims on product labeling.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/25/2017

Desc: Aloe acne Prevention and Repair Toner
Notes: Center review determined products contain drug claims on product labeling.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/25/2017

Desc: Aloe Acne Removing Deep Cleanser
Notes: Center review determined products contain drug claims on product labeling.

Taizhou Nanfeng Pharmaceutical Co
Date Published : 10/08/2013
No. 8 Nanfeng East Rd. , Zhejiang, CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/08/2013

Desc: Feng Shi Zhui Feng Tou Guwah Pills

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/08/2013

Desc: Feng Shi Zhui Feng Tou Guwah Pills

Taizhou Yadai Daily-Use Co., Ltd.
Date Published : 09/08/2020
Bldg 2 Fl. 2 , 95-1 Dongtaihe Rd; Jiaojiang District , Taizhou, Zhejiang CHINA
62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 09/08/2020

Desc: Al-kogel 75% Alcohol Antiseptic Gel
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... for the sanitization and asepsis of hands and forearms. It provides an effective action against a wide range of microorganisms including bacteria, viruses and germs using mechanism of action of protein denaturation ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. In addition, the product appears to be an unapproved new drug as the product label does not distinguish between active and inactive ingredients which makes all listed ingredients active ingredients which is not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance.

Tcm Adaptogen Warehouse Co Ltd
Date Published : 12/01/2014
Dazhai Rd , Xian Shaanxi, CHINA
54 E - - 48 Ginkgo biloba (Herbal & Botanical Teas)
Date Published: 12/01/2014

Desc: Gingko Extract 24%
Notes: The referenced products appear to be unapproved new drugs as the product labels; accompanying literature; and website (www.tcmadaptogen.com) include; but are not limited to; the following claims; EPIMEDIUM EXTRACT ICARIIN 10% ( on website) It is suggested that this Chinese medicine had therapeutic effect on sexual disorder and immunologic inadequacy; SAW PALMETO EXTRACT 25% (on website) ***proved useful in chronic bronchial coughs; whooping-cough ***; GINGKO EXTRACT 24% ( on website)***ginkgo therapy resulted in improved *** measures in patients participants with Alzheimer disease

54 E - - 58 Saw Palmetto (Herbal & Botanical Teas)
Date Published: 12/01/2014

Desc: Saw Palmetto Extract 25%
Notes: The referenced products appear to be unapproved new drugs as the product labels; accompanying literature; and website (www.tcmadaptogen.com) include; but are not limited to; the following claims; EPIMEDIUM EXTRACT ICARIIN 10% ( on website) It is suggested that this Chinese medicine had therapeutic effect on sexual disorder and immunologic inadequacy; SAW PALMETO EXTRACT 25% (on website) ***proved useful in chronic bronchial coughs; whooping-cough ***; GINGKO EXTRACT 24% ( on website) ***ginkgo therapy resulted in improved *** measures in patients participants with Alzheimer disease.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 12/01/2014

Desc: Epimedium Extract Icariin 10%
Notes: The referenced products appear to be unapproved new drugs as the product labels; accompanying literature; and website (www.tcmadaptogen.com) include; but are not limited to; the following claims; EPIMEDIUM EXTRACT ICARIIN 10% ( on website) It is suggested that this Chinese medicine had therapeutic effect on sexual disorder and immunologic inadequacy; SAW PALMETO EXTRACT 25% (on website) ***proved useful in chronic bronchial coughs; whooping-cough ***; GINGKO EXTRACT 24% ( on website) ***ginkgo therapy resulted in improved *** measures in patients participants with Alzheimer disease.

54 F - - 48 Ginkgo biloba (Herbal & Botanicals, not Teas)
Date Published: 12/01/2014

Desc: Gingko Extract 24%
Notes: The referenced products appear to be unapproved new drugs as the product labels; accompanying literature; and website (www.tcmadaptogen.com) include; but are not limited to; the following claims; EPIMEDIUM EXTRACT ICARIIN 10% ( on website) It is suggested that this Chinese medicine had therapeutic effect on sexual disorder and immunologic inadequacy; SAW PALMETO EXTRACT 25% (on website) ***proved useful in chronic bronchial coughs; whooping-cough ***; GINGKO EXTRACT 24% ( on website)***ginkgo therapy resulted in improved *** measures in patients participants with Alzheimer disease. ;

54 F - - 58 Saw Palmetto (Herbal & Botanicals, not Teas)
Date Published: 12/01/2014

Desc: Saw Palmetto Extract 25%
Notes: The referenced products appear to be unapproved new drugs as the product labels; accompanying literature; and website (www.tcmadaptogen.com) include; but are not limited to; the following claims; EPIMEDIUM EXTRACT ICARIIN 10% ( on website) It is suggested that this Chinese medicine had therapeutic effect on sexual disorder and immunologic inadequacy; SAW PALMETO EXTRACT 25% (on website) ***proved useful in chronic bronchial coughs; whooping-cough ***; GINGKO EXTRACT 24% ( on website) ***ginkgo therapy resulted in improved *** measures in patients participants with Alzheimer disease.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/01/2014

Desc: Epimedium Extract Icariin 10%
Notes: The referenced products appear to be unapproved new drugs as the product labels; accompanying literature; and website (www.tcmadaptogen.com) include; but are not limited to; the following claims; EPIMEDIUM EXTRACT ICARIIN 10% ( on website) It is suggested that this Chinese medicine had therapeutic effect on sexual disorder and immunologic inadequacy; SAW PALMETO EXTRACT 25% (on website) ***proved useful in chronic bronchial coughs; whooping-cough ***; GINGKO EXTRACT 24% ( on website)***ginkgo therapy resulted in improved *** measures in patients participants with Alzheimer disease.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/01/2014

Desc: Saw Palmetto Extract 25%
Notes: The referenced products appear to be unapproved new drugs as the product labels; accompanying literature; and website (www.tcmadaptogen.com) include; but are not limited to; the following claims; EPIMEDIUM EXTRACT ICARIIN 10% ( on website) It is suggested that this Chinese medicine had therapeutic effect on sexual disorder and immunologic inadequacy; SAW PALMETO EXTRACT 25% (on website) ***proved useful in chronic bronchial coughs; whooping-cough ***; GINGKO EXTRACT 24% ( on website)***ginkgo therapy resulted in improved *** measures in patients participants with Alzheimer disease.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/01/2014

Desc: Gingko Extract 24%
Notes: The referenced products appear to be unapproved new drugs as the product labels; accompanying literature; and website (www.tcmadaptogen.com) include; but are not limited to; the following claims; EPIMEDIUM EXTRACT ICARIIN 10% ( on website) It is suggested that this Chinese medicine had therapeutic effect on sexual disorder and immunologic inadequacy; SAW PALMETO EXTRACT 25% (on website) ***proved useful in chronic bronchial coughs; whooping-cough ***; GINGKO EXTRACT 24% ( on website) ***ginkgo therapy resulted in improved *** measures in patients participants with Alzheimer disease.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/01/2014

Desc: Epimedium Extract Icariin 10%
Notes: The referenced products appear to be unapproved new drugs as the product labels; accompanying literature; and website (www.tcmadaptogen.com) include; but are not limited to; the following claims; EPIMEDIUM EXTRACT ICARIIN 10% ( on website) It is suggested that this Chinese medicine had therapeutic effect on sexual disorder and immunologic inadequacy; SAW PALMETO EXTRACT 25% (on website) ***proved useful in chronic bronchial coughs; whooping-cough ***; GINGKO EXTRACT 24% ( on website) ***ginkgo therapy resulted in improved *** measures in patients participants with Alzheimer disease.

Tianjin Aike Technology Development Co. Ltd.
Date Published : 12/18/2013
No. 15, Yingshui Road , Tianjin, Tianjin CHINA
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 12/18/2013

Desc: Feminine Hygiene Gel

61 W - - 99 A-Fungal N.E.C.
Date Published: 12/18/2013

Desc: Feminine Hygiene Gel

65 X - - 04 Octoxynol 9 (Spermaticide)
Date Published: 12/18/2013

Desc: Feminine Hygiene Gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/18/2013

Desc: Feminine Hygiene Gel

Tianjin Hezhi Pharmaceutical Co., Ltd.
Date Published : 07/17/2014
No. 22 Quanfa Road , Wuqing , Tianjin, Tianjin CHINA
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 07/17/2014

Desc: Fluaid Oral Pain Reliever
Notes: Labeled as oral pain reliever and temporarily relieves symptoms due to flu

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 07/17/2014

Desc: Coldaid Oral Pain Reliever
Notes: Labeled as oral pain reliever and temporarily relieves symptoms due to cold

60 L - - 99 Analgesic, N.E.C.
Date Published: 07/17/2014

Desc: Coldaid Oral Pain Reliever
Notes: Labeled as oral pain reliever and temporarily relieves symptoms due to cold

60 L - - 99 Analgesic, N.E.C.
Date Published: 07/17/2014

Desc: Fluaid Oral Pain Reliever
Notes: Labeled as oral pain reliever and temporarily relieves symptoms due to flu

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/17/2014

Desc: Coldaid Oral Pain Reliever
Notes: Labeled as oral pain reliever and temporarily relieves symptoms due to cold

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/17/2014

Desc: Fluaid Oral Pain Reliever
Notes: Labeled as oral pain reliever and temporarily relieves symptoms due to flu

Tianjin Medicines & Health Products Import & Export Corp.
Date Published : 01/17/2017
Hai Tai Information Square, Hi-Tech Indu , Building C 5th Floor; NO. 8 Huatiandao , Tianjin, Tianjin CHINA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/17/2017

Desc: Yin Chiao Chieh Tu Tablets (Cold Season Support)

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/17/2017

Desc: Tong Xuan Li Fei Pian Tablets (Perilla & Peucedanuma Combo)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/17/2017

Desc: Yin Chiao Chieh Tu Tablets (Cold Season Support)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/17/2017

Desc: Tong Xuan Li Fei Pian Tablets (Perilla & Peucedanuma Combo)

Tianjin Medicines & Health Products Import & Export Corp.
Date Published : 05/06/2013
Hai Tai Information Square, Hi-Tech Indu , Building C 5th Floor; NO. 8 Huatiandao , Tianjin, Tianjin CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/06/2013

Notes: Royal dragon herbal tonic ball; note: Product was found to contain undeclared vardenafil

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/06/2013

Desc: Royal dragon herbal tonic ball
Notes: note; Product was found to contain undeclared vardenafil ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/06/2013

Desc: Royal dragon herbal tonic ball
Notes: note; Product was found to contain undeclared vardenafil ;

Tianjin Oculax Biotech, Inc.
Date Published : 05/03/2016
6 Ziyuan Road , B201 Huayuan Domain District , Tianjin, Tianjin CHINA
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/03/2016

Desc: 3T Oculax Acupoint Patch
Notes: Claims found on product label and website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/03/2016

Desc: 3T Oculax Acupoint Patch
Notes: Claims found on product label and website

80 B - - WJ Locator, Acupuncture Point
Date Published: 05/03/2016

Desc: 3T Oculax Acupoint Patch
Notes: Claims found on product label and website

Tibet Gold Source Living Creature Engineering Ltd
Date Published : 11/16/2012
Pull Peking Rd , 18th on the 55th , Sa City Tibet, Tibet CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/16/2012

Desc: Hard Ten Days Capsules
Notes: china

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/16/2012

Desc: Hard Ten Days Capsules
Notes: china

Tibet Jin Wei Long Health Medicine Co., Ltd.
Date Published : 05/13/2015
No.98 Min Zu Road , Lhasa, CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/13/2015

Desc: Miraculous Evil Root Tablets
Notes: product contains undeclared Sildenafil

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 05/13/2015

Desc: Miraculous Evil Root Tablets
Notes: product contains undeclared Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/13/2015

Desc: Miraculous Evil Root Tablets
Notes: product contains undeclared Sildenafil

Unknown name
Date Published : 05/17/2012
NO 59 Threeblog Xiashiwei Area , Fuyong Town, Bao'an District , Shenzhen, CHINA
31 A - - -- Coffee
Date Published: 06/28/2012

Desc: Health Slimming Coffee French Slimming Coffee
Notes: china

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/28/2012

Desc: Health Slimming Coffee French Slimming Coffee
Notes: china

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 06/28/2012

Desc: Health Slimming Coffee French Slimming Coffee
Notes: china

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 05/17/2012

Desc: Tengda
Notes: China

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/28/2012

Desc: Health Slimming Coffee French Slimming Coffee
Notes: china

Upervised By Guangzhou Feilanyashi Trade Co.,Ltd.
Date Published : 04/08/2010
Rm 706, Zhong Ren Group Shang Yuan Gang , Guangzhou, CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/08/2010

Desc: Foot Patch
Notes: Note; Labeling makes bodily structure and function claims including strengthening the immune system.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/08/2010

Desc: Foot Patch
Notes: Note;Labeling makes bodily structure and function claims including strengthening the immune system.

VEGAR COSMETICS
Date Published : 06/13/2018
F 5 , No 12 Taian Rd; Xiangqiao , Chaozhou, Guangdong CHINA
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 06/13/2018

Desc: Simply Mascara

VIXA BIOPHARMACEUTICAL CO., LTD
Date Published : 02/03/2021
NEW & HIGH-TECH INDUST. , YUNNAN, CHINA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 02/03/2021

Desc: SKINEAL Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory, Antipruritic'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 02/03/2021

Desc: SKINEAL Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory, Antipruritic'.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 02/03/2021

Desc: SKINEAL Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory, Antipruritic'.

56 D - - 41 Neomycin Sulfate (Aminoglycosides)
Date Published: 02/03/2021

Desc: SKINEAL Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory, Antipruritic'.

56 G - - 99 Antifungal N.E.C.
Date Published: 02/03/2021

Desc: SKINEAL Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory, Antipruritic'.

61 H - - 99 Anti-Bacterial, N.E.C.
Date Published: 02/03/2021

Desc: SKINEAL Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory, Antipruritic'.

61 W - - 47 Ketoconazole (Anti-Fungal) (Not Antibiotic)
Date Published: 02/03/2021

Desc: SKINEAL Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory, Antipruritic'.

61 W - - 99 A-Fungal N.E.C.
Date Published: 02/03/2021

Desc: SKINEAL Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory, Antipruritic'.

64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 02/03/2021

Desc: SKINEAL Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory, Antipruritic'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2021

Desc: SKINEAL Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory, Antipruritic'.

Wan Bao International Manufacturing Corporation (USA)
Date Published : 07/09/2012
27 He Pin Road , Hainan Province, Hainan CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/09/2012

Desc: Man King Dietary Supplement
Notes: Note: Analytical testing by FDA found undeclared Sildenafil; China

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/09/2012

Desc: Man King Dietary Supplement
Notes: Note: Analytical testing by FDA found undeclared Sildenafil; China

Wan Shou Tang Medical Co. LTD
Date Published : 07/28/2015
Unknown , Beijing, CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/28/2015

Desc: Jinbu Huqian Wan Capsules
Notes: Contains undeclared Chlorpheniramine; Dexamethasone and Furosemide.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/28/2015

Desc: Jinbu Huqian Wan Capsules
Notes: Contains undeclared Chlorpheniramine; Dexamethasone and Furosemide.

Wang Wei
Date Published : 12/23/2013
Shang Zhong West Rd , Shanghai, Shanghai CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/23/2013

Desc: Ja Dera
Notes: Note; Analytical testing by FDA revealed these products contain undeclared Sibutramine.

Weihai Baihe Biology Technological Co., Ltd.
Date Published : 03/10/2021
No. 552, Chengda road, Swan Lake Economic Technical Development Zone , Rongcheng , Shandong, Shandong CHINA
54 Y - - 08 Coenzyme Q10 (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 03/10/2021

Desc: Coenzyme Q10 Softgel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/10/2021

Desc: Coenzyme Q10 Softgel

Weimin Medicine Manufactory
Date Published : 09/30/2009
Unknown , Beijing, CHINA
54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 09/30/2009

Notes: Gynostemma Pentaphylla And Evening Primrose Pills; 10/28/2005

54 H - - -- Fats and Lipid Substances
Date Published: 09/30/2009

Notes: Gynostemma Pentaphylla And Evening Primrose Pills; 10/28/2005

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 09/30/2009

Notes: Gynostemma Pentaphylla And Evening Primrose Pills; 10/28/2005

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: Gynostemma Pentaphylla And Evening Primrose Pills; 10/28/2005

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Gynostemma Pentaphylla And Evening Primrose Pills; 10/28/2005

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Gynostemma Pentaphylla And Evening Primrose Pills; 10/28/2005

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Gynostemma Pentaphylla And Evening Primrose Pills; 10/28/2005

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Gynostemma Pentaphylla And Evening Primrose Pills; 10/28/2005

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Gynostemma Pentaphylla And Evening Primrose Pills; 10/28/2005

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Gynostemma Pentaphylla And Evening Primrose Pills; 10/28/2005

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Gynostemma Pentaphylla And Evening Primrose Pills; 10/28/2005

Wuhain Ixin Globe Trade Co Ltd
Date Published : 05/26/2010
613 Zhujiang Tqiyancheng Plaza , Guangzhou, CHINA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 05/26/2010

Desc: Kaboom Action Strips (Sexual Performance Strips) Marketed as a Dietary Supplement Contains Sildenafil
Notes: China

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 05/26/2010

Notes: Kaboom Action Strips (Sexual Performance Strips) Marketed as a Dietary Supplement Contains Sildenafil; China

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 05/26/2010

Notes: Kaboom Action Strips (Sexual Performance Strips) Marketed as a Dietary Supplement Contains Sildenafil; China ;

61 - - - -- Human and Animal Drugs
Date Published: 05/26/2010

Notes: Kaboom Action Strips (Sexual Performance Strips) Marketed as a Dietary Supplement Contains Sildenafil; China ;

62 - - - -- Human and Animal Drugs
Date Published: 05/26/2010

Notes: Kaboom Action Strips (Sexual Performance Strips) Marketed as a Dietary Supplement Contains Sildenafil; China ;

63 - - - -- Human and Animal Drugs
Date Published: 05/26/2010

Notes: Kaboom Action Strips (Sexual Performance Strips) Marketed as a Dietary Supplement Contains Sildenafil; China ;

64 - - - -- Human and Animal Drugs
Date Published: 05/26/2010

Notes: Kaboom Action Strips (Sexual Performance Strips) Marketed as a Dietary Supplement Contains Sildenafil; China ;

65 - - - -- Human and Animal Drugs
Date Published: 05/26/2010

Notes: Kaboom Action Strips (Sexual Performance Strips) Marketed as a Dietary Supplement Contains Sildenafil; China ;

66 - - - -- Human and Animal Drugs
Date Published: 05/26/2010

Notes: Kaboom Action Strips (Sexual Performance Strips) Marketed as a Dietary Supplement Contains Sildenafil; China ;

Wuhan Fulai Pharmaceutical Technology Co., Ltd
Date Published : 08/11/2016
Wuhuan Industrial Park, Xinji , Wuhan, Hubei CHINA
60 L - - 99 Analgesic, N.E.C.
Date Published: 08/11/2016

Desc: AvaLin Patches with 5% Lidocaine and 1.25% Menthol (External Analgesic Patch)

60 Q - - 07 Lidocaine
Date Published: 08/11/2016

Desc: AvaLin Patches with 5% Lidocaine and 1.25% Menthol (External Analgesic Patch)

Wuxi Accobio Biotech Inc.
Date Published : 12/21/2011
Jinxicun , Binhu , Wuxi, Jiangsu CHINA
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/21/2011

Desc: Idebenone
Notes: China

Wuxi Cima Science Co.,Ltd
Date Published : 12/30/2013
# 138 Meiliang Road , Binhu , Wuxi, Jiangsu CHINA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/30/2013

Desc: Piracetam
Notes: Country; China

Xi 'an Arooxy Technology Co., Ltd
Date Published : 04/13/2016
Room 502,Building E,ZTE industy zone, , Xi'an, Shanxisheng CHINA
64 J - - 01 Oxygen (Medicinal Gas)
Date Published: 04/13/2016

Desc: Rocket Oxygen (Portable Recreational Inhaler)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/13/2016

Desc: Rocket Oxygen (Portable Recreational Inhaler)

77 K - - CO Inhaler, Nasal
Date Published: 04/13/2016

Desc: Rocket Oxygen (Portable Recreational Inhaler)

Xiamen Origin Biotech Co. Ltd.
Date Published : 06/09/2014
NO. 7 Xiang Yue Road , Xiamen Torch , Xiamen, Fujian CHINA
62 I - - 04 Asparaginase (Anti-Neoplastic)
Date Published: 06/09/2014

Desc: L ? Asparaginase (Bulk raw material)

Xian Lyphar Biotech Co Ltd
Date Published : 09/13/2016
Tang NO 11 , Yan Rd Hi Tech; Ind Zone , Xian, CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/13/2016

Desc: FoliGain
Notes: Product contains undeclared human growth hormone

62 C - - 41 Minoxidil (Anti-Hypertensive)
Date Published: 09/13/2016

Desc: FoliGain
Notes: Product contains undeclared human growth hormone

64 R - - 18 Human Growth Hormone (Hormone)
Date Published: 09/13/2016

Desc: FoliGain
Notes: Product contains undeclared human growth hormone

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/13/2016

Desc: FoliGain
Notes: Product contains undeclared human growth hormone

Xiehe Group Co., Ltd
Date Published : 09/13/2019
19-A-8 Sanhao Street , Shenyang, Liaoning, Unknown CHINA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/13/2019

Desc: BM Oral Solution and any product containing the ingredient staphylococcin
Notes: 4/1/1998

Xin Wei Hong Kong Biotechnology
Date Published : 10/02/2015
C2-328 , Haikou, Hainan CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Germany Niubian Tablets
Notes: Contains undeclared Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/02/2015

Desc: Germany Niubian Tablets
Notes: Contains undeclared Sildenafil

Xizang Jin Shengli Health Products Co. LTD.
Date Published : 07/29/2015
People Road NO 128 , Block B , La Sa, CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/29/2015

Desc: African Black Ant Capsules
Notes: Contains undeclared Sildenafil

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 07/29/2015

Desc: African Black Ant Capsules
Notes: Contains undeclared Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/29/2015

Desc: African Black Ant Capsules
Notes: Contains undeclared Sildenafil

Xuan Zhao Jin Xing Yuan Hutian
Date Published : 09/30/2009
Developing Area , Huaihua, Hunan CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: 5/28/2008 Shanghai Ultra/Shanghai Ultra X Capsules These products are promoted as dietary supplements for men and women. FDA analysis found sildenfil and taladafil in these products. Sildenfil is the active ingrediant in the FDA approved drug Viagra. Taladafil is the active ingrediant in the FDA approved drug Cialis. These drugs are only approved to treat erectile dysfunction (ED) as indicated in the FDA approved drug applications.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2009

Notes: 5/28/2008 Shanghai Ultra/Shanghai Ultra X Capsules

Xun Lung Xin
Date Published : 09/13/2012
Unknown , Marketing Department , Canton, CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/23/2012

Desc: Dai Dai Hua Jiao Nang
Notes: Analyical testing by FDA revealed the product contains undeclared sibutramine and phenolphthalein

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/13/2012

Desc: Botanical Slimming Soft Gels Meizitang
Notes: Note; Product contains undeclared Sibutramine

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 09/13/2012

Desc: Botanical Slimming Soft Gels Meizitang
Notes: Note; Product contains undeclared Sibutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/23/2012

Desc: Dai Dai Hua Jiao Nang
Notes: Analyical testing by FDA revealed the product contains undeclared sibutramine and phenolphthalein

YANGZHOU ROYAL HOME PRODUCTS MANUFACTURE CO., LTD.
Date Published : 03/27/2023
922-923, 28# WANHONG CITY , GARDEN, YANGZHOU , Jiangsu, CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Dentakleen toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 11/05/2007

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: Dentakleen toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 11/05/2007

Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd
Date Published : 03/27/2023
Industrial Park , 7 Sitong Road; Hangjizhen Hanjiang , Yangzhou, Jiangsu CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Dentakleen toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 09/12/2007

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: Dentakleen toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 09/12/2007

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: Dentakleen toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 09/12/2007

Yangzhou Huangxuan Daily Chemical Co., Ltd
Date Published : 01/07/2021
No. 999 Phoenix Island Road , Taianzhen , Yangzhou, Jiangsu CHINA
62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 01/07/2021

Desc: Sanitizing Spray

Yangzhou Huangxuan Daily Chemical Co., Ltd
Date Published : 03/08/2021
No. 999 Phoenix Island Road , Taianzhen , Yangzhou, Jiangsu CHINA
62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 03/08/2021

Desc: Hand Sanitizer (Rose Ocean and Lemon Scented)

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 03/08/2021

Desc: Hand Sanitizer (Rose Ocean and Lemon Scented)

Yangzhou Olande Cosmetic Co., Ltd
Date Published : 08/11/2020
Xinglong Road , Hangjizhen Hanjiang , Yangzhou, Jiangsu CHINA
62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 08/11/2020

Desc: Leafree Instant Hand Sanitizer
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '75% EDIBLE ALCOHOL' and 'Sterilization and bacteriostatis'.

Yiwu Deshi Import
Date Published : 06/02/2011
Room 1901 699 Chouzhou , Yiwu, CHINA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 06/02/2011

Desc: Panive Skin Whitening and Freckle Remover Cream
Notes: China                                                                          

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 08/22/2011

Desc: VC Skin Cream (Anti-freckle cream suit-Vitamin C)
Notes: China                                                                          

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/28/2011

Desc: Fair and Lovely Skin Cream
Notes: China                                                                          

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/22/2011

Desc: VC Skin Cream (Anti-freckle cream suit-Vitamin C)
Notes: China                                                                          

66 - - - -- Human and Animal Drugs
Date Published: 08/22/2011

Desc: VC Skin Cream (Anti-freckle cream suit-Vitamin C)
Notes: China                                                                          

Yiwu Deshi Import And Export Company Limited
Date Published : 06/02/2011
1619 Boulveard 16 , Zhejiang, CHINA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 06/02/2011

Desc: Panive Skin Whitening and Freckle Remover Cream
Notes: China

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 08/22/2011

Desc: VC Skin Cream (Anti-freckle cream suit-Vitamin C)
Notes: China

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/22/2011

Desc: VC Skin Cream (Anti-freckle cream suit-Vitamin C)
Notes: China

66 - - - -- Human and Animal Drugs
Date Published: 08/22/2011

Desc: VC Skin Cream (Anti-freckle cream suit-Vitamin C)
Notes: China

Yiwu Huarong Co., Ltd.
Date Published : 09/21/2017
001 Niansanli Industrial Zone, Yiwu , Zhejiang, CHINA
53 G - - 03 Foundations (Makeup Preparations, not for Eyes)
Date Published: 09/21/2017

Desc: BB Beauty Balm Cream

53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 09/21/2017

Desc: BB Beauty Balm Cream

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 09/21/2017

Desc: BB Beauty Balm Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/21/2017

Desc: BB Beauty Balm Cream

Yiwu Lier Import And Export Co Ltd
Date Published : 03/27/2023
4-5 Floor Chouzhou North Road Yiwu City , Zhejiang Province, CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Toothpaste (Pepei)
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 03/20/2009

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: Toothpaste (Pepei)
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 03/20/2009

Yiwu Majiali Imp Exp Co Ltd
Date Published : 03/27/2023
3f No 3 Bldg No 25 , Zhejiang, CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Cresent Cavity Fighting toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 10/09/2007

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: Cresent Cavity Fighting toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 10/09/2007

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: Cresent Cavity Fighting toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 10/09/2007

Yongnan Daily Use Chemical Factory
Date Published : 03/27/2023
No 123 Yongning Xinyong Road , Xiaolanzhen , Zhongshan, Guangdong CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Escents toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 10/09/2007

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: Escents toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 10/09/2007

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: Escents toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 10/09/2007

Yueqing Dajingshenyin Food Patch Trading Firm
Date Published : 04/26/2013
Jiangdong Street Qingkou Road , Yiwu , Jinhua, Zhejiang CHINA
53 Y Y - 99 Other Cosmetic and Cosmetic Products, N.E.C., Not Elsewhere Classified (NEC)
Date Published: 04/26/2013

Desc: Kiyome Kinoki Cleansing Detox Foot Pads
Notes: Note; manuf per test document provided by import broker;china

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/26/2013

Desc: Kiyome Kinoki Cleansing Detox Foot Pads
Notes: Note; manuf per test document provided by import broker;china

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/26/2013

Desc: Kiyome Kinoki Cleansing Detox Foot Pads
Notes: Note; manuf per test document provided by import broker;china

80 F - - QM Bandage, Elastic
Date Published: 04/26/2013

Desc: Kiyome Kinoki Cleansing Detox Foot Pads
Notes: Note; manuf per test document provided by import broker;china

80 K - - YS Insoles, Medical
Date Published: 04/26/2013

Desc: Kiyome Kinoki Cleansing Detox Foot Pads
Notes: Note; manuf per test document provided by import broker;china

Yunnan Bai'an Medicinal Science & Technology Co. Ltd
Date Published : 06/15/2012
18th Lianghe Toad , Xishan District , Kunming, CHINA
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 06/15/2012

Desc: Lishou Fuling Herbal Tea Capsules
Notes: CHINA

Yunnan Baiyao Group Co., Ltd.
Date Published : 12/13/2023
No. 3686 Yunnan Baiyao Street , Chenggong , Kunming, Yunnan CHINA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/13/2023

Desc: Yunnan Baiyao Powder

Yunnun Druos Works
Date Published : 06/16/2015
389 Xin Yang Rd. , Yunnun, CHINA
54 Y - - 04 Ginseng Unconventional Dietary Speciality for Humans or Animals
Date Published: 06/16/2015

Desc: Ginseng She Lian Wan Capsules
Notes: The aforementioned product appears to be an unapproved new drug as FDA analysis found undeclared chlorpheniramine and dexamethasone in the product. In addition; the aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product's intended use from the product label include but are not limited to the following; 'INDICATIONS; Traditionally use for lumbago; gout; arthrodynia; myasthenia; limb numbness; pains induced by acclimation fever and rheumatism; osteocope and arthritis'.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/16/2015

Desc: Ginseng She Lian Wan Capsules
Notes: The aforementioned product appears to be an unapproved new drug as FDA analysis found undeclared chlorpheniramine and dexamethasone in the product. In addition; the aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product's intended use from the product label include but are not limited to the following; 'INDICATIONS; Traditionally use for lumbago; gout; arthrodynia; myasthenia; limb numbness; pains induced by acclimation fever and rheumatism; osteocope and arthritis'.

61 X - - 08 Chlorpheniramine Maleate (Anti-Histaminic)
Date Published: 06/16/2015

Desc: Ginseng She Lian Wan Capsules
Notes: The aforementioned product appears to be an unapproved new drug as FDA analysis found undeclared chlorpheniramine and dexamethasone in the product. In addition; the aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product's intended use from the product label include but are not limited to the following; 'INDICATIONS; Traditionally use for lumbago; gout; arthrodynia; myasthenia; limb numbness; pains induced by acclimation fever and rheumatism; osteocope and arthritis'.

64 L - - 19 Dexamethasone (Glucocorticoid)
Date Published: 06/16/2015

Desc: Ginseng She Lian Wan Capsules
Notes: The aforementioned product appears to be an unapproved new drug as FDA analysis found undeclared chlorpheniramine and dexamethasone in the product. In addition; the aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product's intended use from the product label include but are not limited to the following; 'INDICATIONS; Traditionally use for lumbago; gout; arthrodynia; myasthenia; limb numbness; pains induced by acclimation fever and rheumatism; osteocope and arthritis'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/16/2015

Desc: Ginseng She Lian Wan Capsules
Notes: The aforementioned product appears to be an unapproved new drug as FDA analysis found undeclared chlorpheniramine and dexamethasone in the product. In addition; the aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product's intended use from the product label include but are not limited to the following; 'INDICATIONS; Traditionally use for lumbago; gout; arthrodynia; myasthenia; limb numbness; pains induced by acclimation fever and rheumatism; osteocope and arthritis'.

ZHEJIANG CAMEL TRANSWORLD (ORGANIC FOOD) CO., LTD.
Date Published : 03/09/2010
218 Ti Yu Chang Rd. , Hangzhou, Zhejiangsheng CHINA
31 K - - -- Tea
Date Published: 03/09/2010

Desc: Pai You Guo Tea
Notes: China

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/09/2010

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 03/09/2010

61 - - - -- Human and Animal Drugs
Date Published: 03/09/2010

62 - - - -- Human and Animal Drugs
Date Published: 03/09/2010

63 - - - -- Human and Animal Drugs
Date Published: 03/09/2010

64 - - - -- Human and Animal Drugs
Date Published: 03/09/2010

65 - - - -- Human and Animal Drugs
Date Published: 03/09/2010

66 - - - -- Human and Animal Drugs
Date Published: 03/09/2010

ZHOU
Date Published : 09/04/2012
Qu , Kai Fa , Hua Shi, He bei CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/04/2012

Desc: 2 Day Diet (Japan Lingzhi) Slimming Formula
Notes: NOTE; Product contains undeclared Phenolphthalein

63 H - - 17 Phenolphthalein (Cathartic)
Date Published: 09/04/2012

Desc: 2 Day Diet (Japan Lingzhi) Slimming Formula
Notes: NOTE; Product contains undeclared Phenolphthalein

Zhang Yan Hong
Date Published : 07/06/2012
Ji Nan Shi ying Xiong Shan Lu 18-1 Hao , Jinan, CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/06/2012

Desc: Ja Der 100% Natural Weight Loss Supplement
Notes: China;Note; Analytical testing by FDA revealed the product contains undeclared Sibutramine.

Zhejiang Bangli Medical Products Co., Ltd
Date Published : 05/25/2016
Huachuan Block, Zhengjia Village , 118 South Of Yuegui Road; Xiangzhu Town , Yongkang, Zhejiang CHINA
60 L - - 99 Analgesic, N.E.C.
Date Published: 05/25/2016

Desc: Velma Pain Relief Patch

60 L - - 99 Analgesic, N.E.C.
Date Published: 07/21/2016

Desc: Premium Lidocaine 5% Extra Lidocaine Ointment

60 L - - 99 Analgesic, N.E.C.
Date Published: 05/25/2016

Desc: Lorenza Pain Relief Patch

60 L - - 99 Analgesic, N.E.C.
Date Published: 05/25/2016

Desc: Silvera Pain Relief Patch

60 L - - 99 Analgesic, N.E.C.
Date Published: 05/25/2016

Desc: Remaxazon External Patch

60 L - - 99 Analgesic, N.E.C.
Date Published: 06/09/2016

Desc: Soothee Patch

60 L - - 99 Analgesic, N.E.C.
Date Published: 05/25/2016

Desc: Permavan External Patch

60 Q - - 07 Lidocaine
Date Published: 07/21/2016

Desc: Premium Lidocaine 5% Extra Lidocaine Ointment

60 Q - - 67 Lidocaine (Anesthetic)
Date Published: 05/25/2016

Desc: Permavan External Patch

60 Q - - 67 Lidocaine (Anesthetic)
Date Published: 05/25/2016

Desc: Silvera Pain Relief Patch

60 Q - - 67 Lidocaine (Anesthetic)
Date Published: 05/25/2016

Desc: Remaxazon External Patch

60 Q - - 67 Lidocaine (Anesthetic)
Date Published: 06/09/2016

Desc: Soothee Patch

60 Q - - 67 Lidocaine (Anesthetic)
Date Published: 05/25/2016

Desc: Lorenza Pain Relief Patch

60 Q - - 67 Lidocaine (Anesthetic)
Date Published: 07/21/2016

Desc: Premium Lidocaine 5% Extra Lidocaine Ointment

60 Q - - 67 Lidocaine (Anesthetic)
Date Published: 05/25/2016

Desc: Velma Pain Relief Patch

62 M - - 08 Menthol (Anti-Pruritic)
Date Published: 05/25/2016

Desc: Velma Pain Relief Patch

62 M - - 08 Menthol (Anti-Pruritic)
Date Published: 05/25/2016

Desc: Permavan External Patch

62 M - - 08 Menthol (Anti-Pruritic)
Date Published: 05/25/2016

Desc: Silvera Pain Relief Patch

62 M - - 08 Menthol (Anti-Pruritic)
Date Published: 05/25/2016

Desc: Remaxazon External Patch

62 M - - 08 Menthol (Anti-Pruritic)
Date Published: 06/09/2016

Desc: Soothee Patch

62 M - - 08 Menthol (Anti-Pruritic)
Date Published: 05/25/2016

Desc: Lorenza Pain Relief Patch

89 I - - MD Pack, Hot Or Cold, Disposable
Date Published: 05/25/2016

Desc: Permavan External Patch

89 I - - MD Pack, Hot Or Cold, Disposable
Date Published: 05/25/2016

Desc: Velma Pain Relief Patch

89 I - - MD Pack, Hot Or Cold, Disposable
Date Published: 06/09/2016

Desc: Soothee Patch

89 I - - MD Pack, Hot Or Cold, Disposable
Date Published: 05/25/2016

Desc: Remaxazon External Patch

89 I - - MD Pack, Hot Or Cold, Disposable
Date Published: 05/25/2016

Desc: Silvera Pain Relief Patch

89 I - - MD Pack, Hot Or Cold, Disposable
Date Published: 05/25/2016

Desc: Lorenza Pain Relief Patch

89 O - - MW adhesive backed thermal skin patches
Date Published: 05/25/2016

Desc: Velma Pain Relief Patch

89 O - - MW adhesive backed thermal skin patches
Date Published: 05/25/2016

Desc: Lorenza Pain Relief Patch

89 O - - MW adhesive backed thermal skin patches
Date Published: 05/25/2016

Desc: Silvera Pain Relief Patch

89 O - - MW adhesive backed thermal skin patches
Date Published: 05/25/2016

Desc: Remaxazon External Patch

89 O - - MW adhesive backed thermal skin patches
Date Published: 05/25/2016

Desc: Permavan External Patch

89 O - - MW adhesive backed thermal skin patches
Date Published: 06/09/2016

Desc: Soothee Patch

Zhejiang Bohai Import And Export Co., Ltd.
Date Published : 03/27/2023
302 Room, No. 546, Chouzhou Road , Zhejiang, CHINA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: Cresent Cavity Fighting toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 10/09/2007

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: Cresent Cavity Fighting toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 10/09/2007

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: Cresent Cavity Fighting toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 10/09/2007

Zhejiang Sanhe Bio-tech Co.,Ltd
Date Published : 07/28/2014
No1.Jiangdian Road, , Jiangshan, CN-33 CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/28/2014

Desc: Red Yeast Rice (Bulk Ingredient)
Notes: Product found to contain Lovastatin at higher than trace concentration levels.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/28/2014

Desc: Red Yeast Rice (Bulk Ingredient)
Notes: Product found to contain Lovastatin at higher than trace concentration levels.

Zheng Xing Zhangguang
Date Published : 06/11/2013
1701 Hanwei Guanghua Road , Peking, CHINA
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 06/11/2013

Desc: Zhangguang 101G Hair Tonic
Notes: NOTE; Zheng Xing Zhangguang; Peking; China is the manufacturer per OASIS

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 06/11/2013

Desc: Zhangguang 101B Formula
Notes: NOTE; Zheng Xing Zhangguang; Peking; China is the manufacturer per OASIS.

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 06/11/2013

Desc: Zhangguang 101F Hair Tonic
Notes: NOTE; Zheng Xing Zhangguang; Peking; China is the manufacturer per OASIS. ;

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 06/11/2013

Desc: Zhangguang 101G Hair Tonic
Notes: NOTE; Zheng Xing Zhangguang; Peking; China is the manufacturer per OASIS

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 06/11/2013

Desc: Zhangguang 101B Formula
Notes: NOTE; Zheng Xing Zhangguang; Peking; China is the manufacturer per OASIS

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 06/11/2013

Desc: Zhangguang 101F Hair Tonic
Notes: NOTE; Zheng Xing Zhangguang; Peking; China is the manufacturer per OASIS. ;

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 06/11/2013

Desc: Zhangguang 101B Formula
Notes: NOTE; Zheng Xing Zhangguang; Peking; China is the manufacturer per OASIS

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 06/11/2013

Desc: Zhangguang 101F Hair Tonic
Notes: NOTE; Zheng Xing Zhangguang; Peking; China is the manufacturer per OASIS. ;

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 06/11/2013

Desc: Zhangguang 101G Hair Tonic
Notes: NOTE; Zheng Xing Zhangguang; Peking; China is the manufacturer per OASIS

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 06/11/2013

Desc: Zhangguang 101B Formula
Notes: NOTE; Zheng Xing Zhangguang; Peking; China is the manufacturer per OASIS.

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 06/11/2013

Desc: Zhangguang 101G Hair Tonic
Notes: NOTE; Zheng Xing Zhangguang; Peking; China is the manufacturer per OASIS

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 06/11/2013

Desc: Zhangguang 101F Hair Tonic
Notes: NOTE; Zheng Xing Zhangguang; Peking; China is the manufacturer per OASIS. ;

Zheng Xu Bin
Date Published : 11/09/2016
Huang Shi Road , Baiyun , Guangzhou, Guangdong CHINA
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 11/09/2016

Desc: Botanical Slimming Gold Version
Notes: Medical claims made on product labels and website. FDA lab analysis found undeclared Sibutramine in product.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/09/2016

Desc: Botanical Slimming Gold Version
Notes: Medical claims made on product labels and website. FDA lab analysis found undeclared Sibutramine in product.

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 11/09/2016

Desc: Botanical Slimming Gold Version
Notes: Medical claims made on product labels and website. FDA lab analysis found undeclared Sibutramine in product.

Zhuhai Aofute Medical Technology Co., Ltd.
Date Published : 03/05/2020
Building 2, No. 33 Room 202 , Yong Nan Rd; Jinwan , Zhuhai, Guangdong CHINA
60 - - - -- Human and Animal Drugs
Date Published: 03/05/2020

Desc: Magic Spray for Pain Relief
Notes: Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling.

61 - - - -- Human and Animal Drugs
Date Published: 03/05/2020

Desc: Magic Spray for Pain Relief
Notes: Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling.

62 - - - -- Human and Animal Drugs
Date Published: 03/05/2020

Desc: Magic Spray for Pain Relief
Notes: Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling.

63 - - - -- Human and Animal Drugs
Date Published: 03/05/2020

Desc: Magic Spray for Pain Relief
Notes: Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling.

64 - - - -- Human and Animal Drugs
Date Published: 03/05/2020

Desc: Magic Spray for Pain Relief
Notes: Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling.

65 - - - -- Human and Animal Drugs
Date Published: 03/05/2020

Desc: Magic Spray for Pain Relief
Notes: Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling.

66 - - - -- Human and Animal Drugs
Date Published: 03/05/2020

Desc: Magic Spray for Pain Relief
Notes: Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling.

Zhuji Jianhe Paper Co., Ltd
Date Published : 08/11/2020
F/4, Anhua Town, Zhuji , No. 32 Huaxi Road , Shaoxing, Zhejiang CHINA
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/03/2020

Desc: JIANHE 75% Alcohol Wipes
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing.

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 03/04/2021

Desc: 75% ALCOHOL WIPES
Notes: The product appears to be an unapproved new drug as the product's label suggests both that the product is a consumer antiseptic wash and consumer antiseptic rub. Thus, as formulated and labeled, the product does not conform to the Tentative Final Monograph or FDA's Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry.                                                                                                                                                    

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 12/03/2020

Desc: JIANHE 75% Alcohol Wipes
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing.

61 H - - 99 Anti-Bacterial, N.E.C.
Date Published: 12/03/2020

Desc: JIANHE 75% Alcohol Wipes
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing.

62 F - - 23 Isopropyl Alcohol (Anti-Infective, Topical)
Date Published: 12/03/2020

Desc: JIANHE 75% Alcohol Wipes
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing.

62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 03/04/2021

Desc: 75% ALCOHOL WIPES
Notes: The product appears to be an unapproved new drug as the product's label suggests both that the product is a consumer antiseptic wash and consumer antiseptic rub. Thus, as formulated and labeled, the product does not conform to the Tentative Final Monograph or FDA's Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry.                                                                                                                                                    

62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 12/03/2020

Desc: JIANHE 75% Alcohol Wipes
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing.

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 12/03/2020

Desc: JIANHE 75% Alcohol Wipes
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing.

64 A - - 99 Disinfectant N.E.C.
Date Published: 12/03/2020

Desc: JIANHE 75% Alcohol Wipes
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing.

64 A - - 99 Disinfectant N.E.C.
Date Published: 03/04/2021

Desc: 75% ALCOHOL WIPES
Notes: The product appears to be an unapproved new drug as the product's label suggests both that the product is a consumer antiseptic wash and consumer antiseptic rub. Thus, as formulated and labeled, the product does not conform to the Tentative Final Monograph or FDA's Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry.                                                                                                                                                    

chendgu Hygeia Health Product Co.,Ltd
Date Published : 06/29/2011
No. 181 Of West Fuqin Road , Chengdu, Sichuan CHINA
28 C - - 99 Natural Extract or Flavor, N.E.C.
Date Published: 06/29/2011

Notes: Custom Blend Mix composedof one or more of the following; Rhizona Polygonati Wolfberry Fruit; Ginseng Barbary Wolfberry Fruit extract Rhizoma Polygonate Clove Extract; Ginseng Tall Ganoderma Extract; Clove Lotus Leaf extract; China

31 K - - 99 Tea, N.E.C.
Date Published: 06/29/2011

Notes: Custom Blend Mix composedof one or more of the following; Rhizona Polygonati Wolfberry Fruit; Ginseng Barbary Wolfberry Fruit extract Rhizoma Polygonate Clove Extract; Ginseng Tall Ganoderma Extract; Clove Lotus Leaf extract; China

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/29/2011

Notes: Custom Blend Mix composedof one or more of the following; Rhizona Polygonati Wolfberry Fruit; Ginseng Barbary Wolfberry Fruit extract Rhizoma Polygonate Clove Extract; Ginseng Tall Ganoderma Extract; Clove Lotus Leaf extract; China

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/29/2011

Notes: Custom Blend Mix composed of one or more of the following; Rhizona Polygonati Wolfberry Fruit; Ginseng Barbary Wolfberry Fruit extract Rhizoma Polygonate Clove Extract; Ginseng Tall Ganoderma Extract; Clove Lotus Leaf extract; China

chengdu Hygeia Health Product Co.,Ltd
Date Published : 06/29/2011
No. 181 Fuqinxilu , Jinniu , Chengdu, Sichuan CHINA
28 C - - 99 Natural Extract or Flavor, N.E.C.
Date Published: 06/29/2011

Notes: Custom Blend Mix composedof one or more of the following; Rhizona Polygonati Wolfberry Fruit; Ginseng Barbary Wolfberry Fruit extract Rhizoma Polygonate Clove Extract; Ginseng Tall Ganoderma Extract; Clove Lotus Leaf extract; China

31 K - - 99 Tea, N.E.C.
Date Published: 06/29/2011

Notes: Custom Blend Mix composedof one or more of the following; Rhizona Polygonati Wolfberry Fruit; Ginseng Barbary Wolfberry Fruit extract Rhizoma Polygonate Clove Extract; Ginseng Tall Ganoderma Extract; Clove Lotus Leaf extract; China

54 F - - 83 Citrus Aurantium ( Herbal & Botanical other than Teas)
Date Published: 05/07/2012

Desc: Slim Extreme Gold Gelslim Herbal Slimming Capsules
Notes: China

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/07/2012

Desc: Viaextreme Ultimate Sexual Enhancer Dietary Supplement
Notes: China

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/29/2011

Notes: Custom Blend Mix composedof one or more of the following; Rhizona Polygonati Wolfberry Fruit; Ginseng Barbary Wolfberry Fruit extract Rhizoma Polygonate Clove Extract; Ginseng Tall Ganoderma Extract; Clove Lotus Leaf extract; China

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/29/2011

Notes: Custom Blend Mix composed of one or more of the following; Rhizona Polygonati Wolfberry Fruit; Ginseng Barbary Wolfberry Fruit extract Rhizoma Polygonate Clove Extract; Ginseng Tall Ganoderma Extract; Clove Lotus Leaf extract; China

fuzhou cheer trading co. ltd.
Date Published : 10/13/2010
Room1003,C Zhongshan Building , No.152 Hudong Road, Gulou District , Fuzhou, Fujiansheng CHINA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 10/13/2010

Desc: Playboy Viagra (Blood Tonic)
Notes: China

gansu meheco import & export co.,ltd
Date Published : 12/05/2017
360 Jiayuguan , Lanzhou, Gansu CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/05/2017

Desc: GUI PI WAN
Notes: The product appears to be an unapproved new drug as the product includes claims such as, "… [U]sed for amnesia, insomnia, vertigo, tinnitus, ...hemafecia".

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/05/2017

Desc: KE CHUAN PIAN
Notes: The product appears to be an unapproved new drug as the product includes claims such as; ?Indication; Relieving cough and wheezing. Used for influenza.?

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/05/2017

Desc: JIU ZI HUI CHUN WAN
Notes: The product appears to be an unapproved new drug as the product includes claims such as, "Indication: This formula helps premature ejaculation caused by Kidney Yang deficiency".

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/05/2017

Desc: JIANG YA PIAN
Notes: The product appears to be an unapproved new drug as the product includes claims such as; "Indication; ...Used for...conjunctival congestion and hypertension...".

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/05/2017

Desc: Liu Wei Huang Wan
Notes: The product appears to be an unapproved new drug as the product includes claims such as, "Indication: Used for deficiency of the kidney yin marked by dizziness, tinnitus, ache, fever and diabetes".

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/05/2017

Desc: Gan Bin Zhi Ben Pian (Hepati-Care Tablet)
Notes: The product appears to be an unapproved new drug as the product includes claims such as, "Indication: This formula is designed to help people with Chronic Hepatitis B or C or had Hepatitis, liver cirrhosis and for people who suffer from Liver cancer." "It ... regenerates damaged Liver Cells."

sha 991
Date Published : 12/18/2012
fengyang shiye , xuelei, CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/18/2012

Desc: Unmarked dark and light green capsules
Notes: Sibutramine

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/18/2012

Desc: Extra strength 7 days herbal slim capsules
Notes: Sibutramine

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/18/2012

Desc: Unmarked dark and light green capsules
Notes: Sibutramine

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/18/2012

Desc: Extra strength 7 days herbal slim capsules
Notes: Sibutramine

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 12/18/2012

Desc: Extra strength 7 days herbal slim capsules
Notes: Sibutramine

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 12/18/2012

Desc: Unmarked dark and light green capsules
Notes: Sibutramine


COLOMBIA


C.I. American Bayer
Date Published : 10/02/2013
CALLE 24B #80B-73 , OFICINA 202 , Bogota, Cundinamarca COLOMBIA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2013

Desc: Bronqui Flu Dietary Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/02/2013

Desc: Bronqui Flu Dietary Supplement

C.I. Expotextiles Y Confecciones
Date Published : 09/29/2010
Cra 78f No.0-33 Int. 15 Apto. 302 , Bogota, COLOMBIA
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/29/2010

Desc: Thermoactive Gel-Lipo Illusion
Notes: Colombia

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2010

Desc: Thermoactive Gel-Lipo Illusion
Notes: Colombia

Confecciones Salome Ltda
Date Published : 09/20/2016
Carrera 23D No. 13-37 , Cali, COLOMBIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/20/2016

Desc: Thermo Slim Body Gel (Hot Gel) - Fajas Salome La Original Gel Corporal Caliente

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/20/2016

Desc: Thermo Slim Body Gel (Hot Gel) - Fajas Salome La Original Gel Corporal Caliente

Drogueria Samuel Hahneman Fundacion Palcossio
Date Published : 03/11/2022
Carrera 42 E No 88-20 , Barranquilla, COLOMBIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/11/2022

Notes: Cancer treatment- Product purportedly made from extracts of Turkey Buzzard (Vulture) and reinforced with 333 anticancer plants. 7/31/1992

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 03/11/2022

Notes: Cancer treatment- Product purportedly made from extracts of Turkey Buzzard (Vulture) and reinforced with 333 anticancer plants. 7/31/1992

61 - - - -- Human and Animal Drugs
Date Published: 03/11/2022

Notes: Cancer treatment- Product purportedly made from extracts of Turkey Buzzard (Vulture) and reinforced with 333 anticancer plants. 7/31/1992

62 - - - -- Human and Animal Drugs
Date Published: 03/11/2022

Notes: Cancer treatment- Product purportedly made from extracts of Turkey Buzzard (Vulture) and reinforced with 333 anticancer plants. 7/31/1992

63 - - - -- Human and Animal Drugs
Date Published: 03/11/2022

Notes: Cancer treatment- Product purportedly made from extracts of Turkey Buzzard (Vulture) and reinforced with 333 anticancer plants. 7/31/1992

64 - - - -- Human and Animal Drugs
Date Published: 03/11/2022

Notes: Cancer treatment- Product purportedly made from extracts of Turkey Buzzard (Vulture) and reinforced with 333 anticancer plants. 7/31/1992

65 - - - -- Human and Animal Drugs
Date Published: 03/11/2022

Notes: Cancer treatment- Product purportedly made from extracts of Turkey Buzzard (Vulture) and reinforced with 333 anticancer plants. 7/31/1992

66 - - - -- Human and Animal Drugs
Date Published: 03/11/2022

Notes: Cancer treatment- Product purportedly made from extracts of Turkey Buzzard (Vulture) and reinforced with 333 anticancer plants. 7/31/1992

Laboratories Dermanat S.A.
Date Published : 09/20/2016
Carrera 32 No. 7-19 , Yumbo, Valle COLOMBIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/20/2016

Desc: Thermo Slim Body Gel (Hot Gel) - Fajas Salome La Original Gel Corporal Caliente

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/20/2016

Desc: Thermo Slim Body Gel (Hot Gel) - Fajas Salome La Original Gel Corporal Caliente

Laboratorios Farma Par Sas
Date Published : 01/26/2018
Cra 20 # 70 A-54 , Bogota, COLOMBIA
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 01/26/2018

Desc: DermClarFace
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… [P]rotect it against the impact of free radicals, pollution, tobacco, exposure to the sun. It also helps to reduce the depth of wrinkles and lines of expression and to prevent their formation …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 01/26/2018

Desc: Filler Bust
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: (label) '… Increases the bust area …'; (website) '… [E]nhances bust volume by increasing the adipose tissue in this area …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 01/26/2018

Desc: DD (Daily Defense) Cream
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '… Prevents premature skin aging caused by sun exposure …'; '… Protects the skin after surgery (post-peeling and dermabrasion), hyperchromias (sic) sun protection, and allergic recent scars …'.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 01/26/2018

Desc: Tensioning Solution Sodium Piruvate 1%
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '… Helps reduce flaccidity …'.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 01/26/2018

Desc: Purifying Solution Artichoke Extract
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Purifying with lipodystrophic action …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 01/26/2018

Desc: Natural Reducing Extracts
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Natural adjunctive treatment for obesity …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 01/26/2018

Desc: HydraDerm LW 1%
Notes: The product appears to be an unapproved new drug as the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 01/26/2018

Desc: HydraDerm LW 1%
Notes: The product appears to be an unapproved new drug as the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 01/26/2018

Desc: Filler Bust
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: (label) '… Increases the bust area …'; (website) '… [E]nhances bust volume by increasing the adipose tissue in this area …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 01/26/2018

Desc: Tensioning Solution Sodium Piruvate 1%
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '… Helps reduce flaccidity …'.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 01/26/2018

Desc: DermClarFace
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… [P]rotect it against the impact of free radicals, pollution, tobacco, exposure to the sun. It also helps to reduce the depth of wrinkles and lines of expression and to prevent their formation …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 01/26/2018

Desc: DD (Daily Defense) Cream
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '… Prevents premature skin aging caused by sun exposure …'; '… Protects the skin after surgery (post-peeling and dermabrasion), hyperchromias (sic) sun protection, and allergic recent scars …'.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 01/26/2018

Desc: Natural Reducing Extracts
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Natural adjunctive treatment for obesity …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 01/26/2018

Desc: Purifying Solution Artichoke Extract
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Purifying with lipodystrophic action …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 01/26/2018

Desc: DermClarFace
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… [P]rotect it against the impact of free radicals, pollution, tobacco, exposure to the sun. It also helps to reduce the depth of wrinkles and lines of expression and to prevent their formation …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 01/26/2018

Desc: Purifying Solution Artichoke Extract
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Purifying with lipodystrophic action …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 01/26/2018

Desc: DD (Daily Defense) Cream
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '… Prevents premature skin aging caused by sun exposure …'; '… Protects the skin after surgery (post-peeling and dermabrasion), hyperchromias (sic) sun protection, and allergic recent scars …'.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 01/26/2018

Desc: HydraDerm LW 1%
Notes: The product appears to be an unapproved new drug as the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 01/26/2018

Desc: Filler Bust
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: (label) '… Increases the bust area …'; (website) '… [E]nhances bust volume by increasing the adipose tissue in this area …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 01/26/2018

Desc: Natural Reducing Extracts
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Natural adjunctive treatment for obesity …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 01/26/2018

Desc: Tensioning Solution Sodium Piruvate 1%
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '… Helps reduce flaccidity …'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/26/2018

Desc: Natural Reducing Extracts
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Natural adjunctive treatment for obesity …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/26/2018

Desc: DD (Daily Defense) Cream
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '… Prevents premature skin aging caused by sun exposure …'; '… Protects the skin after surgery (post-peeling and dermabrasion), hyperchromias (sic) sun protection, and allergic recent scars …'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/26/2018

Desc: HydraDerm LW 1%
Notes: The product appears to be an unapproved new drug as the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/26/2018

Desc: Filler Bust
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: (label) '… Increases the bust area …'; (website) '… [E]nhances bust volume by increasing the adipose tissue in this area …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/26/2018

Desc: Purifying Solution Artichoke Extract
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Purifying with lipodystrophic action …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/26/2018

Desc: DermClarFace
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… [P]rotect it against the impact of free radicals, pollution, tobacco, exposure to the sun. It also helps to reduce the depth of wrinkles and lines of expression and to prevent their formation …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/26/2018

Desc: Tensioning Solution Sodium Piruvate 1%
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '… Helps reduce flaccidity …'.

TMCI Ltda
Date Published : 09/30/2011
Unknown , Bogota, COLOMBIA
66 B - - 44 Nicotine Delivery System
Date Published: 09/30/2011

Desc: Electronic cigarette


CONGO, DEM REP OF (KINSHASA)


Angel Cosmetics
Date Published : 02/28/2024
Rue Limitee 17e , Kinshasa, CONGO, DEM REP OF (KINSHASA)
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Caro Light Lightening Beauty Lotion

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Caro Light Lightening Beauty Lotion

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 02/28/2024

Desc: Caro Light Lightening Beauty Lotion

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 02/28/2024

Desc: Caro Light Lightening Beauty Lotion

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 02/28/2024

Desc: Caro Light Lightening Beauty Lotion

63 V - - 99 Depigmentor N.E.C.
Date Published: 02/28/2024

Desc: Caro Light Lightening Beauty Lotion

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/28/2024

Desc: Caro Light Lightening Beauty Lotion


COSTA RICA


Natural Aloe de Costa Rica
Date Published : 12/27/2023
Sur De La Entrada Principal De Liberia 4 Km , Liberia, Guanacaste COSTA RICA
54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued))
Date Published: 12/27/2023

Desc:           AMBROTOSE COMPLEX POWDER

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/27/2023

Desc:           AMBROTOSE COMPLEX POWDER

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/27/2023

Desc:           AMBROTOSE COMPLEX POWDER

Punta International de las Americas SA
Date Published : 09/30/2009
Punta Punta , Costado Este Del Auto Blanco Nacional , San Jose, COSTA RICA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 08/06/2020

Desc: Abarelix
Notes:                   

64 R - - 21 Somatropin (Hormone)
Date Published: 08/06/2020

Notes:                   

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                   


CROATIA


DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o.
Date Published : 02/09/2024
Production site: Sveta Nedjelja , Headquarters: Vijenac Frane Gotovca 8 , Zagreb-slobostina, Grad Zagreb CROATIA
25 S - - 01 Mushroom, Common (Agaricus Bisporus), Fungi Products, N.E.C.
Date Published: 02/09/2024

Desc: LENTIFORM DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

25 S - - 01 Mushroom, Common (Agaricus Bisporus), Fungi Products, N.E.C.
Date Published: 02/09/2024

Desc: AGARIKON PLUS DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

25 S - - 01 Mushroom, Common (Agaricus Bisporus), Fungi Products, N.E.C.
Date Published: 02/09/2024

Desc: AGARIKON 1 DIETARY SUPPLEMENT 100% PURE MUSHROOM
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/09/2024

Desc: AGARIKON PLUS DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/09/2024

Desc: LENTIFORM DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/09/2024

Desc: AGARIKON 1 DIETARY SUPPLEMENT 100% PURE MUSHROOM
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/09/2024

Desc: AGARIKON 1 DIETARY SUPPLEMENT 100% PURE MUSHROOM
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/09/2024

Desc: AGARIKON PLUS DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/09/2024

Desc: LENTIFORM DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

66 - - - -- Human and Animal Drugs
Date Published: 02/09/2024

Desc: AGARIKON 1 DIETARY SUPPLEMENT 100% PURE MUSHROOM
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

66 - - - -- Human and Animal Drugs
Date Published: 02/09/2024

Desc: AGARIKON PLUS DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

66 - - - -- Human and Animal Drugs
Date Published: 02/09/2024

Desc: LENTIFORM DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

JGL d.d.
Date Published : 01/12/2015
Svilno 20 , Rijeka, Primorsko-goranska CROATIA
62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 01/12/2015

Desc: Aqua Maris Nasal Spray
Notes: Problem(s); The product?s label makes moisturizing claims related to structure/function or disease conditions but without an approved NDA for the claims.

Myko San
Date Published : 02/09/2024
Miramarska Cesta 109/1000 , Zagreb, Grad Zagreb CROATIA
25 S - - 01 Mushroom, Common (Agaricus Bisporus), Fungi Products, N.E.C.
Date Published: 02/09/2024

Desc: AGARIKON 1 DIETARY SUPPLEMENT 100% PURE MUSHROOM
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

25 S - - 01 Mushroom, Common (Agaricus Bisporus), Fungi Products, N.E.C.
Date Published: 02/09/2024

Desc: AGARIKON PLUS DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

25 S - - 01 Mushroom, Common (Agaricus Bisporus), Fungi Products, N.E.C.
Date Published: 02/09/2024

Desc: LENTIFORM DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/09/2024

Desc: AGARIKON PLUS DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/09/2024

Desc: LENTIFORM DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/09/2024

Desc: AGARIKON 1 DIETARY SUPPLEMENT 100% PURE MUSHROOM
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/09/2024

Desc: LENTIFORM DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/09/2024

Desc: AGARIKON PLUS DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/09/2024

Desc: AGARIKON 1 DIETARY SUPPLEMENT 100% PURE MUSHROOM
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

66 - - - -- Human and Animal Drugs
Date Published: 02/09/2024

Desc: AGARIKON PLUS DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

66 - - - -- Human and Animal Drugs
Date Published: 02/09/2024

Desc: AGARIKON 1 DIETARY SUPPLEMENT 100% PURE MUSHROOM
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

66 - - - -- Human and Animal Drugs
Date Published: 02/09/2024

Desc: LENTIFORM DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT
Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.


CURACAO


Curacao Ecocity Projects N.V.
Date Published : 08/13/2021
Aloe Vera Plantation , Kaminda Mitologia 138 , Willemstad, CURACAO
54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued))
Date Published: 08/13/2021

Desc: Herbal Supplement for Digestive System Support
Notes: The product label makes claims such as (not an all-inclusive list): ‘Helps relieve Irritable Bowel Syndrome (IBS) symptoms” and “helps relieve upset stomach”

54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued))
Date Published: 08/13/2021

Desc: Herbal Supplement for Diabetic Support
Notes: The product label makes claims such as (not an all- inclusive list): “HERBAL SUPPLEMENT FOR DIABETIC SUPPORT” and “helps maintain a healthy blood sugar level.”

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/13/2021

Desc: Herbal Supplement for Diabetic Support
Notes: The product label makes claims such as (not an all- inclusive list): “HERBAL SUPPLEMENT FOR DIABETIC SUPPORT” and “helps maintain a healthy blood sugar level.”

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/13/2021

Desc: Herbal Supplement for Digestive System Support
Notes: The product label makes claims such as (not an all-inclusive list): ‘Helps relieve Irritable Bowel Syndrome (IBS) symptoms” and “helps relieve upset stomach”


CYPRUS


Horphag Research (Europe) Ltd
Date Published : 12/13/2017
Karaiskaki 38, Kanika Alexander Court , 1st Floor, Office 113 CD , Lemesos, Lemesos CYPRUS
54 A - - 99 Vitamin, N.E.C.
Date Published: 12/13/2017

Desc: PRELOX DIETARY SUPPLEMENT
Notes: Medical claims made on product website

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/13/2017

Desc: PRELOX DIETARY SUPPLEMENT
Notes: Medical claims made on product website

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 12/13/2017

Desc: PRELOX DIETARY SUPPLEMENT
Notes: Medical claims made on product website

Pelikon Investments Limited
Date Published : 07/30/2019
Peter Kraus, Mykinon , Nicosia No. 1065, CYPRUS
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 07/30/2019

Desc: Abarelix
Notes:                            

64 R - - 21 Somatropin (Hormone)
Date Published: 10/07/2020

Notes:                            

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 10/07/2020

Notes:                            


CZECH REPUBLIC


A. Werner & Co.
Date Published : 09/30/2009
P.O. Box 615 , Prague, CZECH REPUBLIC
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: 9/23/1993

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Botanicus, Spol S.R.O.
Date Published : 04/11/2014
Ostra 8 289 22 Lysa , Nad Labem, CZECH REPUBLIC
53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations)
Date Published: 04/11/2014

Desc: Calendula Treatment Cream
Notes: Problem -- Unapproved New Drug

53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations)
Date Published: 04/11/2014

Desc: Facial Regeneration Oil with Neroli Flower
Notes: Problem -- Unapproved New Drug

53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations)
Date Published: 04/11/2014

Desc: Patchouli Hand Cream
Notes: Problem -- Unapproved New Drug

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/11/2014

Desc: Facial Regeneration Oil with Neroli Flower
Notes: Problem -- Unapproved New Drug

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/11/2014

Desc: Patchouli Hand Cream
Notes: Problem -- Unapproved New Drug

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/11/2014

Desc: Calendula Treatment Cream
Notes: Problem -- Unapproved New Drug

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 04/11/2014

Desc: Calendula Treatment Cream
Notes: Problem -- Unapproved New Drug

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 04/11/2014

Desc: Facial Regeneration Oil with Neroli Flower
Notes: Problem -- Unapproved New Drug

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 04/11/2014

Desc: Patchouli Hand Cream
Notes: Problem -- Unapproved New Drug

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/11/2014

Desc: Calendula Treatment Cream
Notes: Problem -- Unapproved New Drug

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/11/2014

Desc: Patchouli Hand Cream
Notes: Problem -- Unapproved New Drug

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/11/2014

Desc: Facial Regeneration Oil with Neroli Flower
Notes: Problem -- Unapproved New Drug

Contipro a.s.
Date Published : 08/11/2010
Dolni Dobrouc 401 , Dolni Dobrouc, CZECH REPUBLIC
78 M - - RE Solution, Sodium Hyaluronate
Date Published: 08/11/2010

Desc: Hyiodine
Notes: Product is a Sodium Hyaluronate solution containing Iodine; Czech Republic

Labora S.R.O.
Date Published : 08/13/2013
Dobra Voda 20 , U TOUZIME , Tepla, CZECH REPUBLIC
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 08/13/2013

Desc: Fresh Elixir Ancienne
Notes: drug claims found on package labeling and consignee website

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 08/13/2013

Desc: Fresh Creme Ancienne
Notes: drug claims found on package labeling and consignee website

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 08/13/2013

Desc: Fresh Creme Ancienne
Notes: drug claims found on package labeling and consignee website

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 08/13/2013

Desc: Fresh Elixir Ancienne
Notes: drug claims found on package labeling and consignee website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/13/2013

Desc: Fresh Elixir Ancienne
Notes: drug claims found on package labeling and consignee website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/13/2013

Desc: Fresh Creme Ancienne
Notes: drug claims found on package labeling and consignee website


DENMARK


3 A Pharmacy.com & 3 Amed
Date Published : 09/30/2009
Jakob Neubert , Aginavej 5 , Copenhagen s, DENMARK
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                  

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Panacea International Ltd. (Pharmanabolics.com)
Date Published : 09/30/2009
Copthall, P.B. Box 2331 , Roseau, DENMARK
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                         ; Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril. 5/19/2005

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                         ; Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril. 5/19/2005

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                         ; Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril. 5/19/2005

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                         ; Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril. 5/19/2005

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                         ; Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril. 5/19/2005

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                         ; Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril. 5/19/2005

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                         ; Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril. 5/19/2005

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                         ; Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril. 5/19/2005

Plum A/S
Date Published : 08/05/2015
Frederik Plums Vej 2 , Assens, DENMARK
64 W - - 99 Irrigation Solution N.E.C.
Date Published: 08/05/2015

Desc: Plum Eyewash

65 F - - 06 Water, Purified (Eyewash)
Date Published: 08/05/2015

Desc: Plum Eyewash


DOMINICA


Dominicana Coconut Products
Date Published : 07/06/2010
Belfast Main Road , Mahaut, DOMINICA
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 07/06/2010

Desc: Carib Germicidal Soap
Notes: Dominica

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 07/06/2010

Desc: Carib Germicidal Soap
Notes: Dominica

Pharmacy International
Date Published : 09/30/2009
61 King George , Roseau, DOMINICA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 06/15/2020

Desc: Abarelix
Notes:                            

64 R - - 21 Somatropin (Hormone)
Date Published: 06/15/2020

Notes:                            

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                              

Pharmacy-Network and/or Noprescriptiondrugs.com
Date Published : 09/30/2009
Azenith International LLC , Copthall PO BOX 2331 , Roseau, St. George, DOMINICA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/30/2019

Notes: All drugs. GPI = DR.                                                          These two firms are operating under the same firm address and two different websites.;Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril.; 5/19/2005

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 07/30/2019

Notes: All drugs. GPI = DR.                                                          These two firms are operating under the same firm address and two different websites.;Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril.; 5/19/2005

61 - - - -- Human and Animal Drugs
Date Published: 07/30/2019

Notes: All drugs. GPI = DR.                                                          These two firms are operating under the same firm address and two different websites.;Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril.; 5/19/2005

62 - - - -- Human and Animal Drugs
Date Published: 07/30/2019

Notes: All drugs. GPI = DR.                                                          These two firms are operating under the same firm address and two different websites.;Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril.; 5/19/2005

63 - - - -- Human and Animal Drugs
Date Published: 07/30/2019

Notes: All drugs. GPI = DR.                                                          These two firms are operating under the same firm address and two different websites.;Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril.; 5/19/2005

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                                                        

64 - - - -- Human and Animal Drugs
Date Published: 07/30/2019

Notes: All drugs. GPI = DR.                                                          These two firms are operating under the same firm address and two different websites.;Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril.; 5/19/2005

65 - - - -- Human and Animal Drugs
Date Published: 07/30/2019

Notes: All drugs. GPI = DR.                                                          These two firms are operating under the same firm address and two different websites.;Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril.; 5/19/2005

66 - - - -- Human and Animal Drugs
Date Published: 07/30/2019

Notes: All drugs. GPI = DR.                                                          These two firms are operating under the same firm address and two different websites.;Background: The following websites have been found to be selling the Risk Management Distribution Drugs (RM-D)drugs Isotretinoin, Humatrope, and/or Clozaril.; 5/19/2005


DOMINICAN REPUBLIC (THE)


Alopecil Corporation, S.R.L.
Date Published : 07/19/2013
Haina, D.N. , Autopista 30 De Mayo No. 111 , Santo Domingo Oeste, Santo Domingo DOMINICAN REPUBLIC (THE)
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/19/2013

Desc: Cleopatra Slendering Cream

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/19/2013

Desc: Cleopatra Slendering Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/19/2013

Desc: Cleopatra Slendering Cream

Boe Dominicana C X A
Date Published : 04/04/2012
Aut Duarte Km 13 , Santo Domingo De Guzman, Distrito Nacional DOMINICAN REPUBLIC (THE)
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 04/18/2023

Desc: Ligao de Leche Suplemento Capilar

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 04/04/2012

Desc: Hair Rinse Crece Pelo
Notes: Dominican Republic

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 07/25/2013

Desc: Shampoo Crecepelo

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 04/18/2023

Desc: Ligao de Leche Suplemento Capilar

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 07/25/2013

Desc: Shampoo Crecepelo

53 E - - -- Hair Preps(Non-Coloring)
Date Published: 01/25/2023

Desc: Ligao De Leche Barniz Capilar

53 E - - -- Hair Preps(Non-Coloring)
Date Published: 01/25/2023

Desc: Ligao De Leche Mascarilla Acondicionadora

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2023

Desc: Ligao De Leche Barniz Capilar

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2023

Desc: Ligao De Leche Mascarilla Acondicionadora

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/18/2023

Desc: Ligao de Leche Suplemento Capilar

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/25/2013

Desc: Shampoo Crecepelo

Boe Dominicana SRL
Date Published : 06/05/2013
Carretera De Cueta Km 2 , Villa Mella, Santo Domingo, Distrito Nacional DOMINICAN REPUBLIC (THE)
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 04/18/2023

Desc: Ligao de Leche Suplemento Capilar

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 04/18/2023

Desc: Ligao de Leche Suplemento Capilar

53 E - - -- Hair Preps(Non-Coloring)
Date Published: 01/25/2023

Desc: Ligao De Leche Barniz Capilar

53 E - - -- Hair Preps(Non-Coloring)
Date Published: 01/25/2023

Desc: Ligao De Leche Mascarilla Acondicionadora

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 06/05/2013

Desc: Adelgaze Crema Termoactiva Thermoactive Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2023

Desc: Ligao De Leche Barniz Capilar

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2023

Desc: Ligao De Leche Mascarilla Acondicionadora

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/05/2013

Desc: Adelgaze Crema Termoactiva Thermoactive Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/18/2023

Desc: Ligao de Leche Suplemento Capilar

CASA EL ORIENTAL DE FERMIN FONG
Date Published : 05/24/2010
UNKNOWN , DOMINICAN REPUBLIC, DOMINICAN REPUBLIC (THE)
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 05/24/2010

Desc: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal
Notes: Dominican Republic

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal

61 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal

62 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal

63 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal

64 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal

65 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal

66 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal

Compound Brothers Dominicana CBD,
Date Published : 08/11/2014
Autopista Las Americas Km 27 1/2 , La Caleta , Boca Chica, DO-32 DOMINICAN REPUBLIC (THE)
54 A - - 05 Vitamin B12 (Cyanocobalamin)
Date Published: 08/12/2014

Desc: MIC with Cyanocobalamin Injection

54 A - - 05 Vitamin B12 (Cyanocobalamin)
Date Published: 08/12/2014

Desc: Vitamin B12 Methylcobalamin Injection

54 A - - 05 Vitamin B12 (Cyanocobalamin)
Date Published: 08/12/2014

Desc: Super MIC Injection (MIC with Vitamin B Complex and L-Carnitine)

54 A - - 05 Vitamin B12 (Cyanocobalamin)
Date Published: 08/12/2014

Desc: Injectable solution amber vial (Vitamin B-12 vials)

54 A - - 11 Hydroxocobalamin (Vitamin)
Date Published: 08/12/2014

Desc: Hydroxocobalamin Injection

54 A - - 99 Vitamin, N.E.C.
Date Published: 08/12/2014

Desc: Super MIC Injection (MIC with Vitamin B Complex and L-Carnitine)

54 A - - 99 Vitamin, N.E.C.
Date Published: 08/12/2014

Desc: Arginine Hydrochloride Injection

54 A - - 99 Vitamin, N.E.C.
Date Published: 08/12/2014

Desc: MIC with Cyanocobalamin Injection

54 A - - 99 Vitamin, N.E.C.
Date Published: 08/12/2014

Desc: Methylcobalamin Injection

54 A - - 99 Vitamin, N.E.C.
Date Published: 08/12/2014

Desc: Hydroxocobalamin Injection

54 A - - 99 Vitamin, N.E.C.
Date Published: 08/12/2014

Desc: Vitamin B12 Methylcobalamin Injection

54 A - - 99 Vitamin, N.E.C.
Date Published: 08/12/2014

Desc: L-Carnitine Injection

54 A - - 99 Vitamin, N.E.C.
Date Published: 08/12/2014

Desc: Glutathione Injection

54 A - - 99 Vitamin, N.E.C.
Date Published: 08/12/2014

Desc: MIC with Methylcobalamin Injection

54 A - - 99 Vitamin, N.E.C.
Date Published: 08/12/2014

Desc: Tri-Amino Injection 300 mg/mL

54 A - - 99 Vitamin, N.E.C.
Date Published: 08/12/2014

Desc: MIC Injection

54 A - - 99 Vitamin, N.E.C.
Date Published: 08/12/2014

Desc: G.A.C. 375 Injection USP

54 A - - 99 Vitamin, N.E.C.
Date Published: 08/12/2014

Desc: Injectable solution amber vial (Vitamin B-12 vials)

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/11/2014

Notes: All drug products within GPI=DR, VI, & AB are subject to DWPE according to this alert, including injectable vitamins.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/11/2014

Notes: All drug products within GPI=DR, VI, & AB are subject to DWPE according to this alert, including injectable vitamins.

56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/11/2014

Notes: All drug products within GPI=DR, VI, & AB are subject to DWPE according to this alert, including injectable vitamins.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 J - - 02 Arginine HCl (Ammonia Detoxicant)
Date Published: 08/12/2014

Desc: Arginine Hydrochloride Injection

60 - - - -- Human and Animal Drugs
Date Published: 08/11/2014

Notes: All drug products within GPI=DR, VI, & AB are subject to DWPE according to this alert, including injectable vitamins.

61 - - - -- Human and Animal Drugs
Date Published: 08/11/2014

Notes: All drug products within GPI=DR, VI, & AB are subject to DWPE according to this alert, including injectable vitamins.

62 - - - -- Human and Animal Drugs
Date Published: 08/11/2014

Notes: All drug products within GPI=DR, VI, & AB are subject to DWPE according to this alert, including injectable vitamins.

63 - - - -- Human and Animal Drugs
Date Published: 08/11/2014

Notes: All drug products within GPI=DR, VI, & AB are subject to DWPE according to this alert, including injectable vitamins.

64 - - - -- Human and Animal Drugs
Date Published: 08/11/2014

Notes: All drug products within GPI=DR, VI, & AB are subject to DWPE according to this alert, including injectable vitamins.

65 C - - 07 Levocarnitine (Nutrient/Tonic)
Date Published: 08/12/2014

Desc: Super MIC Injection (MIC with Vitamin B Complex and L-Carnitine)

65 C - - 07 Levocarnitine (Nutrient/Tonic)
Date Published: 08/12/2014

Desc: L-Carnitine Injection

65 - - - -- Human and Animal Drugs
Date Published: 08/11/2014

Notes: All drug products within GPI=DR, VI, & AB are subject to DWPE according to this alert, including injectable vitamins.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/12/2014

Desc: Tri-Amino Injection 300 mg/mL

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/12/2014

Desc: MIC with Cyanocobalamin Injection

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/12/2014

Desc: L-Carnitine Injection

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/12/2014

Desc: Glutathione Injection

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/12/2014

Desc: Arginine Hydrochloride Injection

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/12/2014

Desc: Injectable solution amber vial (Vitamin B-12 vials)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/12/2014

Desc: G.A.C. 375 Injection USP

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/12/2014

Desc: Methylcobalamin Injection

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/12/2014

Desc: Super MIC Injection (MIC with Vitamin B Complex and L-Carnitine)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/12/2014

Desc: Hydroxocobalamin Injection

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/12/2014

Desc: Vitamin B12 Methylcobalamin Injection

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/12/2014

Desc: MIC Injection

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/12/2014

Desc: MIC with Methylcobalamin Injection

66 - - - -- Human and Animal Drugs
Date Published: 08/11/2014

Notes: All drug products within GPI=DR, VI, & AB are subject to DWPE according to this alert, including injectable vitamins.

Distribuidora Comercial La Familia, Eirl
Date Published : 07/25/2013
Vil C Juan E Jimenez 134 , Santo Domingo, D.n., Distrito Nacional DOMINICAN REPUBLIC (THE)
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 07/25/2013

Desc: Shampoo Crecepelo

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 07/25/2013

Desc: Shampoo Crecepelo

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/25/2013

Desc: Shampoo Crecepelo

Laboratorio Internacional Magnac
Date Published : 01/14/2010
Ave Jose Francisco Pena Gomez , Haina San Crist, DOMINICAN REPUBLIC (THE)
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/14/2010

Notes: Bisolbom Adult Bisolbom Children Country: Dominican Republic

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Bisolbom Adult Bisolbom Children Country: Dominican Republic

61 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Bisolbom Adult Bisolbom Children Country: Dominican Republic

62 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Bisolbom Adult Bisolbom Children Country: Dominican Republic

63 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Bisolbom Adult Bisolbom Children Country: Dominican Republic

64 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Bisolbom Adult Bisolbom Children Country: Dominican Republic

65 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Bisolbom Adult Bisolbom Children Country: Dominican Republic

66 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Bisolbom Adult Bisolbom Children Country: Dominican Republic

Laboratorio Magnachem International, S.A.
Date Published : 01/14/2010
Esq Calle K , Ave Jose Francisco Pena Gomez , Haina, DOMINICAN REPUBLIC (THE)
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/14/2010

Notes: Bisolbom Adult Bisolbom Children Country: Dominican Republic

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Bisolbom Adult Bisolbom Children Country: Dominican Republic

61 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Bisolbom Adult Bisolbom Children Country: Dominican Republic

62 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Bisolbom Adult Bisolbom Children Country: Dominican Republic

63 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Bisolbom Adult Bisolbom Children Country: Dominican Republic

64 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Bisolbom Adult Bisolbom Children Country: Dominican Republic

65 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Bisolbom Adult Bisolbom Children Country: Dominican Republic

66 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Bisolbom Adult Bisolbom Children Country: Dominican Republic

Laboratorios Alfa, SRL (Plant)
Date Published : 06/28/2022
La Isabela Highway, Km 14 , Duarte Highway , Pantoja, Santo Domingo DOMINICAN REPUBLIC (THE)
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 06/28/2022

Desc: Resfridol
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘ANTI-FLU’; ‘Nasal congestion’; ‘Headaches’; ‘Fever’; ‘Sneezing and tearing’.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/28/2022

Desc: Resfridol
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘ANTI-FLU’; ‘Nasal congestion’; ‘Headaches’; ‘Fever’; ‘Sneezing and tearing’.

60 L - - -- Analgesic
Date Published: 06/28/2022

Desc: Resfridol
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘ANTI-FLU’; ‘Nasal congestion’; ‘Headaches’; ‘Fever’; ‘Sneezing and tearing’.

61 X - - -- A-Histaminic
Date Published: 06/28/2022

Desc: Resfridol
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘ANTI-FLU’; ‘Nasal congestion’; ‘Headaches’; ‘Fever’; ‘Sneezing and tearing’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/28/2022

Desc: Resfridol
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘ANTI-FLU’; ‘Nasal congestion’; ‘Headaches’; ‘Fever’; ‘Sneezing and tearing’.

Laboratorios Dr. Collado S.A.
Date Published : 04/07/2020
Parque Industrial Duarte Km 22 1/2 , Autopista Duarte , Santo Domingo Norte, Santo Domingo DOMINICAN REPUBLIC (THE)
55 Q - - 98 Sodium Lauryl Sulfate (Pharmaceutic Necessity - Surfactant)
Date Published: 04/07/2020

Desc: Borasol Liquid Antiseptic

Laboratorios Dr. Collado S.A.
Date Published : 09/04/2013
Parque Industrial Duarte Km 22 1/2 , Autopista Duarte , Santo Domingo Norte, Santo Domingo DOMINICAN REPUBLIC (THE)
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/04/2013

Desc: Body cream locion panicida

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/04/2013

Desc: Body cream locion panicida

Laboratorios Key C Por A
Date Published : 05/06/2014
Calle Central No. 3 , Zona Industrial de Herrera , Santo Domingo, DOMINICAN REPUBLIC (THE)
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/06/2014

Desc: Sana Kriss Endurecedor de Unas

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 05/06/2014

Desc: Sana Kriss Endurecedor de Unas

Laboratorios Mk, Sa
Date Published : 02/19/2014
Calle 21 Nave. 8 Zona Ind. , Santo Domingo, DOMINICAN REPUBLIC (THE)
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 02/19/2014

Desc: Vitaly Adjuvant Anti-Hair Loss Mini Vial-Droppers

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 02/19/2014

Desc: Vitaly Adjuvant Anti Hair Loss

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 02/19/2014

Desc: Vitaly Adjuvant Hair Growth Drops

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 02/19/2014

Desc: Vitaly Adjuvant Hair Growth Mini Vial-Droppers

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 02/19/2014

Desc: Vitaly Anti-Dandruff Drops

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 02/19/2014

Desc: Vitaly Shampoo Adjuvant Anti-Hair Loss

Laboratorios Roldan S.A.
Date Published : 06/06/2013
Carretera Sanchez Av Independencia, KM 5 , Santo Domingo, DOMINICAN REPUBLIC (THE)
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 10/20/2021

Desc: Antimicrobial Soap; Jabon Germicida Roldan
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “effective for the elimination of germs that affect the skin” and “has an antiseptic and antipruritic action”.                                                                                               

60 L - - 07 Camphorated Oil
Date Published: 10/04/2013

Desc: ?Mento-Dol Forte? Ointment

60 L - - 07 Camphorated Oil
Date Published: 06/06/2013

Desc: Methodol Spray Analgesic Anti-inflammatory Anti-rheumatic

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 10/20/2021

Desc: Antimicrobial Soap; Jabon Germicida Roldan
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “effective for the elimination of germs that affect the skin” and “has an antiseptic and antipruritic action”.                                                                                               

62 M - - 09 Liquid Phenol (Anti-Pruritic)
Date Published: 10/20/2021

Desc: Antimicrobial Soap; Jabon Germicida Roldan
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “effective for the elimination of germs that affect the skin” and “has an antiseptic and antipruritic action”.                                                                                               

64 A - - 20 Triclosan (Disinfectant)
Date Published: 10/20/2021

Desc: Antimicrobial Soap; Jabon Germicida Roldan
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “effective for the elimination of germs that affect the skin” and “has an antiseptic and antipruritic action”.                                                                                               

65 L - - 11 Titanium Dioxide (Protectant)
Date Published: 10/20/2021

Desc: Antimicrobial Soap; Jabon Germicida Roldan
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “effective for the elimination of germs that affect the skin” and “has an antiseptic and antipruritic action”.                                                                                               

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/20/2021

Desc: Antimicrobial Soap; Jabon Germicida Roldan
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “effective for the elimination of germs that affect the skin” and “has an antiseptic and antipruritic action”.                                                                                               

Nifarmed S.A.
Date Published : 04/07/2020
Av. Palacio De Los Deportes No. 71 El Millon , Santo Domingo De Guzman, DOMINICAN REPUBLIC (THE)
56 B - - 03 Amoxicillin Trihydrate (Penicillin, Synthetically Produced)
Date Published: 04/07/2020

Desc: Amoxicilina Capsules

Quantrol Research Institute
Date Published : 09/30/2009
Ave. Sarasota Edificio , Embajador Edif. E, 8-I , Santo Domingo, DOMINICAN REPUBLIC (THE)
62 I - - 99 Anti-Neoplastic N.E.C.
Date Published: 09/30/2009

Notes: Quantrol I or Quantrol II or CanCell (May be invoiced as water) 12/12/1995 AKA Quantrol Agency or Quantum Research

R.L.M. Suministros Medicos
Date Published : 04/23/2020
Calle Socorro Sanchez No. 56 , Sector Gazcue , Santo Domingo, DOMINICAN REPUBLIC (THE)
53 - - - -- Cosmetics
Date Published: 04/23/2020

Desc: Botulinum Toxin Types A & B

65 Q - - 02 Botox
Date Published: 04/24/2020

Desc: Botulinum Toxin Types A & B

65 Q - - 07 Myobloc
Date Published: 04/24/2020

Desc: Botulinum Toxin Types A & B

Rey Fruit S R L
Date Published : 03/10/2016
Zona Franca Puerto Plata Nave A-7 , Puerto Plata, Zona Franpuerto Plata, Zon, DOMINICAN REPUBLIC (THE)
54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd
Date Published: 03/10/2016

Desc: Capsules of Moringa's Seeds
Notes: Product's label makes drug claims

54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd
Date Published: 03/10/2016

Desc: Capsules of Moringa's Leaves
Notes: Product's label makes drug claims

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/10/2016

Desc: Capsules of Moringa's Seeds
Notes: Product's label makes drug claims

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/10/2016

Desc: Capsules of Moringa's Leaves
Notes: Product's label makes drug claims


EGYPT


El Captain Co. For Extracting Natural Oils & Cosmetics
Date Published : 10/06/2016
1st Industrial Zone , Obour, Cairo EGYPT
53 L - - 11 Argan Oil
Date Published: 10/06/2016

Desc: Nigella Sativa (Virgin Black Seed Oil)
Notes: Medical claims on product labels

54 F - - 04 Camomille (Herbal & Botanicals, not Teas)
Date Published: 10/06/2016

Desc: Camomile Oil
Notes: Medical claims on product labels

54 F - - 10 Garlic (Herbal & Botanicals, not Teas)
Date Published: 10/06/2016

Desc: Garlic Oil
Notes: Medical claims on product labels

54 F - - 20 Mint (Herbal & Botanicals, not Teas - if tea form see 31P)
Date Published: 10/06/2016

Desc: Mint Oil
Notes: Medical claims on product labels

55 R - - 65 Sesame Oil (Pharmaceutic Necessity - Vehicle)
Date Published: 10/06/2016

Desc: Sesame Oil
Notes: Medical claims on product labels

63 H - - 08 Castor Oil (Cathartic)
Date Published: 10/06/2016

Desc: Castor Oil
Notes: Medical claims on product labels

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 10/06/2016

Desc: Castor Oil
Notes: Medical claims on product labels

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 10/06/2016

Desc: Camomile Oil
Notes: Medical claims on product labels

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 10/06/2016

Desc: Nigella Sativa (Virgin Black Seed Oil)
Notes: Medical claims on product labels

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 10/06/2016

Desc: Sesame Oil
Notes: Medical claims on product labels

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 10/06/2016

Desc: Garlic Oil
Notes: Medical claims on product labels

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 10/06/2016

Desc: Mint Oil
Notes: Medical claims on product labels


EL SALVADOR


Biokemical, S.A. de C.V
Date Published : 05/19/2011
Calle Alberto Masferrer No 174-A , Autopista Comalapa Kilometro 17 1/2 , Santo Tomas, San Salvador EL SALVADOR
54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 05/19/2011

Desc: Foskrol High Potency Nutritional Supplement
Notes: El Salvador

54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 10/10/2019

Desc: Foskrol Escolar Nutritional Supplements
Notes: El Salvador; 05/17/2011

54 A - - 99 Vitamin, N.E.C.
Date Published: 10/10/2019

Desc: Foskrol Escolar Nutritional Supplements
Notes: El Salvador; 05/17/2011

54 A - - 99 Vitamin, N.E.C.
Date Published: 05/19/2011

Desc: Foskrol High Potency Nutritional Supplement
Notes: El Salvador

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/19/2011

Desc: Foskrol High Potency Nutritional Supplement
Notes: El Salvador

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/10/2019

Desc: Foskrol Escolar Nutritional Supplements
Notes: El Salvador; 05/17/2011

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/10/2019

Desc: Foskrol Escolar Nutritional Supplements
Notes: El Salvador; 05/17/2011

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/19/2011

Desc: Foskrol High Potency Nutritional Supplement
Notes: El Salvador

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/19/2011

Desc: Foskrol High Potency Nutritional Supplement
Notes: El Salvador

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/19/2011

Desc: Foskrol Escolar Nutritional Supplement
Notes: El Salvador

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 10/10/2019

Desc: Neurosex Forte
Notes: El Salvador; 10/14/2010

Compania Farmaceutica, S.A. de C.V.
Date Published : 03/31/2017
Final Av. Melvin Jones , 12 Calle Ote. No. 20 Col. Utila , Santa Tecla, La Libertad EL SALVADOR
65 L - - 99 Protectant N.E.C.
Date Published: 03/31/2017

Desc: Suaviderm Crema (Suaviderm Diaper Rash Cream)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/31/2017

Desc: Suaviderm Crema (Suaviderm Diaper Rash Cream)

Establecimientos Ancalmo S.A. de C.V.
Date Published : 06/16/2015
Boulevard Walter Deininger , Colonia la Sultana , Antiguo Cuscatlan, La Libertad EL SALVADOR
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/16/2015

Desc: ZORRITONE CARAMELS

Koret S. A. de C. V.
Date Published : 09/03/2010
Km 12.5 Carretera A Comalapa , San Marcos, San Salvador EL SALVADOR
54 A - - -- Vitamin
Date Published: 09/13/2017

Desc: Glotolin Syrup

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/03/2010

Desc: Ferricalon Jarabe Syrup
Notes: El Salvador; Associated FEI #3007242312; FEI #3006847934; FEI #3007837398; FEI #3006847934;FEI #3003854115

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/03/2010

Desc: Ferricalon Jarabe Syrup
Notes: El Salvador; Associated FEI #3007242312; FEI 3006847934; FEI 3007837398;FEI #3006847934;FEI #3003854115

61 X - - 14 Cyproheptadine HCl (Anti-Histaminic)
Date Published: 09/13/2017

Desc: Glotolin Syrup

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/13/2017

Desc: Glotolin Syrup

LABORATORIOS FARMACEUTICOS ENMILEN
Date Published : 02/07/2011
11 Calle Poniente Blocka#11 , Residencia Los Cipreses , Santa Tecla, La Libertad EL SALVADOR
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/07/2011

Desc: Neuro-Cebral
Notes: El Salvador

Laboratorios Combisa S.A. de C.V.
Date Published : 02/14/2012
Highway to San Marcos N 428 , San Marcos City, El Salvador EL SALVADOR
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/14/2012

Desc: Prolife Dietary Supplement
Notes: El Salvador

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/14/2012

Desc: Prolife Dietary Supplement
Notes: El Salvador

Laboratorios Vidos
Date Published : 09/03/2010
Unknown , Unknown, EL SALVADOR
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/03/2010

Desc: Ferricalon Jarabe Syrup
Notes: El Salvador

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/03/2010

Desc: Ferricalon Jarabe Syrup
Notes: El Salvador

Laboratorios Vijosa, S.A. de C.V.
Date Published : 02/07/2011
Zona Industrial Merliot , Calle L-3 No. 10 , Antiguo Cuscatlan, La Libertad EL SALVADOR
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/07/2011

Desc: Ferridoce
Notes: El Salvador

Procaps S.A. de C.V.
Date Published : 02/07/2011
Boulevard Of The National Army, Km 5 1/2 , Soyapango, San Salvador EL SALVADOR
56 K - - 10 Chloramphenicol
Date Published: 01/17/2013

Desc: Intestinomicina Suspension and Tablets

56 K - - 11 Chloramphenicol Palmitate
Date Published: 01/17/2013

Desc: Intestinomicina Suspension and Tablets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/07/2011

Desc: Baczol Anti-Flu
Notes: El Salvador

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/17/2013

Desc: Intestinomicina Suspension and Tablets

drogueria saimed, S.A de C.V. de El Salvador
Date Published : 06/30/2014
Unknown , Unknown, UNKNOWN EL SALVADOR
56 B - - 03 Amoxicillin Trihydrate (Penicillin, Synthetically Produced)
Date Published: 03/25/2015

Desc: Amoxicilina 500 mg capsulas
Notes: OAISS declared Mfg is drogueria saimed; El Salvador. MFg. indicated on product label is drogueria saimed; El Salvador and Caplin Point Laboratories Ltd; India.
Problems: AMOXICILLIN;

61 W - - 45 Fluconazole (Anti-Fungal) (Not Antibiotic)
Date Published: 06/30/2014

Desc: Fluconazol Capsulas

laboratorio Butter Pharma
Date Published : 09/13/2017
Carretera Comalapa Km 12 1/2 , San Marcos, EL SALVADOR
54 A - - -- Vitamin
Date Published: 09/13/2017

Desc: Glotolin Syrup

61 X - - 14 Cyproheptadine HCl (Anti-Histaminic)
Date Published: 09/13/2017

Desc: Glotolin Syrup

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/13/2017

Desc: Glotolin Syrup


FIJI


Ocean Soaps Limited
Date Published : 02/01/2018
41-45 Sautamata Street , Lautoka, FIJI
53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 02/01/2018

Desc: Natural Coconut Oil Tiare Infusion

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 02/01/2018

Desc: Natural Coconut Oil Tiare Infusion

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 02/01/2018

Desc: Natural Coconut Oil Tiare Infusion

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 02/01/2018

Desc: Natural Coconut Oil Tiare Infusion

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/01/2018

Desc: Natural Coconut Oil Tiare Infusion


FINLAND


Oy Gustav Paulig Ab
Date Published : 02/07/2011
Leikosaarentie 32 , Helsinki, FINLAND
65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 02/07/2011

Desc: Full Contact for Men
Notes: Finland


FRANCE


Activa SARL
Date Published : 07/31/2012
49 rue de Ponthieu , Paris, Paris FRANCE
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Activa Well Being Elimination Extended Release
Notes: France

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Activa Well Being Detox Immediate Release
Notes: France

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Activa Well Being Symiotic Extended Release
Notes: France

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Activa Human Structure OleaTonic Cerebral
Notes: France

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Activa Well Being Articular Extended Release
Notes: France

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Activa Well Being Man Immediate Release
Notes: France

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Activa Well Being Digestion Immediate Release
Notes: France

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Activa Well Being Immunity Immediate Release
Notes: France

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Activa Well Being Respiration Extended Release
Notes: France

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Activa Well Being Sleep Extended Release
Notes: France

Boiron
Date Published : 09/12/2023
2 avenue de l ouest Lyonnais , Messimy, Rhone FRANCE
66 V B K 99 Miscellaneous Patent Medicines, Etc., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Optique 1 Eye Drops

C.F.E.B. - Sisley
Date Published : 06/06/2013
Zac Des Bethunes , 32 Avenue Des Bethunes , Saint-Ouen-L'Aumone, Val-d'Oise FRANCE
53 L - - -- Skin Care Prep
Date Published: 06/06/2013

Desc: Sisleya Global Anti-Age Cream
Notes: France

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 06/06/2013

Desc: Sisleya Global Anti-Age Cream
Notes: France

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/06/2013

Desc: Sisleya Global Anti-Age Cream
Notes: France

Clarins
Date Published : 03/15/2012
4 rue Berteaux Dumas , BP 174 , Neuilly Sur Seine, Hauts de Seine FRANCE
53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 03/15/2012

Desc: Clarins Mult-Active Day Early Wrinkle Correction Cream
Notes: France

Cosmetique Active Production
Date Published : 09/30/2009
Avenue Rene Levayer , La Roche Posay, Vienne FRANCE
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/30/2009

Notes: 3/2/2005 These products appear to be new drugs without an approved application (NDA). These products contain ingrediants that are not permitted in the final rule for Sunscreen Drug Products for Over the Counter Human use (21 CFR 352).505(a) charge.

65 L - - 99 Protectant N.E.C.
Date Published: 09/30/2009

Notes: 3/2/2005

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 09/30/2009

Notes: 3/2/2005

Cosmetique Active Production
Date Published : 08/01/2012
Z.I. De Vichy-Rhue , Creuzier Le Vieux, Allier FRANCE
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);France

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);France

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);France

62 C - - 41 Minoxidil (Anti-Hypertensive)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);France

62 C - - 99 Anti-Hypertensive N.E.C.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);France

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);France

Fragrance Productions S.A.
Date Published : 07/21/2017
ZI Edmond Poillot , Chartres Cedex, FRANCE
66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 07/21/2017

Desc: Lancaster Sun Sport Mist (All SPF Strengths)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/21/2017

Desc: Lancaster Sun Sport Mist (All SPF Strengths)

Francos
Date Published : 04/29/2019
1 rue des Mardeaux , Villebarou, Loir Et Cher FRANCE
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/29/2019

Desc: Velvet Nourishing Cream with Saffron Flowers (Soin Velours aux Fleurs de Safran)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/29/2019

Desc: Velvet Nourishing Cream with Saffron Flowers (Soin Velours aux Fleurs de Safran)

Health Supplements
Date Published : 10/04/2016
26 Rue General De Gaulle La , Gibervillegiberville, FRANCE
53 I - - 02 Mouthwashes and Breath Fresheners (Liquids and Sprays), without Fluoride (Oral Hygiene Products)
Date Published: 10/04/2016

Desc: Macact Mouthwash

54 A - - 14 Vit D
Date Published: 10/04/2016

Desc: Macact Mouthwash

54 A - - 14 Vit D
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

54 A - - 15 Vitamin D2 (Calciferol)
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

54 A - - 99 Vitamin, N.E.C.
Date Published: 10/04/2016

Desc: Macact Mouthwash

54 A - - 99 Vitamin, N.E.C.
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/04/2016

Desc: Macact Mouthwash

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/04/2016

Desc: Macact Mouthwash

55 P - - 72 Oleic Acid (Pharmaceutic Necessity - Emulsion Adjunct)
Date Published: 10/04/2016

Desc: Macact Mouthwash

55 P - - 72 Oleic Acid (Pharmaceutic Necessity - Emulsion Adjunct)
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/04/2016

Desc: Macact Mouthwash

Health Supplements
Date Published : 10/04/2016
81 rue du General Leclerc , Tourlaville, Manche FRANCE
53 I - - 02 Mouthwashes and Breath Fresheners (Liquids and Sprays), without Fluoride (Oral Hygiene Products)
Date Published: 10/04/2016

Desc: Macact Mouthwash

54 A - - 14 Vit D
Date Published: 10/04/2016

Desc: Macact Mouthwash

54 A - - 14 Vit D
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

54 A - - 15 Vitamin D2 (Calciferol)
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

54 A - - 99 Vitamin, N.E.C.
Date Published: 10/04/2016

Desc: Macact Mouthwash

54 A - - 99 Vitamin, N.E.C.
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/04/2016

Desc: Macact Mouthwash

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/04/2016

Desc: Macact Mouthwash

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

55 P - - 72 Oleic Acid (Pharmaceutic Necessity - Emulsion Adjunct)
Date Published: 10/04/2016

Desc: Macact Mouthwash

55 P - - 72 Oleic Acid (Pharmaceutic Necessity - Emulsion Adjunct)
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/04/2016

Desc: Macact Mouthwash

L'Oreal
Date Published : 08/01/2012
14 rue Royale , Paris, Paris FRANCE
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);France ;

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);France ;

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);France

62 C - - 41 Minoxidil (Anti-Hypertensive)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);France ;

62 C - - 99 Anti-Hypertensive N.E.C.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);France ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);France ;

LABORATOIRES B.L.C. THALGO COSMETIC
Date Published : 02/24/2012
Domaine des Chataigniers, RN7 , Roquebrune-sur-Argens, VAR FRANCE
53 M - - 01 Suntan Gels, Creams, Liquids (not Sunscreen) (Suntan Preparations)
Date Published: 02/24/2012

Desc: Bio Protective Sunscreen
Notes: France

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/24/2012

Desc: Bio Protective Sunscreen
Notes: France

LABORATOIRES INNOXA
Date Published : 01/02/2024
24 Rue Erlanger , Paris, Paris FRANCE
53 C - - -- Eye Makeup Prep
Date Published: 01/02/2024

Desc: INNOXA Laboratoires Triple Action Eye Spray
Notes: DWPE applies to Red and Irritated Eyes (YEUX ROUGES ET IRRITES) indication and Very Dry and Tired Eyes (YEUX TRES SECS ET FATIGUES) indication. Indications located on principal display panel.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/02/2024

Notes: INNOXA Laboratoires Triple Action Eye Spray; DWPE applies to Red and Irritated Eyes (YEUX ROUGES ET IRRITES) indication and Very Dry and Tired Eyes (YEUX TRES SECS ET FATIGUES) indication. Indications located on principal display panel.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 01/02/2024

Notes: INNOXA Laboratoires Triple Action Eye Spray; DWPE applies to Red and Irritated Eyes (YEUX ROUGES ET IRRITES) indication and Very Dry and Tired Eyes (YEUX TRES SECS ET FATIGUES) indication. Indications located on principal display panel.

60 - - - -- Human and Animal Drugs
Date Published: 01/02/2024

Notes: INNOXA Laboratoires Triple Action Eye Spray; DWPE applies to Red and Irritated Eyes (YEUX ROUGES ET IRRITES) indication and Very Dry and Tired Eyes (YEUX TRES SECS ET FATIGUES) indication. Indications located on principal display panel.

61 - - - -- Human and Animal Drugs
Date Published: 01/02/2024

Notes: INNOXA Laboratoires Triple Action Eye Spray; DWPE applies to Red and Irritated Eyes (YEUX ROUGES ET IRRITES) indication and Very Dry and Tired Eyes (YEUX TRES SECS ET FATIGUES) indication. Indications located on principal display panel.

62 - - - -- Human and Animal Drugs
Date Published: 01/02/2024

Notes: INNOXA Laboratoires Triple Action Eye Spray; DWPE applies to Red and Irritated Eyes (YEUX ROUGES ET IRRITES) indication and Very Dry and Tired Eyes (YEUX TRES SECS ET FATIGUES) indication. Indications located on principal display panel.

63 - - - -- Human and Animal Drugs
Date Published: 01/02/2024

Notes: INNOXA Laboratoires Triple Action Eye Spray; DWPE applies to Red and Irritated Eyes (YEUX ROUGES ET IRRITES) indication and Very Dry and Tired Eyes (YEUX TRES SECS ET FATIGUES) indication. Indications located on principal display panel.

64 - - - -- Human and Animal Drugs
Date Published: 01/02/2024

Notes: INNOXA Laboratoires Triple Action Eye Spray; DWPE applies to Red and Irritated Eyes (YEUX ROUGES ET IRRITES) indication and Very Dry and Tired Eyes (YEUX TRES SECS ET FATIGUES) indication. Indications located on principal display panel.

65 - - - -- Human and Animal Drugs
Date Published: 01/02/2024

Notes: INNOXA Laboratoires Triple Action Eye Spray; DWPE applies to Red and Irritated Eyes (YEUX ROUGES ET IRRITES) indication and Very Dry and Tired Eyes (YEUX TRES SECS ET FATIGUES) indication. Indications located on principal display panel.

66 - - - -- Human and Animal Drugs
Date Published: 01/02/2024

Notes: INNOXA Laboratoires Triple Action Eye Spray; DWPE applies to Red and Irritated Eyes (YEUX ROUGES ET IRRITES) indication and Very Dry and Tired Eyes (YEUX TRES SECS ET FATIGUES) indication. Indications located on principal display panel.

Laboratoire Galanic Pierre Fabre
Date Published : 07/28/2014
45 Place Abel Gance , Boulogne Billancourt, Hauts de Seine FRANCE
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 07/28/2014

Desc: Eau Thermale Avene Antirougeurs Dermo-Nettoyant Lacte; Redness Relief Dermo-Cleansing Milk
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Plaine de Ganaussac; Cambounet Sur Le Sor; France.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/28/2014

Desc: Eau Thermale Avene Antirougeurs Fort Soin Concentre Rougers Installees; Relief Concentrate for Chronic Redness; Anti-redness Plus
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Plaine de Ganaussac; Cambounet Sur Le Sor; France.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/28/2014

Desc: Eau Thermale Avene Serenage Serum Nutri-Redensifying Vital Serum; Anti-aging Mature Skin
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Les Bain D Avenue; Avene; Herault; France. ;

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/28/2014

Desc: Eau Thermale Avene Antirougeurs Dermo-Nettoyant Lacte; Redness Relief Dermo-Cleansing Milk
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Plaine de Ganaussac; Cambounet Sur Le Sor; France.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/28/2014

Desc: Eau Thermale Avene D-Pigment Legere-Light; Dark Spot Corrector
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Les Bain D Avenue; Avene; Herault; France.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/28/2014

Desc: Eau Thermale Avene Antirougeurs Fort Soin Concentre Rougers Installees; Relief Concentrate for Chronic Redness; Anti-redness Plus
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Plaine de Ganaussac; Cambounet Sur Le Sor; France.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/28/2014

Desc: Eau Thermale Avene D-Pigment Legere-Light; Dark Spot Corrector
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Les Bain D Avenue; Avene; Herault; France.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/28/2014

Desc: Eau Thermale Avene Serenage Serum Nutri-Redensifying Vital Serum; Anti-aging Mature Skin
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Les Bain D Avenue; Avene; Herault; France.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/28/2014

Desc: Eau Thermale Avene Antirougeurs Dermo-Nettoyant Lacte; Redness Relief Dermo-Cleansing Milk
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Plaine de Ganaussac; Cambounet Sur Le Sor; France.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/28/2014

Desc: Eau Thermale Avene Antirougeurs Fort Soin Concentre Rougers Installees; Relief Concentrate for Chronic Redness; Anti-redness Plus
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Plaine de Ganaussac; Cambounet Sur Le Sor; France.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/28/2014

Desc: Eau Thermale Avene D-Pigment Legere-Light; Dark Spot Corrector
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Les Bain D Avenue; Avene; Herault; France.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/28/2014

Desc: Eau Thermale Avene Serenage Serum Nutri-Redensifying Vital Serum; Anti-aging Mature Skin
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Les Bain D Avenue; Avene; Herault; France.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/28/2014

Desc: Eau Thermale Avene Antirougeurs Dermo-Nettoyant Lacte; Redness Relief Dermo-Cleansing Milk
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Plaine de Ganaussac; Cambounet Sur Le Sor; France.

Laboratoires Mitchell Srl
Date Published : 09/30/2009
unknown , Paris, FRANCE
53 L C - -- Skin Care Prep, Cream
Date Published: 09/30/2009

Notes: 10/15/1999 Dermacare Gel

64 L - - 28 Fluocinonide (Glucocorticoid)
Date Published: 09/30/2009

Notes: 10/15/1999 Dermacare Gel.

Laboratoires Pronutri
Date Published : 07/31/2012
Pronutri , 10e rue; BP 556 5th avenue - 17 Rue , Carros CEDEX, Alpes Maritimes FRANCE
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Activa Well Being Articular Extended Release
Notes: France

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Activa Well Being Man Immediate Release
Notes: France

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Activa Well Being Symbiotic Extended Release
Notes: France

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Activa Well Being Respiration Extended Release
Notes: France

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Activa Well Being Immunity Release
Notes: France

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Activa Well Being Sleep Extended Release
Notes: France

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Activa Human Structure OleaTonic Cerebral
Notes: France

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Activa Well Being Elimination Extended Release
Notes: France

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Activa Well Being Digestion Immediate Release
Notes: France

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Activa Well Being Detox Immediate Release
Notes: France

Materiel Medical And Co
Date Published : 08/01/2012
594 Chemin De La Sourceespace Lumiere , Hyereshyeres, FRANCE
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);France

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);France

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);France

62 C - - 41 Minoxidil (Anti-Hypertensive)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);France

62 C - - 99 Anti-Hypertensive N.E.C.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);France

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);France

Monsieur A. Noiret
Date Published : 09/13/2019
10 Rue Saint Nicolas , 77260 La Ferte Sous , Jouarre, FRANCE
60 L - - 99 Analgesic, N.E.C.
Date Published: 09/13/2019

Desc: pain relief patch
Notes: 5/25/2016

60 Q - - 07 Lidocaine
Date Published: 09/13/2019

Desc: pain relief patch
Notes: 5/25/2016

60 Q - - 67 Lidocaine (Anesthetic)
Date Published: 09/13/2019

Desc: pain relief patch
Notes: 5/25/2016

62 M - - 08 Menthol (Anti-Pruritic)
Date Published: 09/13/2019

Desc: pain relief patch
Notes: 5/25/2016

89 I - - MD Pack, Hot Or Cold, Disposable
Date Published: 09/13/2019

Desc: pain relief patch
Notes: 5/25/2016

89 O - - MW adhesive backed thermal skin patches
Date Published: 09/13/2019

Desc: pain relief patch
Notes: 5/25/2016

Pharmaster +
Date Published : 06/05/2020
Pharmaster Mcs Pharma Erstein , Krafft Zone Industrielle , Erstein, Alsace FRANCE
77 K - - CO Inhaler, Nasal
Date Published: 06/05/2020

Desc: Simply Saline Nasal Pump Mist
Notes: This product appears to be an unapproved new drug as the product label includes claims such as: "Comforting mist flushes allergens to help clear congestion while long-lasting moisture helps soothe irritated nasal and sinus passages."

Pierre Fabre Dermo Cosmetique
Date Published : 07/28/2014
La Plaine , Cambounet Sur Le Sor, FRANCE
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 07/28/2014

Desc: Eau Thermale Avene Antirougeurs Dermo-Nettoyant Lacte; Redness Relief Dermo-Cleansing Milk
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Plaine de Ganaussac; Cambounet Sur Le Sor; France.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/28/2014

Desc: Eau Thermale Avene Antirougeurs Fort Soin Concentre Rougers Installees; Relief Concentrate for Chronic Redness; Anti-redness Plus
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Plaine de Ganaussac; Cambounet Sur Le Sor; France.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/28/2014

Desc: Eau Thermale Avene Antirougeurs Dermo-Nettoyant Lacte; Redness Relief Dermo-Cleansing Milk
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Plaine de Ganaussac; Cambounet Sur Le Sor; France.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/28/2014

Desc: Eau Thermale Avene Antirougeurs Dermo-Nettoyant Lacte; Redness Relief Dermo-Cleansing Milk
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Plaine de Ganaussac; Cambounet Sur Le Sor; France.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/28/2014

Desc: Eau Thermale Avene Antirougeurs Fort Soin Concentre Rougers Installees; Relief Concentrate for Chronic Redness; Anti-redness Plus
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Plaine de Ganaussac; Cambounet Sur Le Sor; France.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/28/2014

Desc: Eau Thermale Avene Antirougeurs Dermo-Nettoyant Lacte; Redness Relief Dermo-Cleansing Milk
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Plaine de Ganaussac; Cambounet Sur Le Sor; France.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/28/2014

Desc: Eau Thermale Avene Antirougeurs Fort Soin Concentre Rougers Installees; Relief Concentrate for Chronic Redness; Anti-redness Plus
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Plaine de Ganaussac; Cambounet Sur Le Sor; France.

Pierre Fabre Dermo-Cosmetique
Date Published : 07/28/2014
Unite' De Production D'Avene , Avene, Herault FRANCE
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/28/2014

Desc: Eau Thermale Avene D-Pigment Legere-Light; Dark Spot Corrector
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Les Bain D Avenue; Avene; Herault; France.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/28/2014

Desc: Eau Thermale Avene Serenage Serum Nutri-Redensifying Vital Serum; Anti-aging Mature Skin
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Les Bain D Avenue; Avene; Herault; France.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/28/2014

Desc: Eau Thermale Avene Serenage Serum Nutri-Redensifying Vital Serum; Anti-aging Mature Skin
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Les Bain D Avenue; Avene; Herault; France.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/28/2014

Desc: Eau Thermale Avene D-Pigment Legere-Light; Dark Spot Corrector
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Les Bain D Avenue; Avene; Herault; France.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/28/2014

Desc: Eau Thermale Avene D-Pigment Legere-Light; Dark Spot Corrector
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Les Bain D Avenue; Avene; Herault; France.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/28/2014

Desc: Eau Thermale Avene Serenage Serum Nutri-Redensifying Vital Serum; Anti-aging Mature Skin
Notes: Product label shows Pierre Fabre; 45 Place Abel Gance; Boulogne; France. Importer states mfg. is Pierre Fabre Dermo Cosmetique; Les Bain D Avenue; Avene; Herault; France.

Silky Pleasure Cosmetic
Date Published : 12/12/2012
Unknown , Paris, FRANCE
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 03/07/2016

Desc: EL-BARAKA BLACK SEED SOAP NATURAL SOAP FOR BODY

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/07/2016

Desc: EL-BARAKA BLACK SEED SOAP NATURAL SOAP FOR BODY

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 12/12/2012

Desc: Acne Pimple Soap
Notes: France

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 12/12/2012

Desc: Papaya Skin whitening Soap
Notes: France

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 03/07/2016

Desc: EL-BARAKA BLACK SEED SOAP NATURAL SOAP FOR BODY

Technature Alginates Algues Et Derives
Date Published : 01/21/2016
Z 1 De Lannuzel , Dirnon, FRANCE
53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 01/21/2016

Desc: Sensitive Skin Mask (Masque Peau Sensible)
Notes: Firms website makes structure/function claims

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 01/21/2016

Desc: Aloe Vera Mask
Notes: Firms website makes structure/function claims

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 01/21/2016

Desc: Acerola Mask (Masque Acerola)
Notes: Firms website makes structure/function claims

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 01/21/2016

Desc: Eye Patch Biocellulose
Notes: Firms website makes structure/function claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/21/2016

Desc: Acerola Mask (Masque Acerola)
Notes: Firms website makes structure/function claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/21/2016

Desc: Eye Patch Biocellulose
Notes: Firms website makes structure/function claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/21/2016

Desc: Aloe Vera Mask
Notes: Firms website makes structure/function claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/21/2016

Desc: Sensitive Skin Mask (Masque Peau Sensible)
Notes: Firms website makes structure/function claims

Vabel Laboratoire
Date Published : 06/13/2019
ZI de Morcourt , Saint Quentin, FRANCE
53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 06/13/2019

Desc: Swell Hair Thickening Serum
Notes: The product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list); 'safely reverses thinning'; the product website includes disease claims such as (not an all-inclusive list); 'the solution for women who want to safely and effectively reverse hair thinning'; 'works for women of all ages who experience hair thinning'; and ' safely reverses hair thinning'.

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 06/13/2019

Desc: Swell Hair Thickening Serum
Notes: The product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list); 'safely reverses thinning'; the product website includes disease claims such as (not an all-inclusive list); 'the solution for women who want to safely and effectively reverse hair thinning'; 'works for women of all ages who experience hair thinning'; and ' safely reverses hair thinning'. ;

Veld'S Hoche Freidland
Date Published : 02/16/2011
226 Rue Du Faubourg Saint Honore , Paris, FRANCE
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 02/16/2011

Desc: Xim Up Face Anti-Wrinkle Solution
Notes: France

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/16/2011

Desc: Xim Up Face Anti-Wrinkle Solution
Notes: France

Victoria Albi Sarl
Date Published : 06/28/2013
18 Boulevard De Strasbourg , Paris, FRANCE
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 06/28/2013

Desc: Makari hand and body
Notes: France

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/28/2013

Desc: Makari hand and body
Notes: France


GAMBIA, THE


DEGGEH FOODS INTERNATIONAL
Date Published : 03/11/2013
Kotu Kerr Sering , Serrekunda, GAMBIA, THE
31 K - - 99 Tea, N.E.C.
Date Published: 03/11/2013

Desc: Moringa Leaf Tea

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/11/2013

Desc: Moringa Leaf Capsules

54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued)
Date Published: 03/11/2013

Desc: Moringa Leaf Capsules

54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd
Date Published: 03/11/2013

Desc: Moringa Leaf Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/11/2013

Desc: Moringa Leaf Capsules


GEORGIA


GFC KULA
Date Published : 04/14/2016
17 Shindis Road , Gori, None of the above GEORGIA
20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 04/14/2016

Desc: Apple Juice
Notes: Medical claims on product labeling

20 S - - 04 Quince, Core Fruit Juices or Concentrates
Date Published: 04/14/2016

Desc: Quince Juice
Notes: Medical claims on product labeling

21 D - - 99 Mixed Fruit, Juices or Concentrates N.E.C.,
Date Published: 04/14/2016

Desc: Blackberry
Notes: Medical claims on product labeling

21 K - - 03 Cherry, Juice, Pit Fruit Juices or Concentrates
Date Published: 04/14/2016

Desc: Cherry Juice
Notes: Medical claims on product labeling

22 K - - 01 Pomegranate, Juice, Other Fruit Juices or Concentrates
Date Published: 04/14/2016

Desc: Pomegranate Juice
Notes: Medical claims on product labeling

New Techniques Laboratory Ltd
Date Published : 03/27/2012
47 Mtskheta Str , Tbilisi, Borjomi GEORGIA
54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 03/27/2012

Desc: Apis Resistant
Notes: Georgia


GERMANY


Abnoba GmbH
Date Published : 07/28/2020
Hohenzollernstr. 16 , Pforzheim, Baden-wurttemberg GERMANY
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/28/2020

Desc: AbnobaViscum
Notes: The product appears to be an unapproved new drug as the product's promotional website includes claims such as (not an all-inclusive list): 'AbnobaVISCUM is an anthroposophical medicine for extended treatment in tumor disease'.

63 X - - 99 Diagostic Aid (Drugs) N.E.C.
Date Published: 07/28/2020

Desc: AbnobaViscum
Notes: The product appears to be an unapproved new drug as the product's promotional website includes claims such as (not an all-inclusive list): 'AbnobaVISCUM is an anthroposophical medicine for extended treatment in tumor disease'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/28/2020

Desc: AbnobaViscum
Notes: The product appears to be an unapproved new drug as the product's promotional website includes claims such as (not an all-inclusive list): 'AbnobaVISCUM is an anthroposophical medicine for extended treatment in tumor disease'.

Alcina
Date Published : 09/30/2009
unknown , Bielefeld, GERMANY
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Aquanova AG
Date Published : 04/14/2020
Birkenweg 8-10 , Darmstadt, Hesse GERMANY
41 E - - 99 Meal Replacements (Not labeled for treatment of disease)
Date Published: 04/14/2020

Desc: Nanofy Curcumin with Vitamin D3
Notes: The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and is intended for use in the cure, mitigation, treatment or prevention of disease. The product appears to be a drug, as per Section 201(g)(1)(B), lacking adequate directions for use [Misbranded, Section 502(f)(1)]. The product appears to not be GRAS and effective for its intended uses; therefore, it is a "new drug", as per Section 201(p) of the Act [21U.S.C.§321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA, as per Section 505(a) of the Act [21 U.S.C.§355(a)].

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 04/14/2020

Desc: Nanofy Curcumin with Vitamin D3
Notes: The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and is intended for use in the cure, mitigation, treatment or prevention of disease. The product appears to be a drug, as per Section 201(g)(1)(B), lacking adequate directions for use [Misbranded, Section 502(f)(1)]. The product appears to not be GRAS and effective for its intended uses; therefore, it is a "new drug", as per Section 201(p) of the Act [21U.S.C.§321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA, as per Section 505(a) of the Act [21 U.S.C.§355(a)].

54 A - - 99 Vitamin, N.E.C.
Date Published: 04/14/2020

Desc: Nanofy Curcumin with Vitamin D3
Notes: The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and is intended for use in the cure, mitigation, treatment or prevention of disease. The product appears to be a drug, as per Section 201(g)(1)(B), lacking adequate directions for use [Misbranded, Section 502(f)(1)]. The product appears to not be GRAS and effective for its intended uses; therefore, it is a "new drug", as per Section 201(p) of the Act [21U.S.C.§321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA, as per Section 505(a) of the Act [21 U.S.C.§355(a)].

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/14/2020

Desc: Nanofy Curcumin with Vitamin D3
Notes: The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and is intended for use in the cure, mitigation, treatment or prevention of disease. The product appears to be a drug, as per Section 201(g)(1)(B), lacking adequate directions for use [Misbranded, Section 502(f)(1)]. The product appears to not be GRAS and effective for its intended uses; therefore, it is a "new drug", as per Section 201(p) of the Act [21U.S.C.§321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA, as per Section 505(a) of the Act [21 U.S.C.§355(a)].

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/14/2020

Desc: Nanofy Curcumin with Vitamin D3
Notes: The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and is intended for use in the cure, mitigation, treatment or prevention of disease. The product appears to be a drug, as per Section 201(g)(1)(B), lacking adequate directions for use [Misbranded, Section 502(f)(1)]. The product appears to not be GRAS and effective for its intended uses; therefore, it is a "new drug", as per Section 201(p) of the Act [21U.S.C.§321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA, as per Section 505(a) of the Act [21 U.S.C.§355(a)].

Bayer Weimar GmbH und Co. KG
Date Published : 04/25/2012
Dobereinerstr. 20 , Weimar, Thuringia GERMANY
61 B - - 02 Cyproterone Acetate (Anti-Androgen)
Date Published: 04/25/2012

Desc: Cyproterone Acetate Ethinylestradiol Antiandrogen Therapy Diane 35
Notes: Germany

Biologische Heilmittel Heel Gmbh
Date Published : 03/21/2012
Dr.-Reckeweg-Str. 2-4 , Baden-Baden, Baden-Wurttemberg GERMANY
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Traumeel Injection Solution
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Lymphomyosot Injection Solution

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Spascupreel Injection Solution
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Zeel Injection Solution
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Lymphomyosot X Injection Solution
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Neuralgo-Rheum Injection Solution
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Engystol Injection Solution
Notes: 6/15/2020

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Spascupreel Injection Solution
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Lymphomyosot X Injection Solution
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Neuralgo-Rheum Injection Solution
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Zeel Injection Solution
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Lymphomyosot Injection Solution

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Engystol Injection Solution
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Traumeel Injection Solution
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Neuralgo-Rheum Injection Solution
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Zeel Injection Solution
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Lymphomyosot Injection Solution

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Engystol Injection Solution
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Traumeel Injection Solution
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Lymphomyosot X Injection Solution
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Spascupreel Injection Solution
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Engystol Injection Solution
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Lymphomyosot X Injection Solution
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Lymphomyosot Injection Solution

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Traumeel Injection Solution
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Spascupreel Injection Solution
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Zeel Injection Solution
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Neuralgo-Rheum Injection Solution
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Engystol Injection Solution
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Lymphomyosot Injection Solution

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Spascupreel Injection Solution
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Zeel Injection Solution
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Neuralgo-Rheum Injection Solution
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Lymphomyosot X Injection Solution
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Traumeel Injection Solution
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Traumeel Injection Solution
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Spascupreel Injection Solution
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Engystol Injection Solution
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Lymphomyosot X Injection Solution
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Neuralgo-Rheum Injection Solution
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Lymphomyosot Injection Solution

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Zeel Injection Solution
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Engystol Injection Solution
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Lymphomyosot X Injection Solution
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Neuralgo-Rheum Injection Solution
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Spascupreel Injection Solution
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Lymphomyosot Injection Solution

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Zeel Injection Solution
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Traumeel Injection Solution
Notes: 6/15/2020

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 03/21/2012

Desc: Nectadyn Cough Syrup 125 ml
Notes: Germany

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Zeel Injection Solution
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Lymphomyosot Injection Solution

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Spascupreel Injection Solution
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Neuralgo-Rheum Injection Solution
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Engystol Injection Solution
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Traumeel Injection Solution
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Lymphomyosot X Injection Solution
Notes: 6/15/2020

Dr Reinwald Healthcare Gmbh + Co Kg
Date Published : 11/09/2016
Kunden Und Therapeutenbetreuung , Schwarzenbruck, GERMANY
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 11/09/2016

Desc: Rerum (Emulsion with Vitamin D3; D2; Oleic Acid and Chondroitin); Dietary Supplement

54 A - - 14 Vit D
Date Published: 11/09/2016

Desc: Rerum (Emulsion with Vitamin D3; D2; Oleic Acid and Chondroitin); Dietary Supplement

54 A - - 15 Vitamin D2 (Calciferol)
Date Published: 11/09/2016

Desc: Rerum (Emulsion with Vitamin D3; D2; Oleic Acid and Chondroitin); Dietary Supplement

54 A - - 99 Vitamin, N.E.C.
Date Published: 11/09/2016

Desc: Rerum (Emulsion with Vitamin D3; D2; Oleic Acid and Chondroitin); Dietary Supplement

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/09/2016

Desc: Rerum (Emulsion with Vitamin D3; D2; Oleic Acid and Chondroitin); Dietary Supplement

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/09/2016

Desc: Rerum (Emulsion with Vitamin D3; D2; Oleic Acid and Chondroitin); Dietary Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/09/2016

Desc: Rerum (Emulsion with Vitamin D3; D2; Oleic Acid and Chondroitin); Dietary Supplement

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 11/09/2016

Desc: Rerum (Emulsion with Vitamin D3; D2; Oleic Acid and Chondroitin); Dietary Supplement

Dr. Reinwald Healthcare Gmbh + co kg
Date Published : 11/09/2016
Prackenfelser Str. 18 , Altdorf B. Nurnberg, Bavaria GERMANY
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 11/09/2016

Desc: Rerum (Emulsion with Vitamin D3; D2; Oleic Acid and Chondroitin); Dietary Supplement

54 A - - 14 Vit D
Date Published: 11/09/2016

Desc: Rerum (Emulsion with Vitamin D3; D2; Oleic Acid and Chondroitin); Dietary Supplement

54 A - - 15 Vitamin D2 (Calciferol)
Date Published: 11/09/2016

Desc: Rerum (Emulsion with Vitamin D3; D2; Oleic Acid and Chondroitin); Dietary Supplement

54 A - - 99 Vitamin, N.E.C.
Date Published: 11/09/2016

Desc: Rerum (Emulsion with Vitamin D3; D2; Oleic Acid and Chondroitin); Dietary Supplement

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/09/2016

Desc: Rerum (Emulsion with Vitamin D3; D2; Oleic Acid and Chondroitin); Dietary Supplement

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/09/2016

Desc: Rerum (Emulsion with Vitamin D3; D2; Oleic Acid and Chondroitin); Dietary Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/09/2016

Desc: Rerum (Emulsion with Vitamin D3; D2; Oleic Acid and Chondroitin); Dietary Supplement

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 11/09/2016

Desc: Rerum (Emulsion with Vitamin D3; D2; Oleic Acid and Chondroitin); Dietary Supplement

Evonik Industries
Date Published : 08/15/2022
Rellinghauser Str. 1-11 , Essen, North Rhine-Westphalia GERMANY
55 R - - 99 Pharmaceutic Necessities, N.E.C.
Date Published: 08/15/2022

Desc: Ceramides Xblend
Notes: The product appears to be an unapproved new drug as the firm’s website, and product brochure labeling include, but are not limited to the following: “Helps to reduce transepidermal water loss”; “Helps to Improve Skin Barrier. A clinical study showed that balanced lipid mixtures containing ceramides are effective in improving skin barrier.”; “[V]olunteers using ceramide containing products had significantly better skin recovery after stress.”; “Helps to soothe contact dermatitis, allergic contact dermatitis, or atopic dermatitis”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/15/2022

Desc: Ceramides Xblend
Notes: The product appears to be an unapproved new drug as the firm’s website, and product brochure labeling include, but are not limited to the following: “Helps to reduce transepidermal water loss”; “Helps to Improve Skin Barrier. A clinical study showed that balanced lipid mixtures containing ceramides are effective in improving skin barrier.”; “[V]olunteers using ceramide containing products had significantly better skin recovery after stress.”; “Helps to soothe contact dermatitis, allergic contact dermatitis, or atopic dermatitis”.

Flaeminger Spirituosen GmbH Zahna&Co.Getraenkeproduktions KG
Date Published : 09/30/2009
Kopnicker Str. 1 , Zahna-Elster, Saxony-Anhalt GERMANY
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                             

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

GP Grenzach Produktions GmbH
Date Published : 10/08/2013
Emil-Barell-Str. 7 , Grenzach-Wyhlen, Baden-Wurttemberg GERMANY
61 W - - 04 Clotrimazole (Anti-Fungal) (Not Antibiotic)
Date Published: 09/18/2014

Desc: Canesten Foot Cream - Clotrimazole 1% Cream
Notes: Unapproved New Drug; Misbranded

61 W - - 04 Clotrimazole (Anti-Fungal) (Not Antibiotic)
Date Published: 10/08/2013

Desc: Clotrimazole Vaginal Cream 2% (Canesten V)

Gefra
Date Published : 12/10/2009
19246 Zorrentin , Berlin, GERMANY
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/10/2009

Desc: Glycerin Cream

55 Q - - 16 Glycerin (Pharmaceutic Necessity - Humectant)
Date Published: 12/10/2009

Desc: Glycerin Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/10/2009

Desc: Glycerin Cream

Goldeneye Permanent System Gmbh
Date Published : 05/02/2018
Mittelwegring 31 , Jockgrim, Rhineland-Palatinate GERMANY
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-action deep low base skin refiner exfoliation essence

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/02/2018

Desc: bdr Laser Effect peptide complex face mask

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-charge N hydro serum maximum skin energizer

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-action tonic professional multi active booster

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-fine pore minimizing fluid complex

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-construct enriched nourishing formula

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/02/2018

Desc: ; bdr Re-vital PH pure harmony care soothing skin optimizer

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/02/2018

Desc: bdr bio cell mask

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/02/2018

Desc: bdr Beauty Defect Repair OTC skin products (bdr Re-action natural low base skin refiner exfoliation essence

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/02/2018

Desc: bdr stretch lift mask

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-charge contour push up serum high-potential moisturizer

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-lax 3 multiple level serum highly-potential youth elixir

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-fresh gel mask face

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-vital balance care intense age control

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-move PH pure harmony cleanser

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-set 4D 4 dimensional age-repair code

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-vital PH pure harmony care soothing skin optimizer

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/02/2018

Desc: ; bdr Re-vital PH pure harmony care soothing skin optimizer

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/02/2018

Desc: bdr Beauty Defect Repair OTC skin products (bdr Re-action natural low base skin refiner exfoliation essence

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-vital balance care intense age control

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/02/2018

Desc: bdr stretch lift mask

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-construct enriched nourishing formula

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-vital PH pure harmony care soothing skin optimizer

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/02/2018

Desc: bdr Laser Effect peptide complex face mask

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-charge N hydro serum maximum skin energizer

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-action deep low base skin refiner exfoliation essence

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-action tonic professional multi active booster

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-lax 3 multiple level serum highly-potential youth elixir

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-fine pore minimizing fluid complex

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/02/2018

Desc: bdr bio cell mask

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-move PH pure harmony cleanser

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-fresh gel mask face

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-charge contour push up serum high-potential moisturizer

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/02/2018

Desc: bdr Re-set 4D 4 dimensional age-repair code

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/02/2018

Desc: bdr Re-action tonic professional multi active booster

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/02/2018

Desc: bdr Re-set 4D 4 dimensional age-repair code

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/02/2018

Desc: bdr stretch lift mask

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/02/2018

Desc: bdr Re-lax 3 multiple level serum highly-potential youth elixir

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/02/2018

Desc: bdr Laser Effect peptide complex face mask

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/02/2018

Desc: ; bdr Re-vital PH pure harmony care soothing skin optimizer

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/02/2018

Desc: bdr Re-vital PH pure harmony care soothing skin optimizer

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/02/2018

Desc: bdr Re-vital balance care intense age control

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/02/2018

Desc: bdr Re-charge N hydro serum maximum skin energizer

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/02/2018

Desc: bdr Re-fresh gel mask face

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/02/2018

Desc: bdr Beauty Defect Repair OTC skin products (bdr Re-action natural low base skin refiner exfoliation essence

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/02/2018

Desc: bdr Re-fine pore minimizing fluid complex

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/02/2018

Desc: bdr Re-construct enriched nourishing formula

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/02/2018

Desc: bdr Re-move PH pure harmony cleanser

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/02/2018

Desc: bdr Re-charge contour push up serum high-potential moisturizer

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/02/2018

Desc: bdr bio cell mask

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/02/2018

Desc: bdr Re-action deep low base skin refiner exfoliation essence

Heitland and Petre International Gmbh
Date Published : 07/06/2015
Grauenbarge 1 , Celle, Lower Saxony GERMANY
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2015

Desc: AMINTAmed with Microsilver Camomile Paste

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2015

Desc: Ultimate Stem Cell 24h-cream

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2015

Desc: AMINTAmed Balm night

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2015

Desc: AMINTAmed Camomile Paste CABI

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2015

Desc: Creme-Gel Jour (sample)

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2015

Desc: AMINTAmed Camomile Paste Tinted

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2015

Desc: AMINTAmed Camomile Paste Tinted (sample)

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2015

Desc: AMINTAmed Balm

Hermes Arzneimittel GmbH
Date Published : 09/18/2013
Hans-Urmiller-Ring 52 , Wolfratshausen, Bavaria GERMANY
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/18/2013

Desc: PharmaNac

60 T - - 99 Antagonist, N.E.C.
Date Published: 09/18/2013

Desc: PharmaNac

65 B - - 01 Acetylcysteine (Mucolytic)
Date Published: 09/18/2013

Desc: PharmaNac

65 B - - 99 Mucolytic N.E.C.
Date Published: 09/18/2013

Desc: PharmaNac

Hevert Arzneimittel GmbH & Co. KG
Date Published : 06/15/2020
In der Weiherwiese 1 , Nusbaum, Rhineland-Palatinate GERMANY
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Hevert Arnica Solution for Injection
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Hevert Gelsemium Comp. Solution for Injection
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Hevert Hepar Comp. Solution for Injection
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Hevert Lymphaden Comp. Solution for Injection
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Hevert Calmvalera Comp. Solution for Injection
Notes: 6/15/2020

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Hepar Comp. Solution for Injection
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Gelsemium Comp. Solution for Injection
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Arnica Solution for Injection
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Lymphaden Comp. Solution for Injection
Notes: 6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Calmvalera Comp. Solution for Injection
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Gelsemium Comp. Solution for Injection
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Lymphaden Comp. Solution for Injection
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Calmvalera Comp. Solution for Injection
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Arnica Solution for Injection
Notes: 6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Hepar Comp. Solution for Injection
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Gelsemium Comp. Solution for Injection
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Lymphaden Comp. Solution for Injection
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Hepar Comp. Solution for Injection
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Arnica Solution for Injection
Notes: 6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Calmvalera Comp. Solution for Injection
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Calmvalera Comp. Solution for Injection
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Lymphaden Comp. Solution for Injection
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Gelsemium Comp. Solution for Injection
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Hepar Comp. Solution for Injection
Notes: 6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Arnica Solution for Injection
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Gelsemium Comp. Solution for Injection
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Hepar Comp. Solution for Injection
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Arnica Solution for Injection
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Calmvalera Comp. Solution for Injection
Notes: 6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Lymphaden Comp. Solution for Injection
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Calmvalera Comp. Solution for Injection
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Lymphaden Comp. Solution for Injection
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Hepar Comp. Solution for Injection
Notes: 6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Arnica Solution for Injection
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Gelsemium Comp. Solution for Injection
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Hepar Comp. Solution for Injection
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Lymphaden Comp. Solution for Injection
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Calmvalera Comp. Solution for Injection
Notes: 6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Arnica Solution for Injection
Notes: 6/15/2020

Holopack Verpackungstechnik GmbH
Date Published : 11/01/2012
Bahnhofstr. 18 , Sulzbach-Laufen, Baden-Wurttemberg GERMANY
53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 11/01/2012

Desc: Viscontour Serum Topical Hyaluronic Acid

64 W - - 99 Irrigation Solution N.E.C.
Date Published: 08/05/2015

Desc: Plum Eyewash

65 F - - 06 Water, Purified (Eyewash)
Date Published: 08/05/2015

Desc: Plum Eyewash

HorFerVit Pharma GMBH (Hormone Fermente Vitamine)
Date Published : 09/30/2009
Wehdestrabe 16 , Oldenburg, GERMANY
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/04/2019

Notes: Polyerga, 6/5/1990

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Polyerga, 6/5/1990

61 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Polyerga, 6/5/1990

62 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Polyerga, 6/5/1990

63 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Polyerga, 6/5/1990

64 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Polyerga, 6/5/1990

65 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Polyerga, 6/5/1990

66 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Polyerga, 6/5/1990

International Products
Date Published : 09/13/2019
Unknown Street , Stuttgart 1, GERMANY
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: All drugs; 11/23/1988

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 11/23/1988

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 11/23/1988

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 11/23/1988

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 11/23/1988

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 11/23/1988

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 11/23/1988

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 11/23/1988

Laboratorium Prof Dr H Dyckerhoff Gmbh & Co
Date Published : 10/22/2018
Robert Perthel Strabe 49 , Koln, GERMANY
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/22/2018

Desc: Osteochondrin S

Laboratorium Soluna Heilmittel Gmbh
Date Published : 06/04/2015
Artur-Proeller-Str. 7 , Donauworth, Bavaria GERMANY
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/04/2015

Desc: Nr.16 Renalin Homeopathic Medicine With Spagyric Elements Oral Drops

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/04/2015

Desc: Nr.11 Matrigen II Homeopathic Medicine With Spagyric Elements Oral Drops

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/04/2015

Desc: Nr.5 Cordiak Homeopathic Medicine With Spagyric Elements Oral Drops

Laverana Gmgh
Date Published : 07/27/2011
4 Am Weingarten , Wennigsen, GERMANY
53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 07/27/2011

Desc: Laverna Organic Mint Toner
Notes: Germany

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 08/08/2011

Desc: Laverna Organic Mint Toner
Notes: Germany

Meditech Human Pharmaceutical
Date Published : 11/27/2017
Lorachstr. 238 , Ingolbdheim, GERMANY
60 K - - 99 Anabolic, N.E.C.
Date Published: 11/27/2017

Desc: Anavar (Oxandrolone)
Notes: The product appears to be an unapproved new drug as the product website includes claims such as; "...Promotes great strength gains and solid lean mass gains...".

60 K - - 99 Anabolic, N.E.C.
Date Published: 11/27/2017

Desc: Clenbuterol
Notes: The product appears to be an unapproved new drug as the product website includes claims such as; "...very effective fat loss stimulant with anti-catabolic properties...".

Medscorp
Date Published : 09/30/2009
Courty Aunan Blc. 5-6, Office 6b , Nurburger, GERMANY
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 08/20/2020

Desc: Abarelix
Notes:                 

64 R - - 21 Somatropin (Hormone)
Date Published: 08/20/2020

Notes:                 

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                 

Merz Pharmaceuticals GmbH
Date Published : 04/23/2020
Eckenheimer Landstr. 100 , Frankfurt Am Main, Hassia GERMANY
65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Bocouture Botulinum Toxin Type A

PLANTAFOOD MEDICAL GMBH
Date Published : 09/20/2019
Am Sportplatz 3 , Leiningen, Rhineland-Palatinate GERMANY
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/20/2019

Desc: Sugarit
Notes: This product appears to be an unapproved new drug as the product label and promotional website include disease claims such as (not an all-inclusive list): '...Supports Lower Blood Sugar...; ...Anti-thrombocyte aggregation, lowers high blood pressure...'.

Plantafood Medical Gmbh
Date Published : 09/20/2019
Horst-Uhlig-Str. 3 , Laudert, Rhineland-Palatinate GERMANY
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/20/2019

Desc: Sugarit
Notes: This product appears to be an unapproved new drug as the product label and promotional website include disease claims such as (not an all-inclusive list): '...Supports Lower Blood Sugar...; ...Anti-thrombocyte aggregation, lowers high blood pressure...'.

Solupharm Pharmazeutische Erzeugnisse Gmbh
Date Published : 06/15/2020
Industriestr. 3 , Melsungen, Hesse GERMANY
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Hevert Hepar Comp. Solution for Injection
Notes: ;6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Notes: Hevert Arnica Solution for Injection ;6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Hevert Gelsemium Comp. Solution for Injection
Notes: 6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Hevert Lymphaden Comp. Solution for Injection
Notes: ;6/15/2020

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/08/2020

Desc: Hevert Calmvalera Comp. Solution for Injection
Notes: ;6/15/2020

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Gelsemium Comp. Solution for Injection
Notes: ;6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Hepar Comp. Solution for Injection
Notes: ;6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Calmvalera Comp. Solution for Injection
Notes: ;6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Notes: Hevert Arnica Solution for Injection ;6/15/2020

60 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Lymphaden Comp. Solution for Injection
Notes: ;6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Hepar Comp. Solution for Injection
Notes: ;6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Notes: Hevert Arnica Solution for Injection ;6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Lymphaden Comp. Solution for Injection
Notes: ;6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Gelsemium Comp. Solution for Injection
Notes: ;6/15/2020

61 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Calmvalera Comp. Solution for Injection
Notes: ;6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Calmvalera Comp. Solution for Injection
Notes: ;6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Hepar Comp. Solution for Injection
Notes: ;6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Lymphaden Comp. Solution for Injection
Notes: ;6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Notes: Hevert Arnica Solution for Injection ;6/15/2020

62 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Gelsemium Comp. Solution for Injection
Notes: ;6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Gelsemium Comp. Solution for Injection
Notes: ;6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Calmvalera Comp. Solution for Injection
Notes: ;6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Lymphaden Comp. Solution for Injection
Notes: ;6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Notes: Hevert Arnica Solution for Injection ;6/15/2020

63 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Hepar Comp. Solution for Injection
Notes: ;6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Notes: Hevert Arnica Solution for Injection ;6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Lymphaden Comp. Solution for Injection
Notes: ;6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Calmvalera Comp. Solution for Injection
Notes: ;6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Hepar Comp. Solution for Injection
Notes: ;6/15/2020

64 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Gelsemium Comp. Solution for Injection
Notes: ;6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Calmvalera Comp. Solution for Injection
Notes: ;6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Gelsemium Comp. Solution for Injection
Notes: ;6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Hepar Comp. Solution for Injection
Notes: ;6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Lymphaden Comp. Solution for Injection
Notes: ;6/15/2020

65 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Notes: Hevert Arnica Solution for Injection ;6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Hepar Comp. Solution for Injection
Notes: ;6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Notes: Hevert Arnica Solution for Injection ;6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Lymphaden Comp. Solution for Injection
Notes: ;6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Gelsemium Comp. Solution for Injection
Notes: ;6/15/2020

66 - - - -- Human and Animal Drugs
Date Published: 12/08/2020

Desc: Hevert Calmvalera Comp. Solution for Injection
Notes: ;6/15/2020

Tana Cosmetics
Date Published : 03/04/2014
August-Bebel-Str. 213 , Bielefeld, North Rhine-Westphalia GERMANY
53 C - - 04 Eye Lotion (Eye Makeup Preparations)
Date Published: 03/04/2014

Desc: Tana Lashpower Eyelash Serum

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 03/04/2014

Desc: Tana Lashpower Eyelash Serum

Tana Cosmetics Manoa
Date Published : 03/04/2014
Box 102801 , Bielefeld, GERMANY
53 C - - 04 Eye Lotion (Eye Makeup Preparations)
Date Published: 03/04/2014

Desc: Tana Lashpower Eyelash Serum

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 03/04/2014

Desc: Tana Lashpower Eyelash Serum

Weber & Weber International GmbH & Co. KG
Date Published : 05/14/2019
Herrschinger Str. 33 , Inning A. Ammersee, Bavaria GERMANY
20 G - - 08 Tangelo (Citrus)
Date Published: 05/14/2019

Desc: Petadolex 75
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Less Migraines ... The only butter bur extract used in migraine clinical trials ...'. In addition, the product website includes claims such as (not an all-inclusive list): ' ... Chronic brain blood flow issues ... The Canadian Headache Society strongly recommends butterbur petasites ... '.

54 B - - 99 Mineral N.E.C.
Date Published: 05/14/2019

Desc: Petadolex 75
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Less Migraines ... The only butter bur extract used in migraine clinical trials ...'. In addition, the product website includes claims such as (not an all-inclusive list): ' ... Chronic brain blood flow issues ... The Canadian Headache Society strongly recommends butterbur petasites ... '.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/14/2019

Desc: Petadolex 75
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Less Migraines ... The only butter bur extract used in migraine clinical trials ...'. In addition, the product website includes claims such as (not an all-inclusive list): ' ... Chronic brain blood flow issues ... The Canadian Headache Society strongly recommends butterbur petasites ... '.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/14/2019

Desc: Petadolex 75
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list); '... Less Migraines ... The only butter bur extract used in migraine clinical trials ...'. In addition; the product website includes claims such as (not an all-inclusive list); ' ... Chronic brain blood flow issues ... The Canadian Headache Society strongly recommends butterbur petasites ... '.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/14/2019

Desc: Petadolex 75
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Less Migraines ... The only butter bur extract used in migraine clinical trials ...'. In addition, the product website includes claims such as (not an all-inclusive list): ' ... Chronic brain blood flow issues ... The Canadian Headache Society strongly recommends butterbur petasites ... '.


GHANA


Alafia Bitters Herbal Institute and Clinic
Date Published : 12/21/2018
House # MD2/4 Zongo Junction , Madina, GHANA
28 - - - -- Spices, Flavors And Salts
Date Published: 12/21/2018

Desc: Alafia Bitters Liquid

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 12/21/2018

Desc: Alafia Bitters Liquid

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/21/2018

Notes: Alafia Bitters Liquid

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 12/21/2018

Notes: Alafia Bitters Liquid

61 - - - -- Human and Animal Drugs
Date Published: 12/21/2018

Notes: Alafia Bitters Liquid

62 - - - -- Human and Animal Drugs
Date Published: 12/21/2018

Notes: Alafia Bitters Liquid

63 - - - -- Human and Animal Drugs
Date Published: 12/21/2018

Notes: Alafia Bitters Liquid

64 - - - -- Human and Animal Drugs
Date Published: 12/21/2018

Notes: Alafia Bitters Liquid

65 - - - -- Human and Animal Drugs
Date Published: 12/21/2018

Notes: Alafia Bitters Liquid

66 - - - -- Human and Animal Drugs
Date Published: 12/21/2018

Notes: Alafia Bitters Liquid

Angel Herbal Products Industry
Date Published : 08/23/2011
PO Box 7455 , Kumasi, GHANA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 08/23/2011

Desc: Angel Cream
Notes: Ghana

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/23/2011

Desc: Angel Cream
Notes: Ghana

Asietu Adam Bitters
Date Published : 10/25/2012
A 113 Buokron Estate , Kumasi, GH-AH GHANA
30 F - - 99 Beverage Base of Non-Fruit Origin, N.E.C.
Date Published: 10/25/2012

Desc: Blood Purifying Tonic

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 10/25/2012

Desc: Blood Purifying Tonic

Capital O2 Natural Health Company Ltd
Date Published : 11/30/2017
6 Carcass Road , South Odorkor , South Odorkor, Greater Accra GHANA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2020

Desc: Living Bitters Tonic
Notes: The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a). Furthermore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be a drug within the meaning of Section 201(g) and the label lacks adequate directions for use [Misbranded, Section 502(f)(1)].

54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued))
Date Published: 03/16/2020

Desc: Living Bitters Tonic
Notes: The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a). Furthermore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be a drug within the meaning of Section 201(g) and the label lacks adequate directions for use [Misbranded, Section 502(f)(1)].

66 M - - 99 Tranquilizer N.E.C.
Date Published: 11/30/2017

Desc: Great Swedish Bitters Liquid
Notes: The product appears to be an unapproved new drug. Examples of labeling claims, including claims on the www.capitalo2.com website, include but are not limited to the following. • "INDICATIONS: Herbal medicine for managing insomnia, promotes blood circulation and for strenghtening [sic] the immune system." • "G-Swedish Bitters® is a combination of a 26-potent herb formula that strengthens the heart and enhances blood circulation throughout the body. It assists in the prevention of and recovery from stroke, paralysis and high blood pressure, and manages hypertension, insomnia and boosts the immune system."

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 11/30/2017

Desc: Great Swedish Bitters Liquid
Notes: The product appears to be an unapproved new drug. Examples of labeling claims, including claims on the www.capitalo2.com website, include but are not limited to the following. • "INDICATIONS: Herbal medicine for managing insomnia, promotes blood circulation and for strenghtening [sic] the immune system." • "G-Swedish Bitters® is a combination of a 26-potent herb formula that strengthens the heart and enhances blood circulation throughout the body. It assists in the prevention of and recovery from stroke, paralysis and high blood pressure, and manages hypertension, insomnia and boosts the immune system."

Dannex Ltd
Date Published : 02/11/2020
North Industrial Area , 5 Dadeban Rd. Ring Road North , Accra, GHANA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/11/2020

Desc: Durol Tonic
Notes: The product appears to be an unapproved new drug as the label of the product includes claims such as (not an all-inclusive list): 'Indications: ... Loss of appetite ... Neuritis'.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 02/11/2020

Desc: Durol Tonic
Notes: The product appears to be an unapproved new drug as the label of the product includes claims such as (not an all-inclusive list): 'Indications: ... Loss of appetite ... Neuritis'.

66 - - - -- Human and Animal Drugs
Date Published: 02/11/2020

Desc: Durol Tonic
Notes: The product appears to be an unapproved new drug as the label of the product includes claims such as (not an all-inclusive list): 'Indications: ... Loss of appetite ... Neuritis'.

Dannex Ltd
Date Published : 02/11/2020
North Industrial Area , 5 Dadeban Rd. Ring Road North , Accra, GHANA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/11/2020

Desc: Durol Tonic
Notes: The product appears to be an unapproved new drug as the label of the product includes claims such as (not an all-inclusive list): 'Indications: ... Loss of appetite ... Neuritis'.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 02/11/2020

Desc: Durol Tonic
Notes: The product appears to be an unapproved new drug as the label of the product includes claims such as (not an all-inclusive list): 'Indications: ... Loss of appetite ... Neuritis'.

66 - - - -- Human and Animal Drugs
Date Published: 02/11/2020

Desc: Durol Tonic
Notes: The product appears to be an unapproved new drug as the label of the product includes claims such as (not an all-inclusive list): 'Indications: ... Loss of appetite ... Neuritis'.

Geo Medicore Limited
Date Published : 09/16/2019
Factory: Plot No. 312 to 315 , Kuntunse , Accra-Ghana, GHANA
61 H - - 11 Sulfathiazole
Date Published: 09/16/2019

Desc: Sulphathiazole
Notes: 12/27/2018

HENACENT LIMITED
Date Published : 07/17/2018
125 B NUNGUA , Lashibi, GH-AA GHANA
23 B - - 07 Peanut, Shelled
Date Published: 07/17/2018

Desc: Fresh PEANUT

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/17/2018

Desc: Fresh PEANUT

Insaaniyya Herbal Drug Center
Date Published : 07/25/2011
P. O. Box KN 3230 , Kaneshie-Accra, GHANA
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/25/2011

Desc: Mercy Ointment
Notes: Ghana

Ipca Laboratories Ltd(for Phyto-Riker (GIHOC) Pharmaceutical
Date Published : 09/07/2021
Mile 7, Dome , Off Nsawam Rd , Accra, GHANA
62 M - - 08 Menthol (Anti-Pruritic)
Date Published: 09/07/2021

Desc: ZUBES Extra Strong Cough Mixture
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "ZUBES EXTRA STRONG COUGH MIXTURE… for quick relief from cough, colds and sore throat… for cough, colds & sore throat”.

62 U - - 99 Anti-Tussive/Cold N.E.C.
Date Published: 09/07/2021

Desc: ZUBES Extra Strong Cough Mixture
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "ZUBES EXTRA STRONG COUGH MIXTURE… for quick relief from cough, colds and sore throat… for cough, colds & sore throat”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/07/2021

Desc: ZUBES Extra Strong Cough Mixture
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "ZUBES EXTRA STRONG COUGH MIXTURE… for quick relief from cough, colds and sore throat… for cough, colds & sore throat”.

Jebacoci Company Ltd
Date Published : 10/02/2014
P.O. Box Ds171 , Dansoman-Accra, GHANA
53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 10/02/2014

Desc: Jeba Naturals Hair Fertilizer
Notes: Product labeling and corresponding website (www.jebanaturals.com) state claims such as but not limited to the following; Prevents the fundamental causes of baldness; prevents dandruff; prevents itchy scalp; rapid hair growth guaranteed.

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 10/02/2014

Desc: Jeba Naturals Hair Fertilizer
Notes: Product labeling and corresponding website (www.jebanaturals.com) state claims such as but not limited to the following; Prevents the fundamental causes of baldness; prevents dandruff; prevents itchy scalp; rapid hair growth guaranteed.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/02/2014

Desc: Jeba Naturals Hair Fertilizer
Notes: Product labeling and corresponding website (www.jebanaturals.com) state claims such as but not limited to the following; Prevents the fundamental causes of baldness; prevents dandruff; prevents itchy scalp; rapid hair growth guaranteed.

Karafi Limited
Date Published : 09/30/2009
23 Karafi Street , Takoradi, GHANA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Desc: Karafi Bitters
Notes: 7/27/09

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Desc: Karafi Bitters
Notes: 7/27/09

Letap Pharmaceuticals Ltd.
Date Published : 08/11/2021
Plot 107, Graphic Road , B.P. 3346 , Accra, GHANA
56 B - - 03 Amoxicillin Trihydrate (Penicillin, Synthetically Produced)
Date Published: 08/11/2021

Desc: Amoxicillin Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/11/2021

Notes: Amoxicillin Capsules

Taabea Company Limited
Date Published : 11/16/2021
Plot 24 , Block U , Aputuogya-Bosomtwi, Kumasi GHANA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/16/2021

Desc: Taabea Herbal Mixture
Notes: Labeling statements documenting the intended use of the product include, but may not limited to the following: “Malaria, General body pains, and Loss of Appetite”.

54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd
Date Published: 11/16/2021

Desc: Taabea Herbal Mixture
Notes: Labeling statements documenting the intended use of the product include, but may not limited to the following: “Malaria, General body pains, and Loss of Appetite”.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 11/16/2021

Desc: Taabea Herbal Mixture
Notes: Labeling statements documenting the intended use of the product include, but may not limited to the following: “Malaria, General body pains, and Loss of Appetite”.

Tiwaa Bernice
Date Published : 04/23/2015
Tantra Hill House 10 , Sunyani, GHANA
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/23/2015

Desc: Diproson Lotion
Notes:                                                                                                                                                                                                           

64 L - - 06 Betamethasone Dipropionate (Glucocorticoid)
Date Published: 04/23/2015

Desc: Diproson Lotion
Notes:                                                                                                                                                                                                           

YESU MO AFRICAN MARKET
Date Published : 02/27/2020
Rasta , No. 12 Paya Loop , Teshi, GHANA
54 E - - -- Herbal and Botanical
Date Published: 02/27/2020

Desc: ATTOTE Original
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Diabetes, blood pressure, visual blurring, stomach ache, fever general fatigue, sexual weakness, sinusitis, ulcer, painful menstruation, vaginal discharge . . . kidney trouble, hemorrhoids, bloated stomach, constipation, typhoid fever . . . impotence, hernia, cyst, fibroma . . .'.

54 J - - -- Herbal and Botanical II
Date Published: 02/27/2020

Desc: ATTOTE Original
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Diabetes, blood pressure, visual blurring, stomach ache, fever general fatigue, sexual weakness, sinusitis, ulcer, painful menstruation, vaginal discharge . . . kidney trouble, hemorrhoids, bloated stomach, constipation, typhoid fever . . . impotence, hernia, cyst, fibroma . . .'.

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 02/27/2020

Desc: ATTOTE Original
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Diabetes, blood pressure, visual blurring, stomach ache, fever general fatigue, sexual weakness, sinusitis, ulcer, painful menstruation, vaginal discharge . . . kidney trouble, hemorrhoids, bloated stomach, constipation, typhoid fever . . . impotence, hernia, cyst, fibroma . . .'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/27/2020

Desc: ATTOTE Original
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Diabetes, blood pressure, visual blurring, stomach ache, fever general fatigue, sexual weakness, sinusitis, ulcer, painful menstruation, vaginal discharge . . . kidney trouble, hemorrhoids, bloated stomach, constipation, typhoid fever . . . impotence, hernia, cyst, fibroma . . .'.

dependable pharmacy LTD
Date Published : 07/27/2021
7 New Road, Green House , Madina, GHANA
63 H - - 99 Cathartic N.E.C.
Date Published: 07/27/2021

Desc: Adom Koo Mixture- Kooku Aduro
Notes: Dependable Pharmacy Ltd. appears to be also known as Dependable Herbal Home.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/27/2021

Desc: Adom Koo Mixture- Kooku Aduro
Notes: Dependable Pharmacy Ltd. appears to be also known as Dependable Herbal Home.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/27/2021

Desc: Adom Koo Mixture- Kooku Aduro
Notes: Dependable Pharmacy Ltd. appears to be also known as Dependable Herbal Home.

kama industries ltd
Date Published : 06/17/2020
NORTH , PO Box 5437 , Accra, GHANA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/17/2020

Desc: Tres-Orix Forte Oral Solution

61 X - - 14 Cyproheptadine HCl (Anti-Histaminic)
Date Published: 06/17/2020

Desc: Tres-Orix Forte Oral Solution

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/17/2020

Desc: Tres-Orix Forte Oral Solution


GREECE


Apivita SA
Date Published : 01/21/2014
Industrial Park, Strongyli , Markopoulo, GREECE
53 J D - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Liquid, Lotion
Date Published: 09/13/2019

Desc: Intimate Cleansing Gel
Notes: 2/27/2012

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 05/29/2014

Desc: Intimate Gentle Cleansing Gel
Notes: Unapproved New Drug

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 01/21/2014

Desc: Wine Elixir Anti-Wrinkle Eye - Lip Cream

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 01/21/2014

Desc: Natural Serum Lifting

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 01/21/2014

Desc: Wine Elixir Anti-Wrinkle - Restoring Face Oil

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 01/21/2014

Desc: Queen Bee Firming - Restoring Rich Face Cream

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 01/21/2014

Desc: Wine Elixir Anti-Wrinkle - Firming Rich Face Cream

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 01/21/2014

Desc: Queen Bee Firming - Restoring Serum

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 01/21/2014

Desc: Queen Bee Firming - Restoring Rich Face Cream

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 01/21/2014

Desc: Wine Elixir Anti-Wrinkle - Firming Night Cream

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 01/21/2014

Desc: Wine Elixir Anti-Wrinkle - Firming Rich Face Cream

53 L - - 07 Night (Skin Care Preparations)
Date Published: 01/21/2014

Desc: Wine Elixir Anti-Wrinkle - Firming Night Cream

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 01/21/2014

Desc: Wine Elixir Anti-Wrinkle - Firming Night Cream

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 01/21/2014

Desc: Wine Elixir Anti-Wrinkle - Firming Rich Face Cream

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 01/21/2014

Desc: Wine Elixir Anti-Wrinkle - Restoring Face Oil

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/29/2014

Desc: Intimate Gentle Cleansing Gel
Notes: Unapproved New Drug

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 01/21/2014

Desc: Wine Elixir Anti-Wrinkle - Restoring Face Oil

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 01/21/2014

Desc: Wine Elixir Anti-Wrinkle Eye - Lip Cream

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 01/21/2014

Desc: Natural Serum Lifting

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 01/21/2014

Desc: Queen Bee Firming - Restoring Serum

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 01/21/2014

Desc: Queen Bee Firming - Restoring Rich Face Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/21/2014

Desc: Natural Serum Lifting

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/29/2014

Desc: Intimate Gentle Cleansing Gel
Notes: Unapproved New Drug

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/21/2014

Desc: Queen Bee Firming - Restoring Serum

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/21/2014

Desc: Wine Elixir Anti-Wrinkle - Firming Rich Face Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/21/2014

Desc: Wine Elixir Anti-Wrinkle - Restoring Face Oil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/21/2014

Desc: Queen Bee Firming - Restoring Rich Face Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/21/2014

Desc: Wine Elixir Anti-Wrinkle - Firming Night Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/21/2014

Desc: Wine Elixir Anti-Wrinkle Eye - Lip Cream

Direct-RX Meds and Or Direct RX Meds
Date Published : 09/30/2009
58 , Xanthi, GREECE
65 V - - 13 Clozapine (Sedative)
Date Published: 09/30/2009

Desc:
Notes: Phone: 909.909.9000. webmaster@drxmeds.com and www.drxmeds.com 2/8/2007

European Pills (European-Pills.com)
Date Published : 09/30/2009
Georgios Mitropoulos , 113 Aristomenous St. , Kalamata, GREECE
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                         

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Famar Ave
Date Published : 06/13/2016
Avlonos 49th , Athina, GREECE
60 S - - 99 Antacid, N.E.C.
Date Published: 06/13/2016

Desc: Woodwards Gripe Water

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/13/2016

Desc: Woodwards Gripe Water

G.S. PAPANIKOLAOU BROS O.E.
Date Published : 06/15/2011
Messinis Street 2 , Kalamata, Messinias GREECE
21 G - - 09 Olives (Pit Fruit)
Date Published: 06/15/2011

Desc: Kalamata Olives Packed in Olive Oil
Notes: Greece;Note: The article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an effective new drug application (NDA) due to the following label claims: Olive oil reduces the risk of coronary heart disease by lowering LDL (bad) cholesterol.. and Olive oil can protect against cancers and is associated with reducing high blood pressure.

GIAMKO SMPC
Date Published : 05/23/2018
Iroon Polytechniou St 77 , Kalamata, Messinias GREECE
31 P - - 04 Tea, Camomille, Chamomile (Tea Substitute)
Date Published: 05/23/2018

Desc: Chamomile Tea

54 E - - 04 Camomille (Herbal & Botanical Teas)
Date Published: 05/23/2018

Desc: Chamomile Tea

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/23/2018

Desc: Chamomile Tea

GIAMKO SMPC
Date Published : 05/23/2018
Iroon Polytechniou St 77 , Kalamata, Messinias GREECE
31 K - - 99 Tea, N.E.C.
Date Published: 06/20/2018

Desc: Mountain Tea

31 P - - 04 Tea, Camomille, Chamomile (Tea Substitute)
Date Published: 05/23/2018

Desc: Chamomile Tea

54 E - - 04 Camomille (Herbal & Botanical Teas)
Date Published: 05/23/2018

Desc: Chamomile Tea

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/23/2018

Desc: Chamomile Tea

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/20/2018

Desc: Mountain Tea

Olive Fabrica, G.Dafnis & S.Dafnis General Partnership
Date Published : 06/28/2022
Aghios Matthaios , Corfu, Ionioi Nisoi GREECE
26 A - - 09 Virgin Olive Oil, Crude
Date Published: 06/28/2022

Desc: kyoord High-phenolic Olive Oil

26 C - - 04 Olive Oil, Refined, Single Ingredient
Date Published: 06/28/2022

Desc: kyoord High-phenolic Olive Oil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/28/2022

Desc: kyoord High-phenolic Olive Oil

RGCC SA
Date Published : 10/11/2022
Industrial Area Of Flor , Florina, GREECE
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/11/2022

Desc: Genistein

VAMVAKOUSIS & SIA OMETATRON
Date Published : 07/22/2014
Kallithea , Perikleous 2 , Athens, GREECE
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/22/2014

Desc: Netra food supplement
Notes: Problem(s);Unapproved New Drug; Misbranded Drug;FDA analysis found Sildenafil analogs in this product; which is being promoted as a dietary supplement.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/22/2014

Desc: Netra food supplement
Notes: Problem(s);Unapproved New Drug; Misbranded Drug;FDA analysis found Sildenafil analogs in this product; which is being promoted as a dietary supplement.


GRENADA


Discount Meds
Date Published : 09/30/2009
PO BOX 1005 , Grand Anse , St. Georges, GRENADA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 07/20/2020

Desc: Abarelix
Notes:                      

64 R - - 21 Somatropin (Hormone)
Date Published: 07/20/2020

Notes:                      

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                      


GUYANA


New GPC Inc.
Date Published : 03/31/2017
Lot A1 Farm , East Bank Demerara, GUYANA
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 03/31/2017

Desc: Nutrophos Liquid Nerve Tonic With Vitamin B
Notes: The Nutrophos Liquid Nerve Tonic With Vitamin B product appears to be an unapproved new drug as the product label includes claims such as: 'Liquid Nerve Tonic … Recommended treatment for listlessness, loss of appetite, sleeplessness …; NUTROPHOS improves the appetite, soothes frayed nerves …'. This DWPE listing does not apply to the firm's Nutrophos Liquid Dietary Supplement With B Vitamins And Minerals product.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/31/2017

Desc: Nutrophos Liquid Nerve Tonic With Vitamin B
Notes: The Nutrophos Liquid Nerve Tonic With Vitamin B product appears to be an unapproved new drug as the product label includes claims such as: 'Liquid Nerve Tonic … Recommended treatment for listlessness, loss of appetite, sleeplessness …; NUTROPHOS improves the appetite, soothes frayed nerves …'. This DWPE listing does not apply to the firm's Nutrophos Liquid Dietary Supplement With B Vitamins And Minerals product.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/31/2017

Desc: Nutrophos Liquid Nerve Tonic With Vitamin B
Notes: The Nutrophos Liquid Nerve Tonic With Vitamin B product appears to be an unapproved new drug as the product label includes claims such as: 'Liquid Nerve Tonic … Recommended treatment for listlessness, loss of appetite, sleeplessness …; NUTROPHOS improves the appetite, soothes frayed nerves …'. This DWPE listing does not apply to the firm's Nutrophos Liquid Dietary Supplement With B Vitamins And Minerals product.

Twins Manufacturing Chemists
Date Published : 11/08/2010
31 Industrial Estate , Ruimveldt, GY-NOTA GUYANA
54 A - - 99 Vitamin, N.E.C.
Date Published: 01/10/2018

Desc: FERROTONE MULTIVITAMIN IRON TONIC
Notes: Medical claims made on product label

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/10/2018

Desc: FERROTONE MULTIVITAMIN IRON TONIC
Notes: Medical claims made on product label

62 U - - 99 Anti-Tussive/Cold N.E.C.
Date Published: 11/08/2010

Desc: Tussadryl Compound Linctus
Notes: Guyana

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/10/2018

Desc: FERROTONE MULTIVITAMIN IRON TONIC
Notes: Medical claims made on product label

Yasco Seafoods Inc
Date Published : 06/02/2017
Eccles Industrial Estate 68 , Georgetown, GUYANA
54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 06/02/2017

Desc: Becoactin Syrup
Notes: The product appears to be an unapproved new drug as the product packaging insert includes claims such as: ' Indications: Appetite Stimulant ; Pharmacology: Cyproheptadine is an antihistamine, anticholinergic & antiserotonergic agent. Cyproheptadine is use to stimulate appetite. Vitamine B complex acts as coenzymes in metabolic reactions & also helps to improve appetite & body weight '

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/02/2017

Desc: Becoactin Syrup
Notes: The product appears to be an unapproved new drug as the product packaging insert includes claims such as: ' Indications: Appetite Stimulant ; Pharmacology: Cyproheptadine is an antihistamine, anticholinergic & antiserotonergic agent. Cyproheptadine is use to stimulate appetite. Vitamine B complex acts as coenzymes in metabolic reactions & also helps to improve appetite & body weight '

61 X - - 14 Cyproheptadine HCl (Anti-Histaminic)
Date Published: 06/02/2017

Desc: Becoactin Syrup
Notes: The product appears to be an unapproved new drug as the product packaging insert includes claims such as: ' Indications: Appetite Stimulant ; Pharmacology: Cyproheptadine is an antihistamine, anticholinergic & antiserotonergic agent. Cyproheptadine is use to stimulate appetite. Vitamine B complex acts as coenzymes in metabolic reactions & also helps to improve appetite & body weight '

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/02/2017

Desc: Becoactin Syrup
Notes: The product appears to be an unapproved new drug as the product packaging insert includes claims such as: ' Indications: Appetite Stimulant ; Pharmacology: Cyproheptadine is an antihistamine, anticholinergic & antiserotonergic agent. Cyproheptadine is use to stimulate appetite. Vitamine B complex acts as coenzymes in metabolic reactions & also helps to improve appetite & body weight '


HAITI


Pharval Laboratories
Date Published : 04/07/2020
Rue Freres Simmons 13 , Port-Au-Prince, ouest HAITI
54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 04/07/2020

Desc: Fertone

54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 04/07/2020

Desc: Fertone Plus

54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 04/07/2020

Desc: Multival Forte

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/07/2020

Desc: Fertone

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/07/2020

Desc: Multival Forte

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/07/2020

Desc: Fertone Plus


HONDURAS


Chemexc - Organic Hope
Date Published : 09/30/2009
Km 6 Desvio Al Picacho , Carretera Al Cristo Del Picacho , Tegucigalpa, Francisco Morazan HONDURAS
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: 3/13/2008. Kalawalla Herbal Supplement Immuno C Food Supplement.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 3/13/2008. Kalawalla Herbal Supplement Immuno C Food Supplement.


HONG KONG SAR


4PX Worldwide Express CO LTD
Date Published : 08/19/2012
08 Kwong Sant Hong CTR 151-153 , Hoi Bun Rd , Kwun Tong Kowloon, HONG KONG SAR
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/19/2012

Desc: 7 Day Herbal Slim
Notes: China; Note; Analytical testing by FDA revealed the product contains undeclared Sibutramine.

America Manhatton Pharmaceutical International Group Company
Date Published : 04/27/2017
Room 806, No.153C Building, Nathan Road , Tsimshatsui, HONG KONG SAR
65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 04/27/2017

Desc: African Viagra Capsules
Notes: Product was found to contain Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/27/2017

Desc: African Viagra Capsules
Notes: Product was found to contain Sildenafil

Apollo Express Co Ltd.
Date Published : 06/13/2012
Kerry Cargo Centre Rm 201 , Wang Hoi Rd , Kowloon, HONG KONG SAR
60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 06/13/2012

Desc: Fruit Plant Losing Fat Capsules
Notes: Hong Kong

Chinky Enterprises
Date Published : 09/13/2019
3/F , Kundamal House; 2-4 Prat Avenue , Tsim Sha Tsui, Kowloon HONG KONG SAR
53 - - - -- Cosmetics
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

73 - - - -- Anesthesiology
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

74 - - - -- Cardiovascular
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

76 - - - -- Dental
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

77 - - - -- Ear,Nose And Throat
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

78 - - - -- Gastroenterological & Urological
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

79 - - - -- General & Plastic Surgery
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

80 - - - -- General Hospital/Personal Use
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

84 - - - -- Neurological
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

85 - - - -- Obstetrical & Gynecological
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

86 - - - -- Ophthalmic
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

87 - - - -- Orthopedic
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

89 - - - -- Physical Medicine
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

90 - - - -- Radiology
Date Published: 09/13/2019

Notes: Bamboo Crystal Foot Plaster, 3/8/2007

Esse Express Worldwide Limited
Date Published : 08/07/2014
Rm. 225-226, 2/F , Loong King Mansion B Industrial Center , Hung Hom, Kowloon, Hong Kong HONG KONG SAR
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/07/2014

Desc: Gold Vigra Capsules
Notes: Product contains undeclared Sildenafil

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/07/2014

Desc: Gold Vigra Capsules
Notes: Product contains undeclared Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/07/2014

Desc: Gold Vigra Capsules
Notes: Product contains undeclared Sildenafil

Essence Master Limited
Date Published : 10/01/2013
Room 502 3 Commercial House 35 Queens , Hong Kong, HONG KONG SAR
30 B - - 04 Beverage Base, Mixed Fruit, Liquid
Date Published: 10/01/2013

Desc: Smart Sense Ananas Strawberry Balance (Powder Drinking Preparation/10 Gram Sachets)
Notes: Analytical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein

31 A - - 02 Coffee, Ground
Date Published: 01/31/2014

Desc: Smart Sense Acai Berry Coffee

31 A - - 02 Coffee, Ground
Date Published: 01/31/2014

Desc: Leptin Slimming Coffee-Rose Curve Coffee

31 A - - 02 Coffee, Ground
Date Published: 01/31/2014

Desc: Leptin GreenCoffee 800

31 A - - 03 Coffee, Instant
Date Published: 01/31/2014

Desc: Leptin Slimming Coffee-Rose Curve Coffee

31 A - - 03 Coffee, Instant
Date Published: 01/31/2014

Desc: Leptin GreenCoffee 800

31 A - - 03 Coffee, Instant
Date Published: 01/31/2014

Desc: Smart Sense Acai Berry Coffee

31 A - - 99 Coffee, N.E.C.
Date Published: 01/31/2014

Desc: Leptin Slimming Coffee-Rose Curve Coffee

31 A - - 99 Coffee, N.E.C.
Date Published: 01/31/2014

Desc: Smart Sense Acai Berry Coffee

31 A - - 99 Coffee, N.E.C.
Date Published: 01/31/2014

Desc: Leptin GreenCoffee 800

31 K - - 02 Tea, Green
Date Published: 01/31/2014

Desc: Leptin Slimming Green Tea

31 M - - 01 Tea With Fruit (peels, chunks, bits or pieces)
Date Published: 01/31/2014

Desc: Leptin All-in-One Fat Loss Formula Iced Fruit Tea

31 M - - 99 Blended Teas, N.E.C.
Date Published: 01/31/2014

Desc: Leptin All-in-One Fat Loss Formula Iced Fruit Tea

34 B - - 99 Chocolate and Cocoa, N.E.C.
Date Published: 01/31/2014

Desc: Leptin Weight Loss Chocolate

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 01/31/2014

Desc: Leptin Slimming Coffee-Rose Curve Coffee

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 01/31/2014

Desc: Leptin Slimming Green Tea

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 01/31/2014

Desc: Leptin Weight Loss Chocolate

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 01/31/2014

Desc: Leptin GreenCoffee 800

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/31/2014

Desc: Smart Sense Acai Berry Coffee

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/31/2014

Desc: LingZhi Plus

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/31/2014

Desc: Leptin Weight Loss Chocolate

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/31/2014

Desc: Leptin GreenCoffee 800

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/31/2014

Desc: Leptin Slimming Coffee-Rose Curve Coffee

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/31/2014

Desc: Leptin Slimming Green Tea

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/31/2014

Desc: Leptin All-in-One Fat Loss Formula Iced Fruit Tea

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 01/31/2014

Desc: Leptin Slimming Coffee-Rose Curve Coffee

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 01/31/2014

Desc: Leptin Slimming Green Tea

63 H - - 17 Phenolphthalein (Cathartic)
Date Published: 01/31/2014

Desc: Leptin GreenCoffee 800

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/01/2013

Desc: Smart Sense Ananas Strawberry Balance (Powder Drinking Preparation/10 Gram Sachets)
Notes: Analytical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein

Eu Yan Sang (Hong Kong) Ltd.
Date Published : 03/06/2015
Yuen Long Industrial Estate Yuen Long , 10-12 Wang Lee Street , Yuen Long, New Territories HONG KONG SAR
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/06/2015

Desc: Bo Ying Compound
Notes: Product label bears medical claims and therefore the product is considered as a drug without an effective NDA. Product was found to contain lead by New York City Department of Health & Mental Hygiene.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/06/2015

Desc: Bo Ying Compound
Notes: Product label bears medical claims and therefore the product is considered as a drug without an effective NDA. Product was found to contain lead by New York City Department of Health & Mental Hygiene.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/06/2015

Desc: Bo Ying Compound
Notes: Product label bears medical claims and therefore the product is considered as a drug without an effective NDA. Product was found to contain lead by New York City Department of Health & Mental Hygiene.

HLYWL-JGS
Date Published : 08/21/2012
P.O. box No. 68107 , East Post office , Kowloon, HONG KONG SAR
60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 08/21/2012

Desc: Unmarked Green/White caps
Notes: Hong Kong; Note; Analytical testing by FDA revealed the product contains undeclared sibutramine and phenolphthalein

Hong Kong Data Express Ltd
Date Published : 09/05/2014
Unit C, 4/F , Yoo Hoo Tower, Kwai Fung , Kwai Chung, HONG KONG SAR
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/05/2014

Desc: Effortless weight loss NEW YOU
Notes: Product contains undeclared Sibutramine HCl and Phenolphthalein

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 09/05/2014

Desc: Effortless weight loss NEW YOU
Notes: Product contains undeclared Sibutramine HCl and Phenolphthalein

63 H - - 17 Phenolphthalein (Cathartic)
Date Published: 09/05/2014

Desc: Effortless weight loss NEW YOU
Notes: Product contains undeclared Sibutramine HCl and Phenolphthalein

Hong Kong Genic Biology Technology Engineering Company Ltd.
Date Published : 08/11/2015
Room 1106, No. C building , No. 18 Canton Road , Tsimshatsui, HONG KONG SAR
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/11/2015

Desc: Sex Love Secret Code Capsules
Notes: Contains undeclared Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/11/2015

Desc: Sex Love Secret Code Capsules
Notes: Contains undeclared Sildenafil

Hong Kong Hongwei Biological Research Center
Date Published : 02/27/2015
Unknown , Unknown, Unknown HONG KONG SAR
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/12/2016

Desc: Black Ant King
Notes: Found to contain undeclared Sildenafil

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/27/2015

Desc: Zhen Gongfu Capsules
Notes: The aforementioned product appears to be an unapproved new drug as a sample of the product found the product contains sildenafil. In addition; the product appears to be an unapproved new drug as the product label states; in part; This product is the substitute for American Viagra successfully developed by Hong Kong Hongwei Biological Research Center.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/21/2017

Notes: All Drug and Drug Product;Only drug and drug products are subject to DWPE under Industry Code 54;

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/21/2017

Notes: All Drug and Drug Product;Only drug and drug products are subject to DWPE under Industry Code 54;

56 - - - -- Antibiotics (Human/Animal)
Date Published: 07/21/2017

Notes: All Drug and Drug Product;Only drug and drug products are subject to DWPE under Industry Code 54;

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 07/21/2017

Notes: All Drug and Drug Product;Only drug and drug products are subject to DWPE under Industry Code 54;

61 - - - -- Human and Animal Drugs
Date Published: 07/21/2017

Notes: All Drug and Drug Product;Only drug and drug products are subject to DWPE under Industry Code 54;

62 - - - -- Human and Animal Drugs
Date Published: 07/21/2017

Notes: All Drug and Drug Product;Only drug and drug products are subject to DWPE under Industry Code 54;

63 - - - -- Human and Animal Drugs
Date Published: 07/21/2017

Notes: All Drug and Drug Product;Only drug and drug products are subject to DWPE under Industry Code 54;

64 - - - -- Human and Animal Drugs
Date Published: 07/21/2017

Notes: All Drug and Drug Product;Only drug and drug products are subject to DWPE under Industry Code 54;

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 02/27/2015

Desc: Zhen Gongfu Capsules
Notes: The aforementioned product appears to be an unapproved new drug as a sample of the product found the product contains sildenafil. In addition; the product appears to be an unapproved new drug as the product label states; in part; This product is the substitute for American Viagra successfully developed by Hong Kong Hongwei Biological Research Center.

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 02/12/2016

Desc: Black Ant King
Notes: Found to contain undeclared Sildenafil

65 - - - -- Human and Animal Drugs
Date Published: 07/21/2017

Notes: All Drug and Drug Product;Only drug and drug products are subject to DWPE under Industry Code 54;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/27/2015

Desc: Zhen Gongfu Capsules
Notes: The aforementioned product appears to be an unapproved new drug as a sample of the product found the product contains sildenafil. In addition; the product appears to be an unapproved new drug as the product label states; in part; This product is the substitute for American Viagra successfully developed by Hong Kong Hongwei Biological Research Center. ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/12/2016

Desc: Black Ant King
Notes: Found to contain undeclared Sildenafil

66 - - - -- Human and Animal Drugs
Date Published: 07/21/2017

Notes: All Drug and Drug Product;Only drug and drug products are subject to DWPE under Industry Code 54;

Hong Kong Jingongfu Biotechnology Co., Ltd.
Date Published : 02/26/2021
2068 Austin Road , Tsim SHa Tsui, HONG KONG SAR
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/26/2021

Notes: U.S.A Viagra; Herb Viagra; The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Male sexual stimulant; The product can effectively activate PDA producing factors ofadrenal[sic] gland, renew sperm, accomplish multiejaculation[sic] andmulti-orgasm[sic]. It can quickly renwe[sic] the sperm after sex to avoidweariness[sic] and effect to kidney.' In addition, FDA analysis of product found product contains undeclared Sildenafil which cause the product to be a misbranded drug product under section 502(f)(2) of the FD&C Act.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 02/26/2021

Notes: U.S.A Viagra; Herb Viagra; The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Male sexual stimulant; The product can effectively activate PDA producing factors ofadrenal[sic] gland, renew sperm, accomplish multiejaculation[sic] andmulti-orgasm[sic]. It can quickly renwe[sic] the sperm after sex to avoidweariness[sic] and effect to kidney.' In addition, FDA analysis of product found product contains undeclared Sildenafil which cause the product to be a misbranded drug product under section 502(f)(2) of the FD&C Act.

56 - - - -- Antibiotics (Human/Animal)
Date Published: 02/26/2021

Notes: U.S.A Viagra; Herb Viagra; The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Male sexual stimulant; The product can effectively activate PDA producing factors ofadrenal[sic] gland, renew sperm, accomplish multiejaculation[sic] andmulti-orgasm[sic]. It can quickly renwe[sic] the sperm after sex to avoidweariness[sic] and effect to kidney.' In addition, FDA analysis of product found product contains undeclared Sildenafil which cause the product to be a misbranded drug product under section 502(f)(2) of the FD&C Act.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 02/26/2021

Notes: U.S.A Viagra; Herb Viagra; The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Male sexual stimulant; The product can effectively activate PDA producing factors ofadrenal[sic] gland, renew sperm, accomplish multiejaculation[sic] andmulti-orgasm[sic]. It can quickly renwe[sic] the sperm after sex to avoidweariness[sic] and effect to kidney.' In addition, FDA analysis of product found product contains undeclared Sildenafil which cause the product to be a misbranded drug product under section 502(f)(2) of the FD&C Act.

61 - - - -- Human and Animal Drugs
Date Published: 02/26/2021

Notes: U.S.A Viagra; Herb Viagra; The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Male sexual stimulant; The product can effectively activate PDA producing factors ofadrenal[sic] gland, renew sperm, accomplish multiejaculation[sic] andmulti-orgasm[sic]. It can quickly renwe[sic] the sperm after sex to avoidweariness[sic] and effect to kidney.' In addition, FDA analysis of product found product contains undeclared Sildenafil which cause the product to be a misbranded drug product under section 502(f)(2) of the FD&C Act.

62 - - - -- Human and Animal Drugs
Date Published: 02/26/2021

Notes: U.S.A Viagra; Herb Viagra; The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Male sexual stimulant; The product can effectively activate PDA producing factors ofadrenal[sic] gland, renew sperm, accomplish multiejaculation[sic] andmulti-orgasm[sic]. It can quickly renwe[sic] the sperm after sex to avoidweariness[sic] and effect to kidney.' In addition, FDA analysis of product found product contains undeclared Sildenafil which cause the product to be a misbranded drug product under section 502(f)(2) of the FD&C Act.

63 - - - -- Human and Animal Drugs
Date Published: 02/26/2021

Notes: U.S.A Viagra; Herb Viagra; The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Male sexual stimulant; The product can effectively activate PDA producing factors ofadrenal[sic] gland, renew sperm, accomplish multiejaculation[sic] andmulti-orgasm[sic]. It can quickly renwe[sic] the sperm after sex to avoidweariness[sic] and effect to kidney.' In addition, FDA analysis of product found product contains undeclared Sildenafil which cause the product to be a misbranded drug product under section 502(f)(2) of the FD&C Act.

64 - - - -- Human and Animal Drugs
Date Published: 02/26/2021

Notes: U.S.A Viagra; Herb Viagra; The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Male sexual stimulant; The product can effectively activate PDA producing factors ofadrenal[sic] gland, renew sperm, accomplish multiejaculation[sic] andmulti-orgasm[sic]. It can quickly renwe[sic] the sperm after sex to avoidweariness[sic] and effect to kidney.' In addition, FDA analysis of product found product contains undeclared Sildenafil which cause the product to be a misbranded drug product under section 502(f)(2) of the FD&C Act.

65 - - - -- Human and Animal Drugs
Date Published: 02/26/2021

Notes: U.S.A Viagra; Herb Viagra; The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Male sexual stimulant; The product can effectively activate PDA producing factors ofadrenal[sic] gland, renew sperm, accomplish multiejaculation[sic] andmulti-orgasm[sic]. It can quickly renwe[sic] the sperm after sex to avoidweariness[sic] and effect to kidney.' In addition, FDA analysis of product found product contains undeclared Sildenafil which cause the product to be a misbranded drug product under section 502(f)(2) of the FD&C Act.

66 - - - -- Human and Animal Drugs
Date Published: 02/26/2021

Notes: U.S.A Viagra; Herb Viagra; The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Male sexual stimulant; The product can effectively activate PDA producing factors ofadrenal[sic] gland, renew sperm, accomplish multiejaculation[sic] andmulti-orgasm[sic]. It can quickly renwe[sic] the sperm after sex to avoidweariness[sic] and effect to kidney.' In addition, FDA analysis of product found product contains undeclared Sildenafil which cause the product to be a misbranded drug product under section 502(f)(2) of the FD&C Act.

Hong Kong Sun Biological Engineer Corporation
Date Published : 06/25/2015
28-6A Austin Road , Tsim Sha Tsui , HONG KONG SAR
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/25/2015

Desc: Vigour 300 Tablets
Notes: Problems; Sildenafil

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 06/25/2015

Desc: Vigour 300 Tablets
Notes: Problems; Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/25/2015

Desc: Vigour 300 Tablets
Notes: Problems; Sildenafil

Hong Kong Tianlong Technology International Group Company
Date Published : 07/03/2013
20/F , Hua Chiao Commercial Centre , Mong Kok, Kowloon HONG KONG SAR
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/03/2013

Desc: Zhonghua Niubian Tablets
Notes: Hong Kong;Note; FDA analysis found Sildenafil in product

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/29/2015

Desc: German Black Ant Pills (Shengjingpian or Zhansheng Weige Chaoyue Xilishi)
Notes: Contains undeclared Sildenafil. Product label contains structure/function claims.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/03/2013

Desc: Zhonghua Niubian Tablets
Notes: Hong Kong;Note; FDA analysis found Sildenafil in product

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 07/29/2015

Desc: German Black Ant Pills (Shengjingpian or Zhansheng Weige Chaoyue Xilishi)
Notes: Contains undeclared Sildenafil. Product label contains structure/function claims.

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 07/03/2013

Desc: Zhonghua Niubian Tablets
Notes: Hong Kong;Note; FDA analysis found Sildenafil in product

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/29/2015

Desc: German Black Ant Pills (Shengjingpian or Zhansheng Weige Chaoyue Xilishi)
Notes: Contains undeclared Sildenafil. Product label contains structure/function claims.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/03/2013

Desc: Zhonghua Niubian Tablets
Notes: Hong Kong;Note; FDA analysis found Sildenafil in product

Hong Kong Xinsheng Biological Tech Research Center
Date Published : 08/27/2015
Tower C 28F Sunshine Plaza No. 76 Jiulo , Unknown, HONG KONG SAR
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/27/2015

Desc: Effective Viagra Tablets
Notes: Found to contain undeclared Sildenafil

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 08/27/2015

Desc: Effective Viagra Tablets
Notes: Found to contain undeclared Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/27/2015

Desc: Effective Viagra Tablets
Notes: Found to contain undeclared Sildenafil

HongKong Xin Yuan Express Ltd
Date Published : 11/02/2012
5 TH No 14 Lanes Sanlian Buki , Longgang, HONG KONG SAR
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/02/2012

Desc: 3X Slimming Power
Notes: Note; Analytical testing by FDA revealed the product contains undeclared Sibutramine.

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 11/02/2012

Desc: 3X Slimming Power
Notes: Note; Analytical testing by FDA revealed the product contains undeclared Sibutramine.

Hongkong Jiuyuejiu Biology Technology CO., LTD
Date Published : 04/27/2017
1226, Tsim Sha Tsui , Unknown, HONG KONG SAR
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/27/2017

Desc: Power Tablets
Notes: Product was found to contain undeclared Sildenafil

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 04/27/2017

Desc: Power Tablets
Notes: Product was found to contain undeclared Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/27/2017

Desc: Power Tablets
Notes: Product was found to contain undeclared Sildenafil

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 04/27/2017

Desc: Power Tablets
Notes: Product was found to contain undeclared Sildenafil

Hugh Source International Ltd.
Date Published : 04/23/2020
Roon 2501-4, Wealth Commercial Centre , 42-56 Kwong Wa Street , Mongkok, Kowloon HONG KONG SAR
53 - - - -- Cosmetics
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 07 Myobloc
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

JiuDu Yuan Bio Medicine Group.,Ltd
Date Published : 11/01/2016
1106A room Jin MaoMansion , Shanghai, HONG KONG SAR
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 11/01/2016

Desc: Shark Extract Tablets
Notes: Product was found to contain undeclared Sildenafil

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/08/2019

Desc: Super Hard 180 Hours Capsules
Notes: Contains undeclared Sildenafil ; 7/08/2015

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 10/08/2019

Desc: Top Man Supplement
Notes: Labeling claims and product was found to contain undeclared Sildenafil

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 10/08/2019

Desc: Top Man Supplement
Notes: Labeling claims and product was found to contain undeclared Sildenafil

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 11/01/2016

Desc: Shark Extract Tablets
Notes: Product was found to contain undeclared Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/08/2019

Desc: Super Hard 180 Hours Capsules
Notes: Contains undeclared Sildenafil ; 7/08/2015

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/01/2016

Desc: Shark Extract Tablets
Notes: Product was found to contain undeclared Sildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/08/2019

Desc: Top Man Supplement
Notes: Labeling claims and product was found to contain undeclared Sildenafil

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 11/01/2016

Desc: Shark Extract Tablets
Notes: Product was found to contain undeclared Sildenafil

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 10/08/2019

Desc: Top Man Supplement
Notes: Labeling claims and product was found to contain undeclared Sildenafil

King Fortress (Hong Kong) Limited
Date Published : 09/13/2022
Wah Sang , 14-18 Wong Chuk Yeung Street , Sha Tin, New Territories HONG KONG SAR
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 09/13/2022

Desc: Bourbon Spice Invigorating Hair and Beard Conditioner
Notes: The product may be sold individually or included in an ‘Essential Men’s Grooming Kit’. The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "[S]timulates the scalp and skin … that promote health and beard growth”; “Regenerates & stimulates the scalp promoting healthy hair growth”

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 09/13/2022

Desc: Bold Hold Firm Hold Styling Gel
Notes: The product may be sold individually or included in an ‘Essential Men’s Grooming Kit’. The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "[F]or healthy scalp & hair growth”; “Prevents irritation”.

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 09/13/2022

Desc: Bourbon Spice Invigorating Hair and Beard Conditioner
Notes: The product may be sold individually or included in an ‘Essential Men’s Grooming Kit’. The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "[S]timulates the scalp and skin … that promote health and beard growth”; “Regenerates & stimulates the scalp promoting healthy hair growth”

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 09/13/2022

Desc: Gold Reserve Luxury Shaving Cream and Beard Wash
Notes: The product may be sold individually or included in an ‘Essential Men’s Grooming Kit’. The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "Prevents irritation”

53 K - - -- Shaving Prep
Date Published: 09/13/2022

Desc: Bold Hold Firm Hold Styling Gel
Notes: The product may be sold individually or included in an ‘Essential Men’s Grooming Kit’. The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "[F]or healthy scalp & hair growth”; “Prevents irritation”.

53 K - - -- Shaving Prep
Date Published: 09/13/2022

Desc: Gold Reserve Luxury Shaving Cream and Beard Wash
Notes: The product may be sold individually or included in an ‘Essential Men’s Grooming Kit’. The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "Prevents irritation”

53 K - - -- Shaving Prep
Date Published: 09/13/2022

Desc: Bourbon Spice Invigorating Hair and Beard Conditioner
Notes: The product may be sold individually or included in an ‘Essential Men’s Grooming Kit’. The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "[S]timulates the scalp and skin … that promote health and beard growth”; “Regenerates & stimulates the scalp promoting healthy hair growth”

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/13/2022

Desc: Gold Reserve Luxury Shaving Cream and Beard Wash
Notes: The product may be sold individually or included in an ‘Essential Men’s Grooming Kit’. The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "Prevents irritation”

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/13/2022

Desc: Bold Hold Firm Hold Styling Gel
Notes: The product may be sold individually or included in an ‘Essential Men’s Grooming Kit’. The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "[F]or healthy scalp & hair growth”; “Prevents irritation”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/13/2022

Desc: Bourbon Spice Invigorating Hair and Beard Conditioner
Notes: The product may be sold individually or included in an ‘Essential Men’s Grooming Kit’. The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "[S]timulates the scalp and skin … that promote health and beard growth”; “Regenerates & stimulates the scalp promoting healthy hair growth”

Kwan Dong Tun Pak Tong Med
Date Published : 05/24/2010
Fu Wah Ind Poldg 17 Hei Yip St , Yuen Long, HONG KONG SAR
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 05/26/2010

Desc: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal La Flecha/ Hong Kong SAR

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 05/24/2010

Desc: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal
Notes: Hong Kong SAR

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal "La Flecha"

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal "La Flecha"

61 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal "La Flecha"

62 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal "La Flecha"

63 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal "La Flecha"

64 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal "La Flecha"

65 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal "La Flecha"

66 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal "La Flecha"

Kwan Dong Tung Pak Tong Medicine Manufactory Ltd
Date Published : 05/24/2010
Room 8b, 5/f, Block A , 256-264 Texaco Road , Tsuen Wan, HONG KONG SAR
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal "La Flecha"

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 05/24/2010

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal "La Flecha"

61 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal "La Flecha"

62 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal "La Flecha"

63 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal "La Flecha"

64 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal "La Flecha"

65 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal "La Flecha"

66 - - - -- Human and Animal Drugs
Date Published: 05/24/2010

Notes: Arrow Brand Medicated Oil & Embrocation (Aceite Medicinal "La Flecha"

Let Start Technology Co
Date Published : 08/18/2014
63-75 Ta Chuen Ping Street , Kwai Chung, HONG KONG SAR
28 O - - 99 Essential Oils for Flavoring, n.e.c.
Date Published: 08/18/2014

Desc: Hemp Hookahzz E-liquid (Essential Oil for Atomizer)
Notes: Unapproved New Drug; Misbranded Drug

55 Q - - 58 Glycerin (Pharmaceutic Necessity - Solvent)
Date Published: 08/18/2014

Desc: Hemp Hookahzz E-liquid (Essential Oil for Atomizer)
Notes: Unapproved New Drug; Misbranded Drug

55 Q - - 58 Glycerin (Pharmaceutic Necessity - Solvent)
Date Published: 08/18/2014

Desc: E-cigarette with essential oil cartridge
Notes: Unapproved New Drug; Misbranded Drug

66 B - - 44 Nicotine Delivery System
Date Published: 08/18/2014

Desc: E-cigarette with essential oil cartridge
Notes: Unapproved New Drug; Misbranded Drug

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/18/2014

Desc: Hemp Hookahzz E-liquid (Essential Oil for Atomizer)
Notes: Unapproved New Drug; Misbranded Drug

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/18/2014

Desc: E-cigarette with essential oil cartridge
Notes: Unapproved New Drug; Misbranded Drug

98 C - - 99 Smokeless Tobacco, Not Elsewhere Classified (N.E.C.)
Date Published: 08/18/2014

Desc: Hemp Hookahzz E-liquid (Essential Oil for Atomizer)
Notes: Unapproved New Drug; Misbranded Drug

98 C - - 99 Smokeless Tobacco, Not Elsewhere Classified (N.E.C.)
Date Published: 08/18/2014

Desc: E-cigarette with essential oil cartridge
Notes: Unapproved New Drug; Misbranded Drug

Luxembourg Medicine Company Limited
Date Published : 08/30/2021
Wai Yuen Tong Medicine Building , 9 Wang Kwong Road , Kowloon Bay, Kowloon HONG KONG SAR
66 - - - -- Human and Animal Drugs
Date Published: 08/30/2021

Desc: Madame Pearl's Cough Syrup
Notes:                                                                                               

M & A COMPANY
Date Published : 02/23/2011
Room 1807 Fo , Fo Tan Industrial Centre; 26-28 Au Pui Wan Street , Sha Tin, New Territories HONG KONG SAR
62 M - - 08 Menthol (Anti-Pruritic)
Date Published: 02/23/2011

Desc: Herbal Plaster
Notes: Hong Kong

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/23/2011

Desc: Japanese Mushroom Dietary Supplement
Notes: Hong Kong

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/25/2011

Desc: M & A Golden 50

M.G.L
Date Published : 05/22/2012
Unknown , Unknown, HONG KONG SAR
60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 05/22/2012

Desc: Acai Berry Soft Gel
Notes: china

Magnum Pharmaceuticals
Date Published : 11/07/2017
Unknown , Central, HONG KONG SAR
60 K - - 99 Anabolic, N.E.C.
Date Published: 11/27/2017

Desc: Clenbuterol
Notes: The product appears to be an unapproved new drug as the product website includes claims such as; "...very effective fat loss stimulant with anti-catabolic properties...".

60 K - - 99 Anabolic, N.E.C.
Date Published: 11/07/2017

Desc: Various Anabolic Steroids- Tren A 100 (Trenbolone Acetate)

60 K - - 99 Anabolic, N.E.C.
Date Published: 11/07/2017

Desc: Primo 100 (Methenolone Enanthate Injection)

60 K - - 99 Anabolic, N.E.C.
Date Published: 12/13/2017

Desc: Cypionax (Testosterone Cypionate)
Notes: Mecial claims made in mfg. website (www.tpdrug.com)

60 K - - 99 Anabolic, N.E.C.
Date Published: 11/07/2017

Desc: Drostan-P 100 (Drostanolone Propionate Injections)

60 K - - 99 Anabolic, N.E.C.
Date Published: 11/07/2017

Desc: Stanol-AW-100 (Stanozolol Injection)

60 K - - 99 Anabolic, N.E.C.
Date Published: 11/27/2017

Desc: Anavar (Oxandrolone)
Notes: The product appears to be an unapproved new drug as the product website includes claims such as; ...Promotes great strength gains and solid lean mass gains...".

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/07/2017

Desc: Various Anabolic Steroids- Tren A 100 (Trenbolone Acetate)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/07/2017

Desc: Stanol-AW-100 (Stanozolol Injection)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/07/2017

Desc: Drostan-P 100 (Drostanolone Propionate Injections)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/07/2017

Desc: Primo 100 (Methenolone Enanthate Injection)

Mester Trading
Date Published : 08/21/2012
10F Tech Bldg. E Heping Rd , Longhua St, Baoan Dist. Shenzhen , Guangdong, HONG KONG SAR
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 08/21/2012

Desc: Magic Slim Tea
Notes: Hong Kong; Note; Analytical testing by FDA revealed the product contains undeclared sibutramine

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 08/21/2012

Desc: 2 Day Diet-Japan Lingzhi Slimming formula
Notes: Hong Kong; Note; Analytical testing by FDA revealed the product contains undeclared sibutramine

Ming-fu Bio-Pharmaceutical Co., Ltd.
Date Published : 03/06/2015
Junction Road, Tsim Sha Tsui , Hang Sen Building 18A , Kowloon, HONG KONG SAR
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/06/2015

Desc: Abdomen Smoothing Capsules
Notes: Problem; Sibutramine

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 03/06/2015

Desc: Abdomen Smoothing Capsules
Notes: Problem; Sibutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/06/2015

Desc: Abdomen Smoothing Capsules
Notes: Problem; Sibutramine

No. 8 11alley
Date Published : 08/22/2012
xia shi wei district hu yong town , boan district , shen zhen city guangdong, HONG KONG SAR
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 08/22/2012

Desc: Magic Slim
Notes: Hong Kong;Note: Analytical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/02/2012

Desc: Body Envy Slimming Capsules
Notes: Analystical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/22/2012

Desc: Magic Slim
Notes: Hong Kong;Note; Analytical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/02/2012

Desc: Body Envy Slimming Capsules
Notes: Analystical testing by FDA revealed the product contains undeclared Sibutramine and Phenolphthalein

Panda International Trade Co., Ltd.
Date Published : 01/19/2012
Henan Building , 90 Jaffe Road , Wan Chai, Hong Kong Island HONG KONG SAR
53 - - - -- Cosmetics
Date Published: 01/19/2012

Notes: Lulanjina Skin Cream

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/19/2012

Notes: Lulanjina Skin Cream

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Lulanjina Skin Cream

61 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Lulanjina Skin Cream

62 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

63 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Lulanjina Skin Cream

64 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Lulanjina Skin Cream

65 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Lulanjina Skin Cream

66 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Lulanjina Skin Cream

Peking Medicine Manufactory
Date Published : 04/04/2011
Unit B, 7/F, Phase 1 , Leader Industry Centre , Tsuen Wan, New Territories HONG KONG SAR
61 X B A 99 Anti-Histaminic N.E.C., Human - Non/Rx Combination Ingredient, Prompt Release Tablets
Date Published: 04/04/2011

Desc: Armadillo Trade Mark Counter Poison Pill
Notes: Hong Kong

SUPERPOWERS HERBAL EMPOWERMENT
Date Published : 02/03/2022
148 Des Voeux Road , Hong Kong, HONG KONG SAR
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 02/03/2022

Desc: ROCK HARD Male Enhancement Tea
Notes: The product appears to be an unapproved new drug as the product’s promotional website includes statements such as (not an all-inclusive list): ‘I’ve been struggling with ED and almost gave up. Tried prescription pills, but they did not do anything. I saw an ad for Rock Hard and thought why not. I just finished the 30 days and man…my erections are back.’; ‘After hitting my late 40s I basically lost all my interest in sex as ED hit me pretty hard. I tried this program for fun but ended up getting a life-changing experience!’

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2022

Desc: ROCK HARD Male Enhancement Tea
Notes: The product appears to be an unapproved new drug as the product’s promotional website includes statements such as (not an all-inclusive list): ‘I’ve been struggling with ED and almost gave up. Tried prescription pills, but they did not do anything. I saw an ad for Rock Hard and thought why not. I just finished the 30 days and man…my erections are back.’; ‘After hitting my late 40s I basically lost all my interest in sex as ED hit me pretty hard. I tried this program for fun but ended up getting a life-changing experience!’

SUPGRL Group Limited
Date Published : 12/15/2023
50 Stanley Street , Suite C, Level 7 World Trust Tower , Central, Kowloon HONG KONG SAR
53 M - - 02 Indoor Tanning Preparations (Suntan Preparations)
Date Published: 12/15/2023

Desc: PERMATAN Tanning Sublingual Oral Spray

53 M - - 02 Indoor Tanning Preparations (Suntan Preparations)
Date Published: 12/15/2023

Desc: PERMATAN Tanning Nasal Spray Triple Strength

53 M - - 02 Indoor Tanning Preparations (Suntan Preparations)
Date Published: 12/15/2023

Desc: PERMATAN Sublingual Drops; Triple Strength

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/15/2023

Desc: PERMATAN Sublingual Drops; Triple Strength

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/15/2023

Desc: PERMATAN Tanning Nasal Spray Triple Strength

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/15/2023

Desc: PERMATAN Tanning Sublingual Oral Spray

San Lian Technology Co Ltd
Date Published : 05/05/2014
Rm 30, 11/F, Thriving Ind. Ctr. No 26-38 , Tsuen Wantsuen Wan, HONG KONG SAR
28 O - - 99 Essential Oils for Flavoring, n.e.c.
Date Published: 05/05/2014

Desc: Essential Oils for e-cigarettes
Notes: Problem; Unapproved New Drug

55 Q - - 44 Monothioglycerol (Pharmaceutic Necessity - Preservative)
Date Published: 05/05/2014

Desc: Essential Oils for e-cigarettes
Notes: Problem; Unapproved New Drug

55 Q - - 58 Glycerin (Pharmaceutic Necessity - Solvent)
Date Published: 05/05/2014

Desc: Essential Oils for e-cigarettes
Notes: Problem; Unapproved New Drug

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/05/2014

Desc: Essential Oils for e-cigarettes
Notes: Problem; Unapproved New Drug

98 C - - 99 Smokeless Tobacco, Not Elsewhere Classified (N.E.C.)
Date Published: 05/05/2014

Desc: Essential Oils for e-cigarettes
Notes: Problem; Unapproved New Drug

Shop 1 G/F Free Trade
Date Published : 07/27/2012
CTR 49 Tsun Yip St , Kwun Tong KLN, HONG KONG SAR
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/02/2012

Desc: Advance Slim 5
Notes: Note; Analytical testing by FDA revealed these products contain undeclared Sibutramine; in addition; Super Slim and Advance Slim 5 also contained Phenolphthalein.;Sibutramine;Phenolphthalein

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/31/2012

Desc: Perfect Slim
Notes: Hong Kong SAR; Note; Analytical testing by FDA revealed the product contains undeclared Sibutramine.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/16/2012

Desc: Unmarked Green Soft Gelcaps

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/27/2012

Desc: Pai You Guo Slim Capsule
Notes: Hong Kong SAR; Note; Analytical testing by FDA revealed the product contains undeclared Phenolphalein and Sibutramine.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/02/2012

Desc: Super Slim
Notes: Note; Analytical testing by FDA revealed these products contain undeclared Sibutramine; in addition; Super Slim and Advance Slim 5 also contained Phenolphthalein.;Sibutramine;Phenolphthalein ;

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/02/2012

Desc: PhentraBurn Slimming Capsules
Notes: Note; Analytical testing by FDA revealed these products contain undeclared Sibutramine; in addition; Super Slim and Advance Slim 5 also contained Phenolphthalein.;Sibutramine

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 11/02/2012

Desc: PhentraBurn Slimming Capsules
Notes: Note; Analytical testing by FDA revealed these products contain undeclared Sibutramine; in addition; Super Slim and Advance Slim 5 also contained Phenolphthalein.;Sibutramine

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 11/02/2012

Desc: Advance Slim 5
Notes: Note; Analytical testing by FDA revealed these products contain undeclared Sibutramine; in addition; Super Slim and Advance Slim 5 also contained Phenolphthalein.;Sibutramine;Phenolphthalein

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 11/02/2012

Desc: Super Slim
Notes: Note; Analytical testing by FDA revealed these products contain undeclared Sibutramine; in addition; Super Slim and Advance Slim 5 also contained Phenolphthalein.;Sibutramine;Phenolphthalein

Sing Kwong Plastic Boxes Fty. Ltd.
Date Published : 06/20/2012
6/F, Yat Sang Industrial Building, No. , Kowloon, HONG KONG SAR
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/20/2012

Desc: Whitening Essence Mask Lemon Hot Mask Ginseng Pearl Soft Mask

Smart Sense Group Limited
Date Published : 10/25/2021
17/F Winner Commercial Building , 401-3 Lockhart Road, Causeway Bay , Hong Kong, HONG KONG SAR
29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 10/25/2021

Desc: Liver Support Food Supplement
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. Product appears to be adulterated within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] in that the product is not generally recognized as safe and effective for the above referenced uses and for the following claims noted on liver support product page at www.bellaallnatural.com/products/liver-support-capsules: “Liver Support may help get rid of any excess fat and toxins specifically around the liver. It may also assist people that suffer from greasy liver. . .May Also helps to clear skin, from. . . acne.”

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/25/2021

Desc: Liver Support Food Supplement
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. Product appears to be adulterated within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] in that the product is not generally recognized as safe and effective for the above referenced uses and for the following claims noted on liver support product page at www.bellaallnatural.com/products/liver-support-capsules: “Liver Support may help get rid of any excess fat and toxins specifically around the liver. It may also assist people that suffer from greasy liver. . .May Also helps to clear skin, from. . . acne.”

Smart Sense International Limited
Date Published : 01/31/2014
Commercial House , 35 Queen's Road Central , Hong Kong Island, Hong Kong HONG KONG SAR
31 A - - 02 Coffee, Ground
Date Published: 01/31/2014

Desc: Leptin GreenCoffee 800

31 A - - 02 Coffee, Ground
Date Published: 01/31/2014

Desc: Smart Sense Acai Berry Coffee

31 A - - 02 Coffee, Ground
Date Published: 01/31/2014

Desc: Leptin Slimming Coffee-Rose Curve Coffee

31 A - - 03 Coffee, Instant
Date Published: 01/31/2014

Desc: Leptin Slimming Coffee-Rose Curve Coffee

31 A - - 03 Coffee, Instant
Date Published: 01/31/2014

Desc: Leptin GreenCoffee 800

31 A - - 03 Coffee, Instant
Date Published: 01/31/2014

Desc: Smart Sense Acai Berry Coffee

31 A - - 99 Coffee, N.E.C.
Date Published: 01/31/2014

Desc: Leptin GreenCoffee 800

31 A - - 99 Coffee, N.E.C.
Date Published: 01/31/2014

Desc: Smart Sense Acai Berry Coffee

31 A - - 99 Coffee, N.E.C.
Date Published: 01/31/2014

Desc: Leptin Slimming Coffee-Rose Curve Coffee

31 K - - 02 Tea, Green
Date Published: 01/31/2014

Desc: Leptin Slimming Green Tea

31 M - - 01 Tea With Fruit (peels, chunks, bits or pieces)
Date Published: 01/31/2014

Desc: Leptin All-in-One Fat Loss Formula Iced Fruit Tea

31 M - - 99 Blended Teas, N.E.C.
Date Published: 01/31/2014

Desc: Leptin All-in-One Fat Loss Formula Iced Fruit Tea

34 B - - 99 Chocolate and Cocoa, N.E.C.
Date Published: 01/31/2014

Desc: Leptin Weight Loss Chocolate

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 01/31/2014

Desc: Leptin Slimming Coffee-Rose Curve Coffee

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 01/31/2014

Desc: Leptin Weight Loss Chocolate

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 01/31/2014

Desc: Leptin GreenCoffee 800

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 01/31/2014

Desc: Leptin Slimming Green Tea

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/31/2014

Desc: Leptin Slimming Coffee-Rose Curve Coffee

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/31/2014

Desc: Smart Sense Acai Berry Coffee

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/31/2014

Desc: Leptin All-in-One Fat Loss Formula Iced Fruit Tea

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/31/2014

Desc: Leptin Slimming Green Tea

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/31/2014

Desc: Leptin GreenCoffee 800

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/31/2014

Desc: Leptin Weight Loss Chocolate

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/31/2014

Desc: LingZhi Plus

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 01/31/2014

Desc: Leptin Slimming Coffee-Rose Curve Coffee

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 01/31/2014

Desc: Leptin Slimming Green Tea

63 H - - 17 Phenolphthalein (Cathartic)
Date Published: 01/31/2014

Desc: Leptin GreenCoffee 800

T8
Date Published : 09/30/2009
Flat 01, 11/F , Comweb Plaza; 12 Cheung Yue Street Kln , Hong Kong, Hk-Na HONG KONG SAR
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Desc: ProSlim Plus; 3 Days Fit; Eight Factor Diet; 24 Hours Diet; Slim 3 in 1; 3X Slimming Power; Extrim Plus; Slim 3 in 1 Extra Slim Formula; Slim Express 3600 C; Slim Express; Royal Slimming Formula; Body Creator; Slim Waistline; Body Shaping
Notes: 3/31/09

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2009

Desc: ProSlim Plus; 3 Days Fit; Eight Factor Diet; 24 Hours Diet; Slim 3 in 1; 3X Slimming Power; Extrim Plus; Slim 3 in 1 Extra Slim Formula; Slim Express 3600 C; Slim Express; Royal Slimming Formula; Body Creator; Slim Waistline; Body Shaping
Notes: 3/31/09

TSANG FOOK KEE MEDICINE COMPANY
Date Published : 09/30/2009
G/F , Winsing Building; 5 Ko Shing Street , Sai Ying Pun, Hong Kong Island HONG KONG SAR
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: Chinese Love Stone; Rock Hard; Stud 100; Product has been found to contain the toxin Bufotenine, which is classified by DEA as a Schedule 1 drug.; 9/29/2008

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2009

Notes: Chinese Love Stone; Rock Hard; Stud 100; Product has been found to contain the toxin Bufotenine, which is classified by DEA as a Schedule 1 drug.; 9/29/2008

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/13/2019

Notes: Chinese Love Stone; Rock Hard; Stud 100; Product has been found to contain the toxin Bufotenine, which is classified by DEA as a Schedule 1 drug.; 9/29/2008

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: Chinese Love Stone; Rock Hard; Stud 100; Product has been found to contain the toxin Bufotenine, which is classified by DEA as a Schedule 1 drug.; 9/29/2008

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Chinese Love Stone; Rock Hard; Stud 100; Product has been found to contain the toxin Bufotenine, which is classified by DEA as a Schedule 1 drug.; 9/29/2008

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Chinese Love Stone; Rock Hard; Stud 100; Product has been found to contain the toxin Bufotenine, which is classified by DEA as a Schedule 1 drug.; 9/29/2008

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Chinese Love Stone; Rock Hard; Stud 100; Product has been found to contain the toxin Bufotenine, which is classified by DEA as a Schedule 1 drug.; 9/29/2008

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Chinese Love Stone; Rock Hard; Stud 100; Product has been found to contain the toxin Bufotenine, which is classified by DEA as a Schedule 1 drug.; 9/29/2008

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Chinese Love Stone; Rock Hard; Stud 100; Product has been found to contain the toxin Bufotenine, which is classified by DEA as a Schedule 1 drug.; 9/29/2008

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Chinese Love Stone; Rock Hard; Stud 100; Product has been found to contain the toxin Bufotenine, which is classified by DEA as a Schedule 1 drug.; 9/29/2008

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: Chinese Love Stone; Rock Hard; Stud 100; Product has been found to contain the toxin Bufotenine, which is classified by DEA as a Schedule 1 drug.; 9/29/2008

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Chinese Love Stone; Rock Hard; Stud 100; Product has been found to contain the toxin Bufotenine, which is classified by DEA as a Schedule 1 drug.; 9/29/2008

Unknown Name
Date Published : 08/22/2012
Tung Kwong Road , Bay , Kowloon City, Kowloon HONG KONG SAR
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 08/22/2012

Desc: Unmarked gold capsules
Notes: Hong Kong; Note; Analytical testing by FDA revealed the product contains undeclared sibutramine and phenolphthalein

Win Dragon Ltd
Date Published : 03/27/2023
Rm 1004, Albion Plaza , No 2-6 Granville Road , Kowloon, HONG KONG SAR
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/27/2023

Desc: (Shipper) Escents toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 10/09/2007

63 R - - -- Dental Caries Prophyl
Date Published: 03/27/2023

Desc: (Shipper) Escents toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 10/09/2007

76 N - - XZ Kit, dental hygiene
Date Published: 03/27/2023

Desc: (Shipper) Escents toothpaste
Notes: Firm previously listed on deactivated Import Alert 66-74 for containing Diethylene Glycol (DEG); DWPE date; 10/09/2007

Wong Lap Kwong Medicine Company Limited
Date Published : 08/30/2021
Ground Floor , 93A Fuk Wa Street , Sham Shui Po, Kowloon HONG KONG SAR
66 - - - -- Human and Animal Drugs
Date Published: 08/30/2021

Desc: Wong Lop Kong Oil
Notes:                                                                                                                             

XI AN CHINA HERBS BIO TECH CO LT
Date Published : 10/28/2016
NO 26 XINGHUA ROAD XING , HONG KONG, HONG KONG SAR
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/28/2016

Desc: Goddess Vaginal Detox Pearls
Notes: Medical claims on product labels & website

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 10/28/2016

Desc: Goddess Vaginal Detox Pearls
Notes: Medical claims on product labels & website

XinXin Trading Company
Date Published : 11/06/2012
Unit C, F/F, Yoohoo tower , 38-24 kwai fung crescent , Kwai Chung, HONG KONG SAR
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/06/2012

Desc: Beautiful Slim body
Notes: Note; Analytical testing by FDA revealed the product contains undeclared Sibutramine.

Yeung Kong Foods Co
Date Published : 09/25/2012
Flat F , Blk.9 26. Melody Garden , Tuen Mun Nt, Not Applicable HONG KONG SAR
31 K - - 40 Tea, Instant Mix (with Lemon, Sugar, Etc.)
Date Published: 09/25/2012

Desc: Ban Lan Gen Chong Ji Herbal Tea

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/25/2012

Desc: Ban Lan Gen Chong Ji Herbal Tea

Yunnan Bai'an Medicinal science and techbology co ltd.
Date Published : 12/18/2012
Unknown , Unknown, HONG KONG SAR
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/18/2012

Desc: Lishou Fuling Jiaonang
Notes: Problem; Sibutramine

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/04/2019

Desc: Lishou Fuling Jiaonang
Notes: Problem; Sibutramine; 12/18/2012

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 09/04/2019

Desc: Lishou Fuling Jiaonang
Notes: Problem; Sibutramine; 12/18/2012

kaifeng trading
Date Published : 01/15/2013
Unit C , F4f Yoo Hoo Tower; 38-42 Kwai Fung Crescent; Fung , Kwai Chung, New Territories HONG KONG SAR
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/15/2013

Desc: Unmarked Purple Capsule
Notes: Sibutramine

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/15/2013

Desc: Unmarked Purple Capsule
Notes: Sibutramine

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 01/15/2013

Desc: Unmarked Purple Capsule
Notes: Sibutramine


HUNGARY


HYD LLC
Date Published : 12/08/2017
Szent Istvan Ut 87 , Gyomro, HUNGARY
65 F - - 99 Water N.E.C. (Pharmaceutic Aid)
Date Published: 12/08/2017

Desc: PREVENTA 45 CARBONATED DRINKING WATER
Notes: The product appears to be an unapproved new drug as the firm's website includes claims such as " Why should we drink Preventa deuterium-depleted water?..."In healthy cells, this process functions properly, but in cancer cells the process is damaged and cannot secure the level of deuterium depletion typical for healthy cells" and "The results indicated that lowering deuterium level had an advantageous influence on the susceptibility to depression."

Kedo Eurocosmetics Kft.
Date Published : 09/28/2010
Kulterulet 082/9 , Peteri, HUNGARY
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/28/2010

Desc: My Girl?s Radiation Cream Rosemary Gel
Notes: Hungary

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 09/28/2010

Desc: My Girl's Radiation Cream Rosemary Gel
Notes: Hungary

Maltacourt Hungary Kft. Vecses
Date Published : 01/21/2016
Almaskert Ut 4 , Vecses, Pest HUNGARY
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/21/2016

Desc: Aroma Therapipe TM2 Mineral Salt Inhaler
Notes: Products label and Firms website makes drug claims

73 C - - AF Nebulizer (Direct Patient Interface)
Date Published: 01/21/2016

Desc: Aroma Therapipe TM2 Mineral Salt Inhaler
Notes: Products label and Firms website makes drug claims

77 K - - CO Inhaler, Nasal
Date Published: 01/21/2016

Desc: Aroma Therapipe TM2 Mineral Salt Inhaler
Notes: Products label and Firms website makes drug claims

Reanal Private Ltd
Date Published : 10/06/2011
Po Box 54 , Budapest, HUNGARY
60 L - - 99 Analgesic, N.E.C.
Date Published: 10/06/2011

Desc: Nicoflex Ointment
Notes: Hungary

Sopipa-Pharma Ltd
Date Published : 01/21/2016
1146 Budapest, Francia Street 57/C , Hungary, HUNGARY
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/21/2016

Desc: Aroma Therapipe TM2 Mineral Salt Inhaler
Notes: Products label and Firms website makes drug claims

73 C - - AF Nebulizer (Direct Patient Interface)
Date Published: 01/21/2016

Desc: Aroma Therapipe TM2 Mineral Salt Inhaler
Notes: Products label and Firms website makes drug claims

77 K - - CO Inhaler, Nasal
Date Published: 01/21/2016

Desc: Aroma Therapipe TM2 Mineral Salt Inhaler
Notes: Products label and Firms website makes drug claims


ICELAND


GeoSilica Iceland
Date Published : 06/01/2018
Granasbraut 506 , Reykjanesba, ICELAND
54 A - - 99 Vitamin, N.E.C.
Date Published: 06/01/2018

Desc: Silica Supplement

54 A - - 99 Vitamin, N.E.C.
Date Published: 06/01/2018

Desc: Recover Muscles & Nerves Minerals

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/01/2018

Desc: Silica Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/01/2018

Desc: Recover Muscles & Nerves Minerals


INDIA


AABHAR INTERNATIONAL
Date Published : 11/03/2010
101-B SMIT APTS, OGHADBHAI LANE, M.G.RD , GHATKOPER ( E ) , Mumbai, Maharashtra INDIA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 11/03/2010

Desc: Neem active Toothpaste
Notes: India

53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 11/03/2010

Desc: Vicco VAJRADANTI Ayurvedic Medicine for Gums and Teeth Toothpaste
Notes: India

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 11/03/2010

Desc: Vicco VAJRADANTI Ayurvedic Medicine for Gums and Teeth Toothpaste
Notes: India

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 11/03/2010

Desc: Neem active Toothpaste
Notes: India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/03/2010

Desc: Vicco VAJRADANTI Ayurvedic Medicine for Gums and Teeth Toothpaste
Notes: India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/03/2010

Desc: Neem active Toothpaste
Notes: India

ADRET RETAIL PVT LTD
Date Published : 07/24/2017
1 Gupta Lane , Kolkata, West Bengal INDIA
53 - - - -- Cosmetics
Date Published: 06/26/2019

Desc: Kapiva Herbals Mahanarayan Oil

53 - - - -- Cosmetics
Date Published: 06/26/2019

Desc: Kapiva Herbals Brahmi Amla Hair Oil

53 - - - -- Cosmetics
Date Published: 06/26/2019

Desc: Kapiva Herbals Mahamas Oil (Niramis)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/13/2019

Desc: Kapiva Herbals Dietary Supplements (ALL PRODUCTS AND FORMULATIONS)
Notes: These products appears to be unapproved new drugs as the promotional website for the products includes disease claims such as (not an all-inclusive list): '...[H]elps breakdown the buildup of excessive blood sugar...; ...[E]ffective against piles...; [H]elp preventing skin infections...; [E]ffective ayurvedic medicine to reduce diarrhea [sic] and dysentery...'.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/24/2017

Desc: Clove Oil

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/13/2019

Desc: Kapiva Herbals Dietary Supplements (ALL PRODUCTS AND FORMULATIONS)
Notes: These products appears to be unapproved new drugs as the promotional website for the products includes disease claims such as (not an all-inclusive list): '...[H]elps breakdown the buildup of excessive blood sugar...; ...[E]ffective against piles...; [H]elp preventing skin infections...; [E]ffective ayurvedic medicine to reduce diarrhea [sic] and dysentery...'.

55 P - - 86 Clove Oil (Pharmaceutic Necessity - Flavor)
Date Published: 07/24/2017

Desc: Clove Oil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/13/2019

Desc: Kapiva Herbals Dietary Supplements (ALL PRODUCTS AND FORMULATIONS)
Notes: These products appears to be unapproved new drugs as the promotional website for the products includes disease claims such as (not an all-inclusive list): '...[H]elps breakdown the buildup of excessive blood sugar...; ...[E]ffective against piles...; [H]elp preventing skin infections...; [E]ffective ayurvedic medicine to reduce diarrhea [sic] and dysentery...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/24/2017

Desc: Clove Oil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/26/2019

Desc: Kapiva Herbals Brahmi Amla Hair Oil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/26/2019

Desc: Kapiva Herbals Mahamas Oil (Niramis)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/26/2019

Desc: Kapiva Herbals Mahanarayan Oil

AERO INDUSTRIES
Date Published : 09/21/2018
Plot No. 654/2, 100 Shed Area , G.I.D.C , Vapi, INDIA
60 L - - 99 Analgesic, N.E.C.
Date Published: 09/21/2018

Desc: MOOV Pain Relief Specialist Spray
Notes: The product appears to be an unapproved new drug as the product label includes claims such as, but not limited to: '... Pain relief specialist ... Uses: Relief from backache, body ache, muscle pain, sprain or joint pain ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/21/2018

Desc: MOOV Pain Relief Specialist Spray
Notes: The product appears to be an unapproved new drug as the product label includes claims such as, but not limited to: '... Pain relief specialist ... Uses: Relief from backache, body ache, muscle pain, sprain or joint pain ...'.

ALLAYURVEDA.COM (PVT) LTD
Date Published : 01/20/2011
1 Gupta Lane , Kolkata, West Bengal INDIA
54 E - - 94 Ashwagandha (Herbal & Botanical Teas)
Date Published: 01/20/2011

Desc: Garbhapal Ras (Ros Yog Sagar)
Notes: India

54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas)
Date Published: 01/20/2011

Desc: Garbhapal Ras (Ros Yog Sagar)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/20/2011

Desc: Garbhapal Ras (Ros Yog Sagar)
Notes: India

ALMIGHTY AGRO INDUSTRY
Date Published : 08/10/2017
A-01 Muhana Madi , Gateno-3 , Jaipur, Rajasthan INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/10/2017

Desc: Livatonic Syrup

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/10/2017

Desc: Livatonic Syrup

ALOE PLUS INTERNATIONAL
Date Published : 05/18/2015
225 Aarey Colony Road , Mumbai, Maharashtra INDIA
20 D - - 01 Blackberry Juice, Berry Juice or Concentrates
Date Published: 05/18/2015

Desc: Jamun Juice Drink (Indian Blackberry)
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure and associated website; www.aloeplus.in; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product brochure and associated website include but are not limited to the following; [brochure] [H]as medicinal properties for the management of diabetes. Jamun Juice is helpful in skin related ailments ; and [website] [T] o cure digestive disorders.

20 D - - 24 Wolfberry (Chinese or Southeast Asian berry of the Chinese matrimony vine, w/slight licorice flavor)
Date Published: 05/18/2015

Desc: Goji Berry Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure and associated website; www.aloeplus.in; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product brochure and associated website include but are not limited to the following; [brochure] [M]ay help prevent cancer and illnesses; including heart diseases may help to control cholesterol levels & heart attacks have used goji berries to treat many common health problems like diabetes; high blood pressure; fever and age-related eye problems ; and [website] [M]ay help prevent cancer and illnesses; including heart diseases extremely effective in fighting cancer lower bad cholesterol levels and protect the heart from disease. Goji berries also has been linked with a lower risk of high cholesterol and heart attack prevent certain eye conditions such as macular degeneration If you are suffering from insomnia; try eating goji berries.

21 V - - 43 Noni, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 05/18/2015

Desc: Noni Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the products intended use from the product brochure includes but is not limited to the following; Alleviates Symptoms of Arthritis Fights Heart Disease Helps Control Diabetes Reduces symptoms of Asthma Helps to reduce Cholesterol Helps to relieve pain It is known to be rich in phytochemicals that can help in prevention on disease such as diabetes; Cancer & other heart diseases.

22 D - - 05 Bitter Melon, Juice, Vine Fruit Juices or Concentrates
Date Published: 05/18/2015

Desc: Karela Juice Drink (Bitter Gourd Juice)
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure and associated website; www.aloeplus.in; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product brochure and associated website include but are not limited to the following; [brochure] Helpful in Constipation & Piles. Helpful in Diabetes Helpful in Blood Disorders It helps to control Sugar level It helps to build your immune system & increase your bodys resistance against infection. It is highly beneficial in the treatment of blood disorders ; and [website] [I] ncrease your bodys resistance against infection. At the same time; it is also highly beneficial in the treatment of blood disorders highly beneficial in diabetes.

22 K - - 01 Pomegranate, Juice, Other Fruit Juices or Concentrates
Date Published: 05/18/2015

Desc: Pomegranate Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure and associated website; www.aloeplus.in; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product brochure and associated website include but are not limited to the following; [brochure] The anti-inflammatory benefits of pomegranate juice help prevent damage against sperms that leads them to becoming sluggish and losing the ability to fertilize an egs (sic) Drinking pomegranate juice fight against erectile dysfunction; and [website] [H]aemorrhoids (sic); conjunctivitis is especially beneficial for diabetics If you suffer from high blood pressure; make sure that pomegranates juice is a regular part of your diet.

24 J - - 09 Gourd, Juice
Date Published: 05/18/2015

Desc: Lauki Juice Drink (Bottle Gourd Juice)
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure and associated website; www.aloeplus.in; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product brochure and associated website include but are not limited to the following; [brochure] It is effective against constipation and other digestive disorders Problems like diarrhea can be solved by drinking its juice. It plays a very important role in treating urinary disorders; and [website] [I]t helps to reduce weight in natural manner and is also effective against constipation and other digestive disorders is used in treatment of stomach acidity & indigestion.

24 W - - 71 Wheat Grass, Juice or Drink
Date Published: 05/18/2015

Desc: Wheat Grass Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the products intended use from the product brochure includes but is not limited to the following;Supplements intake of dietary fiber which helps control blood sugar level; cholesterol level & prevents Constipation helps combat Thalassemia & Anaemia .

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 05/18/2015

Desc: Aloe Vera Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure and associated website; www.aloeplus.in; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product brochure and associated website include but are not limited to the following; brochure Stress; Arthritis; Diabetes; Heart Disease ; and website Reduce blood sugar in diabetes conditions; Relieves Constipation

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 05/18/2015

Desc: Tulsi Basil Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product website; www.aloeplus.in; implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the products intended use from the website includes but is not limited to the following;[I]ncrease your bodys resistance against infection highly beneficial in the treatment of blood disorders.

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 05/18/2015

Desc: Neem Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure and associated website; www.aloeplus.in; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product brochure and associated website include but are not limited to the following; [brochure] [A]ntiinflammatory ; and [website] [A] ntiinflammatory .

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 05/18/2015

Desc: Noni Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the products intended use from the product brochure includes but is not limited to the following; Alleviates Symptoms of Arthritis Fights Heart Disease Helps Control Diabetes Reduces symptoms of Asthma Helps to reduce Cholesterol Helps to relieve pain It is known to be rich in phytochemicals that can help in prevention on disease such as diabetes; Cancer & other heart diseases. ;

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 05/18/2015

Desc: Karela Juice Drink (Bitter Gourd Juice)
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure and associated website; www.aloeplus.in; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product brochure and associated website include but are not limited to the following; [brochure] Helpful in Constipation & Piles. Helpful in Diabetes Helpful in Blood Disorders It helps to control Sugar level It helps to build your immune system & increase your bodys resistance against infection. It is highly beneficial in the treatment of blood disorders ; and [website] [I] ncrease your bodys resistance against infection. At the same time; it is also highly beneficial in the treatment of blood disorders highly beneficial in diabetes.

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 05/18/2015

Desc: Lauki Juice Drink (Bottle Gourd Juice)
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure and associated website; www.aloeplus.in; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product brochure and associated website include but are not limited to the following; [brochure] It is effective against constipation and other digestive disorders Problems like diarrhea can be solved by drinking its juice. It plays a very important role in treating urinary disorders; and [website] [I]t helps to reduce weight in natural manner and is also effective against constipation and other digestive disorders is used in treatment of stomach acidity & indigestion

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 05/18/2015

Desc: Wheat Grass Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the products intended use from the product brochure includes but is not limited to the following;Supplements intake of dietary fiber which helps control blood sugar level; cholesterol level & prevents Constipation helps combat Thalassemia & Anaemia

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 05/18/2015

Desc: Goji Berry Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure and associated website; www.aloeplus.in; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product brochure and associated website include but are not limited to the following; [brochure] [M]ay help prevent cancer and illnesses; including heart diseases may help to control cholesterol levels & heart attacks have used goji berries to treat many common health problems like diabetes; high blood pressure; fever and age-related eye problems ; and [website] [M]ay help prevent cancer and illnesses; including heart diseases extremely effective in fighting cancer lower bad cholesterol levels and protect the heart from disease. Goji berries also has been linked with a lower risk of high cholesterol and heart attack prevent certain eye conditions such as macular degeneration If you are suffering from insomnia; try eating goji berries

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 05/18/2015

Desc: Pomegranate Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure and associated website; www.aloeplus.in; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product brochure and associated website include but are not limited to the following; [brochure] The anti-inflammatory benefits of pomegranate juice help prevent damage against sperms that leads them to becoming sluggish and losing the ability to fertilize an egs (sic) Drinking pomegranate juice fight against erectile dysfunction; and [website] [H]aemorrhoids (sic); conjunctivitis is especially beneficial for diabetics If you suffer from high blood pressure; make sure that pomegranates juice is a regular part of your diet. ;

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 05/18/2015

Desc: Jamun Juice Drink (Indian Blackberry)
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure and associated website; www.aloeplus.in; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product brochure and associated website include but are not limited to the following; [brochure] [H]as medicinal properties for the management of diabetes. Jamun Juice is helpful in skin related ailments ; and [website] [T] o cure digestive disorders. ;

54 F - - 93 Noni (Herbal & Botanicals, not Teas)
Date Published: 05/18/2015

Desc: Noni Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the products intended use from the product brochure includes but is not limited to the following; Alleviates Symptoms of Arthritis Fights Heart Disease Helps Control Diabetes Reduces symptoms of Asthma Helps to reduce Cholesterol Helps to relieve pain It is known to be rich in phytochemicals that can help in prevention on disease such as diabetes; Cancer & other heart diseases. ;

54 K - - 06 Holy Basil (Herbal & Botanicals, not Teas II)
Date Published: 05/18/2015

Desc: Tulsi Basil Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product website; www.aloeplus.in; implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the products intended use from the website includes but is not limited to the following;[I]ncrease your bodys resistance against infection highly beneficial in the treatment of blood disorders.

54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued))
Date Published: 05/18/2015

Desc: Aloe Vera Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure and associated website; www.aloeplus.in; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product brochure and associated website include but are not limited to the following; brochure Stress; Arthritis; Diabetes; Heart Disease ; and website Reduce blood sugar in diabetes conditions; Relieves Constipation

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/18/2015

Desc: Jamun Juice Drink (Indian Blackberry)
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure and associated website; www.aloeplus.in; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product brochure and associated website include but are not limited to the following; [brochure] [H]as medicinal properties for the management of diabetes. Jamun Juice is helpful in skin related ailments ; and [website] [T] o cure digestive disorders.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/18/2015

Desc: Karela Juice Drink (Bitter Gourd Juice)
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure and associated website; www.aloeplus.in; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product brochure and associated website include but are not limited to the following; [brochure] Helpful in Constipation & Piles. Helpful in Diabetes Helpful in Blood Disorders It helps to control Sugar level It helps to build your immune system & increase your bodys resistance against infection. It is highly beneficial in the treatment of blood disorders ; and [website] [I] ncrease your bodys resistance against infection. At the same time; it is also highly beneficial in the treatment of blood disorders highly beneficial in diabetes.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/18/2015

Desc: Tulsi Basil Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product website; www.aloeplus.in; implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the products intended use from the website includes but is not limited to the following;[I]ncrease your bodys resistance against infection highly beneficial in the treatment of blood disorders

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/18/2015

Desc: Wheat Grass Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the products intended use from the product brochure includes but is not limited to the following;Supplements intake of dietary fiber which helps control blood sugar level; cholesterol level & prevents Constipation helps combat Thalassemia & Anaemia

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/18/2015

Desc: Aloe Vera Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure and associated website; www.aloeplus.in; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product brochure and associated website include but are not limited to the following; brochure Stress; Arthritis; Diabetes; Heart Disease ; and website Reduce blood sugar in diabetes conditions; Relieves Constipation

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/18/2015

Desc: Goji Berry Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure and associated website; www.aloeplus.in; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product brochure and associated website include but are not limited to the following; [brochure] [M]ay help prevent cancer and illnesses; including heart diseases may help to control cholesterol levels & heart attacks have used goji berries to treat many common health problems like diabetes; high blood pressure; fever and age-related eye problems ; and [website] [M]ay help prevent cancer and illnesses; including heart diseases extremely effective in fighting cancer lower bad cholesterol levels and protect the heart from disease. Goji berries also has been linked with a lower risk of high cholesterol and heart attack prevent certain eye conditions such as macular degeneration If you are suffering from insomnia; try eating goji berries. ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/18/2015

Desc: Neem Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure and associated website; www.aloeplus.in; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product brochure and associated website include but are not limited to the following; [brochure] [A]ntiinflammatory ; and [website] [A] ntiinflammatory . ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/18/2015

Desc: Pomegranate Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure and associated website; www.aloeplus.in; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product brochure and associated website include but are not limited to the following; [brochure] The anti-inflammatory benefits of pomegranate juice help prevent damage against sperms that leads them to becoming sluggish and losing the ability to fertilize an egs (sic) Drinking pomegranate juice fight against erectile dysfunction; and [website] [H]aemorrhoids (sic); conjunctivitis is especially beneficial for diabetics If you suffer from high blood pressure; make sure that pomegranates juice is a regular part of your diet.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/18/2015

Desc: Noni Juice Drink
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the products intended use from the product brochure includes but is not limited to the following; Alleviates Symptoms of Arthritis Fights Heart Disease Helps Control Diabetes Reduces symptoms of Asthma Helps to reduce Cholesterol Helps to relieve pain It is known to be rich in phytochemicals that can help in prevention on disease such as diabetes; Cancer & other heart diseases. ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/18/2015

Desc: Lauki Juice Drink (Bottle Gourd Juice)
Notes: The aforementioned product appears to be an unapproved new drug as the product brochure and associated website; www.aloeplus.in; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product brochure and associated website include but are not limited to the following; [brochure] It is effective against constipation and other digestive disorders Problems like diarrhea can be solved by drinking its juice. It plays a very important role in treating urinary disorders; and [website] [I]t helps to reduce weight in natural manner and is also effective against constipation and other digestive disorders is used in treatment of stomach acidity & indigestion. ;

ALPA LABORATORIES LTD
Date Published : 04/07/2020
33/2 A.B. ROAD PIGDAMBE , INDORE, INDIA
61 W - - 31 Tolnaftate (Anti-Fungal) (Not Antibiotic)
Date Published: 04/07/2020

Desc: Quinaderm Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/07/2020

Desc: Alpalide Nimesulide Gel

AMRUTAM LIFE CARE PRIVATE LIMITED
Date Published : 07/12/2013
607 - 608 Navadi Bandar Road , Surat, Gujarat INDIA
50 - - - -- Color Additiv Food/Drug/Cosmetic
Date Published: 07/12/2013

Notes: Diexi Zoom-Zooma-Zoom;Note; FDA analysis found Sildenafil in Zoom-Zooma-Zoom and Metformin in Diexi

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/12/2013

Desc: Diexi Zoom-Zooma-Zoom
Notes: FDA analysis found Sildenafil in Zoom- Zooma-Zoom and Metformin in Diexi

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/12/2013

Notes: Diexi Zoom-Zooma-Zoom;Note: FDA analysis found Sildenafil in Zoom- Zooma-Zoom and Metformin in Diexi

56 - - - -- Antibiotics (Human/Animal)
Date Published: 07/12/2013

Notes: Diexi Zoom-Zooma-Zoom;Note; FDA analysis found Sildenafil in Zoom-Zooma-Zoom and Metformin in Diexi

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Diexi Zoom-Zooma-Zoom;Note: FDA analysis found Sildenafil in Zoom- Zooma-Zoom and Metformin in Diexi

61 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Diexi Zoom-Zooma-Zoom;Note: FDA analysis found Sildenafil in Zoom- Zooma-Zoom and Metformin in Diexi

62 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Diexi Zoom-Zooma-Zoom;Note: FDA analysis found Sildenafil in Zoom- Zooma-Zoom and Metformin in Diexi

63 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Diexi Zoom-Zooma-Zoom;Note: FDA analysis found Sildenafil in Zoom- Zooma-Zoom and Metformin in Diexi

64 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Diexi Zoom-Zooma-Zoom;Note: FDA analysis found Sildenafil in Zoom- Zooma-Zoom and Metformin in Diexi

65 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Diexi Zoom-Zooma-Zoom;Note: FDA analysis found Sildenafil in Zoom- Zooma-Zoom and Metformin in Diexi

66 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Diexi Zoom-Zooma-Zoom;Note: FDA analysis found Sildenafil in Zoom- Zooma-Zoom and Metformin in Diexi

ASHWIN FINE CHEMICALS AND PHARMACEUTICALS
Date Published : 03/17/2015
3, SHANTA INDL EST , OFF: W E HIGHWAY , KASHIMIRA, THANE - MAHARAHSTRA INDIA
53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 08/22/2016

Desc: Ashwin's Adulsa Syrup (Ashwin Adulsa Oil)
Notes: Medical claims on product label

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 03/17/2015

Desc: Kalonji Oil (Nigella Sativa Oil; Black Seed Oil)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/22/2016

Desc: Ashwin's Adulsa Syrup (Ashwin Adulsa Oil)
Notes: Medical claims on product label

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/17/2015

Desc: Kalonji Oil (Nigella Sativa Oil; Black Seed Oil)

Aayu Impex
Date Published : 09/27/2010
Pavapuri Apts , 1 Shop No , Mumbai, Maharashtra INDIA
56 G - - 99 Antifungal N.E.C.
Date Published: 09/27/2010

Desc: Sandal Face Pack
Notes: India

56 X - - 99 Diag Invitro Antibiotic N.E.C.
Date Published: 09/27/2010

Desc: Amla Powder
Notes: India

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 09/27/2010

Desc: Sandal Face Pack
Notes: India

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 09/27/2010

Desc: Amla Powder
Notes: India

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 09/27/2010

Desc: Boroplus Cream
Notes: India

Abhaya Exports Pvt. Ltd.
Date Published : 07/08/2016
1st Floor , 2a Grant Street , Kolkata, West Bengal INDIA
26 C - - 99 Refined Vegetable Oil, Single Ingredient, N.E.C.
Date Published: 07/08/2016

Desc: Hamdard Roghan Badam Shirin Sweet Almond Oil
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'Strengthens brain and nerves', 'Removes constipation in a natural way', 'Relieves constipation', and 'Fights dandruff'.

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 07/08/2016

Desc: Hamdard Roghan Badam Shirin Sweet Almond Oil
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'Strengthens brain and nerves', 'Removes constipation in a natural way', 'Relieves constipation', and 'Fights dandruff'.

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 07/08/2016

Desc: Hamdard Roghan Badam Shirin Sweet Almond Oil
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'Strengthens brain and nerves', 'Removes constipation in a natural way', 'Relieves constipation', and 'Fights dandruff'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/08/2016

Desc: Hamdard Roghan Badam Shirin Sweet Almond Oil
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'Strengthens brain and nerves', 'Removes constipation in a natural way', 'Relieves constipation', and 'Fights dandruff'.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/06/2023

Desc: Vedic Secrets Neem Powder

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2016

Desc: Hamdard Roghan Badam Shirin Sweet Almond Oil
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'Strengthens brain and nerves', 'Removes constipation in a natural way', 'Relieves constipation', and 'Fights dandruff'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/06/2023

Desc: Vedic Secrets Neem Powder

Accra Pac (India) Pvt Ltd
Date Published : 09/21/2018
Plot No 1105 G.I.D.C. Phase Iii , Vapi, Gujarat INDIA
60 L - - 99 Analgesic, N.E.C.
Date Published: 09/21/2018

Desc: MOOV Pain Relief Specialist Spray
Notes: The product appears to be an unapproved new drug as the product label includes claims such as, but not limited to: '... Pain relief specialist ... Uses: Relief from backache, body ache, muscle pain, sprain or joint pain ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/21/2018

Desc: MOOV Pain Relief Specialist Spray
Notes: The product appears to be an unapproved new drug as the product label includes claims such as, but not limited to: '... Pain relief specialist ... Uses: Relief from backache, body ache, muscle pain, sprain or joint pain ...'.

Adret Retail
Date Published : 09/13/2019
P-83, Benaras Road , Howrah-8 , West Bengal, INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/13/2019

Desc: Kapiva Herbals Dietary Supplements (ALL PRODUCTS AND FORMULATIONS)
Notes: These products appears to be unapproved new drugs as the promotional website for the products includes disease claims such as (not an all-inclusive list): '...[H]elps breakdown the buildup of excessive blood sugar...; ...[E]ffective against piles...; [H]elp preventing skin infections...; [E]ffective ayurvedic medicine to reduce diarrhea [sic] and dysentery...'.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/13/2019

Desc: Kapiva Herbals Dietary Supplements (ALL PRODUCTS AND FORMULATIONS)
Notes: These products appears to be unapproved new drugs as the promotional website for the products includes disease claims such as (not an all-inclusive list): '...[H]elps breakdown the buildup of excessive blood sugar...; ...[E]ffective against piles...; [H]elp preventing skin infections...; [E]ffective ayurvedic medicine to reduce diarrhea [sic] and dysentery...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/13/2019

Desc: Kapiva Herbals Dietary Supplements (ALL PRODUCTS AND FORMULATIONS)
Notes: These products appears to be unapproved new drugs as the promotional website for the products includes disease claims such as (not an all-inclusive list): '...[H]elps breakdown the buildup of excessive blood sugar...; ...[E]ffective against piles...; [H]elp preventing skin infections...; [E]ffective ayurvedic medicine to reduce diarrhea [sic] and dysentery...'.

Aero Pharma (Silvassa)
Date Published : 06/13/2013
127/1 Preeti Indl , Amli , Silvassa, Dadra And Nagar Haveli INDIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 06/13/2013

Desc: Fair and Glow for ageless fair skin

Ajanta Medicals PVT.LTD.
Date Published : 12/17/2010
71 , Ponda, Goa INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/17/2010

Desc: Ajanta's Adusol (Ayurvedic Compound with Tulsi Expectorant)
Notes: India

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/17/2010

Desc: Ajanta's Adusol (Ayurvedic Compound with Tulsi Expectorant)
Notes: India

64 H - - 99 Expectorant N.E.C.
Date Published: 12/17/2010

Desc: Ajanta's Adusol (Ayurvedic Compound with Tulsi Expectorant)
Notes: India

Ajanta Pharma Limited
Date Published : 09/30/2009
318 Linking Road , Mumbai, INDIA
65 P D - 02 Sildenafil Citrate (Regulator), Human - Rx/Combination Ingredient
Date Published: 09/13/2019

Notes: Kamagra 100mg oral tablet; 4/4/2003

Ajanta Pharma Ltd.
Date Published : 01/20/2017
B-4/5/6 MIDC Industrial Area , Paithan , Aurangabad, Maharashtra INDIA
65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 01/20/2017

Desc: Kamarga
Notes: Product contains Sildenafil Citrate

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/20/2017

Desc: Kamarga
Notes: Product contains Sildenafil Citrate

Ajmera Herbals Limited
Date Published : 02/24/2012
276 Sector E Sanwer Road , Madhya Pradesh, INDIA
61 P - - 99 Anti-Diabetic N.E.C.
Date Published: 02/24/2012

Desc: WinDiabetes Capsules
Notes: India

Alfa Soaps & Toiletries P Ltd
Date Published : 07/12/2016
Plot No. R-897 , Mumbai, INDIA
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 07/12/2016

Desc: Symba Medicated Antiseptic Soap

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 07/12/2016

Desc: Symba Carrot Strong Bleaching Soap

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 07/12/2016

Desc: Symba Papaya Natural Whitening Soap

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/12/2016

Desc: Symba Medicated Antiseptic Soap

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/12/2016

Desc: Symba Carrot Strong Bleaching Soap

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/12/2016

Desc: Symba Papaya Natural Whitening Soap

Amar Remedies Ltd.
Date Published : 10/16/2012
375/14 Hill Industrial Estate , Zari Road, Kachigam , Daman, Daman and Diu INDIA
63 R - - 05 Sodium Monofluorophosphate (Dental Caries Prophylactic)
Date Published: 10/16/2012

Desc: Morning Fresh Flouride Toothpaste

Ameya Packaging
Date Published : 05/29/2014
B-2/A, UPSIDC, Selakui , Uttarakhand, Dehradun INDIA
53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 05/29/2014

Desc: Parachute ADVANSED Ayurvedic HAIR OIL

Amrutanjan Health Care Ltd
Date Published : 12/18/2013
Luz Church Rd , Chennai, INDIA
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/29/2014

Desc: Amrutanjan Aromatic Balm Massage for Headache

55 P - - 93 Eucalyptus Oil (Pharmaceutic Necessity - Flavor)
Date Published: 05/29/2014

Desc: AMRUTANJAN Headache Balm Massage

60 L - - 99 Analgesic, N.E.C.
Date Published: 05/29/2014

Desc: AMRUTANJAN STRONG PAIN BALM

60 L - - 99 Analgesic, N.E.C.
Date Published: 05/29/2014

Desc: Amrutanjan Aromatic Balm Massage for Headache

60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 05/29/2014

Desc: AMRUTANJAN Headache Balm Massage

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 05/29/2014

Desc: Amrutanjan Aromatic Balm Massage for Headache

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 05/29/2014

Desc: AMRUTANJAN Headache Balm Massage

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 05/29/2014

Desc: AMRUTANJAN STRONG PAIN BALM

66 L - - 99 Thyromimetic N.E.C.
Date Published: 12/18/2013

Desc: Amrutanjan Aromatic Balm Message for Headache

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/18/2013

Desc: Amrutanjan Aromatic Balm Message for Headache

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/29/2014

Desc: AMRUTANJAN STRONG PAIN BALM

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 05/29/2014

Desc: AMRUTANJAN STRONG PAIN BALM

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 05/29/2014

Desc: AMRUTANJAN Headache Balm Massage

Amrutanjan Health Care Ltd
Date Published : 12/19/2013
Plot No 14 , Industrial Developement , Hyderabad, Telangana INDIA
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/29/2014

Desc: Amrutanjan Aromatic Balm Massage for Headache

55 P - - 93 Eucalyptus Oil (Pharmaceutic Necessity - Flavor)
Date Published: 05/29/2014

Desc: AMRUTANJAN Headache Balm Massage

60 L - - 99 Analgesic, N.E.C.
Date Published: 05/29/2014

Desc: Amrutanjan Aromatic Balm Massage for Headache

60 L - - 99 Analgesic, N.E.C.
Date Published: 05/29/2014

Desc: AMRUTANJAN STRONG PAIN BALM

60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 05/29/2014

Desc: AMRUTANJAN Headache Balm Massage

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 05/29/2014

Desc: AMRUTANJAN Headache Balm Massage

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 05/29/2014

Desc: Amrutanjan Aromatic Balm Massage for Headache

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 05/29/2014

Desc: AMRUTANJAN STRONG PAIN BALM

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/19/2013

Desc: Amrutanjan Aromatic Balm Message for Headache

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/29/2014

Desc: AMRUTANJAN STRONG PAIN BALM

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 05/29/2014

Desc: AMRUTANJAN Headache Balm Massage

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 05/29/2014

Desc: AMRUTANJAN STRONG PAIN BALM

Amrutanjan Limited
Date Published : 05/29/2014
4245 Luz Church Road , Mylopore, TN INDIA
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/29/2014

Desc: Amrutanjan Aromatic Balm Massage for Headache

55 P - - 93 Eucalyptus Oil (Pharmaceutic Necessity - Flavor)
Date Published: 05/29/2014

Desc: AMRUTANJAN Headache Balm Massage

60 L - - 99 Analgesic, N.E.C.
Date Published: 05/29/2014

Desc: AMRUTANJAN STRONG PAIN BALM

60 L - - 99 Analgesic, N.E.C.
Date Published: 05/29/2014

Desc: Amrutanjan Aromatic Balm Massage for Headache

60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 05/29/2014

Desc: AMRUTANJAN Headache Balm Massage

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 05/29/2014

Desc: AMRUTANJAN STRONG PAIN BALM

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 05/29/2014

Desc: Amrutanjan Aromatic Balm Massage for Headache

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 05/29/2014

Desc: AMRUTANJAN Headache Balm Massage

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/29/2014

Desc: AMRUTANJAN STRONG PAIN BALM

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 05/29/2014

Desc: AMRUTANJAN STRONG PAIN BALM

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 05/29/2014

Desc: AMRUTANJAN Headache Balm Massage

Ancient Greenfields
Date Published : 02/28/2018
4/159-A2, Vadavalli to Kanuvai Road , Kalappanaickenpalayam , Coimbatore, Tamil Nadu INDIA
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 03/02/2023

Desc: Triphala Powder

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 03/02/2023

Desc: Bacopa Powder

54 A - - 99 Vitamin, N.E.C.
Date Published: 02/28/2018

Desc: Moringa Capsule
Notes: The product appears to be an unapproved new drug as the product includes drug/disease claims on their website, such as, "Lowers high cholesterol and blood sugar levels" and "Prevents pain in the joints".

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/02/2023

Desc: Triphala Powder

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/28/2018

Desc: Moringa Capsule
Notes: The product appears to be an unapproved new drug as the product includes drug/disease claims on their website, such as, "Lowers high cholesterol and blood sugar levels" and "Prevents pain in the joints".

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/02/2023

Desc: Bacopa Powder

54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued)
Date Published: 02/28/2018

Desc: Moringa Capsule
Notes: The product appears to be an unapproved new drug as the product includes drug/disease claims on their website, such as, "Lowers high cholesterol and blood sugar levels" and "Prevents pain in the joints".

54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd
Date Published: 02/28/2018

Desc: Moringa Capsule
Notes: The product appears to be an unapproved new drug as the product includes drug/disease claims on their website, such as, "Lowers high cholesterol and blood sugar levels" and "Prevents pain in the joints".

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/02/2023

Desc: Bacopa Powder

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/02/2023

Desc: Triphala Powder

Ava Cholayil Health Care Pvt Ltd
Date Published : 02/21/2012
61-62, Sidco Industrial Estate , Chennai-600 124, Tamilnadu, INDIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/21/2012

Desc: Medimix Ayurvedic Soap

Ayur Herbals
Date Published : 11/19/2014
24a Shivaji Marg(Najafgarh Road) , New Delhi, INDIA
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 11/19/2014

Desc: Ayur Herbal Coconut Shampoo for Dry Hair
Notes: Problem; Unapproved New Drug

Ayurvedic Bhawan Ltd.
Date Published : 09/13/2019
Gwalior Road , Jhansi, INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/13/2019

Desc: Mahalakshmi Vilas Ras with gold
Notes: 5/4/2006

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/13/2019

Desc: Mahalakshmi Vilas Ras with gold
Notes: 5/4/2006

Ayush Herbs Pvt. Ltd
Date Published : 04/22/2013
25 Phase 1 Industrial Area , Distt. Kangra , Nagrota Bagwan, Himachal Pradesh INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/22/2013

Desc: Carditone Powder Herbal Blend

Azafran Innovacion Ltd.
Date Published : 01/02/2024
507 508 Plot 506 , Village - Vinchhiya , Sanand, Gujarat INDIA
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 01/02/2024

Desc: Azafran Neem & Turmeric Skin Clearing Bath Bar

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/02/2024

Desc: Azafran Neem & Turmeric Skin Clearing Bath Bar

B-Tex Ointment Mfg. Co.
Date Published : 12/02/2016
C-17, Udyog Nagar , Navsari-396 445 , Gujarat, INDIA
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/02/2016

Desc: B-TEX (Salicylic Acid Ointment)
Notes: OTC Monograph Violations

64 X - - 06 Salicylic Acid (Keratolytic)
Date Published: 12/02/2016

Desc: B-TEX (Salicylic Acid Ointment)
Notes: OTC Monograph Violations

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/02/2016

Desc: B-TEX (Salicylic Acid Ointment)
Notes: OTC Monograph Violations

BAIDYANATH AYURVED BHAWAN PVT LTD
Date Published : 07/18/2022
1 Gupta Lane , Kolkata, West Bengal INDIA
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/18/2022

Desc: Mahanarayan Tel
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “THE RENOWNED OIL FOR JOINTS AND MUSCULAR PAINS” and “Indications - Joints Pain, Backache, Groin and Calf Pain, Paralysis”.                                                                                                                                                                                                                                                                                           

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/18/2022

Desc: Mahanarayan Tel
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “THE RENOWNED OIL FOR JOINTS AND MUSCULAR PAINS” and “Indications - Joints Pain, Backache, Groin and Calf Pain, Paralysis”.                                                                                                                                                                                                                                                                                           

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/18/2022

Desc: Mahanarayan Tel
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “THE RENOWNED OIL FOR JOINTS AND MUSCULAR PAINS” and “Indications - Joints Pain, Backache, Groin and Calf Pain, Paralysis”.                                                                                                                                                                                                                                                                                           

BRIYOSIS SOFT CAPS PVT. LTD.
Date Published : 11/23/2016
176 - 1 - 1 Opp , Jarod-Rasulabad Road , Jarod, Gujarat INDIA
66 S - - 51 Tadalafil
Date Published: 11/23/2016

Desc: Tadalafil Softgel Capsule
Notes: Tadalafil

BSD ORGANICS
Date Published : 11/05/2020
24 Gangai Amman Koil Street , Tamil Nadu, INDIA
54 F - - 16 Licorice (Herbal & Botanicals, not Teas)
Date Published: 11/05/2020

Desc: BSD ORGANICS Licorice Root/Athimathuram Powder
Notes: The product appears to be an unapproved new drug as the product's label and promotional websites include claims such as (not an all-inclusive list): 'BENEFITS & USAGES: With its anti-fungal, antibacterial, anti- oxidizing and anti-inflammatory properties, Mulethi root can protect you from skin rashes, allergies, UV rays, redness and similar skin problems'; '...Eat the mixture to get relief from cough'.

54 F - - 16 Licorice (Herbal & Botanicals, not Teas)
Date Published: 11/05/2020

Desc: BSD ORGANICS Vasambu/Sweet Flag
Notes: The product appears to be an unapproved new drug as the product's label and promotional websites include claims such as (not an all-inclusive list): 'Vasambu for acid reflux, indigestion and stomach problems'.

54 Y - - 17 Vegetable Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 11/05/2020

Desc: BSD ORGANICS Unpeeled Sky Fruit/Thean kai
Notes: The product appears to be an unapproved new drug as the product's label and promotional websites include claims such as (not an all-inclusive list): 'Sky fruit is commonly used as herbal remedy... Eat half of the seed if your sugar level is below 200 and take full seed if your sugar level is above 200'; 'Control Diabetes / Sugar levels naturally with BSD Organics Sky Fruit / Then Kai natural herb'.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 11/05/2020

Desc: BSD ORGANICS Vasambu/Sweet Flag
Notes: The product appears to be an unapproved new drug as the product's label and promotional websites include claims such as (not an all-inclusive list): 'Vasambu for acid reflux, indigestion and stomach problems'.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 11/05/2020

Desc: BSD ORGANICS Licorice Root/Athimathuram Powder
Notes: The product appears to be an unapproved new drug as the product's label and promotional websites include claims such as (not an all-inclusive list): 'BENEFITS & USAGES: With its anti-fungal, antibacterial, anti- oxidizing and anti-inflammatory properties, Mulethi root can protect you from skin rashes, allergies, UV rays, redness and similar skin problems'; '...Eat the mixture to get relief from cough'.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 11/05/2020

Desc: BSD ORGANICS Unpeeled Sky Fruit/Thean kai
Notes: The product appears to be an unapproved new drug as the product's label and promotional websites include claims such as (not an all-inclusive list): 'Sky fruit is commonly used as herbal remedy... Eat half of the seed if your sugar level is below 200 and take full seed if your sugar level is above 200'; 'Control Diabetes / Sugar levels naturally with BSD Organics Sky Fruit / Then Kai natural herb'.

Baidyanath Ayurved
Date Published : 09/13/2019
Gwalior Road , Jhansi, INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/13/2019

Desc: Majayograj Guggulu w/silver & Makardhwaj Swarna Mahayograj Guggulu with gold
Notes: 5/4/2006

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/13/2019

Desc: Majayograj Guggulu w/silver & Makardhwaj Swarna Mahayograj Guggulu with gold
Notes: 5/4/2006

Ban Labs Ltd
Date Published : 02/06/2020
C-4 UPSIDC, Selaqui , Dehradun, Uttaranchal INDIA
53 E - - -- Hair Preps(Non-Coloring)
Date Published: 02/06/2020

Desc: SESA Ayurvedic Hair Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Clinically proven and trusted by doctors for various hair and scalp diseases and disorders'; 'SESA Improves [sic] blood circulation to the follicles. Protects scalp and hair shaft from seborrheic dermatitis'; 'Prevents bacterial and fungal infection of scalp [sic]'; 'helps to remove Dandruff & Lice'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/06/2020

Desc: SESA Ayurvedic Hair Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Clinically proven and trusted by doctors for various hair and scalp diseases and disorders'; 'SESA Improves [sic] blood circulation to the follicles. Protects scalp and hair shaft from seborrheic dermatitis'; 'Prevents bacterial and fungal infection of scalp [sic]'; 'helps to remove Dandruff & Lice'.

Ban Labs Ltd
Date Published : 03/31/2015
Dhaula Kaun Tehsil Dist: Sirmour H.P. , Paonta Sahib, INDIA
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 03/31/2015

Desc: Sesa Oil Anti Dandruff Therapy
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;Sesa Oil Antidandruff Therapy; Advanced Herbal Anti-Dandruff Therapy specially blended with mixture of 18 Active Herbs. 8 Hair Nourishing Oils & Mill processed through KSHIRPAK VIDHI which helps to Alleviate itching; controls fungal infection flaky dandruff and revitalizes hair & scalp thereby ensures Healthy & Dandruff Free Hair.

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 03/31/2015

Desc: Sesa Anti-Dandruff Shampoo
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following;anti dandruff Shampoo ? for dandruff free hair; Sesa Anti Dandruff Shampoo ? eliminates excessive dead cells and dandruff and gradually normalize the scalp; Ketoconazole & Australian Tea Tree Oil are known for their antibacterial and antifungal properties are combined with Spearmint Oil to purify and fortify hair follicles; ? Helps to prevent Flaking & Itching Associates with Dandruff.

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 03/31/2015

Desc: Sesa Anti-Dandruff Hair Cream
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;Sesa Anti Dandruff Hair Cream; For dandruff free hair; Made with Powerful Natural Ingredients Tea tree oil and Lemon oil unblocking clogged hair follicles by controlling dandruff; helpful in protecting the scalp from bacterial and fungal problems and reduces itching; Tea Tree Oil ? Controls dandruff ? helpful in protecting the scalp.

53 E - - -- Hair Preps(Non-Coloring)
Date Published: 02/06/2020

Desc: SESA Ayurvedic Hair Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Clinically proven and trusted by doctors for various hair and scalp diseases and disorders'; 'SESA Improves [sic] blood circulation to the follicles. Protects scalp and hair shaft from seborrheic dermatitis'; 'Prevents bacterial and fungal infection of scalp [sic]'; 'helps to remove Dandruff & Lice'.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 03/31/2015

Desc: Caley Dr.s Care Anti-Bacterial Soap
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the products intended use from the product labeling includes but is not limited to the following;Caley Dr.s Care Anti-Bacterial Soap.

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 03/31/2015

Desc: Caley Dr.s Care Anti-Bacterial Soap
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the products intended use from the product labeling includes but is not limited to the following;Caley Dr.s Care Anti-Bacterial Soap

62 S - - 99 Anti-Seborrheic N.E.C.
Date Published: 03/31/2015

Desc: Sesa Oil Anti Dandruff Therapy
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;Sesa Oil Antidandruff Therapy; Advanced Herbal Anti-Dandruff Therapy specially blended with mixture of 18 Active Herbs. 8 Hair Nourishing Oils & Mill processed through KSHIRPAK VIDHI which helps to Alleviate itching; controls fungal infection flaky dandruff and revitalizes hair & scalp thereby ensures Healthy & Dandruff Free Hair.

62 S - - 99 Anti-Seborrheic N.E.C.
Date Published: 03/31/2015

Desc: Sesa Anti-Dandruff Hair Cream
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;Sesa Anti Dandruff Hair Cream; For dandruff free hair; Made with Powerful Natural Ingredients Tea tree oil and Lemon oil unblocking clogged hair follicles by controlling dandruff; helpful in protecting the scalp from bacterial and fungal problems and reduces itching; Tea Tree Oil Controls dandruff helpful in protecting the scalp

62 S - - 99 Anti-Seborrheic N.E.C.
Date Published: 03/31/2015

Desc: Sesa Anti-Dandruff Shampoo
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti dandruff Shampoo for dandruff free hair; Sesa Anti Dandruff Shampoo eliminates excessive dead cells and dandruff and gradually normalize the scalp; Ketoconazole & Australian Tea Tree Oil are known for their antibacterial and antifungal properties are combined with Spearmint Oil to purify and fortify hair follicles; Helps to prevent Flaking & Itching Associates with Dandruff.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/06/2020

Desc: SESA Ayurvedic Hair Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Clinically proven and trusted by doctors for various hair and scalp diseases and disorders'; 'SESA Improves [sic] blood circulation to the follicles. Protects scalp and hair shaft from seborrheic dermatitis'; 'Prevents bacterial and fungal infection of scalp [sic]'; 'helps to remove Dandruff & Lice'.

Bio Veda Action Research
Date Published : 05/29/2014
Khasta No 439 42 441 43 Mauja Rampur , Pradesh, INDIA
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 05/29/2014

Desc: BIOTIQUE Bio Walnut Bark FRESH LIFT BODY BUILDING Shampoo

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 05/29/2014

Desc: BIOTIQUE Bio Walnut Bark FRESH LIFT BODY BUILDING Shampoo

Bliss GVS Pharma Limited
Date Published : 09/14/2021
Plot 11 , Dewan Udyog Nagar; Aliyali Village , Palghar, Maharashtra INDIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/14/2021

Desc: FUNBACT-A Triple Action Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘Indications . . . FUNBACT-A® provides a comprehensive treatment for various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin . . . Betamethasone Dipropionate is one of the most potent topical corticosteroid available and rapidly controls the symptoms such as itching, redness, and scaling . . . Clotrimazole is a broad spectrum synthetic antifungal agent which has fungicidal action against all the fungi responsible for superficial fungal infections of skin. . . . Neomycin Sulphate is a broad spectrum antibacterial antibiotic. . . FUNBACT-A TRIPLE ACTION CREAM . . . Antifungal-Antibacterial-Anti-inflammatory. . . Apply to the infected area 2-3 times a day with a gentle rub. . .To be used only under medical supervision…’.

56 D - - 41 Neomycin Sulfate (Aminoglycosides)
Date Published: 09/14/2021

Desc: FUNBACT-A Triple Action Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘Indications . . . FUNBACT-A® provides a comprehensive treatment for various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin . . . Betamethasone Dipropionate is one of the most potent topical corticosteroid available and rapidly controls the symptoms such as itching, redness, and scaling . . . Clotrimazole is a broad spectrum synthetic antifungal agent which has fungicidal action against all the fungi responsible for superficial fungal infections of skin. . . . Neomycin Sulphate is a broad spectrum antibacterial antibiotic. . . FUNBACT-A TRIPLE ACTION CREAM . . . Antifungal-Antibacterial-Anti-inflammatory. . . Apply to the infected area 2-3 times a day with a gentle rub. . .To be used only under medical supervision…’.

56 G - - 99 Antifungal N.E.C.
Date Published: 09/14/2021

Desc: FUNBACT-A Triple Action Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘Indications . . . FUNBACT-A® provides a comprehensive treatment for various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin . . . Betamethasone Dipropionate is one of the most potent topical corticosteroid available and rapidly controls the symptoms such as itching, redness, and scaling . . . Clotrimazole is a broad spectrum synthetic antifungal agent which has fungicidal action against all the fungi responsible for superficial fungal infections of skin. . . . Neomycin Sulphate is a broad spectrum antibacterial antibiotic. . . FUNBACT-A TRIPLE ACTION CREAM . . . Antifungal-Antibacterial-Anti-inflammatory. . . Apply to the infected area 2-3 times a day with a gentle rub. . .To be used only under medical supervision…’.

61 H - - 99 Anti-Bacterial, N.E.C.
Date Published: 09/14/2021

Desc: FUNBACT-A Triple Action Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘Indications . . . FUNBACT-A® provides a comprehensive treatment for various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin . . . Betamethasone Dipropionate is one of the most potent topical corticosteroid available and rapidly controls the symptoms such as itching, redness, and scaling . . . Clotrimazole is a broad spectrum synthetic antifungal agent which has fungicidal action against all the fungi responsible for superficial fungal infections of skin. . . . Neomycin Sulphate is a broad spectrum antibacterial antibiotic. . . FUNBACT-A TRIPLE ACTION CREAM . . . Antifungal-Antibacterial-Anti-inflammatory. . . Apply to the infected area 2-3 times a day with a gentle rub. . .To be used only under medical supervision…’.

61 W - - 04 Clotrimazole (Anti-Fungal) (Not Antibiotic)
Date Published: 09/14/2021

Desc: FUNBACT-A Triple Action Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘Indications . . . FUNBACT-A® provides a comprehensive treatment for various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin . . . Betamethasone Dipropionate is one of the most potent topical corticosteroid available and rapidly controls the symptoms such as itching, redness, and scaling . . . Clotrimazole is a broad spectrum synthetic antifungal agent which has fungicidal action against all the fungi responsible for superficial fungal infections of skin. . . . Neomycin Sulphate is a broad spectrum antibacterial antibiotic. . . FUNBACT-A TRIPLE ACTION CREAM . . . Antifungal-Antibacterial-Anti-inflammatory. . . Apply to the infected area 2-3 times a day with a gentle rub. . .To be used only under medical supervision…’.

64 L - - 06 Betamethasone Dipropionate (Glucocorticoid)
Date Published: 09/14/2021

Desc: FUNBACT-A Triple Action Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘Indications . . . FUNBACT-A® provides a comprehensive treatment for various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin . . . Betamethasone Dipropionate is one of the most potent topical corticosteroid available and rapidly controls the symptoms such as itching, redness, and scaling . . . Clotrimazole is a broad spectrum synthetic antifungal agent which has fungicidal action against all the fungi responsible for superficial fungal infections of skin. . . . Neomycin Sulphate is a broad spectrum antibacterial antibiotic. . . FUNBACT-A TRIPLE ACTION CREAM . . . Antifungal-Antibacterial-Anti-inflammatory. . . Apply to the infected area 2-3 times a day with a gentle rub. . .To be used only under medical supervision…’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/14/2021

Desc: FUNBACT-A Triple Action Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘Indications . . . FUNBACT-A® provides a comprehensive treatment for various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin . . . Betamethasone Dipropionate is one of the most potent topical corticosteroid available and rapidly controls the symptoms such as itching, redness, and scaling . . . Clotrimazole is a broad spectrum synthetic antifungal agent which has fungicidal action against all the fungi responsible for superficial fungal infections of skin. . . . Neomycin Sulphate is a broad spectrum antibacterial antibiotic. . . FUNBACT-A TRIPLE ACTION CREAM . . . Antifungal-Antibacterial-Anti-inflammatory. . . Apply to the infected area 2-3 times a day with a gentle rub. . .To be used only under medical supervision…’.

CMHP Private Limited
Date Published : 06/14/2023
100 Safal Prelude , Ft Ring Road , Ahmedabad, Gujarat INDIA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/14/2023

Desc: Bebelyn Diarrhea Drops

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/14/2023

Desc: Bebelyn Colic Drops

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/14/2023

Desc: Bebelyn Diarrhea Drops

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/14/2023

Desc: Bebelyn Colic Drops

CONZAPP TECHNOLOGIES LLP
Date Published : 12/09/2022
723 - Kk Avenue , Bhavnagar, Gujarat INDIA
61 R - - 07 Methylene Blue (Antidote)
Date Published: 12/09/2022

Desc: MB Cure Methylene Blue Powder

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/09/2022

Desc: MB Cure Methylene Blue Powder

88 K - - FC Methylene Blue, Tissue Stain
Date Published: 12/09/2022

Desc: MB Cure Methylene Blue Powder

Calix Herbal Ltd
Date Published : 04/29/2010
Plot No.265 , Roorkee, INDIA
53 L - - -- Skin Care Prep
Date Published: 04/29/2010

Desc: Under Eye Cream
Notes: India

53 L - - -- Skin Care Prep
Date Published: 07/14/2010

Desc: Neem Scrub (cream)
Notes: India

53 L - - -- Skin Care Prep
Date Published: 07/14/2010

Desc: Neem Massage Cream
Notes: India

53 L - - -- Skin Care Prep
Date Published: 07/14/2010

Desc: Neem Pack (Skin Cream)
Notes: India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/14/2010

Desc: Neem Pack (Skin Cream)
Notes: India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/29/2010

Desc: Under Eye Cream
Notes: India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/14/2010

Desc: Neem Massage Cream
Notes: India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/14/2010

Desc: Neem Scrub (cream)
Notes: India

Caplin Steriles Limited
Date Published : 06/30/2014
895 - 897 Guruvarajakandigai , Survey No; Thiruvallur District , Gummidipoondi, Tamil Nadu INDIA
56 B - - 03 Amoxicillin Trihydrate (Penicillin, Synthetically Produced)
Date Published: 03/25/2015

Desc: Amoxicilina 500 mg capsulas
Notes: OAISS declared Mfg is drogueria saimed; El Salvador. MFg. indicated on product label is drogueria saimed; El Salvador and Caplin Point Laboratories Ltd; India.
Problems: AMOXICILLIN;

61 W - - 45 Fluconazole (Anti-Fungal) (Not Antibiotic)
Date Published: 06/30/2014

Desc: Fluconazol Capsulas

Chakrapani Ayurveda Clinic & Research Center
Date Published : 04/10/2023
8 Diamond Hill , Shanti Path; Tulsi Circle , Jaipur, Rajasthan INDIA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/10/2023

Desc: Sanshamani Vati Tablets

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/10/2023

Desc: Yograj Guggul Tablets

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/10/2023

Desc: Kaishore Guggulu Tablets

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/10/2023

Desc: Mahasudarshan Powder

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/10/2023

Desc: Gokshuradi Guggul Vati Tablets

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/10/2023

Desc: Medohar (Obesity help) Tea

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/10/2023

Desc: Avipattikar Powder

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/10/2023

Desc: Triphala Guggulu Tablets

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/10/2023

Desc: Mansyadi Ghan Vati Tablets

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/10/2023

Desc: Kanchanar Guggul Tablets

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/10/2023

Desc: Shwas (Asthma help) Tea

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/10/2023

Desc: Medohar (Obesity help) Tea

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/10/2023

Desc: Mahasudarshan Powder

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/10/2023

Desc: Gokshuradi Guggul Vati Tablets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/10/2023

Desc: Kaishore Guggulu Tablets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/10/2023

Desc: Triphala Guggulu Tablets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/10/2023

Desc: Yograj Guggul Tablets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/10/2023

Desc: Shwas (Asthma help) Tea

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/10/2023

Desc: Kanchanar Guggul Tablets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/10/2023

Desc: Mansyadi Ghan Vati Tablets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/10/2023

Desc: Sanshamani Vati Tablets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/10/2023

Desc: Avipattikar Powder

Charak Pharma
Date Published : 01/21/2011
Pauti Village , G T Road; Jaurasi Road , Bapura, Haryana INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/21/2011

Desc: Sapera Forte Tablet
Notes: India

Cheminnova Remedies Pvt. Ltd
Date Published : 09/29/2011
Unit - II, 8-23, SVCIE , Sy.No:296/7/6, I.D.A.Bollaram , Medak, INDIA
60 S - - 99 Antacid, N.E.C.
Date Published: 09/29/2011

Desc: Woodward's Celebrated Gripe Water
Notes: India

61 V - - 99 Anti-Flatulent N.E.C.
Date Published: 09/29/2011

Desc: Woodward's Celebrated Gripe Water
Notes: India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2011

Desc: Woodward's Celebrated Gripe Water
Notes: India

Cholayil PVT LTD
Date Published : 11/08/2012
Plot # 8, Sector-6b Sidcul, Harindwar , Uttarakhand , Sidcul, INDIA
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 11/08/2012

Desc: Ayuredic Soap with Herbs

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2012

Desc: Ayuredic Soap with Herbs

Cipla LTD
Date Published : 03/14/2017
Khasra No. 509/1-2 & 520 , Vii-Bhagwanpur , Bhagwanpur, Uttaranchal INDIA
66 S - - 51 Tadalafil
Date Published: 03/14/2017

Desc: Tadacip 20

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/14/2017

Desc: Tadacip 20

Colgate Palmolive
Date Published : 01/12/2018
Sm - 02 Sanand , Plot , Gujrat, Punjab INDIA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 01/12/2018

Desc: Colgate Max Fresh Toothpaste Spicy Fresh

55 R - - 99 Pharmaceutic Necessities, N.E.C.
Date Published: 01/12/2018

Desc: Colgate Max Fresh Toothpaste Spicy Fresh

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/12/2018

Desc: Colgate Max Fresh Toothpaste Spicy Fresh

Colgate-Palmolive (India) Ltd.
Date Published : 12/30/2019
78 Epip Phase I , Plot No , Jhar Majri, Himachal Pradesh INDIA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 12/30/2019

Desc: Colgate Anticavity Toothpaste Herbal

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 12/30/2019

Desc: Colgate Anticavity Toothpaste Herbal

63 R - - -- Dental Caries Prophyl
Date Published: 12/30/2019

Desc: Colgate Anticavity Toothpaste Herbal

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/30/2019

Desc: Colgate Anticavity Toothpaste Herbal

DABUR INDIA LIMITED.
Date Published : 02/04/2020
I.G.C., Balipara, P.O.Ghoramari Di , Stt. Sonitpur , Assam, INDIA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 02/04/2020

Desc: Red Paste For Teeth & Gums

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 02/04/2020

Desc: Red Paste For Teeth & Gums

63 R - - -- Dental Caries Prophyl
Date Published: 02/04/2020

Desc: Red Paste For Teeth & Gums

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/04/2020

Desc: Red Paste For Teeth & Gums

DHARA FOODS PVT .LTD
Date Published : 11/01/2016
Opp. National Research Center , Boriavi , Anand, Gujarat INDIA
03 A - - 03 Biscuits
Date Published: 11/01/2016

Desc: Chyawanprash with Saffron
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?Chyawanprash useful in cough; bronchial asthma; geriatric disorders; loss of appetite; loss of memory; disorders of the nose and throat?.

20 D - - 16 Star Gooseberry Juice, Berry Juice or Concentrates
Date Published: 11/01/2016

Desc: Amla Juice
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?Amla Juice useful for immunodeficiency; hyperacidity; eye; skin diseases and delays aging?.

21 C - - 99 Mixed Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 11/01/2016

Desc: Patanjali Pachak Hing Peda
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?Pachak Hing Peda useful in indigestion; anorexia; & flatulence?.

21 C - - 99 Mixed Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 11/01/2016

Desc: Chyawanprash with Saffron
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?Chyawanprash useful in cough; bronchial asthma; geriatric disorders; loss of appetite; loss of memory; disorders of the nose and throat?.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/01/2016

Desc: Chyawanprash with Saffron
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?Chyawanprash useful in cough; bronchial asthma; geriatric disorders; loss of appetite; loss of memory; disorders of the nose and throat?.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/01/2016

Desc: Patanjali Pachak Hing Peda
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?Pachak Hing Peda useful in indigestion; anorexia; & flatulence?.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/01/2016

Desc: Amla Juice
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?Amla Juice useful for immunodeficiency; hyperacidity; eye; skin diseases and delays aging?.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/01/2016

Desc: Amla Juice
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?Amla Juice useful for immunodeficiency; hyperacidity; eye; skin diseases and delays aging?.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/01/2016

Desc: Patanjali Pachak Hing Peda
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?Pachak Hing Peda useful in indigestion; anorexia; & flatulence?.

DHARA FOODS PVT .LTD
Date Published : 11/01/2016
Opp. National Research Center , Boriavi , Anand, Gujarat INDIA
03 A - - 03 Biscuits
Date Published: 11/01/2016

Desc: Chyawanprash with Saffron
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?Chyawanprash useful in cough; bronchial asthma; geriatric disorders; loss of appetite; loss of memory; disorders of the nose and throat?.

20 D - - 16 Star Gooseberry Juice, Berry Juice or Concentrates
Date Published: 11/01/2016

Desc: Amla Juice
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?Amla Juice useful for immunodeficiency; hyperacidity; eye; skin diseases and delays aging?.

21 C - - 99 Mixed Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 11/01/2016

Desc: Patanjali Pachak Hing Peda
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Pachak Hing Peda useful in indigestion; anorexia; & flatulence.

21 C - - 99 Mixed Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 11/01/2016

Desc: Chyawanprash with Saffron
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?Chyawanprash useful in cough; bronchial asthma; geriatric disorders; loss of appetite; loss of memory; disorders of the nose and throat?.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/01/2016

Desc: Patanjali Pachak Hing Peda
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Pachak Hing Peda useful in indigestion; anorexia; & flatulence.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/01/2016

Desc: Amla Juice
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?Amla Juice useful for immunodeficiency; hyperacidity; eye; skin diseases and delays aging?.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/01/2016

Desc: Chyawanprash with Saffron
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?Chyawanprash useful in cough; bronchial asthma; geriatric disorders; loss of appetite; loss of memory; disorders of the nose and throat?.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/01/2016

Desc: Amla Juice
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?Amla Juice useful for immunodeficiency; hyperacidity; eye; skin diseases and delays aging?.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/01/2016

Desc: Patanjali Pachak Hing Peda
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Pachak Hing Peda useful in indigestion; anorexia; & flatulence.

DR.MILTONS LABORATORIES PRIVATE LTD.
Date Published : 12/27/2011
7/62 B, VILLIANUR ROAD, , Pondicherry, Pondicherry INDIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/27/2011

Desc: Gripe Water
Notes: India

Dabur India
Date Published : 11/01/2021
Lane no. 3, phase-2 , SIDCO Industrial Complex, Bari Brahmana , Jammu, Jammu and Kashmir INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/01/2021

Desc: Dabur Giloy Churna
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “Ayurvedic Medicine” Indications:” … useful for gout and arthritis, and helps purify blood”.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/01/2021

Desc: Dabur Giloy Churna
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “Ayurvedic Medicine” Indications:” … useful for gout and arthritis, and helps purify blood”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/01/2021

Desc: Dabur Giloy Churna
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “Ayurvedic Medicine” Indications:” … useful for gout and arthritis, and helps purify blood”.

Dabur India
Date Published : 02/28/2020
Manakpur Unit , Mank Pur, Himachal Pradesh INDIA
22 C - - 99 Vine Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 02/28/2020

Desc: Dabur Chyawanprash Awaleha
Notes: The product appears to be an unapproved new drug as the product label and promotional website include claims such as (not an all-inclusive list): Label - 'Helps keep you fit by protecting from day to day elements like cough & cold.'; Website - 'Dabur Chyawanprash is a time-tested Ayurvedic formulation of more than 41 Ayurvedic herbs that aid in boosting the immune system, thereby protecting the body from everyday infections like cough & cold etc. caused by bacteria, viruses, dust and weather change.'.

27 Y - - 99 Condiments, N.E.C.
Date Published: 02/28/2020

Desc: Dabur Chyawanprash Awaleha
Notes: The product appears to be an unapproved new drug as the product label and promotional website include claims such as (not an all-inclusive list): Label - 'Helps keep you fit by protecting from day to day elements like cough & cold.'; Website - 'Dabur Chyawanprash is a time-tested Ayurvedic formulation of more than 41 Ayurvedic herbs that aid in boosting the immune system, thereby protecting the body from everyday infections like cough & cold etc. caused by bacteria, viruses, dust and weather change.'.

37 K - - 99 Pastes, n.e.c.
Date Published: 02/28/2020

Desc: Dabur Chyawanprash Awaleha
Notes: The product appears to be an unapproved new drug as the product label and promotional website include claims such as (not an all-inclusive list): Label - 'Helps keep you fit by protecting from day to day elements like cough & cold.'; Website - 'Dabur Chyawanprash is a time-tested Ayurvedic formulation of more than 41 Ayurvedic herbs that aid in boosting the immune system, thereby protecting the body from everyday infections like cough & cold etc. caused by bacteria, viruses, dust and weather change.'.

53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 04/03/2020

Desc: Meswak Complete Oral Care Toothpaste
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'It is scientifically proven to help reduce tartar and plaque, fight germs and bacteria...'; 'Helps prevent tooth decay...'; 'Fights tartar and plaque...'; 'Effective protection against cavities...'; 'Fights tooth decay...'; 'Fights germs & bacteria...'; 'Gingival protection...'.

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 04/03/2020

Desc: Meswak Complete Oral Care Toothpaste
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'It is scientifically proven to help reduce tartar and plaque, fight germs and bacteria...'; 'Helps prevent tooth decay...'; 'Fights tartar and plaque...'; 'Effective protection against cavities...'; 'Fights tooth decay...'; 'Fights germs & bacteria...'; 'Gingival protection...'.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/26/2024

Desc: Dabur Hajmola Herbal Digestive Tablets Regular Flavor
Notes: The product appears to be a drug as defined by section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is an article (other than food) intended to affect the structure or function of the body. Website claims on product label documenting the intended uses of these products include, but are not limited to the following: “Improves digestion for kids and adults” and “Useful in cases of indigestion, loss of appetite and flatulence”. The product appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.                                                                         

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/28/2020

Desc: Dabur Chyawanprash Awaleha
Notes: The product appears to be an unapproved new drug as the product label and promotional website include claims such as (not an all-inclusive list): Label - 'Helps keep you fit by protecting from day to day elements like cough & cold.'; Website - 'Dabur Chyawanprash is a time-tested Ayurvedic formulation of more than 41 Ayurvedic herbs that aid in boosting the immune system, thereby protecting the body from everyday infections like cough & cold etc. caused by bacteria, viruses, dust and weather change.'.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/26/2024

Desc: Dabur Hajmola Herbal Digestive Tablets Regular Flavor
Notes: The product appears to be a drug as defined by section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is an article (other than food) intended to affect the structure or function of the body. Website claims on product label documenting the intended uses of these products include, but are not limited to the following: “Improves digestion for kids and adults” and “Useful in cases of indigestion, loss of appetite and flatulence”. The product appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.                                                                         

60 S - - 99 Antacid, N.E.C.
Date Published: 02/26/2024

Desc: Dabur Hajmola Herbal Digestive Tablets Regular Flavor
Notes: The product appears to be a drug as defined by section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is an article (other than food) intended to affect the structure or function of the body. Website claims on product label documenting the intended uses of these products include, but are not limited to the following: “Improves digestion for kids and adults” and “Useful in cases of indigestion, loss of appetite and flatulence”. The product appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.                                                                         

63 R - - -- Dental Caries Prophyl
Date Published: 04/03/2020

Desc: Meswak Complete Oral Care Toothpaste
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'It is scientifically proven to help reduce tartar and plaque, fight germs and bacteria...'; 'Helps prevent tooth decay...'; 'Fights tartar and plaque...'; 'Effective protection against cavities...'; 'Fights tooth decay...'; 'Fights germs & bacteria...'; 'Gingival protection...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/26/2024

Desc: Dabur Hajmola Herbal Digestive Tablets Regular Flavor
Notes: The product appears to be a drug as defined by section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is an article (other than food) intended to affect the structure or function of the body. Website claims on product label documenting the intended uses of these products include, but are not limited to the following: “Improves digestion for kids and adults” and “Useful in cases of indigestion, loss of appetite and flatulence”. The product appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.                                                                         

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/28/2020

Desc: Dabur Chyawanprash Awaleha
Notes: The product appears to be an unapproved new drug as the product label and promotional website include claims such as (not an all-inclusive list): Label - 'Helps keep you fit by protecting from day to day elements like cough & cold.'; Website - 'Dabur Chyawanprash is a time-tested Ayurvedic formulation of more than 41 Ayurvedic herbs that aid in boosting the immune system, thereby protecting the body from everyday infections like cough & cold etc. caused by bacteria, viruses, dust and weather change.'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2020

Desc: Meswak Complete Oral Care Toothpaste
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'It is scientifically proven to help reduce tartar and plaque, fight germs and bacteria...'; 'Helps prevent tooth decay...'; 'Fights tartar and plaque...'; 'Effective protection against cavities...'; 'Fights tooth decay...'; 'Fights germs & bacteria...'; 'Gingival protection...'.

Dabur India Limited
Date Published : 09/13/2019
P.O. Daburgram , Bihar, INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/13/2019

Desc: Ayurvedic
Notes: 5/4/2006

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/13/2019

Desc: Ayurvedic
Notes: 5/4/2006

Dabur India Limited
Date Published : 11/01/2021
SP -C 162 , Matsya Industrial Area , Alwar, Rajasthan INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/01/2021

Desc: Dabur Giloy Churna
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “Ayurvedic Medicine” Indications:” … useful for gout and arthritis, and helps purify blood”.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/01/2021

Desc: Dabur Giloy Churna
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “Ayurvedic Medicine” Indications:” … useful for gout and arthritis, and helps purify blood”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/01/2021

Desc: Dabur Giloy Churna
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “Ayurvedic Medicine” Indications:” … useful for gout and arthritis, and helps purify blood”.

Dabur India Limited
Date Published : 10/14/2012
225/4/1 Survey No , Village - Saily , Silvassa, Dadra And Nagar Haveli INDIA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 10/14/2012

Desc: Dabur Red Paste for Gum Toothpaste

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 10/14/2012

Desc: Dabur Red Paste for Gum Toothpaste

63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic)
Date Published: 10/14/2012

Desc: Dabur Red Paste for Gum Toothpaste

63 S - - 99 Dental Protectant N.E.C.
Date Published: 10/14/2012

Desc: Dabur Red Paste for Gum Toothpaste

63 U - - 99 Dentin Desensitizer N.E.C.
Date Published: 10/14/2012

Desc: Dabur Red Paste for Gum Toothpaste

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/14/2012

Desc: Dabur Red Paste for Gum Toothpaste

Dabur India Limited
Date Published : 06/13/2013
Village Billanwali Lavana, Baddi , Solan, Himachal Pradesh INDIA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 06/13/2013

Desc: Meswak toothpaste with pure extract of rare herb

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 01/27/2021

Desc: Fairness Creme Bleach
Notes: 06/13/2013

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 01/27/2021

Desc: Fairness Creme Bleach with gulabari
Notes: 6/13/2013

Dabur India Limited
Date Published : 05/29/2014
86 A, Kheda Industrial Area, Pithampur , Dhar, Madhya Pradesh INDIA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 05/29/2014

Desc: Dabur RED TOOTHPOWDER for Healthy Gums & Strong Teeth

Dabur India Limited (Unit-2)
Date Published : 02/04/2020
Integrated Industrial Estate, Plot No 4, Sec-2, Pant Nagar, Distt. Udham Singh Nagar , Udham Singh Nagar, Uttaranchal INDIA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 01/27/2021

Desc: Red Paste for Teeth and Gums "Toothpaste"
Notes: Product appears to be is a drug, as per section 201(g)(1) of the FDCA, 21U.S.C.321(g)(1), and an unapproved new drug, as per section 505(a) of the FDCA, 21U.S.C.355(a). Claims on LBL (21CFR201.128) include: "Fights 7 Dental Problems, Cavities, Bad Breath, Bleeding Gums, Toothache, Yellowing, Plaque, Germs...antiseptic and antibacterial properties...anti-inflammatory". Based on the claims, the product is a drug as defined by section 201(g)(1)(B) of the FDCA, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FDCA, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. OTC drug products intended for use as anticaries are subject to the final rule for Anticaries Drug Products for OTC Human Use (anticaries final rule), 21CFR355. However, it is not labeled or formulated in accordance with this final rule for the reasons explained below. Product is a four-way combination drug product because it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. The anticaries final rule does not permit a four-way combination drug product such as this product. Thus, as formulated and labeled, it does not comply with the final rule described above. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled, is GRAS and effective. Therefore, it appears to be a new drug within the meaning of section 201(p) of the FDCA, 21U.S.C. 321(p). Under sections 505(a) and 301(d) of the FDCA, a new drug may not be introduced/delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Product is not the subject of an FDA-approved application. 3/23/2020

53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 04/03/2020

Desc: Meswak Complete Oral Care Toothpaste
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'It is scientifically proven to help reduce tartar and plaque, fight germs and bacteria...'; 'Helps prevent tooth decay...'; 'Fights tartar and plaque...'; 'Effective protection against cavities...'; 'Fights tooth decay...'; 'Fights germs & bacteria...'; 'Gingival protection...'.

53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 02/04/2020

Desc: Red Paste For Teeth & Gums

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 04/03/2020

Desc: Meswak Complete Oral Care Toothpaste
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'It is scientifically proven to help reduce tartar and plaque, fight germs and bacteria...'; 'Helps prevent tooth decay...'; 'Fights tartar and plaque...'; 'Effective protection against cavities...'; 'Fights tooth decay...'; 'Fights germs & bacteria...'; 'Gingival protection...'.

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 01/27/2021

Desc: Red Paste for Teeth and Gums "Toothpaste"
Notes: Product appears to be is a drug, as per section 201(g)(1) of the FDCA, 21U.S.C.321(g)(1), and an unapproved new drug, as per section 505(a) of the FDCA, 21U.S.C.355(a). Claims on LBL (21CFR201.128) include: "Fights 7 Dental Problems, Cavities, Bad Breath, Bleeding Gums, Toothache, Yellowing, Plaque, Germs...antiseptic and antibacterial properties...anti-inflammatory". Based on the claims, the product is a drug as defined by section 201(g)(1)(B) of the FDCA, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FDCA, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. OTC drug products intended for use as anticaries are subject to the final rule for Anticaries Drug Products for OTC Human Use (anticaries final rule), 21CFR355. However, it is not labeled or formulated in accordance with this final rule for the reasons explained below. Product is a four-way combination drug product because it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. The anticaries final rule does not permit a four-way combination drug product such as this product. Thus, as formulated and labeled, it does not comply with the final rule described above. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled, is GRAS and effective. Therefore, it appears to be a new drug within the meaning of section 201(p) of the FDCA, 21U.S.C. 321(p). Under sections 505(a) and 301(d) of the FDCA, a new drug may not be introduced/delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Product is not the subject of an FDA-approved application. 3/23/2020

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 02/04/2020

Desc: Red Paste For Teeth & Gums

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/27/2021

Desc: Dabur Chyawanprash Jeevanprash
Notes: India 4/2/2012

63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic)
Date Published: 01/27/2021

Desc: Red Paste for Teeth and Gums "Toothpaste"
Notes: Product appears to be is a drug, as per section 201(g)(1) of the FDCA, 21U.S.C.321(g)(1), and an unapproved new drug, as per section 505(a) of the FDCA, 21U.S.C.355(a). Claims on LBL (21CFR201.128) include: "Fights 7 Dental Problems, Cavities, Bad Breath, Bleeding Gums, Toothache, Yellowing, Plaque, Germs...antiseptic and antibacterial properties...anti-inflammatory". Based on the claims, the product is a drug as defined by section 201(g)(1)(B) of the FDCA, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FDCA, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. OTC drug products intended for use as anticaries are subject to the final rule for Anticaries Drug Products for OTC Human Use (anticaries final rule), 21CFR355. However, it is not labeled or formulated in accordance with this final rule for the reasons explained below. Product is a four-way combination drug product because it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. The anticaries final rule does not permit a four-way combination drug product such as this product. Thus, as formulated and labeled, it does not comply with the final rule described above. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled, is GRAS and effective. Therefore, it appears to be a new drug within the meaning of section 201(p) of the FDCA, 21U.S.C. 321(p). Under sections 505(a) and 301(d) of the FDCA, a new drug may not be introduced/delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Product is not the subject of an FDA-approved application. 3/23/2020

63 R - - 99 Dental Caries Prophylactic N.E.C.
Date Published: 01/27/2021

Desc: Red Paste for Teeth and Gums "Toothpaste"
Notes: Product appears to be is a drug, as per section 201(g)(1) of the FDCA, 21U.S.C.321(g)(1), and an unapproved new drug, as per section 505(a) of the FDCA, 21U.S.C.355(a). Claims on LBL (21CFR201.128) include: "Fights 7 Dental Problems, Cavities, Bad Breath, Bleeding Gums, Toothache, Yellowing, Plaque, Germs...antiseptic and antibacterial properties...anti-inflammatory". Based on the claims, the product is a drug as defined by section 201(g)(1)(B) of the FDCA, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FDCA, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. OTC drug products intended for use as anticaries are subject to the final rule for Anticaries Drug Products for OTC Human Use (anticaries final rule), 21CFR355. However, it is not labeled or formulated in accordance with this final rule for the reasons explained below. Product is a four-way combination drug product because it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. The anticaries final rule does not permit a four-way combination drug product such as this product. Thus, as formulated and labeled, it does not comply with the final rule described above. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled, is GRAS and effective. Therefore, it appears to be a new drug within the meaning of section 201(p) of the FDCA, 21U.S.C. 321(p). Under sections 505(a) and 301(d) of the FDCA, a new drug may not be introduced/delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Product is not the subject of an FDA-approved application. 3/23/2020

63 R - - -- Dental Caries Prophyl
Date Published: 04/03/2020

Desc: Meswak Complete Oral Care Toothpaste
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'It is scientifically proven to help reduce tartar and plaque, fight germs and bacteria...'; 'Helps prevent tooth decay...'; 'Fights tartar and plaque...'; 'Effective protection against cavities...'; 'Fights tooth decay...'; 'Fights germs & bacteria...'; 'Gingival protection...'.

63 R - - -- Dental Caries Prophyl
Date Published: 02/04/2020

Desc: Red Paste For Teeth & Gums

63 S - - 99 Dental Protectant N.E.C.
Date Published: 01/27/2021

Desc: Red Paste for Teeth and Gums "Toothpaste"
Notes: Product appears to be is a drug, as per section 201(g)(1) of the FDCA, 21U.S.C.321(g)(1), and an unapproved new drug, as per section 505(a) of the FDCA, 21U.S.C.355(a). Claims on LBL (21CFR201.128) include: "Fights 7 Dental Problems, Cavities, Bad Breath, Bleeding Gums, Toothache, Yellowing, Plaque, Germs...antiseptic and antibacterial properties...anti-inflammatory". Based on the claims, the product is a drug as defined by section 201(g)(1)(B) of the FDCA, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FDCA, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. OTC drug products intended for use as anticaries are subject to the final rule for Anticaries Drug Products for OTC Human Use (anticaries final rule), 21CFR355. However, it is not labeled or formulated in accordance with this final rule for the reasons explained below. Product is a four-way combination drug product because it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. The anticaries final rule does not permit a four-way combination drug product such as this product. Thus, as formulated and labeled, it does not comply with the final rule described above. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled, is GRAS and effective. Therefore, it appears to be a new drug within the meaning of section 201(p) of the FDCA, 21U.S.C. 321(p). Under sections 505(a) and 301(d) of the FDCA, a new drug may not be introduced/delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Product is not the subject of an FDA-approved application. 3/23/2020

63 U - - 99 Dentin Desensitizer N.E.C.
Date Published: 01/27/2021

Desc: Red Paste for Teeth and Gums "Toothpaste"
Notes: Product appears to be is a drug, as per section 201(g)(1) of the FDCA, 21U.S.C.321(g)(1), and an unapproved new drug, as per section 505(a) of the FDCA, 21U.S.C.355(a). Claims on LBL (21CFR201.128) include: "Fights 7 Dental Problems, Cavities, Bad Breath, Bleeding Gums, Toothache, Yellowing, Plaque, Germs...antiseptic and antibacterial properties...anti-inflammatory". Based on the claims, the product is a drug as defined by section 201(g)(1)(B) of the FDCA, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FDCA, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. OTC drug products intended for use as anticaries are subject to the final rule for Anticaries Drug Products for OTC Human Use (anticaries final rule), 21CFR355. However, it is not labeled or formulated in accordance with this final rule for the reasons explained below. Product is a four-way combination drug product because it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. The anticaries final rule does not permit a four-way combination drug product such as this product. Thus, as formulated and labeled, it does not comply with the final rule described above. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled, is GRAS and effective. Therefore, it appears to be a new drug within the meaning of section 201(p) of the FDCA, 21U.S.C. 321(p). Under sections 505(a) and 301(d) of the FDCA, a new drug may not be introduced/delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Product is not the subject of an FDA-approved application. 3/23/2020

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/04/2020

Desc: Red Paste For Teeth & Gums

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/27/2021

Desc: Red Paste for Teeth and Gums "Toothpaste"
Notes: Product appears to be is a drug, as per section 201(g)(1) of the FDCA, 21U.S.C.321(g)(1), and an unapproved new drug, as per section 505(a) of the FDCA, 21U.S.C.355(a). Claims on LBL (21CFR201.128) include: "Fights 7 Dental Problems, Cavities, Bad Breath, Bleeding Gums, Toothache, Yellowing, Plaque, Germs...antiseptic and antibacterial properties...anti-inflammatory". Based on the claims, the product is a drug as defined by section 201(g)(1)(B) of the FDCA, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FDCA, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. OTC drug products intended for use as anticaries are subject to the final rule for Anticaries Drug Products for OTC Human Use (anticaries final rule), 21CFR355. However, it is not labeled or formulated in accordance with this final rule for the reasons explained below. Product is a four-way combination drug product because it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. The anticaries final rule does not permit a four-way combination drug product such as this product. Thus, as formulated and labeled, it does not comply with the final rule described above. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled, is GRAS and effective. Therefore, it appears to be a new drug within the meaning of section 201(p) of the FDCA, 21U.S.C. 321(p). Under sections 505(a) and 301(d) of the FDCA, a new drug may not be introduced/delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Product is not the subject of an FDA-approved application. 3/23/2020

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2020

Desc: Meswak Complete Oral Care Toothpaste
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'It is scientifically proven to help reduce tartar and plaque, fight germs and bacteria...'; 'Helps prevent tooth decay...'; 'Fights tartar and plaque...'; 'Effective protection against cavities...'; 'Fights tooth decay...'; 'Fights germs & bacteria...'; 'Gingival protection...'.

Dabur India Ltd
Date Published : 01/10/2017
8/3 Asaf Ali Road , New Delhi, Delhi INDIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/10/2017

Desc: Pudin Hara Active
Notes: Medical claims made on product label

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 01/10/2017

Desc: Pudin Hara Active
Notes: Medical claims made on product label

Dabur India Ltd
Date Published : 10/14/2015
109 Hpsidc Industrial Area , Baddi, Himachal Pradesh INDIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/14/2015

Desc: Dabur Pudin Hara Pearls

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 10/14/2015

Desc: Dabur Pudin Hara Pearls

Dabur India Ltd Baddi Oral Care Unit
Date Published : 11/22/2010
601 Baddi Tehsil Alagarh , Dist Solan , Malku Majra, Himachal Pradesh INDIA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 11/22/2010

Desc: Dabur Meswak Toothpaste
Notes: India

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 11/22/2010

Desc: Dabur Meswak Toothpaste
Notes: India

63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic)
Date Published: 11/22/2010

Desc: Dabur Meswak Toothpaste
Notes: India

63 S - - 99 Dental Protectant N.E.C.
Date Published: 11/22/2010

Desc: Dabur Meswak Toothpaste
Notes: India

Deltas Pharma( Padmavati )
Date Published : 06/22/2017
Old Industrial Area , Haridwar, INDIA
28 C - - 04 Basil (Sweet Basil), Natural Extract or Flavor (Spice)
Date Published: 06/22/2017

Desc: Deltas Pancha Tulasi Drops Basils - 5
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: ' … Basil species, Ocimum sanctum (Shyam Tulasi) is used for common cold, flu, cough, other respiratory and oral cavity ailments …; … Ocimum citriodorum (Nimbu Tulasi) & Ocimum gratissimum (Ram Tulasi) have antimicrobial & anti-viral action …; … The elixir from basil species is natural adjuvant in opportunistic ailments and prevent frequent recurrence …'

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/22/2017

Desc: Deltas Pancha Tulasi Drops Basils - 5
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: ' … Basil species, Ocimum sanctum (Shyam Tulasi) is used for common cold, flu, cough, other respiratory and oral cavity ailments …; … Ocimum citriodorum (Nimbu Tulasi) & Ocimum gratissimum (Ram Tulasi) have antimicrobial & anti-viral action …; … The elixir from basil species is natural adjuvant in opportunistic ailments and prevent frequent recurrence …'

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/22/2017

Desc: Joddaram Joint Pain Relief Oil
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: ' … Joint Pain Relief Oil …; … Natural support for musculoskeletal discomfort …; … JODDARAM oil, a unique blend of natural essential oils and processed herbs provides soothing relief from muscle and joints pain, backache and sprains. The Unique herbal blend relieves old stiffness and relaxes muscles naturally …; … Joint pain …; … Muscle pain …; … Stiffness …'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/22/2017

Desc: Joddaram Joint Pain Relief Oil
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: ' … Joint Pain Relief Oil …; … Natural support for musculoskeletal discomfort …; … JODDARAM oil, a unique blend of natural essential oils and processed herbs provides soothing relief from muscle and joints pain, backache and sprains. The Unique herbal blend relieves old stiffness and relaxes muscles naturally …; … Joint pain …; … Muscle pain …; … Stiffness …'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/22/2017

Desc: Deltas Pancha Tulasi Drops Basils - 5
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: ' … Basil species, Ocimum sanctum (Shyam Tulasi) is used for common cold, flu, cough, other respiratory and oral cavity ailments …; … Ocimum citriodorum (Nimbu Tulasi) & Ocimum gratissimum (Ram Tulasi) have antimicrobial & anti-viral action …; … The elixir from basil species is natural adjuvant in opportunistic ailments and prevent frequent recurrence …'

Dharmanias International
Date Published : 08/25/2015
97-B, Sector-5 , IMT Manesar , Gurgaon (HR.), INDIA
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 08/25/2015

Desc: Mast Mood Oil

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/25/2015

Desc: Shilajit

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/25/2015

Desc: N.F. Cure

Divya Pharmacy
Date Published : 02/10/2012
A - 1 Industrial Area , Plot No , Hardwar, Uttarakhand INDIA
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/01/2021

Desc: ;Patanjali Roghan Badam Shirin Sweet Almond Oil
Notes: The product appears to be an unapproved new drug as the product's promotional website and label include, but are not limited to, the following claims: '...Insomnia; Dryness of skin; Weakness of brain; Constipation; [R]elieves you of headaches and tiredness. It has natural muscle relaxant properties which reduces stress and helps you relax. Divya Badam Rogan also boosts the brain and improves memory...'. ; DWPE:11/05/2019

54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas)
Date Published: 11/01/2021

Desc: Coronil Tablet
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “Common Use . . . (Immunity booster), Specifically against respiratory Tract Infection & all types of fever (Bacterial, Viral)”.                                                                                                                                                                        

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/01/2021

Desc: Coronil Tablet
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “Common Use . . . (Immunity booster), Specifically against respiratory Tract Infection & all types of fever (Bacterial, Viral)”.                                                                                                                                                                        

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/01/2021

Desc: Divya Swasari Coronil Kit
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “timely and untiring efforts made by several scientists of Patanjali Research Institute have led to the development of an ayurvedic remedy for the restoration of health of Coronavirus (COVID-19) INFECTED PATIENTS.”                                                                                                                                                    

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/10/2012

Desc: ChawanPrash-Herbal Supplement
Notes: NOTE; ChawanPrash Herbal Supplement is being promoted for treatment of cough; cold; and general debility; India

54 G - - 99 Animal By-Products and Extracts, N.E.C.
Date Published: 01/29/2020

Desc: GODHAN ARK/ Distilled Purified Cow's Urine
Notes: 1/29/2020

54 K - - 06 Holy Basil (Herbal & Botanicals, not Teas II)
Date Published: 11/01/2021

Desc: Coronil Tablet
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “Common Use . . . (Immunity booster), Specifically against respiratory Tract Infection & all types of fever (Bacterial, Viral)”.                                                                                                                                                                        

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/01/2021

Desc: Coronil Tablet
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “Common Use . . . (Immunity booster), Specifically against respiratory Tract Infection & all types of fever (Bacterial, Viral)”.                                                                                                                                                                        

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/01/2021

Desc: Divya Swasari Coronil Kit
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “timely and untiring efforts made by several scientists of Patanjali Research Institute have led to the development of an ayurvedic remedy for the restoration of health of Coronavirus (COVID-19) INFECTED PATIENTS.”                                                                                                                                                    

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/12/2023

Desc: Mukta Vati Extra Power Tablets

55 Y - - 99 Pharmaceutic Necessities and Containers, N.E.C.
Date Published: 01/29/2020

Desc: GODHAN ARK/ Distilled Purified Cow's Urine
Notes: 1/29/2020

60 L - - 99 Analgesic, N.E.C.
Date Published: 10/23/2015

Desc: Divya Peedantak Taila Oil

61 N - - 99 Anti-Depressant N.E.C.
Date Published: 06/12/2023

Desc: Mukta Vati Extra Power Tablets

62 C - - 99 Anti-Hypertensive N.E.C.
Date Published: 06/12/2023

Desc: Mukta Vati Extra Power Tablets

65 R - - 99 Replenisher N.E.C.
Date Published: 06/12/2023

Desc: Mukta Vati Extra Power Tablets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/10/2012

Desc: ChawanPrash-Herbal Supplement
Notes: NOTE; ChawanPrash Herbal Supplement is being promoted for treatment of cough; cold; and general debility; India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/01/2021

Desc: Divya Swasari Coronil Kit
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “timely and untiring efforts made by several scientists of Patanjali Research Institute have led to the development of an ayurvedic remedy for the restoration of health of Coronavirus (COVID-19) INFECTED PATIENTS.”                                                                                                                                                    

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/29/2020

Desc: GODHAN ARK/ Distilled Purified Cow's Urine
Notes: 1/29/2020

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/12/2023

Desc: Mukta Vati Extra Power Tablets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/01/2021

Desc: Coronil Tablet
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “Common Use . . . (Immunity booster), Specifically against respiratory Tract Infection & all types of fever (Bacterial, Viral)”.                                                                                                                                                                        

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/23/2015

Desc: Divya Peedantak Taila Oil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/01/2021

Desc: ;Patanjali Roghan Badam Shirin Sweet Almond Oil
Notes: The product appears to be an unapproved new drug as the product's promotional website and label include, but are not limited to, the following claims: '...Insomnia; Dryness of skin; Weakness of brain; Constipation; [R]elieves you of headaches and tiredness. It has natural muscle relaxant properties which reduces stress and helps you relax. Divya Badam Rogan also boosts the brain and improves memory...'. ; DWPE: 11/05/2019

Doctor Care Pharma Care Pvt Ltd
Date Published : 11/21/2022
Plot No:63 , Mother Industrial Park; Zak - Kadadara Road , Kadadara, Gujarat INDIA
62 M - - 08 Menthol (Anti-Pruritic)
Date Published: 11/21/2022

Desc: Menthol Nasal Inhaler

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/21/2022

Desc: Menthol Nasal Inhaler

77 K - - CO Inhaler, Nasal
Date Published: 11/21/2022

Desc: Menthol Nasal Inhaler

Dr. Shelender Dhawan
Date Published : 09/30/2009
1759 Sector 16, Faridabad , Haryana, INDIA
54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 09/30/2009

Notes: psorcure oil, psorcure ointmint, psorcure capsules, psorclean tablets, psorcalm capsules, immunopsor drops 5/25/2006

Emami Limited
Date Published : 12/10/2009
18 R.N. Mukherjee Rd , Calcutta, INDIA
53 L - - -- Skin Care Prep
Date Published: 12/10/2009

Desc: Emami Naturally Fair Pearls Intensive Herbal Fairness Cream

53 M - - -- Suntan Preparations
Date Published: 12/10/2009

Desc: Emami Naturally Fair Pearls Intensive Herbal Fairness Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/10/2009

Desc: Emami Naturally Fair Pearls Intensive Herbal Fairness Cream

Emami Limited
Date Published : 07/24/2015
Plot No. 200, Talasari Sanjan Amgaon Road , Village Dongari , Thane, Maharashtra INDIA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/24/2015

Desc: Zanbu Balm
Notes: 5/29/2014

60 L - - 08 Benzydamine HCl (Analgesic)
Date Published: 07/24/2015

Desc: Zanbu Balm
Notes: 5/29/2014

62 M - - 08 Menthol (Anti-Pruritic)
Date Published: 07/24/2015

Desc: Zanbu Balm
Notes: 5/29/2014

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/24/2015

Desc: Zanbu Balm
Notes: 5/29/2014

Emami Limited
Date Published : 12/18/2013
College Nagar, Abhoypur , North Guwahati, Assam INDIA
50 N - - 29 Zinc Oxide
Date Published: 05/29/2014

Desc: Himani Boro Plus Healthy Skin Antiseptic Cream

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/29/2014

Desc: Emami FAIR AND HANDSOME Fairness Cream for Men

65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 05/29/2014

Desc: Emami FAIR AND HANDSOME Fairness Cream for Men

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/29/2014

Desc: Emami FAIR AND HANDSOME Fairness Cream for Men

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/18/2013

Desc: Himani Navratna Oil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/29/2014

Desc: Himani Boro Plus Healthy Skin Antiseptic Cream

Emami Limited
Date Published : 12/08/2015
Masat , U T; D & Nh , Silvassa, Dadra and Nagar Haveli INDIA
40 M - - 99 Infant Formula Raw Material Component, N.E.C.,
Date Published: 12/08/2015

Desc: Zandu Satavarex Delicious Chocolate Flavor Galactagogue
Notes: Product labeling makes structure/function claims

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 12/08/2015

Desc: Zandu Satavarex Delicious Chocolate Flavor Galactagogue
Notes: Product labeling makes structure/function claims

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/13/2023

Desc: Zandu Triphala Churna Powder

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/08/2015

Desc: Zandu Satavarex Delicious Chocolate Flavor Galactagogue
Notes: Product labeling makes structure/function claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/13/2023

Desc: Zandu Triphala Churna Powder

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/08/2015

Desc: Zandu Satavarex Delicious Chocolate Flavor Galactagogue
Notes: Product labeling makes structure/function claims

Emami Limited
Date Published : 05/29/2014
Plot No. 40-41 , Sector 5 , Pantnagar, West Bengal INDIA
50 N - - 29 Zinc Oxide
Date Published: 05/29/2014

Desc: Himani Boro Plus Healthy Skin Antiseptic Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/29/2014

Desc: Himani Boro Plus Healthy Skin Antiseptic Cream

Emami Limited "Epip Complex
Date Published : 12/18/2013
Amingaon, Guwahati , Assam, INDIA
50 N - - 29 Zinc Oxide
Date Published: 05/29/2014

Desc: Himani Boro Plus Healthy Skin Antiseptic Cream

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 05/29/2014

Desc: Navratna Coconut Cool Oil

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/29/2014

Desc: Emami FAIR AND HANDSOME Fairness Cream for Men

65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 05/29/2014

Desc: Emami FAIR AND HANDSOME Fairness Cream for Men

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/29/2014

Desc: Emami FAIR AND HANDSOME Fairness Cream for Men

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/29/2014

Desc: Himani Boro Plus Healthy Skin Antiseptic Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/29/2014

Desc: Navratna Coconut Cool Oil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/18/2013

Desc: Himani Navratna Oil

Fine Processors Pvt. Ltd.
Date Published : 05/29/2014
D-27, Sector II , Noida, INDIA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 05/29/2014

Desc: Ayurvedic Tooth Powder

Fortune Health Care
Date Published : 04/15/2015
7 Gorwa Water Tank , Vadodara, Gujarat INDIA
65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 04/15/2015

Desc: Filagra Gel Shots (Sildenafil)
Notes: Problem(s); Sildenafil

Franco-Indian Pharmaceuticals Pvt., Ltd.
Date Published : 02/18/2015
54 - B Mathuradas Vasanji Marg , Mumbai, Maharashtra INDIA
56 G - - 99 Antifungal N.E.C.
Date Published: 02/18/2015

Desc: Surfaz-SN Triple action cream

61 H - - 99 Anti-Bacterial, N.E.C.
Date Published: 02/18/2015

Desc: Surfaz-SN Triple action cream

61 W - - 04 Clotrimazole (Anti-Fungal) (Not Antibiotic)
Date Published: 02/18/2015

Desc: Surfaz-SN Triple action cream

61 W - - 99 A-Fungal N.E.C.
Date Published: 02/18/2015

Desc: Surfaz-SN Triple action cream

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 02/18/2015

Desc: Surfaz-SN Triple action cream

GOPALDAS VISRAM
Date Published : 02/09/2021
A - 590/591 Ttc Ind Area , Navi , Navi Mumbai, Maharashtra INDIA
56 D - - 41 Neomycin Sulfate (Aminoglycosides)
Date Published: 02/09/2021

Desc: FUNBACT-A TRIPLE ACTION CREAM
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory'.

56 G - - 99 Antifungal N.E.C.
Date Published: 02/09/2021

Desc: FUNBACT-A TRIPLE ACTION CREAM
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory'.

61 W - - 04 Clotrimazole (Anti-Fungal) (Not Antibiotic)
Date Published: 02/09/2021

Desc: FUNBACT-A TRIPLE ACTION CREAM
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory'.

61 W - - 99 A-Fungal N.E.C.
Date Published: 02/09/2021

Desc: FUNBACT-A TRIPLE ACTION CREAM
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory'.

64 L - - 06 Betamethasone Dipropionate (Glucocorticoid)
Date Published: 02/09/2021

Desc: FUNBACT-A TRIPLE ACTION CREAM
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/09/2021

Desc: FUNBACT-A TRIPLE ACTION CREAM
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory'.

Gautam Global Also DBA Botanika
Date Published : 09/30/2009
34 Old Cannought Place , Dehradun, Up INDIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: Web Sites:www.botanicalremedy.com; www.salaciaoblongacapsules.com

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: Web Sites:www.botanicalremedy.com; www.salaciaoblongacapsules.com

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: Web Sites:www.botanicalremedy.com; www.salaciaoblongacapsules.com

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: Web Sites:www.botanicalremedy.com; www.salaciaoblongacapsules.com

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: Web Sites:www.botanicalremedy.com; www.salaciaoblongacapsules.com

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: Web Sites:www.botanicalremedy.com; www.salaciaoblongacapsules.com

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: Web Sites:www.botanicalremedy.com; www.salaciaoblongacapsules.com

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: Web Sites:www.botanicalremedy.com; www.salaciaoblongacapsules.com

Genius Nature Herbs Pvt
Date Published : 01/14/2013
195 Officers Colony Peur Pachapalyam , Coimbatore, INDIA
54 A - - 99 Vitamin, N.E.C.
Date Published: 01/14/2013

Desc: Moringa Leaf Powder Tablets capsules oil and tea

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 01/14/2013

Desc: Moringa Leaf Powder Tablets capsules oil and tea

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/14/2013

Desc: Moringa Leaf Powder Tablets capsules oil and tea

54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd
Date Published: 01/14/2013

Desc: Moringa Leaf Powder Tablets capsules oil and tea

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/14/2013

Desc: Moringa Leaf Powder Tablets capsules oil and tea

62 V - - 99 Anti-Viral N.E.C.
Date Published: 01/14/2013

Desc: Moringa Leaf Powder Tablets capsules oil and tea

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/14/2013

Desc: Moringa Leaf Powder Tablets capsules oil and tea

Goodcare Pharma Pvt. Ltd.
Date Published : 09/30/2009
Bagi Mouza , Bishnupur-1 , 24 Parganas (South), West Bengal INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/16/2019

Desc: Ranitone/Rani Tonic
Notes: 1/23/2007; www.goodcarepharma.com

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/16/2019

Desc: Ranitone/Rani Tonic
Notes: 1/23/2007; www.goodcarepharma.com

Gopaldas Visram & Co., Ltd.
Date Published : 08/16/2019
Ttc Industrial Area , A327 Midc Mahape , Navi Mumbai, Maharashtra INDIA
56 G - - 99 Antifungal N.E.C.
Date Published: 08/16/2019

Desc: Vagisten-V; Miconazole Nitrate Vaginal Cream

61 W - - 18 Miconazole Nitrate (Anti-Fungal) (Not Antibiotic)
Date Published: 08/16/2019

Desc: Vagisten-V; Miconazole Nitrate Vaginal Cream

61 X - - 14 Cyproheptadine HCl (Anti-Histaminic)
Date Published: 11/16/2021

Desc: Super Apeti Plus Syrup
Notes: “Super Apeti Plus Syrup” appears to be a “new drug” as defined by section 201(p) of the FD&C Act, because it is not generally recognized as safe and effective for its labeled uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the FD&C Act. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. There are no FDA-approved applications in effect for “Super Apeti Plus Syrup.” Therefore, its introduction and delivery for introduction into interstate commerce appears to violate section 505(a) of the FD&C Act.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/16/2019

Desc: Vagisten-V; Miconazole Nitrate Vaginal Cream

Grassroot Nutrition Pvt Ltd
Date Published : 03/25/2016
A - 3 M K Plaza , 1st Floor; Ghodbandar Road; Thane West , Thane, Maharashtra INDIA
45 T - - 99 All Other Products, Non-Nutritive Sweeteners
Date Published: 03/25/2016

Desc: Stevia Leaves
Notes: Claims found on labeling and websites

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/25/2016

Desc: Stevia Leaves
Notes: Claims found on labeling and websites

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/25/2016

Desc: Stevia Leaves
Notes: Claims found on labeling and websites

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/25/2016

Desc: Stevia Leaves
Notes: Claims found on labeling and websites

HAWABAN HARDE DEPOT
Date Published : 06/09/2015
26, Laxmibai Nagar, Fort Ind. Estate , Indore, Madhya Pradesh INDIA
60 S - - 99 Antacid, N.E.C.
Date Published: 06/09/2015

Desc: Hawaban Harde (Spicy Chews)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/09/2015

Desc: Hawaban Harde (Spicy Chews)

HCR Formulations P Ltd
Date Published : 06/29/2017
A - 38 Mahagujarat Estate , Sarkhej - Bavla Highway , Moraiya, Gujarat INDIA
54 D - - -- Unconv Diet Spec (No Vit/Min Stmt)
Date Published: 06/29/2017

Desc: Diabefit Capsules (Diabe Fit)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/29/2017

Desc: Diabefit Capsules (Diabe Fit)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/14/2017

Desc: iB Allegance M Cream

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/29/2017

Desc: Diabefit Capsules (Diabe Fit)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/14/2017

Desc: iB Allegance M Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/29/2017

Desc: Diabefit Capsules (Diabe Fit)

HENKEL INDIA LIMITED
Date Published : 11/03/2010
28 S Roy Road , Kolkata, INDIA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 11/03/2010

Desc: Neem active Toothpaste
Notes: india

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 11/03/2010

Desc: Neem active Toothpaste
Notes: India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/03/2010

Desc: Neem active Toothpaste
Notes: India

HIMALAYA WELLNESS COMPANY
Date Published : 01/04/2024
Plt.No.687,Phase 3,Vasa , Industrial Area,Kiadb, INDIA
54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 01/04/2024

Desc: Himalaya Liv.52 Syrup

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 01/04/2024

Desc: Himalaya Liv.52 Syrup

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/04/2024

Desc: Himalaya Liv.52 Syrup

HINDUSTAN UNILEVER LIMITED PERSO
Date Published : 02/14/2020
DAG NO.21 OFF 122 F.S.G , TINGRAI OFF NH NO.37 DOOM DOOMA , ASSAM, INDIA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 02/14/2020

Desc: Closeup EverFresh Toothpaste
Notes: The product appears to be an unapproved new drug as the label of the product includes claims such as (not an all-inclusive list): 'Closeup Everfresh+ is a fluoride gel toothpaste that cleans deeply and protects against cavities'.

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 02/14/2020

Desc: Closeup EverFresh Toothpaste
Notes: The product appears to be an unapproved new drug as the label of the product includes claims such as (not an all-inclusive list): 'Closeup Everfresh+ is a fluoride gel toothpaste that cleans deeply and protects against cavities'.

63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic)
Date Published: 02/14/2020

Desc: Closeup EverFresh Toothpaste
Notes: The product appears to be an unapproved new drug as the label of the product includes claims such as (not an all-inclusive list): 'Closeup Everfresh+ is a fluoride gel toothpaste that cleans deeply and protects against cavities'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/14/2020

Desc: Closeup EverFresh Toothpaste
Notes: The product appears to be an unapproved new drug as the label of the product includes claims such as (not an all-inclusive list): 'Closeup Everfresh+ is a fluoride gel toothpaste that cleans deeply and protects against cavities'.

HINDUSTAN UNILEVER LTD.
Date Published : 05/29/2014
Unit-8, Plot No.1-(1-H) , SEC.1-A, Sidcul, Ranupur , Haridwar, INDIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/30/2014

Desc: Fair & Lovely MAXFairness? for MEN

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 11/19/2014

Desc: Fair and Lovely Expert Fairness Solution

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 11/19/2014

Desc: Fair and Lovely Expert Fairness Solution

65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 05/29/2014

Desc: Fair & Lovely MAXFairness for MEN

Hallmark Pharmacy
Date Published : 09/30/2009
14 School Lane , Bengali Market , New Delhi, INDIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                            

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Hamdard Laboratories
Date Published : 09/30/2009
B/1-2 Industrial Area , Ghazibad, Uttar Pradesh INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/21/2019

Desc: Safi; Blood Purifier
Notes: 5/4/2006

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/21/2019

Desc: Safi; Blood Purifier
Notes: 5/4/2006

Hamdard Laboratories (India)
Date Published : 06/08/2015
Plot No. 12,13,14,15, Sector 7 , IMT Manesar , Gurgaon, Haryana INDIA
26 C - - 99 Refined Vegetable Oil, Single Ingredient, N.E.C.
Date Published: 07/08/2016

Desc: Hamdard Roghan Badam Shirin Sweet Almond Oil
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'Strengthens brain and nerves', 'Removes constipation in a natural way', 'Relieves constipation', and 'Fights dandruff'.

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 07/08/2016

Desc: Hamdard Roghan Badam Shirin Sweet Almond Oil
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?Strengthens brain and nerves?; ?Removes constipation in a natural way?; ?Relieves constipation?; and ?Fights dandruff?.

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 07/08/2016

Desc: Hamdard Roghan Badam Shirin Sweet Almond Oil
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'Strengthens brain and nerves', 'Removes constipation in a natural way', 'Relieves constipation', and 'Fights dandruff'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/08/2016

Desc: Hamdard Roghan Badam Shirin Sweet Almond Oil
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'Strengthens brain and nerves', 'Removes constipation in a natural way', 'Relieves constipation', and 'Fights dandruff'.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/19/2021

Desc: Hamdard SAFI Natural Blood Purifier; Internal Detox Formula for Natural Glowing Skin
Notes: The product appears to be an unapproved new drug, as its promotional label includes claims such as: "Combine to clear out all toxins from blood...", "Promotes cell repair", "Neem Purifies blood and cures almost every skin disease" and "Keeps it toxin free...". The product appears to be an unapproved new drug, as its promotional website includes claims such as: "CURES CONSTIPATION", "CORRECTS INDIGESTION" and "Eliminates the toxins that usually cause acne and blemishes".

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/08/2015

Desc: SAFI Natural Blood Purifier

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2016

Desc: Hamdard Roghan Badam Shirin Sweet Almond Oil
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'Strengthens brain and nerves', 'Removes constipation in a natural way', 'Relieves constipation', and 'Fights dandruff'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/19/2021

Desc: Hamdard SAFI Natural Blood Purifier; Internal Detox Formula for Natural Glowing Skin
Notes: The product appears to be an unapproved new drug, as its promotional label includes claims such as: "Combine to clear out all toxins from blood...", "Promotes cell repair", "Neem Purifies blood and cures almost every skin disease" and "Keeps it toxin free...". The product appears to be an unapproved new drug, as its promotional website includes claims such as: "CURES CONSTIPATION", "CORRECTS INDIGESTION" and "Eliminates the toxins that usually cause acne and blemishes".

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2015

Desc: SAFI Natural Blood Purifier

Harbhajan Singh Yogi & Sons
Date Published : 08/28/2019
Unknown Street , Chandigarh, INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/28/2019

Desc: HSY 103
Notes: 5/4/2006

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/28/2019

Desc: HSY 103
Notes: 5/4/2006

Harinarayan Pharmacy
Date Published : 08/28/2019
Unknown , Unknown, INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/28/2019

Desc: Gesari
Notes: 5/4/2006

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/28/2019

Desc: Gesari
Notes: 5/4/2006

Health Reactive
Date Published : 04/27/2010
2/Kha/1(A) Vigyan Nagar , Kota, Rajasthan INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/27/2010

Desc: Body Revival Suspension (ayurvedic medicine)
Notes: India

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/27/2010

Desc: Body Revival Suspension (ayurvedic medicine)
Notes: India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/27/2010

Desc: Body Revival Suspension (ayurvedic medicine)
Notes: India

Hemma Herbs Pvt Ltd
Date Published : 01/13/2011
Plot-39, Industrial Area , Kolkata, INDIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 01/13/2011

Desc: Himani Navratna Oil
Notes: India

54 A - - 99 Vitamin, N.E.C.
Date Published: 05/29/2014

Desc: Himani SONA CHANDI Chyawanprash Mind & Body revitalization

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 01/13/2011

Desc: Himani Navratna Oil
Notes: India

Herbo Foundation
Date Published : 09/30/2009
Shed No.24 Industrial Estate , Guwahati, INDIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/30/2009

Notes: 11/3/2006. Fairness Cream for Men. (Fair and handsome)

Herbolab India Pvt Ltd
Date Published : 12/19/2017
Gala No. 65-72, 'D' Wing, 1st Floor, , Span Industrial Complex , Silvassa, Dadra And Nagar Haveli INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/19/2017

Desc: Bright Eyed Capsules
Notes: The product appears to be an unapproved new drug as the product includes claims such as, ""HangOver?", "BRITE-EYED is an .... hangover shield that doubles up as a long term liver protector," and "... [P]revents the hangover ... and liver damage..."

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/02/2021

Desc: After Effect Daily Body Detox

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/02/2021

Desc: Immunity Booster

Herbs And Crops Overseas
Date Published : 05/14/2019
56/A-B, Sumel-5, Near Chamanpura Circle , Asarwa , Ahmedabad, Gujarat INDIA
54 B - - 99 Mineral N.E.C.
Date Published: 05/14/2019

Desc: Fuller's Earth Powder (Betonite/Multani Mitti)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/14/2019

Desc: Fuller's Earth Powder (Betonite/Multani Mitti)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/14/2019

Desc: Fuller's Earth Powder (Betonite/Multani Mitti)

Hesh Herbal PVT LTD
Date Published : 10/25/2010
Singh Industrial Estate No 1 , C/14 Ram Mandir Road , Mumbai, Maharashtra INDIA
53 - - - -- Cosmetics
Date Published: 10/25/2010

Desc: Hesh Amla Powder (Indian Gooseberry)
Notes: India

Hesh Pharma Mfg & Exporter Of Herbal Products
Date Published : 05/26/2017
B/3 Ram , Dr Mitrasen G Mahimtura Lane , Mumbai, Maharashtra INDIA
53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 05/26/2017

Desc: NEEM LEAVES POWDER

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/26/2017

Desc: NEEM LEAVES POWDER

Himalaya Drug Company
Date Published : 04/04/2019
Village Jharmajri, (Barotiwala-Baddi Road) , Dist. Solan H.P , Nalagarh, Himachal Pradesh INDIA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/10/2021

Desc: HIMALAYA GENTLE EXFOLIATING WALNUT SCRUB (WALNUT APPLE)

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/10/2021

Desc: HIMALAYA MEN POWER GLOW LICORICE FACE WASH

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 03/18/2020

Desc: Himalaya Gentle Exfoliating Apricot Scrub
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list); 'Help stimulate fresh cell growth'.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 03/18/2020

Desc: Himalaya Purifying Neem Scrub
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Neem, well-known for its purifying and antibacterial properties, kills problem-causing bacteria ...'; 'Purifying Neem Scrub with Antibacterial Properties'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/18/2020

Desc: Himalaya Purifying Neem Scrub
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Neem, well-known for its purifying and antibacterial properties, kills problem-causing bacteria ...'; 'Purifying Neem Scrub with Antibacterial Properties'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/10/2021

Desc: HIMALAYA REVITALIZING NIGHT CREAM

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/18/2020

Desc: Himalaya Gentle Exfoliating Apricot Scrub
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list); 'Help stimulate fresh cell growth'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/10/2021

Desc: HIMALAYA GENTLE EXFOLIATING WALNUT SCRUB (WALNUT APPLE)

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/04/2019

Desc: Purifying Neem Fash Wash

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/18/2020

Desc: Himalaya Purifying Neem Scrub
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Neem, well-known for its purifying and antibacterial properties, kills problem-causing bacteria ...'; 'Purifying Neem Scrub with Antibacterial Properties'.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/10/2021

Desc: HIMALAYA GENTLE EXFOLIATING WALNUT SCRUB (WALNUT APPLE)

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/18/2020

Desc: Himalaya Gentle Exfoliating Apricot Scrub
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list); 'Help stimulate fresh cell growth'.

53 L - - 07 Night (Skin Care Preparations)
Date Published: 09/10/2021

Desc: HIMALAYA REVITALIZING NIGHT CREAM

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/10/2021

Desc: HIMALAYA GENTLE EXFOLIATING WALNUT SCRUB (WALNUT APPLE)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/18/2020

Desc: Himalaya Purifying Neem Scrub
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Neem, well-known for its purifying and antibacterial properties, kills problem-causing bacteria ...'; 'Purifying Neem Scrub with Antibacterial Properties'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/18/2020

Desc: Himalaya Gentle Exfoliating Apricot Scrub
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list); 'Help stimulate fresh cell growth'.

Himalaya Drug Company Limited
Date Published : 11/19/2014
473/C , Bangalore, Karnataka INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/19/2014

Desc: Himalaya Herbal Healthcare Liv.52 tablets

Himdusian Lever Limited
Date Published : 09/30/2009
Shreinas House , Mumbai, INDIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/30/2009

Notes: 11/3/2003 Fair and Lovely Cream

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/30/2009

Notes: 11/3/2006 Fair and Lovely Cream

Hindstan Lever Ltd
Date Published : 06/02/2010
2-A Kandla Road , Mumbai, INDIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 06/02/2010

Desc: Fair and Lovely Cream
Notes: India

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 06/02/2010

Desc: Fair and Lovely Cream
Notes: India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/02/2010

Desc: Fair and Lovely Cream
Notes: India

Hindustan Lever Ltd.
Date Published : 09/30/2009
Dag No.21 Of 122 F.s.grant, Mouza-tingra , Doomdooma Industrial Estate, Off Nh-37 , Mumbai, Tinsukia District INDIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/30/2009

Notes: Ayurvedic Fairness Cream and Fair and Lovely Cream 11/3/2006. This product contains glyburide and phenforim, which are used to treat diabetes. These products, being promoted as dietary supplements claiming to contain only natural Chinese herbal ingrediants, are available through mail order and can be purchased by telephone or via the internet. These products are being recalled under a Class I recall as a health hazzard.

Hindustan Unileaver Limited
Date Published : 05/29/2014
Unit No. 3, Plot No. 1, Sector , Uttarakhand, INDIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/30/2014

Desc: Fair & Lovely MAXFairness? for MEN

65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 05/29/2014

Desc: Fair & Lovely MAXFairness? for MEN

Hindustan Unilever Limited
Date Published : 03/23/2017
1 Transport Depot Road , Kolkata, West Bengal INDIA
31 K - - -- Tea
Date Published: 03/23/2017

Desc: 3 Roses Natural Care Tea
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ...helps sooth the throat... ; ... helps protect from cough & cold...

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/23/2017

Desc: 3 Roses Natural Care Tea
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ...helps sooth the throat... ; ... helps protect from cough & cold...

Hindustan Unilever Ltd
Date Published : 05/29/2014
Unit 1 ,I Ind Estate,Haridvar , Uttarakhand, INDIA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 02/14/2020

Desc: Closeup EverFresh Toothpaste
Notes: The product appears to be an unapproved new drug as the label of the product includes claims such as (not an all-inclusive list): 'Closeup Everfresh+ is a fluoride gel toothpaste that cleans deeply and protects against cavities'.

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 02/14/2020

Desc: Closeup EverFresh Toothpaste
Notes: The product appears to be an unapproved new drug as the label of the product includes claims such as (not an all-inclusive list): 'Closeup Everfresh+ is a fluoride gel toothpaste that cleans deeply and protects against cavities'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/30/2014

Desc: Fair & Lovely MAXFairness™ for MEN

63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic)
Date Published: 02/14/2020

Desc: Closeup EverFresh Toothpaste
Notes: The product appears to be an unapproved new drug as the label of the product includes claims such as (not an all-inclusive list): 'Closeup Everfresh+ is a fluoride gel toothpaste that cleans deeply and protects against cavities'.

65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 05/29/2014

Desc: Fair & Lovely MAXFairness for MEN

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/14/2020

Desc: Closeup EverFresh Toothpaste
Notes: The product appears to be an unapproved new drug as the label of the product includes claims such as (not an all-inclusive list): 'Closeup Everfresh+ is a fluoride gel toothpaste that cleans deeply and protects against cavities'.

Hindustan Unilever Ltd
Date Published : 05/29/2014
A/Unit-1 Tinsukia , Assam, INDIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/30/2014

Desc: Fair & Lovely MAXFairness? for MEN

65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 05/29/2014

Desc: Fair & Lovely MAXFairness for MEN

Hindustan Unilever Ltd
Date Published : 05/29/2014
A/Unit-1 Tinsukia , Assam, INDIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/30/2014

Desc: Fair & Lovely MAXFairness? for MEN

65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 05/29/2014

Desc: Fair & Lovely MAXFairness for Men

Home Shoppe Direct Merchandising
Date Published : 09/27/2012
1 Chincholi Level Crossing Road , Mumbai, Maharashtra INDIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/27/2012

Desc: Tummy Fit Ayurvedic Medicated Slimming Oil

Indian Meds 4u
Date Published : 09/30/2009
B-311, Place, Gaulind Road , Patna(city), Bihar INDIA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                       

Indianmeds4u.com
Date Published : 09/30/2009
235/a , Mumbai 11, INDIA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                       

IndoVedic Nutrients Pvt. Ltd.
Date Published : 06/12/2023
No. 96, 3 Phase , Peenya Industrial Area , Bangalore, Karnataka INDIA
50 - - - -- Color Additiv Food/Drug/Cosmetic
Date Published: 06/12/2023

Desc: Tetrahydrocurcuminoids (Turmeric White Extract) Powder

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/12/2023

Desc: Tetrahydrocurcuminoids (Turmeric White Extract) Powder

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/12/2023

Desc: Tetrahydrocurcuminoids (Turmeric White Extract) Powder

Ipca Laboratories Limited
Date Published : 09/30/2009
P.O. Sejavta , Ratlam, Madhya Pradesh INDIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug.

Jalaram Industries
Date Published : 09/13/2019
62 Midc Area , Jalgaon, INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/13/2019

Desc: Bal Chamcha
Notes: 5/4/2006

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/13/2019

Desc: Bal Chamcha
Notes: 5/4/2006

Jeet Herbals Products
Date Published : 12/20/2016
Anjali F 223-224 J.P Road7 Bunglows , Andheri, INDIA
53 F - - -- Hair Coloring Prep
Date Published: 12/20/2016

Desc: Karishma Herbal Henna Powder
Notes: The product appears to be an unapproved new drug as the product labeling and firm's website include claims such as; "[C]ontrols dandruff and prevents hair loss" and "Due to the natural cooling effect of the herbs used it improves eyesight and gives sound sleep".

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/20/2016

Desc: Karishma Herbal Henna Powder
Notes: The product appears to be an unapproved new drug as the product labeling and firm's website include claims such as; "[C]ontrols dandruff and prevents hair loss' and 'Due to the natural cooling effect of the herbs used it improves eyesight and gives sound sleep'.

KHSETRAPAL EXPORTS
Date Published : 10/02/2013
Sf - 5 , Ahmedabad, Gujarat INDIA
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 10/02/2013

Desc: Woodward Gripe Water

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/21/2022

Desc: Woodward Gripe Water

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/02/2013

Desc: Woodward Gripe Water

Karan International Ltd
Date Published : 12/01/2011
1003 S C O , Chandigarh, Chandigarh INDIA
31 K - - 02 Tea, Green
Date Published: 12/01/2011

Desc: Green Tea
Notes: India

Ken Life Care
Date Published : 11/20/2018
3 1 Plot No 13 , Kumedi , Indore, Madhya Pradesh INDIA
62 U - - 99 Anti-Tussive/Cold N.E.C.
Date Published: 11/20/2018

Desc: Resfriol Vapour Inhaler

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/20/2018

Desc: Resfriol Vapour Inhaler

77 K - - CO Inhaler, Nasal
Date Published: 11/20/2018

Desc: Resfriol Vapour Inhaler

Kesari Ayurvedic Pharmacy
Date Published : 08/11/2017
Abrama, VIA Vedchha , Gujarat, INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/13/2019

Desc: Balguti Kesaria
Notes: 5/4/2006

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/13/2019

Desc: Balguti Kesaria
Notes: 5/4/2006

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/11/2017

Desc: Balguti Kesaria

60 - - - -- Human and Animal Drugs
Date Published: 08/11/2017

Desc: Balguti Kesaria

61 - - - -- Human and Animal Drugs
Date Published: 08/11/2017

Desc: Balguti Kesaria

62 - - - -- Human and Animal Drugs
Date Published: 08/11/2017

Desc: Balguti Kesaria

63 - - - -- Human and Animal Drugs
Date Published: 08/11/2017

Desc: Balguti Kesaria

64 - - - -- Human and Animal Drugs
Date Published: 08/11/2017

Desc: Balguti Kesaria

65 - - - -- Human and Animal Drugs
Date Published: 08/11/2017

Desc: Balguti Kesaria

66 - - - -- Human and Animal Drugs
Date Published: 08/11/2017

Desc: Balguti Kesaria

Keval Exports Pvt. Ltd
Date Published : 11/21/2022
401, 4th Floor, The Ambience Court Plot , Mumbai, INDIA
28 A - - 99 Whole Spice, N.E.C.
Date Published: 11/21/2022

Desc: Dabur Tulsi Drops

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 11/21/2022

Desc: Dabur Tulsi Drops

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/21/2022

Desc: Dabur Tulsi Drops

Keval Exports Pvt.Ltd
Date Published : 05/28/2013
303 B M C Market Road , Mumbai, Maharashtra INDIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/28/2013

Desc: Ayurvedic Dharasna Malis Tel Massage Oil

Kottakkal Arya Vaidya Sala
Date Published : 02/16/2023
Kottakkal-676 501 Malappuroma , Kerala, INDIA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/16/2023

Notes: Product Description: Kottakkal ayurveda Brahmi Head Oil; Kottakkal ayurveda Kalyanaksharam; Kottakkal ayurveda Sankhabhasmam Capsule; Swarnabhasmam Capsules; Kottakkal ayurveda Aswagandha Churnam; Kottakkal ayurveda Rajanyadi Churnam; Kottakkal ayurveda Shadangam Kwatha Churnam; Kottakkal ayurveda H. T. Kot Tablet; Kanchanaraguggulu Tablet; Kottakkal ayurveda Livokot Tablet; Kottakkal ayurveda Rhukot Tablet; Kottakkal ayurveda Samsamani Vati Tablet;

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 02/16/2023

Notes: Product Description: Kottakkal ayurveda Brahmi Head Oil; Kottakkal ayurveda Kalyanaksharam; Kottakkal ayurveda Sankhabhasmam Capsule; Swarnabhasmam Capsules; Kottakkal ayurveda Aswagandha Churnam; Kottakkal ayurveda Rajanyadi Churnam; Kottakkal ayurveda Shadangam Kwatha Churnam; Kottakkal ayurveda H. T. Kot Tablet; Kanchanaraguggulu Tablet; Kottakkal ayurveda Livokot Tablet; Kottakkal ayurveda Rhukot Tablet; Kottakkal ayurveda Samsamani Vati Tablet;

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 02/16/2023

Notes: Product Description: Kottakkal ayurveda Brahmi Head Oil; Kottakkal ayurveda Kalyanaksharam; Kottakkal ayurveda Sankhabhasmam Capsule; Swarnabhasmam Capsules; Kottakkal ayurveda Aswagandha Churnam; Kottakkal ayurveda Rajanyadi Churnam; Kottakkal ayurveda Shadangam Kwatha Churnam; Kottakkal ayurveda H. T. Kot Tablet; Kanchanaraguggulu Tablet; Kottakkal ayurveda Livokot Tablet; Kottakkal ayurveda Rhukot Tablet; Kottakkal ayurveda Samsamani Vati Tablet;

60 - - - -- Human and Animal Drugs
Date Published: 02/16/2023

Notes: Product Description: Kottakkal ayurveda Brahmi Head Oil; Kottakkal ayurveda Kalyanaksharam; Kottakkal ayurveda Sankhabhasmam Capsule; Swarnabhasmam Capsules; Kottakkal ayurveda Aswagandha Churnam; Kottakkal ayurveda Rajanyadi Churnam; Kottakkal ayurveda Shadangam Kwatha Churnam; Kottakkal ayurveda H. T. Kot Tablet; Kanchanaraguggulu Tablet; Kottakkal ayurveda Livokot Tablet; Kottakkal ayurveda Rhukot Tablet; Kottakkal ayurveda Samsamani Vati Tablet;

61 - - - -- Human and Animal Drugs
Date Published: 02/16/2023

Notes: Product Description: Kottakkal ayurveda Brahmi Head Oil; Kottakkal ayurveda Kalyanaksharam; Kottakkal ayurveda Sankhabhasmam Capsule; Swarnabhasmam Capsules; Kottakkal ayurveda Aswagandha Churnam; Kottakkal ayurveda Rajanyadi Churnam; Kottakkal ayurveda Shadangam Kwatha Churnam; Kottakkal ayurveda H. T. Kot Tablet; Kanchanaraguggulu Tablet; Kottakkal ayurveda Livokot Tablet; Kottakkal ayurveda Rhukot Tablet; Kottakkal ayurveda Samsamani Vati Tablet;

62 - - - -- Human and Animal Drugs
Date Published: 02/16/2023

Notes: Product Description: Kottakkal ayurveda Brahmi Head Oil; Kottakkal ayurveda Kalyanaksharam; Kottakkal ayurveda Sankhabhasmam Capsule; Swarnabhasmam Capsules; Kottakkal ayurveda Aswagandha Churnam; Kottakkal ayurveda Rajanyadi Churnam; Kottakkal ayurveda Shadangam Kwatha Churnam; Kottakkal ayurveda H. T. Kot Tablet; Kanchanaraguggulu Tablet; Kottakkal ayurveda Livokot Tablet; Kottakkal ayurveda Rhukot Tablet; Kottakkal ayurveda Samsamani Vati Tablet;

63 - - - -- Human and Animal Drugs
Date Published: 02/16/2023

Notes: Product Description: Kottakkal ayurveda Brahmi Head Oil; Kottakkal ayurveda Kalyanaksharam; Kottakkal ayurveda Sankhabhasmam Capsule; Swarnabhasmam Capsules; Kottakkal ayurveda Aswagandha Churnam; Kottakkal ayurveda Rajanyadi Churnam; Kottakkal ayurveda Shadangam Kwatha Churnam; Kottakkal ayurveda H. T. Kot Tablet; Kanchanaraguggulu Tablet; Kottakkal ayurveda Livokot Tablet; Kottakkal ayurveda Rhukot Tablet; Kottakkal ayurveda Samsamani Vati Tablet;

64 - - - -- Human and Animal Drugs
Date Published: 02/16/2023

Notes: Product Description: Kottakkal ayurveda Brahmi Head Oil; Kottakkal ayurveda Kalyanaksharam; Kottakkal ayurveda Sankhabhasmam Capsule; Swarnabhasmam Capsules; Kottakkal ayurveda Aswagandha Churnam; Kottakkal ayurveda Rajanyadi Churnam; Kottakkal ayurveda Shadangam Kwatha Churnam; Kottakkal ayurveda H. T. Kot Tablet; Kanchanaraguggulu Tablet; Kottakkal ayurveda Livokot Tablet; Kottakkal ayurveda Rhukot Tablet; Kottakkal ayurveda Samsamani Vati Tablet;

65 - - - -- Human and Animal Drugs
Date Published: 02/16/2023

Notes: Product Description: Kottakkal ayurveda Brahmi Head Oil; Kottakkal ayurveda Kalyanaksharam; Kottakkal ayurveda Sankhabhasmam Capsule; Swarnabhasmam Capsules; Kottakkal ayurveda Aswagandha Churnam; Kottakkal ayurveda Rajanyadi Churnam; Kottakkal ayurveda Shadangam Kwatha Churnam; Kottakkal ayurveda H. T. Kot Tablet; Kanchanaraguggulu Tablet; Kottakkal ayurveda Livokot Tablet; Kottakkal ayurveda Rhukot Tablet; Kottakkal ayurveda Samsamani Vati Tablet;

66 - - - -- Human and Animal Drugs
Date Published: 02/16/2023

Notes: Product Description: Kottakkal ayurveda Brahmi Head Oil; Kottakkal ayurveda Kalyanaksharam; Kottakkal ayurveda Sankhabhasmam Capsule; Swarnabhasmam Capsules; Kottakkal ayurveda Aswagandha Churnam; Kottakkal ayurveda Rajanyadi Churnam; Kottakkal ayurveda Shadangam Kwatha Churnam; Kottakkal ayurveda H. T. Kot Tablet; Kanchanaraguggulu Tablet; Kottakkal ayurveda Livokot Tablet; Kottakkal ayurveda Rhukot Tablet; Kottakkal ayurveda Samsamani Vati Tablet;

Kremoint Pharma Private Limited
Date Published : 05/03/2018
B-8, Additional Ambernath M.I.D.C. , Ambernath (E), Thane District , Mumbai, Maharashtra INDIA
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 05/03/2018

Desc: White Express Creme Action Rapide Formule Avancee

56 D - - 20 Gentamicin (Aminoglycosides)
Date Published: 10/01/2021

Desc: Neutroderm Cream (Betamethasone Dipropionate/Gentamicin/Tolnaftate/Iodochlorhydroxyquinoline)
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “Anti-Fungal”, “Anti-Bacterial” and “Anti-Inflammatory”.

61 A - - 11 Iodochlorhydroxyquin (Anti-Amebic)
Date Published: 10/01/2021

Desc: Neutroderm Cream (Betamethasone Dipropionate/Gentamicin/Tolnaftate/Iodochlorhydroxyquinoline)
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “Anti-Fungal”, “Anti-Bacterial” and “Anti-Inflammatory”.

61 W - - 31 Tolnaftate (Anti-Fungal) (Not Antibiotic)
Date Published: 10/01/2021

Desc: Neutroderm Cream (Betamethasone Dipropionate/Gentamicin/Tolnaftate/Iodochlorhydroxyquinoline)
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “Anti-Fungal”, “Anti-Bacterial” and “Anti-Inflammatory”.

64 L - - 06 Betamethasone Dipropionate (Glucocorticoid)
Date Published: 10/01/2021

Desc: Neutroderm Cream (Betamethasone Dipropionate/Gentamicin/Tolnaftate/Iodochlorhydroxyquinoline)
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “Anti-Fungal”, “Anti-Bacterial” and “Anti-Inflammatory”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/01/2021

Desc: Neutroderm Cream (Betamethasone Dipropionate/Gentamicin/Tolnaftate/Iodochlorhydroxyquinoline)
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “Anti-Fungal”, “Anti-Bacterial” and “Anti-Inflammatory”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/03/2018

Desc: White Express Creme Action Rapide Formule Avancee

Kudos Laboratories
Date Published : 06/16/2014
16 Rajendra Park , New Delhi, INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/16/2014

Desc: US 7 Capsules

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/16/2014

Desc: RB 11 Capsules

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/16/2014

Desc: RSM 7 Capsules

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/16/2014

Desc: VS 11 Granules

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/16/2014

Desc: Gasona Tablets

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/16/2014

Desc: PS 9 Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/16/2014

Desc: VS 11 Granules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/16/2014

Desc: Gasona Tablets

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/16/2014

Desc: PS 9 Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/16/2014

Desc: RB 11 Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/16/2014

Desc: US 7 Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/16/2014

Desc: RSM 7 Capsules

56 Y - - 99 Antibiotic N.E.C.
Date Published: 06/16/2014

Desc: RB 11 Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/16/2014

Desc: VS 11 Granules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/16/2014

Desc: RSM 7 Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/16/2014

Desc: PS 9 Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/16/2014

Desc: Gasona Tablets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/16/2014

Desc: RB 11 Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/16/2014

Desc: US 7 Capsules

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 06/16/2014

Desc: PS 9 Capsules

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 06/16/2014

Desc: RSM 7 Capsules

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 06/16/2014

Desc: VS 11 Granules

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 06/16/2014

Desc: US 7 Capsules

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 06/16/2014

Desc: Gasona Tablets

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 06/16/2014

Desc: RB 11 Capsules

Kumar Organic Products Limited
Date Published : 08/01/2012
Plot 94p, 103 & 104, Pharma Sez , Hn Pura Road, Kiadb Industrial Area , Hassan, Karnataka INDIA
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil).India

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil).India

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil).India

62 C - - 41 Minoxidil (Anti-Hypertensive)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil).India

62 C - - 99 Anti-Hypertensive N.E.C.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil).India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil).India

Kumar Organic Products Ltd.
Date Published : 08/01/2012
Plot No. 36, 60 & 65 and 62, Road No. 3 , Jigani Industrial Area, Anekal Taluk , Bangalore, Karnataka INDIA
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India

62 C - - 41 Minoxidil (Anti-Hypertensive)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India

62 C - - 99 Anti-Hypertensive N.E.C.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India

Kumar Organic Products Ltd.
Date Published : 08/01/2012
Anekai Taluk , S No 49; Jigani Road , Bengaluru, Karnataka INDIA
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India

62 C - - 41 Minoxidil (Anti-Hypertensive)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India

62 C - - 99 Anti-Hypertensive N.E.C.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India

Kundan Kidney Care Centre
Date Published : 11/27/2012
257/6 Vij Nagar , Hoshiarpur Road , Jalandhar City, Punjab INDIA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/27/2012

Desc: Kundan Kidney Care Formula 3
Notes: India

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/27/2012

Desc: Kundan Kidney Care Formula 4
Notes: India

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/27/2012

Desc: Kundan Kidney Care Formula 1
Notes: India

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/27/2012

Desc: Kundan Kidney Care Formula 2
Notes: India

Kunnath Pharmaceticals
Date Published : 08/14/2012
VII/318 B Janasakthi Road , Mudavoor P O , Ernakulam, IN-KL INDIA
66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 08/14/2012

Desc: Musli Power X-Tra
Notes: India

Kunnath Pharmeceuticals
Date Published : 03/28/2013
Os 15 , 3rd Floor,G C D A Comple , Kerala, INDIA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/28/2013

Desc: Mulsi Power Xtra-90 Capsules Herbal Aphrodisiac Supplements
Notes: India

Lodestar Impex
Date Published : 10/14/2015
225/A Parappuram Bldg Aimury , Kerala, INDIA
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 10/14/2015

Desc: DHATHRI CHEMPAKAM SOAP

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 10/14/2015

Desc: DHATHRI DHIN SOAP

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 10/14/2015

Desc: DHATHRI OUSHADA SOAP

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/14/2015

Desc: DHATHRI SCAR CREAM

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/14/2015

Desc: DHATHRI SKIN CARE MOISTURIZER

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 10/14/2015

Desc: DHATHRI FAIRNESS FACEPACK

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 10/14/2015

Desc: DHATHRI KASTURIMANJAL

Loren Beautifiers Pvt. Ltd
Date Published : 04/12/2012
Nazrul Islam Avenue , Tegharia , kolkata, INDIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/12/2012

Desc: Boro Care Cream
Notes: India

Lovincare Cosmetics Pvt Ltd
Date Published : 02/18/2015
Vpo Bathu The Haroli District , Una Hp, INDIA
60 L - - 99 Analgesic, N.E.C.
Date Published: 02/18/2015

Desc: Relispray

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/18/2015

Desc: Relispray

M/S Tarun Enterprises
Date Published : 09/13/2010
8/8 Strachy Road , Allahabad, Uttar Pradesh INDIA
63 X - - 12 Fluorescein Sodium (Diagnostic Aid) (Drugs)
Date Published: 09/13/2010

Desc: Fluorescein Sodium Ophthalmic Strips
Notes: India

86 K - - YC Strip, Fluorescein
Date Published: 09/13/2010

Desc: Fluorescein Sodium Ophthalmic Strips
Notes: India

MEA AME Private Limited
Date Published : 06/11/2019
B-V-158-A MC No. 1259-60 , Kami Road, Sonipat , Haryana, INDIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/11/2019

Desc: Organic Smokes Menthol

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/11/2019

Desc: Organic Smokes Roll Your Own

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/11/2019

Desc: Organic Smokes Mild

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/11/2019

Desc: Organic Smokes Regular

98 - - - -- Tobacco Products
Date Published: 06/11/2019

Desc: Organic Smokes Mild

98 - - - -- Tobacco Products
Date Published: 06/11/2019

Desc: Organic Smokes Roll Your Own

98 - - - -- Tobacco Products
Date Published: 06/11/2019

Desc: Organic Smokes Menthol

98 - - - -- Tobacco Products
Date Published: 06/11/2019

Desc: Organic Smokes Regular

Maharishi Ayurveda Products Pvt. Ltd.
Date Published : 08/03/2017
17 & 18, Noida Special Economic Zone , Noida, Uttar Pradesh INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/03/2017

Desc: Throat Ease Medicinal Herbal Lozenges

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/03/2017

Desc: Throat Ease Medicinal Herbal Lozenges

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/03/2017

Desc: Throat Ease Medicinal Herbal Lozenges

Makson Health Care Private Ltd.
Date Published : 05/29/2014
182 - 183 Gummadidala Mandal , Survey , Annaram, Telangana INDIA
60 L - - 99 Analgesic, N.E.C.
Date Published: 09/25/2015

Desc: Tiger Balm Red

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 09/25/2015

Desc: Tiger Balm Red

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 05/29/2014

Desc: IODEX Double Powder

62 M - - 01 Camphor (Anti-Pruritic)
Date Published: 09/25/2015

Desc: Tiger Balm Red

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/25/2015

Desc: Tiger Balm Red

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 05/29/2014

Desc: IODEX Double Powder

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 09/25/2015

Desc: Tiger Balm Red

Marudhar Impex
Date Published : 03/24/2023
B/36 Sumel Business Park 5 , Ahmedabad, Gujarat INDIA
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 03/24/2023

Desc: Haritaki Plus Capsules

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 03/24/2023

Desc: Haritaki Plus Capsules

54 E - - 94 Ashwagandha (Herbal & Botanical Teas)
Date Published: 03/24/2023

Desc: Haritaki Plus Capsules

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/24/2023

Desc: Haritaki Plus Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/24/2023

Desc: Haritaki Plus Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/24/2023

Desc: Haritaki Plus Capsules

Mehrotra Consumer Products Private Limited
Date Published : 04/01/2019
Ecotech 1 , 26g Sector 31 , Greater Noida, Uttar Pradesh INDIA
25 Y - - 99 Vegetable & Vegetable Products Not Mentioned Elsewhere, N.E.C.
Date Published: 04/01/2019

Desc: Organic Tattva Triphala Powder
Notes: The product appears to be an unapproved new drug as the product labeling bears claims. Example of disease claim from the product website, organictattva.com for the product: "[R]egulates blood pressure...".

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/01/2019

Desc: Organic Tattva Triphala Powder
Notes: The product appears to be an unapproved new drug as the product labeling bears claims. Example of disease claim from the product website, organictattva.com for the product: "[R]egulates blood pressure...".

Meyer Organics Pvt Ltd
Date Published : 03/28/2018
A-303 Road No 32 Wagle Estate , Maharashtra, INDIA
54 A - - 99 Vitamin, N.E.C.
Date Published: 03/28/2018

Desc: MIM BLOOD BUILDER
Notes: Mfg. declared in OASIS is Meyer Organics Pvt Ltd at A-303 Road No 32 Wagle Estate; Maharashtra; India. Regional office declared on labeling is Meyer Organics Ltd at A-177 Wagle Estate Thane; Mumbai 400604; India Mfg. declared on product label is Meyer Organics Pvt Ltd at 10d; 2nd Phase Peenya Ind Area Karnataka; India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/28/2018

Notes: MIM BLOOD BUILDER Notes;Mfg. declared in OASIS is Meyer Organics Pvt Ltd at A-303 Road No 32 Wagle Estate; Maharashtra; India. Regional office declared on labeling is Meyer Organics Ltd at A-177 Wagle Estate Thane; Mumbai 400604; India Mfg. declared on product label is Meyer Organics Pvt Ltd at 10d; 2nd Phase Peenya Ind Area Karnataka; India

Meyer Organics Pvt Ltd
Date Published : 06/02/2017
10d 2nd Phase, Peenya Ind Area , Karnataka, INDIA
54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 06/02/2017

Desc: Becoactin Syrup
Notes: The product appears to be an unapproved new drug as the product packaging insert includes claims such as; ? Indications; Appetite Stimulant ; Pharmacology; Cyproheptadine is an antihistamine; anticholinergic & antiserotonergic agent. Cyproheptadine is use to stimulate appetite. Vitamine B complex acts as coenzymes in metabolic reactions & also helps to improve appetite & body weight

54 A - - 99 Vitamin, N.E.C.
Date Published: 03/28/2018

Desc: MIM BLOOD BUILDER
Notes: Mfg. declared in OASIS is Meyer Organics Pvt Ltd at A-303 Road No 32 Wagle Estate; Maharashtra; India. Regional office declared on labeling is Meyer Organics Ltd at A-177 Wagle Estate Thane; Mumbai 400604; India Mfg. declared on product label is Meyer Organics Pvt Ltd at 10d; 2nd Phase Peenya Ind Area Karnataka; India

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/02/2017

Desc: Becoactin Syrup
Notes: The product appears to be an unapproved new drug as the product packaging insert includes claims such as; Indications; Appetite Stimulant ; Pharmacology; Cyproheptadine is an antihistamine; anticholinergic & antiserotonergic agent. Cyproheptadine is use to stimulate appetite. Vitamine B complex acts as coenzymes in metabolic reactions & also helps to improve appetite & body weight

61 X - - 14 Cyproheptadine HCl (Anti-Histaminic)
Date Published: 06/02/2017

Desc: Becoactin Syrup
Notes: The product appears to be an unapproved new drug as the product packaging insert includes claims such as; ? Indications; Appetite Stimulant ; Pharmacology; Cyproheptadine is an antihistamine; anticholinergic & antiserotonergic agent. Cyproheptadine is use to stimulate appetite. Vitamine B complex acts as coenzymes in metabolic reactions & also helps to improve appetite & body weight

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/02/2017

Desc: Becoactin Syrup
Notes: The product appears to be an unapproved new drug as the product packaging insert includes claims such as; Indications; Appetite Stimulant ; Pharmacology; Cyproheptadine is an antihistamine; anticholinergic & antiserotonergic agent. Cyproheptadine is use to stimulate appetite. Vitamine B complex acts as coenzymes in metabolic reactions & also helps to improve appetite & body weight

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/28/2018

Desc: MIM BLOOD BUILDER
Notes: Mfg. declared in OASIS is Meyer Organics Pvt Ltd at A-303 Road No 32 Wagle Estate; Maharashtra; India. Regional office declared on labeling is Meyer Organics Ltd at A-177 Wagle Estate Thane; Mumbai 400604; India Mfg. declared on product label is Meyer Organics Pvt Ltd at 10d; 2nd Phase Peenya Ind Area Karnataka; India

Meyer Organics, LTD
Date Published : 03/28/2018
A-177 , Wagle Estate , Thane-400 604 (Mumbai), INDIA
54 A - - 99 Vitamin, N.E.C.
Date Published: 03/28/2018

Desc: MIM BLOOD BUILDER
Notes: Mfg. declared in OASIS is Meyer Organics Pvt Ltd at A-303 Road No 32 Wagle Estate; Maharashtra; India. Regional office declared on labeling is Meyer Organics Ltd at A-177 Wagle Estate Thane; Mumbai 400604; India Mfg. declared on product label is Meyer Organics Pvt Ltd at 10d; 2nd Phase Peenya Ind Area Karnataka; India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/28/2018

Desc: MIM BLOOD BUILDER
Notes: Mfg. declared in OASIS is Meyer Organics Pvt Ltd at A-303 Road No 32 Wagle Estate; Maharashtra; India. Regional office declared on labeling is Meyer Organics Ltd at A-177 Wagle Estate Thane; Mumbai 400604; India Mfg. declared on product label is Meyer Organics Pvt Ltd at 10d; 2nd Phase Peenya Ind Area Karnataka; India

NITYA NATURALS PRIVATE LIMITED
Date Published : 10/04/2013
1 MIRZAPUR ROAD , NAINI , Allahabad, Uttar Pradesh INDIA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 10/04/2013

Desc: Nitya Tooth Paste
Notes: structure/function claims found on package labeling and website.

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 10/04/2013

Desc: Nitya Tooth Paste
Notes: structure/function claims found on package labeling and website.

63 S - - 99 Dental Protectant N.E.C.
Date Published: 10/04/2013

Desc: Nitya Tooth Paste
Notes: structure/function claims found on package labeling and website.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/04/2013

Desc: Nitya Tooth Paste
Notes: structure/function claims found on package labeling and website.

NSP International
Date Published : 03/23/2017
86 Plot No 37 , Survey No , Hyderabad, Telangana INDIA
31 K - - -- Tea
Date Published: 03/23/2017

Desc: 3 Roses Natural Care Tea
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ...helps sooth the throat ...; ... helps protect from cough & cold ....

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/23/2017

Desc: 3 Roses Natural Care Tea
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ...helps sooth the throat ...; ... helps protect from cough & cold .... ;

Navjeevan Ayurvedic
Date Published : 09/13/2019
515/17 Manlana Azad , Nallbazaar , Mumbai, INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/13/2019

Desc: Balguti Kesaria
Notes: 5/4/2006

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/13/2019

Desc: Balguti Kesaria
Notes: 5/4/2006

Nisarga Biotech Pvt Ltd
Date Published : 05/29/2014
J2/1 Addl. Midc , Satara, Maharashtra INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/29/2014

Desc: Dr. Kanodia Amla Relax
Notes: Unapproved New Drug

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/29/2014

Desc: Dr. Kanodia Amla Rejuvenate
Notes: UNAPPROVED NEW DRUGS

61 W - - 99 A-Fungal N.E.C.
Date Published: 05/29/2014

Desc: Dr. Kanodia Amla Rejuvenate
Notes: UNAPPROVED NEW DRUGS

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 05/29/2014

Desc: Dr. Kanodia Amla Relax
Notes: Unapproved New Drug

Nitya International
Date Published : 10/04/2013
C-115, Naraina Industrial Area , Phase I , New Delhi-28, INDIA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 10/04/2013

Desc: Nitya Tooth Paste
Notes: structure/function claims found on package labeling and website.

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 10/04/2013

Desc: Nitya Tooth Paste
Notes: structure/function claims found on package labeling and website.

63 S - - 99 Dental Protectant N.E.C.
Date Published: 10/04/2013

Desc: Nitya Tooth Paste
Notes: structure/function claims found on package labeling and website.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/04/2013

Desc: Nitya Tooth Paste
Notes: structure/function claims found on package labeling and website.

OCTAVIUS PHARMA PVT. LTD
Date Published : 08/28/2023
407 - A/4th , Satya Marg, Opp Mother Milk Palace , Ahmedabad, Gujarat INDIA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/28/2023

Desc: Babies Magic Baby Sleep Gripe Water

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/28/2023

Desc: Babies Magic Baby Sleep Gripe Water

PATANJALI AYURVED LIMITED
Date Published : 11/10/2015
Unit III Patanjali Food & Herbal Park , Village Mustafabad, Laksar Road , Haridwar, Uttarakhand INDIA
03 A - - 03 Biscuits
Date Published: 11/01/2016

Desc: Chyawanprash with Saffron
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Chyawanprash useful in cough; bronchial asthma; geriatric disorders; loss of appetite; loss of memory; disorders of the nose and throat.

20 D - - 16 Star Gooseberry Juice, Berry Juice or Concentrates
Date Published: 11/01/2016

Desc: Amla Juice
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Amla Juice useful for immunodeficiency; hyperacidity; eye; skin diseases and delays aging.

21 C - - 99 Mixed Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 11/01/2016

Desc: Chyawanprash with Saffron
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as;Chyawanprash useful in cough; bronchial asthma; geriatric disorders; loss of appetite; loss of memory; disorders of the nose and throat.

21 C - - 99 Mixed Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 11/01/2016

Desc: Patanjali Pachak Hing Peda
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Pachak Hing Peda useful in indigestion; anorexia; & flatulence.

21 U - - 41 Bael Fruit, Subtropical and Tropical Fruit, Jams, Jellies, Preserves, Marmalades, Candied, Butters,
Date Published: 12/09/2020

Desc: Patanjali Bel Candy (Indian Stone Apple Candy Bael Fruit Candy)
Notes: The product appears to be an unapproved new drug as the product's label includes disease claims such as (not an all-inclusive list): '...Useful in...stomach disorder'.

21 V - - 34 Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 05/09/2017

Desc: Karela Amla Juice

21 V - - 34 Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 12/09/2020

Desc: Patanjali Giloy Juice
Notes: The product appears to be an unapproved new drug as the product's website includes disease claims such as (not an all-inclusive list): '... useful in fever rheumatism, gout, jaundice, anaemia [sic], urinary disorders & immuno deficiency."

21 V - - 37 Bilimbi, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 01/29/2024

Desc: Giloy-Amla Juice

21 V - - 37 Bilimbi, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 01/29/2024

Desc: Amla-Aloevera Juice with Wheat Grass

22 K - - 99 Other Fruits and Fruit Products, Other Fruit Juices or Concentrates, N.E.C.
Date Published: 12/09/2020

Desc: Patanjali Giloy Juice
Notes: The product appears to be an unapproved new drug as the product's website includes disease claims such as (not an all-inclusive list): '... useful in fever rheumatism, gout, jaundice, anaemia [sic], urinary disorders & immuno deficiency."

24 V - - 99 Leaf & Stem Vegetables, with Sauce, N.E.C.
Date Published: 01/29/2024

Desc: Giloy-Amla Juice

24 V - - 99 Leaf & Stem Vegetables, with Sauce, N.E.C.
Date Published: 01/29/2024

Desc: Amla-Aloevera Juice with Wheat Grass

28 C - - 99 Natural Extract or Flavor, N.E.C.
Date Published: 07/10/2017

Desc: Packak Hing Peda

30 B - - 06 Beverage Base, Subtropical or Tropical Fruit, Liquid
Date Published: 07/26/2019

Desc: Brahmi Sharbat Thyme-Leaved Gratiola Beverage
Notes: The product appears to be an unapproved new drug as the product's website includes disease claims such as (not an all-inclusive list); '...Patanjali Brahmi sharbat is an ayurvedic proprietary medicated sharbat made with the extracts of Brahmi that provide ... relief from ... Alzheimer's and insomnia...; ...Brahmi is also used for the treatment of epilepsy; insomnia; asthma and rheumatism...'.

30 B - - 06 Beverage Base, Subtropical or Tropical Fruit, Liquid
Date Published: 12/09/2020

Desc: Patanjali Giloy Juice
Notes: The product appears to be an unapproved new drug as the product's website includes disease claims such as (not an all-inclusive list): '... useful in fever rheumatism, gout, jaundice, anaemia [sic], urinary disorders & immuno deficiency."

30 B - - 06 Beverage Base, Subtropical or Tropical Fruit, Liquid
Date Published: 07/26/2019

Desc: Mango Panna Raw Mango Fruit Beverage
Notes: The product appears to be an unapproved new drug as the product's website includes disease claims such as (not an all-inclusive list); '...Prevent constipation...; ...Reduces depression...'.

30 B - - 99 Fruit Beverage Bases, Liquid, N.E.C.
Date Published: 07/26/2019

Desc: Mango Panna Raw Mango Fruit Beverage
Notes: The product appears to be an unapproved new drug as the product's website includes disease claims such as (not an all-inclusive list); '...Prevent constipation...; ...Reduces depression...'.

30 B - - 99 Fruit Beverage Bases, Liquid, N.E.C.
Date Published: 07/26/2019

Desc: Brahmi Sharbat Thyme-Leaved Gratiola Beverage
Notes: The product appears to be an unapproved new drug as the product's website includes disease claims such as (not an all-inclusive list); '...Patanjali Brahmi sharbat is an ayurvedic proprietary medicated sharbat made with the extracts of Brahmi that provide ... relief from ... Alzheimer's and insomnia...; ...Brahmi is also used for the treatment of epilepsy; insomnia; asthma and rheumatism...'.

30 B - - 99 Fruit Beverage Bases, Liquid, N.E.C.
Date Published: 12/09/2020

Desc: Patanjali Giloy Juice
Notes: The product appears to be an unapproved new drug as the product's website includes disease claims such as (not an all-inclusive list): '... useful in fever rheumatism, gout, jaundice, anaemia [sic], urinary disorders & immuno deficiency."

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 07/26/2019

Desc: Brahmi Sharbat Thyme-Leaved Gratiola Beverage
Notes: The product appears to be an unapproved new drug as the product's website includes disease claims such as (not an all-inclusive list); '...Patanjali Brahmi sharbat is an ayurvedic proprietary medicated sharbat made with the extracts of Brahmi that provide ... relief from ... Alzheimer's and insomnia...; ...Brahmi is also used for the treatment of epilepsy; insomnia; asthma and rheumatism...'.

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 07/26/2019

Desc: Mango Panna Raw Mango Fruit Beverage
Notes: The product appears to be an unapproved new drug as the product's website includes disease claims such as (not an all-inclusive list); '...Prevent constipation...; ...Reduces depression...'.

31 K - - 01 Tea, Black
Date Published: 07/26/2019

Desc: Mango Panna Raw Mango Fruit Beverage
Notes: The product appears to be an unapproved new drug as the product's website includes disease claims such as (not an all-inclusive list); '...Prevent constipation...; ...Reduces depression...'.

31 K - - 01 Tea, Black
Date Published: 07/26/2019

Desc: Brahmi Sharbat Thyme-Leaved Gratiola Beverage
Notes: The product appears to be an unapproved new drug as the product's website includes disease claims such as (not an all-inclusive list); '...Patanjali Brahmi sharbat is an ayurvedic proprietary medicated sharbat made with the extracts of Brahmi that provide ... relief from ... Alzheimer's and insomnia...; ...Brahmi is also used for the treatment of epilepsy; insomnia; asthma and rheumatism...'.

33 E - - 02 Caramel Candy Pieces, Hard, without Nuts or Fruit (without Chocolate)
Date Published: 12/09/2020

Desc: Patanjali Ginger Candy
Notes: The product appears to be an unapproved new drug as the product's label includes disease claims such as: Useful in indigestion, cold, cough and throat disease."

33 E - - 02 Caramel Candy Pieces, Hard, without Nuts or Fruit (without Chocolate)
Date Published: 12/09/2020

Desc: Patanjali Bel Candy (Indian Stone Apple Candy Bael Fruit Candy)
Notes: The product appears to be an unapproved new drug as the product's label includes disease claims such as (not an all-inclusive list): '...Useful in...stomach disorder'.

33 L - - 06 Flavored Candy, Soft (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 12/09/2020

Desc: Patanjali Ginger Candy
Notes: The product appears to be an unapproved new drug as the product's label includes disease claims such as: Useful in indigestion, cold, cough and throat disease."

36 B - - 99 Syrups and Molasses, N.E.C.
Date Published: 07/26/2019

Desc: Mango Panna Raw Mango Fruit Beverage
Notes: The product appears to be an unapproved new drug as the product's website includes disease claims such as (not an all-inclusive list); '...Prevent constipation...; ...Reduces depression...'.

36 B - - 99 Syrups and Molasses, N.E.C.
Date Published: 07/26/2019

Desc: Brahmi Sharbat Thyme-Leaved Gratiola Beverage
Notes: The product appears to be an unapproved new drug as the product's website includes disease claims such as (not an all-inclusive list); '...Patanjali Brahmi sharbat is an ayurvedic proprietary medicated sharbat made with the extracts of Brahmi that provide ... relief from ... Alzheimer's and insomnia...; ...Brahmi is also used for the treatment of epilepsy; insomnia; asthma and rheumatism...'.

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 02/16/2024

Desc: Kesh Kanti Hair Cleanser Silk & Shine

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 02/16/2024

Desc: Kesh Kanti Hair Cleanser Anti-Dandruff

53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 02/03/2023

Desc: Patanjali Dant Kanti Natural Toothpaste

53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 11/12/2015

Desc: Patanjali Dant Kanti Dental Cream

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 11/12/2015

Desc: Patanjali Dant Kanti Dental Cream

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 02/03/2023

Desc: Patanjali Dant Kanti Natural Toothpaste

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 11/12/2015

Desc: Patanjali Dant Kanti Dental Cream

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 02/03/2023

Desc: Patanjali Dant Kanti Natural Toothpaste

54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas)
Date Published: 11/01/2021

Desc: Coronil Tablet
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “Common Use . . . (Immunity booster), Specifically against respiratory Tract Infection & all types of fever (Bacterial, Viral)”.                                                                                                                                                                        

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/26/2019

Desc: Mango Panna Raw Mango Fruit Beverage
Notes: The product appears to be an unapproved new drug as the product's website includes disease claims such as (not an all-inclusive list); '...Prevent constipation...; ...Reduces depression...'.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/29/2024

Desc: Amla-Aloevera Juice with Wheat Grass

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/29/2024

Desc: Giloy-Amla Juice

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/01/2021

Desc: Divya Swasari Coronil Kit
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “timely and untiring efforts made by several scientists of Patanjali Research Institute have led to the development of an ayurvedic remedy for the restoration of health of Coronavirus (COVID-19) INFECTED PATIENTS.”                                                                                                                                                    

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/01/2016

Desc: Chyawanprash with Saffron
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Chyawanprash useful in cough; bronchial asthma; geriatric disorders; loss of appetite; loss of memory; disorders of the nose and throat.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/01/2021

Desc: Coronil Tablet
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “Common Use . . . (Immunity booster), Specifically against respiratory Tract Infection & all types of fever (Bacterial, Viral)”.                                                                                                                                                                        

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/01/2016

Desc: Patanjali Pachak Hing Peda
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Pachak Hing Peda useful in indigestion; anorexia; & flatulence.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/26/2019

Desc: Brahmi Sharbat Thyme-Leaved Gratiola Beverage
Notes: The product appears to be an unapproved new drug as the product's website includes disease claims such as (not an all-inclusive list); '...Patanjali Brahmi sharbat is an ayurvedic proprietary medicated sharbat made with the extracts of Brahmi that provide ... relief from ... Alzheimer's and insomnia...; ...Brahmi is also used for the treatment of epilepsy; insomnia; asthma and rheumatism...'.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/09/2020

Desc: Patanjali Giloy Juice
Notes: The product appears to be an unapproved new drug as the product's website includes disease claims such as (not an all-inclusive list): '... useful in fever rheumatism, gout, jaundice, anaemia [sic], urinary disorders & immuno deficiency."

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/01/2016

Desc: Amla Juice
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Amla Juice useful for immunodeficiency; hyperacidity; eye; skin diseases and delays aging.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/25/2017

Desc: CHYAWANPRASH
Notes: Disease claims made on product labeling.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/03/2023

Desc: Patanjali Dant Kanti Natural Toothpaste

54 G - - 99 Animal By-Products and Extracts, N.E.C.
Date Published: 01/29/2020

Desc: GODHAN ARK/ Distilled Purified Cow's Urine

54 K - - 06 Holy Basil (Herbal & Botanicals, not Teas II)
Date Published: 11/01/2021

Desc: Coronil Tablet
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “Common Use . . . (Immunity booster), Specifically against respiratory Tract Infection & all types of fever (Bacterial, Viral)”.                                                                                                                                                                        

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/01/2021

Desc: Divya Swasari Coronil Kit
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “timely and untiring efforts made by several scientists of Patanjali Research Institute have led to the development of an ayurvedic remedy for the restoration of health of Coronavirus (COVID-19) INFECTED PATIENTS.”                                                                                                                                                    

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/01/2021

Desc: Coronil Tablet
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “Common Use . . . (Immunity booster), Specifically against respiratory Tract Infection & all types of fever (Bacterial, Viral)”.                                                                                                                                                                        

55 Y - - 99 Pharmaceutic Necessities and Containers, N.E.C.
Date Published: 01/29/2020

Desc: GODHAN ARK/ Distilled Purified Cow's Urine

60 L - - 99 Analgesic, N.E.C.
Date Published: 11/10/2015

Desc: Patanjali Balm
Notes: There are drug/medical claims on the product label.

60 L - - 99 Analgesic, N.E.C.
Date Published: 11/12/2015

Desc: Patanjali Dant Kanti Dental Cream

63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic)
Date Published: 11/12/2015

Desc: Patanjali Dant Kanti Dental Cream

63 R - - 05 Sodium Monofluorophosphate (Dental Caries Prophylactic)
Date Published: 11/12/2015

Desc: Patanjali Dant Kanti Dental Cream

63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic)
Date Published: 11/12/2015

Desc: Patanjali Dant Kanti Dental Cream

63 R - - 99 Dental Caries Prophylactic N.E.C.
Date Published: 11/12/2015

Desc: Patanjali Dant Kanti Dental Cream

63 R - - -- Dental Caries Prophyl
Date Published: 02/03/2023

Desc: Patanjali Dant Kanti Natural Toothpaste

63 S - - 99 Dental Protectant N.E.C.
Date Published: 11/12/2015

Desc: Patanjali Dant Kanti Dental Cream

63 S - - 99 Dental Protectant N.E.C.
Date Published: 02/03/2023

Desc: Patanjali Dant Kanti Natural Toothpaste

63 T - - 99 Dental Restoration Agent N.E.C.
Date Published: 11/12/2015

Desc: Patanjali Dant Kanti Dental Cream

63 T - - 99 Dental Restoration Agent N.E.C.
Date Published: 02/03/2023

Desc: Patanjali Dant Kanti Natural Toothpaste

64 T - - 99 Immunosuppress N.E.C.
Date Published: 05/09/2017

Desc: Karela Amla Juice

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/01/2016

Desc: Patanjali Pachak Hing Peda
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Pachak Hing Peda useful in indigestion; anorexia; & flatulence.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/01/2021

Desc: Divya Swasari Coronil Kit
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “timely and untiring efforts made by several scientists of Patanjali Research Institute have led to the development of an ayurvedic remedy for the restoration of health of Coronavirus (COVID-19) INFECTED PATIENTS.”                                                                                                                                                    

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/29/2020

Desc: GODHAN ARK/ Distilled Purified Cow's Urine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/26/2019

Desc: Brahmi Sharbat Thyme-Leaved Gratiola Beverage
Notes: The product appears to be an unapproved new drug as the product's website includes disease claims such as (not an all-inclusive list); '...Patanjali Brahmi sharbat is an ayurvedic proprietary medicated sharbat made with the extracts of Brahmi that provide ... relief from ... Alzheimer's and insomnia...; ...Brahmi is also used for the treatment of epilepsy; insomnia; asthma and rheumatism...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/29/2024

Desc: Amla-Aloevera Juice with Wheat Grass

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/09/2020

Desc: Patanjali Bel Candy (Indian Stone Apple Candy Bael Fruit Candy)
Notes: The product appears to be an unapproved new drug as the product's label includes disease claims such as (not an all-inclusive list): '...Useful in...stomach disorder'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: Patanjali Dant Kanti Natural Toothpaste

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/25/2017

Desc: CHYAWANPRASH
Notes: Disease claims made on product labeling.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/01/2016

Desc: Amla Juice
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Amla Juice useful for immunodeficiency; hyperacidity; eye; skin diseases and delays aging.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/29/2024

Desc: Giloy-Amla Juice

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/10/2015

Desc: Patanjali Balm
Notes: There are drug/medical claims on the product label.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/09/2020

Desc: Patanjali Ginger Candy
Notes: The product appears to be an unapproved new drug as the product's label includes disease claims such as: Useful in indigestion, cold, cough and throat disease."

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/26/2019

Desc: Mango Panna Raw Mango Fruit Beverage
Notes: The product appears to be an unapproved new drug as the product's website includes disease claims such as (not an all-inclusive list); '...Prevent constipation...; ...Reduces depression...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/09/2017

Desc: Karela Amla Juice

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/09/2020

Desc: Patanjali Giloy Juice
Notes: The product appears to be an unapproved new drug as the product's website includes disease claims such as (not an all-inclusive list): '... useful in fever rheumatism, gout, jaundice, anaemia [sic], urinary disorders & immuno deficiency."

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/10/2017

Desc: Packak Hing Peda

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/01/2021

Desc: Coronil Tablet
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “Common Use . . . (Immunity booster), Specifically against respiratory Tract Infection & all types of fever (Bacterial, Viral)”.                                                                                                                                                                        

PERCOS INDIA PVT
Date Published : 09/29/2016
2nd Floor , Plot No5 , New Delhi, Delhi INDIA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/29/2016

Desc: SAY GOODBYE TO PSORIASIS OINTMENT
Notes: Medical claims on product labels & website

61 S - - 99 Anti-Eczematic N.E.C.
Date Published: 09/29/2016

Desc: SAY GOODBYE TO PSORIASIS OINTMENT
Notes: Medical claims on product labels & website

62 N - - 99 Anti-Psoriatic N.E.C.
Date Published: 09/29/2016

Desc: SAY GOODBYE TO PSORIASIS OINTMENT
Notes: Medical claims on product labels & website

Pachranga International Inc.
Date Published : 09/23/2010
Plot No 16 , Part - 1; G T Road , Panipat, Haryana INDIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/23/2010

Desc: Dettol Soap
Notes: India

Padmavati Pharmaceuticals
Date Published : 06/22/2017
F/52 Industrial Area , Haridwar, INDIA
28 C - - 04 Basil (Sweet Basil), Natural Extract or Flavor (Spice)
Date Published: 06/22/2017

Desc: Deltas Pancha Tulasi Drops Basils - 5
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: ' … Basil species, Ocimum sanctum (Shyam Tulasi) is used for common cold, flu, cough, other respiratory and oral cavity ailments …; … Ocimum citriodorum (Nimbu Tulasi) & Ocimum gratissimum (Ram Tulasi) have antimicrobial & anti-viral action …; … The elixir from basil species is natural adjuvant in opportunistic ailments and prevent frequent recurrence …'

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/22/2017

Desc: Joddaram Joint Pain Relief Oil
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: ' … Joint Pain Relief Oil …; … Natural support for musculoskeletal discomfort …; … JODDARAM oil, a unique blend of natural essential oils and processed herbs provides soothing relief from muscle and joints pain, backache and sprains. The Unique herbal blend relieves old stiffness and relaxes muscles naturally …; … Joint pain …; … Muscle pain …; … Stiffness …'.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/22/2017

Desc: Deltas Pancha Tulasi Drops Basils - 5
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: ' … Basil species, Ocimum sanctum (Shyam Tulasi) is used for common cold, flu, cough, other respiratory and oral cavity ailments …; … Ocimum citriodorum (Nimbu Tulasi) & Ocimum gratissimum (Ram Tulasi) have antimicrobial & anti-viral action …; … The elixir from basil species is natural adjuvant in opportunistic ailments and prevent frequent recurrence …'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/22/2017

Desc: Joddaram Joint Pain Relief Oil
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: ' … Joint Pain Relief Oil …; … Natural support for musculoskeletal discomfort …; … JODDARAM oil, a unique blend of natural essential oils and processed herbs provides soothing relief from muscle and joints pain, backache and sprains. The Unique herbal blend relieves old stiffness and relaxes muscles naturally …; … Joint pain …; … Muscle pain …; … Stiffness …'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/22/2017

Desc: Deltas Pancha Tulasi Drops Basils - 5
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: ' … Basil species, Ocimum sanctum (Shyam Tulasi) is used for common cold, flu, cough, other respiratory and oral cavity ailments …; … Ocimum citriodorum (Nimbu Tulasi) & Ocimum gratissimum (Ram Tulasi) have antimicrobial & anti-viral action …; … The elixir from basil species is natural adjuvant in opportunistic ailments and prevent frequent recurrence …'

Pankaj Exports
Date Published : 09/21/2018
1104 Krishna Govinda Towers Section 24 , New Bombay, INDIA
60 L - - 99 Analgesic, N.E.C.
Date Published: 09/21/2018

Desc: MOOV Pain Relief Specialist Spray
Notes: The product appears to be an unapproved new drug as the product label includes claims such as, but not limited to: '... Pain relief specialist ... Uses: Relief from backache, body ache, muscle pain, sprain or joint pain ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/21/2018

Desc: MOOV Pain Relief Specialist Spray
Notes: The product appears to be an unapproved new drug as the product label includes claims such as, but not limited to: '... Pain relief specialist ... Uses: Relief from backache, body ache, muscle pain, sprain or joint pain ...'.

Pankaj Exports Private Limited
Date Published : 11/28/2012
419 Plot No , T T C Industrial Road; Mahaphe Midc Road , Navi Mumbai, Maharashtra INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/28/2012

Desc: Kayam Churna Digestive
Notes: Note; Manufacturer per OASIS

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/28/2012

Desc: Kayam Churna Digestive
Notes: Note; Manufacturer per OASIS

Pankajakasthuri Herbals India Ltd.
Date Published : 01/04/2023
Poovachal , Thiruvananthapuram, INDIA
54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas)
Date Published: 01/04/2023

Desc: BREATHE EAZY GRANULES

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/04/2023

Desc: BREATHE EAZY GRANULES

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/04/2023

Desc: BREATHE EAZY GRANULES

Paramount Polish Processors Ltd
Date Published : 05/29/2014
995 1 Camp Road , Central Hope Town, Uttarakhand INDIA
53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 05/29/2014

Desc: Parachute ADVANSED Ayurvedic HAIR OIL

Paras Pharma
Date Published : 05/29/2014
Po Baddi Dist Solan Himachal , Pradesh, INDIA
50 M - - 29 Zinc Oxide
Date Published: 05/29/2014

Desc: Itch Guard Cream

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/29/2014

Desc: MOOV - The PAIN SPECIALIST

60 Q - - 99 Anesthetic, N.E.C.
Date Published: 05/29/2014

Desc: MOOV - The PAIN SPECIALIST

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 05/29/2014

Desc: MOOV - The PAIN SPECIALIST

Patanjali Ayurved
Date Published : 07/18/2022
44a Kuanwala Dehradun , Uttarakhand, INDIA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 07/18/2022

Desc: Saundarya Aloe Vera Gel Kesar Chandan
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “SOLUTION FOR PIMPLES” and “control sunburn, tanning, dark spots, & pigmentation”.                                                                                                                                                                                                                                                                        

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 07/18/2022

Desc: Saundarya Aloe Vera Gel
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “SOLUTION FOR PIMPLES” and “removes dark spots”.                                                                                                                                                                                                                                                                        

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/18/2022

Desc: Saundarya Aloe Vera Gel Kesar Chandan
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “SOLUTION FOR PIMPLES” and “control sunburn, tanning, dark spots, & pigmentation”.                                                                                                                                                                                                                                                                        

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/18/2022

Desc: Saundarya Aloe Vera Gel
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “SOLUTION FOR PIMPLES” and “removes dark spots”.                                                                                                                                                                                                                                                                        

54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued))
Date Published: 07/18/2022

Desc: Saundarya Aloe Vera Gel Kesar Chandan
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “SOLUTION FOR PIMPLES” and “control sunburn, tanning, dark spots, & pigmentation”.                                                                                                                                                                                                                                                                        

54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued))
Date Published: 07/18/2022

Desc: Saundarya Aloe Vera Gel
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “SOLUTION FOR PIMPLES” and “removes dark spots”.                                                                                                                                                                                                                                                                        

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/18/2022

Desc: Saundarya Aloe Vera Gel
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “SOLUTION FOR PIMPLES” and “removes dark spots”.                                                                                                                                                                                                                                                                        

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/18/2022

Desc: Saundarya Aloe Vera Gel Kesar Chandan
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “SOLUTION FOR PIMPLES” and “control sunburn, tanning, dark spots, & pigmentation”.                                                                                                                                                                                                                                                                        

Patanjali Ayurved Limited
Date Published : 12/17/2010
D - 38 , Haridwar, Uttarakhand INDIA
33 C - - 99 Hard Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 02/10/2012

Desc: Bel Candy
Notes: NOTE; Bel Candy is being promoted for treatment of diarrhea; dysentery diseases and jaundice; India

53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 12/17/2010

Desc: Dant Kanti Dental Cream
Notes: India

53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 09/04/2013

Desc: Patanajali Herbal Tooth Paste

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 12/17/2010

Desc: Dant Kanti Dental Cream
Notes: India

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 05/31/2017

Desc: Patanjali Aloe Vera Gel
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as; (label) Instant solution for pimples; Uses; removes dark spots; (patanjaliayurved.net) Aloe Vera plants have medicinal properties and hence are widely used in treating the burns; cuts; insect bites and several other skin ailments. This is one product that you must keep in your house; so that you can easily treat the kitchen burns and other injuries without wasting time

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 09/04/2013

Desc: Patanajali Herbal Tooth Paste

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 05/31/2017

Desc: Patanjali Aloe Vera Gel
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as; (label) Instant solution for pimples; Uses; removes dark spots; (patanjaliayurved.net) Aloe Vera plants have medicinal properties and hence are widely used in treating the burns; cuts; insect bites and several other skin ailments. This is one product that you must keep in your house; so that you can easily treat the kitchen burns and other injuries without wasting time ;

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 07/18/2022

Desc: Saundarya Aloe Vera Gel
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “SOLUTION FOR PIMPLES” and “removes dark spots”.                                                                                                                                                                                                                                                                        

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 07/18/2022

Desc: Saundarya Aloe Vera Gel Kesar Chandan
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “SOLUTION FOR PIMPLES” and “control sunburn, tanning, dark spots, & pigmentation”.                                                                                                                                                                                                                                                                        

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/05/2019

Desc: Patanjali Roghan Badam Shirin Sweet Almond Oil
Notes: The product appears to be an unapproved new drug as the product's promotional website and label include, but are not limited to, the following claims: '...Insomnia; Dryness of skin; Weakness of brain; Constipation; [R]elieves you of headaches and tiredness. It has natural muscle relaxant properties which reduces stress and helps you relax. Divya Badam Rogan also boosts the brain and improves memory...'.

53 L - - -- Skin Care Prep
Date Published: 05/31/2017

Desc: Patanjali Aloe Vera Gel
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as; (label) Instant solution for pimples; Uses; removes dark spots; (patanjaliayurved.net) Aloe Vera plants have medicinal properties and hence are widely used in treating the burns; cuts; insect bites and several other skin ailments. This is one product that you must keep in your house; so that you can easily treat the kitchen burns and other injuries without wasting time

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/18/2022

Desc: Saundarya Aloe Vera Gel Kesar Chandan
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “SOLUTION FOR PIMPLES” and “control sunburn, tanning, dark spots, & pigmentation”.                                                                                                                                                                                                                                                                        

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/18/2022

Desc: Saundarya Aloe Vera Gel
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “SOLUTION FOR PIMPLES” and “removes dark spots”.                                                                                                                                                                                                                                                                        

54 A - - 99 Vitamin, N.E.C.
Date Published: 04/04/2022

Desc: GILOY GHANAVATI Tablets

54 E - - 94 Ashwagandha (Herbal & Botanical Teas)
Date Published: 04/04/2022

Desc: ASHWAGANDHA Capsules

54 E - - 94 Ashwagandha (Herbal & Botanical Teas)
Date Published: 04/04/2022

Desc: GILOY GHANAVATI Tablets

54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas)
Date Published: 04/04/2022

Desc: ASHWAGANDHA Capsules

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/04/2022

Desc: NIMB GHANAVATI (Neem Vati) Tablets

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/04/2022

Desc: ASHWAGANDHA Capsules

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/04/2022

Desc: GILOY GHANAVATI Tablets

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/04/2022

Desc: TULSI GHANAVATI Tablets

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/04/2022

Desc: IMMUNOCHARGE Tablets

54 K - - 06 Holy Basil (Herbal & Botanicals, not Teas II)
Date Published: 04/04/2022

Desc: TULSI GHANAVATI Tablets

54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued))
Date Published: 07/18/2022

Desc: Saundarya Aloe Vera Gel
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “SOLUTION FOR PIMPLES” and “removes dark spots”.                                                                                                                                                                                                                                                                        

54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued))
Date Published: 07/18/2022

Desc: Saundarya Aloe Vera Gel Kesar Chandan
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “SOLUTION FOR PIMPLES” and “control sunburn, tanning, dark spots, & pigmentation”.                                                                                                                                                                                                                                                                        

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/04/2022

Desc: GILOY GHANAVATI Tablets

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 04/04/2022

Desc: TULSI GHANAVATI Tablets

63 R - - 05 Sodium Monofluorophosphate (Dental Caries Prophylactic)
Date Published: 09/04/2013

Desc: Patanajali Herbal Tooth Paste

63 R - - 99 Dental Caries Prophylactic N.E.C.
Date Published: 12/17/2010

Desc: Dant Kanti Dental Cream
Notes: India

63 S - - 99 Dental Protectant N.E.C.
Date Published: 12/17/2010

Desc: Dant Kanti Dental Cream
Notes: India

63 T - - 99 Dental Restoration Agent N.E.C.
Date Published: 12/17/2010

Desc: Dant Kanti Dental Cream
Notes: India

64 T - - 99 Immunosuppress N.E.C.
Date Published: 04/04/2022

Desc: IMMUNOCHARGE Tablets

64 T - - 99 Immunosuppress N.E.C.
Date Published: 04/04/2022

Desc: TULSI GHANAVATI Tablets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/04/2022

Desc: ASHWAGANDHA Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/31/2017

Desc: Patanjali Aloe Vera Gel
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as; (label) Instant solution for pimples; Uses; removes dark spots; (patanjaliayurved.net) Aloe Vera plants have medicinal properties and hence are widely used in treating the burns; cuts; insect bites and several other skin ailments. This is one product that you must keep in your house; so that you can easily treat the kitchen burns and other injuries without wasting time

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/05/2019

Desc: Patanjali Roghan Badam Shirin Sweet Almond Oil
Notes: The product appears to be an unapproved new drug as the product's promotional website and label include, but are not limited to, the following claims: '...Insomnia; Dryness of skin; Weakness of brain; Constipation; [R]elieves you of headaches and tiredness. It has natural muscle relaxant properties which reduces stress and helps you relax. Divya Badam Rogan also boosts the brain and improves memory...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/04/2022

Desc: GILOY GHANAVATI Tablets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/04/2022

Desc: NIMB GHANAVATI (Neem Vati) Tablets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/18/2022

Desc: Saundarya Aloe Vera Gel Kesar Chandan
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “SOLUTION FOR PIMPLES” and “control sunburn, tanning, dark spots, & pigmentation”.                                                                                                                                                                                                                                                                        

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/18/2022

Desc: Saundarya Aloe Vera Gel
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “SOLUTION FOR PIMPLES” and “removes dark spots”.                                                                                                                                                                                                                                                                        

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/04/2022

Desc: IMMUNOCHARGE Tablets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/04/2022

Desc: TULSI GHANAVATI Tablets

Patanjali Ayurved Ltd.
Date Published : 05/31/2017
132, Village - Aurenjebpur , Roorkee, INDIA
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 05/31/2017

Desc: Patanjali Aloe Vera Gel
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as; (label) Instant solution for pimples; Uses; removes dark spots; (patanjaliayurved.net) Aloe Vera plants have medicinal properties and hence are widely used in treating the burns; cuts; insect bites and several other skin ailments. This is one product that you must keep in your house; so that you can easily treat the kitchen burns and other injuries without wasting time

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 05/31/2017

Desc: Patanjali Aloe Vera Gel
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as; (label) Instant solution for pimples; Uses; removes dark spots; (patanjaliayurved.net) Aloe Vera plants have medicinal properties and hence are widely used in treating the burns; cuts; insect bites and several other skin ailments. This is one product that you must keep in your house; so that you can easily treat the kitchen burns and other injuries without wasting time ;

53 L - - -- Skin Care Prep
Date Published: 05/31/2017

Desc: Patanjali Aloe Vera Gel
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as; (label) Instant solution for pimples; Uses; removes dark spots; (patanjaliayurved.net) Aloe Vera plants have medicinal properties and hence are widely used in treating the burns; cuts; insect bites and several other skin ailments. This is one product that you must keep in your house; so that you can easily treat the kitchen burns and other injuries without wasting time ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/31/2017

Desc: Patanjali Aloe Vera Gel
Notes: The product appears to be an unapproved new drug as the product labeling and website include claims such as; (label) Instant solution for pimples; Uses; removes dark spots; (patanjaliayurved.net) Aloe Vera plants have medicinal properties and hence are widely used in treating the burns; cuts; insect bites and several other skin ailments. This is one product that you must keep in your house; so that you can easily treat the kitchen burns and other injuries without wasting time

Percos India Pvt Ltd
Date Published : 09/29/2016
Plot No 23 Sec 68 11e , Handwar, INDIA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/29/2016

Desc: SAY GOODBYE TO PSORIASIS OINTMENT
Notes: Medical claims on product labels & website

61 S - - 99 Anti-Eczematic N.E.C.
Date Published: 09/29/2016

Desc: SAY GOODBYE TO PSORIASIS OINTMENT
Notes: Medical claims on product labels & website

62 N - - 99 Anti-Psoriatic N.E.C.
Date Published: 09/29/2016

Desc: SAY GOODBYE TO PSORIASIS OINTMENT
Notes: Medical claims on product labels & website

Phalada Agro Research Foundation Pvt. Ltd.
Date Published : 11/08/2018
92/5, Kannalli Village, Segehall Cross , Magadi Main Rd , Bangalore, Karnataka INDIA
26 A - - 99 Crude Vegetable Oil, N.E.C.
Date Published: 11/08/2018

Desc: Neem Oil

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 11/08/2018

Desc: Neem Oil

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 11/08/2018

Desc: Triphala Powder

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/08/2018

Desc: Triphala Powder

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/08/2018

Desc: Neem Oil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2018

Desc: Triphala Powder

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2018

Desc: Neem Oil

Piramal Enterprises Ltd
Date Published : 10/27/2009
1 Nirlon Complex , Western Express Highway , Mumbai, Maharashtra INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/27/2009

Desc: Flaxilip Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/29/2009

Desc: Flaxilip Capsules

Pontika Aerotech Limited
Date Published : 07/07/2023
Po Puriwala , Nahan Road , Johron, Himachal Pradesh INDIA
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/26/2023

Desc: FAMILY WELLNESS childrens SALINE NASAL SPRAY

55 R - - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent)
Date Published: 12/26/2023

Desc: FAMILY WELLNESS childrens SALINE NASAL SPRAY

62 G - - 18 Diclofenac Sodium (Anti-Inflammatory)
Date Published: 07/07/2023

Desc: Moov Diclofenac Spray

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/07/2023

Desc: Moov Diclofenac Spray

Procter & Gamble Co
Date Published : 08/06/2010
Phase Ii Doria Po Baddi , Solan, INDIA
62 M B Y 01 Camphor (Anti-Pruritic), Human - Non/Rx Combination Ingredient, NEC
Date Published: 08/06/2010

Desc: Vicks Nasal Inhaler
Notes: india

62 U - - 99 Anti-Tussive/Cold N.E.C.
Date Published: 08/06/2010

Desc: Vicks Nasal Inhaler
Notes: india

77 K - - CO Inhaler, Nasal
Date Published: 08/06/2010

Desc: Vicks Nasal Inhaler
Notes: india

Proctor & Gamble Hygiene And Health Care
Date Published : 08/06/2010
9/5 & 6 Ida , Uppal Hyderablad, INDIA
62 M B Y 01 Camphor (Anti-Pruritic), Human - Non/Rx Combination Ingredient, NEC
Date Published: 08/06/2010

Desc: Vicks Nasal Inhaler

62 U - - 99 Anti-Tussive/Cold N.E.C.
Date Published: 08/06/2010

Desc: Vicks Nasal Inhaler
Notes: india

77 K - - CO Inhaler, Nasal
Date Published: 08/06/2010

Desc: Vicks Nasal Inhaler
Notes: india

Promed Laboratories
Date Published : 10/01/2013
35-A/4 Laxminagar , Industrial Estate , Indore, Madhya Pradesh INDIA
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 10/01/2013

Desc: Woodward Gripe Water

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/01/2013

Desc: Woodward Gripe Water

Pts Packers And Providers Pvt Lt
Date Published : 07/19/2021
Sangkohla Singtam , Sikkim, INDIA
56 D - - 41 Neomycin Sulfate (Aminoglycosides)
Date Published: 07/19/2021

Desc: Surfaz-SN Triple Action Cream

61 W - - 04 Clotrimazole (Anti-Fungal) (Not Antibiotic)
Date Published: 07/19/2021

Desc: Surfaz-SN Triple Action Cream

64 L - - 02 Beclomethasone Dipropionate (Glucocorticoid)
Date Published: 07/19/2021

Desc: Surfaz-SN Triple Action Cream

64 L - - 06 Betamethasone Dipropionate (Glucocorticoid)
Date Published: 07/19/2021

Desc: Surfaz-SN Triple Action Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/19/2021

Desc: Surfaz-SN Triple Action Cream

Quantum Naturals India Private Limited
Date Published : 01/20/2017
42 Plot No , Gurgaon, Haryana INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/20/2017

Desc: ZenAlc Capsules Herbal Supplement
Notes: Disease claims made on product label

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/20/2017

Desc: ZenHab Capsules Herbal Supplement
Notes: Disease claims made on product label

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/20/2017

Desc: ZenFlex Capsules Herbal Supplement
Notes: Disease claims made on product label

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/20/2017

Desc: ZenFlex Capsules -Herbal Supplement
Notes: Disease claims made on product label

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/20/2017

Desc: ZenAlc Capsules Herbal Supplement
Notes: Disease claims made on product label

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/20/2017

Desc: ZenHab Capsules Herbal Supplement
Notes: Disease claims made on product label

RAMONA COSMACEUTICALS PRIVATE LIMITED
Date Published : 04/26/2011
289 Railway Feeder Road , Pudupalaiyam, Tamil Nadu INDIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/26/2011

Desc: Organic Moringa Leaf Powder
Notes: India

RSG Imports & Exports Partnership
Date Published : 10/22/2018
Ram Bagh , 11 - 12 Agar Nagar; A Block , Ludhiana, Punjab INDIA
54 J - - 05 Roselle (Herbal & Botanicals II)
Date Published: 10/22/2018

Desc: Mega Power 15000
Notes: The product appears to be an unapproved new drug as the product as labeling statements documenting the intended uses of this product include; but are not limited to; the following; "Stops Premature Ejaculation".

54 J - - 05 Roselle (Herbal & Botanicals II)
Date Published: 10/22/2018

Desc: Mega Power 10000
Notes: The product appears to be an unapproved new drug as the product as labeling statements documenting the intended uses of this product include; but are not limited to; the following; "Stops Premature Ejaculation".

RUCHI SOYA INDUSTRIES
Date Published : 07/09/2012
Ab Road , Talawali Chanda, Madhya Pradesh INDIA
02 G - - 99 Flours and Meals N.E.C.
Date Published: 07/09/2012

Desc: Nutrella Mini Soya Chunks
Notes: India

02 Y - - 99 Milled Grain Products, N.E.C.
Date Published: 07/09/2012

Desc: Nutrella Mini Soyagranules
Notes: India

02 Y - - 99 Milled Grain Products, N.E.C.
Date Published: 07/09/2012

Desc: Nutrella Mini Soya Chunks
Notes: India

18 C - - 99 Combination Meat-Like Vegetable Protein Products, N.E.C.
Date Published: 07/09/2012

Desc: Nutrella Mini Soya Chunks
Notes: India

18 C - - 99 Combination Meat-Like Vegetable Protein Products, N.E.C.
Date Published: 07/09/2012

Desc: Nutrella Mini Soyagranules
Notes: ; India

18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 07/09/2012

Desc: Nutrella Mini Soya Chunks
Notes: India

18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 07/09/2012

Desc: Nutrella Mini Soyagranules
Notes: ; India

24 A - - 13 Soybeans (See Industry 37 for 'Bean Curd')
Date Published: 07/09/2012

Desc: Nutrella Mini Soyagranules
Notes: India

24 A - - 13 Soybeans (See Industry 37 for 'Bean Curd')
Date Published: 07/09/2012

Desc: Nutrella Mini Soya Chunks
Notes: India

37 B - - 32 Bean curd, n.e.c. (Multiple Food Specialties, Side Dishes & Desserts)
Date Published: 07/09/2012

Desc: Nutrella Mini Soyagranules
Notes: India

37 B - - 32 Bean curd, n.e.c. (Multiple Food Specialties, Side Dishes & Desserts)
Date Published: 07/09/2012

Desc: Nutrella Mini Soya Chunks
Notes: India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/09/2012

Desc: Nutrella Mini Soyagranules
Notes: India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/09/2012

Desc: Nutrella Mini Soya Chunks
Notes: India

RUCHI SOYA INDUSTRIES
Date Published : 01/10/2012
Ab Road , Talawali Chanda, Madhya Pradesh INDIA
02 G - - 99 Flours and Meals N.E.C.
Date Published: 07/09/2012

Desc: Nutrella Mini Soya Chunks
Notes: India

02 G - - 99 Flours and Meals N.E.C.
Date Published: 07/09/2012

Desc: Nutrella Mini Soyagranules
Notes: India

02 Y - - 99 Milled Grain Products, N.E.C.
Date Published: 07/09/2012

Desc: Nutrella Mini Soya Chunks
Notes: India

02 Y - - 99 Milled Grain Products, N.E.C.
Date Published: 07/09/2012

Desc: Nutrella Mini Soyagranules
Notes: India

18 C - - 99 Combination Meat-Like Vegetable Protein Products, N.E.C.
Date Published: 07/09/2012

Desc: Nutrella Mini Soyagranules
Notes: India

18 C - - 99 Combination Meat-Like Vegetable Protein Products, N.E.C.
Date Published: 07/09/2012

Desc: Nutrella Mini Soya Chunks
Notes: India

18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 07/09/2012

Desc: Nutrella Mini Soya Chunks
Notes: India

18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 07/09/2012

Desc: Nutrella Mini Soyagranules
Notes: India

24 A - - 13 Soybeans (See Industry 37 for 'Bean Curd')
Date Published: 07/09/2012

Desc: Nutrella Mini Soya Chunks
Notes: India

24 A - - 13 Soybeans (See Industry 37 for 'Bean Curd')
Date Published: 07/09/2012

Desc: Nutrella Mini Soyagranules
Notes: India

37 B - - 32 Bean curd, n.e.c. (Multiple Food Specialties, Side Dishes & Desserts)
Date Published: 07/09/2012

Desc: Nutrella Mini Soyagranules
Notes: India

37 B - - 32 Bean curd, n.e.c. (Multiple Food Specialties, Side Dishes & Desserts)
Date Published: 07/09/2012

Desc: Nutrella Mini Soya Chunks
Notes: India

37 B - - 99 Multiple Food Specialities, Side Dishes and Desserts, N.E.C.
Date Published: 07/09/2012

Desc: Nutrella Mini Soya Chunks
Notes: India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/10/2012

Desc: Nutrella Mini Soyagranules
Notes: India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/10/2012

Desc: Nutrella Mini Soya Chunks
Notes: India

Radico
Date Published : 09/30/2009
88/17 39 - A Type - D Hsidc Industrial Estate , Faridabad, Haryana INDIA
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 09/30/2009

Notes: 4/18/2007 Herbal Hair Regrowth Shampoo and Serum

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 4/18/2007 Herbal Hair Regrowth Shampoo and Serum

Ramkrishna Vidyut Ayurvedic
Date Published : 11/04/2019
A-12, Midc Area , Osmanabad, INDIA
53 E - - -- Hair Preps(Non-Coloring)
Date Published: 11/04/2019

Desc: Mahabhringaraj Oil (Pure Makas Ayurvedic Medicine)
Notes: The product appears to be an unapproved new drug as the product's label includes, but is not limited to, the following claims: '...Stops Greying and Falling of hair; Cures Sleeplessness; Cures Dandruff; Check hair loss (Alopecia aereata); Cures Palm or Sole Burning Sensations...'.

53 L - - -- Skin Care Prep
Date Published: 11/04/2019

Desc: Mahabhringaraj Oil (Pure Makas Ayurvedic Medicine)
Notes: The product appears to be an unapproved new drug as the product's label includes, but is not limited to, the following claims: '...Stops Greying and Falling of hair; Cures Sleeplessness; Cures Dandruff; Check hair loss (Alopecia aereata); Cures Palm or Sole Burning Sensations...'.

62 S - - -- A-Seborrheic
Date Published: 11/04/2019

Desc: Mahabhringaraj Oil (Pure Makas Ayurvedic Medicine)
Notes: The product appears to be an unapproved new drug as the product's label includes, but is not limited to, the following claims: '...Stops Greying and Falling of hair; Cures Sleeplessness; Cures Dandruff; Check hair loss (Alopecia aereata); Cures Palm or Sole Burning Sensations...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/04/2019

Desc: Mahabhringaraj Oil (Pure Makas Ayurvedic Medicine)
Notes: The product appears to be an unapproved new drug as the product's label includes, but is not limited to, the following claims: '...Stops Greying and Falling of hair; Cures Sleeplessness; Cures Dandruff; Check hair loss (Alopecia aereata); Cures Palm or Sole Burning Sensations...'.

Ramkrishna Vidyut Ayurvedic Pharmacy, Pune(M.S.)
Date Published : 11/04/2019
"Geetai Sanjul", Office No1 , 3rd Floor , Kothrud, Pune, INDIA
53 E - - -- Hair Preps(Non-Coloring)
Date Published: 11/04/2019

Desc: Mahabhringaraj Oil (Pure Makas Ayurvedic Medicine)
Notes: The product appears to be an unapproved new drug as the product's label includes, but is not limited to, the following claims: '...Stops Greying and Falling of hair; Cures Sleeplessness; Cures Dandruff; Check hair loss (Alopecia aereata); Cures Palm or Sole Burning Sensations...'.

53 L - - -- Skin Care Prep
Date Published: 11/04/2019

Desc: Mahabhringaraj Oil (Pure Makas Ayurvedic Medicine)
Notes: The product appears to be an unapproved new drug as the product's label includes, but is not limited to, the following claims: '...Stops Greying and Falling of hair; Cures Sleeplessness; Cures Dandruff; Check hair loss (Alopecia aereata); Cures Palm or Sole Burning Sensations...'.

62 S - - -- A-Seborrheic
Date Published: 11/04/2019

Desc: Mahabhringaraj Oil (Pure Makas Ayurvedic Medicine)
Notes: The product appears to be an unapproved new drug as the product's label includes, but is not limited to, the following claims: '...Stops Greying and Falling of hair; Cures Sleeplessness; Cures Dandruff; Check hair loss (Alopecia aereata); Cures Palm or Sole Burning Sensations...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/04/2019

Desc: Mahabhringaraj Oil (Pure Makas Ayurvedic Medicine)
Notes: The product appears to be an unapproved new drug as the product's label includes, but is not limited to, the following claims: '...Stops Greying and Falling of hair; Cures Sleeplessness; Cures Dandruff; Check hair loss (Alopecia aereata); Cures Palm or Sole Burning Sensations...'.

Rani Drug House
Date Published : 09/30/2009
Trichur (Thrissur) District , Nellayi, Kerala INDIA
31 K - - -- Tea
Date Published: 09/30/2009

Notes: Ranitone/Rani Tonic;                    ; 1/25/2007

31 L - - -- Tea, Decaffeinated
Date Published: 09/30/2009

Notes: Ranitone/Rani Tonic;                    ; 1/25/2007

31 P - - -- Tea Substitutes
Date Published: 09/30/2009

Notes: Ranitone/Rani Tonic;                    ; 1/25/2007

53 B - - -- Bath Prep
Date Published: 09/30/2009

Notes: Ranitone/Rani Tonic;                    ; 1/25/2007

53 E - - -- Hair Preps(Non-Coloring)
Date Published: 09/30/2009

Notes: Ranitone/Rani Tonic;                    ; 1/25/2007

53 F - - -- Hair Coloring Prep
Date Published: 09/30/2009

Notes: Ranitone/Rani Tonic;                    ; 1/25/2007

53 J - - -- Personal Cleanliness
Date Published: 09/30/2009

Notes: Ranitone/Rani Tonic;                    ; 1/25/2007

53 L - - -- Skin Care Prep
Date Published: 09/30/2009

Notes: Ranitone/Rani Tonic;                    ; 1/25/2007

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 09/30/2009

Notes: Ranitone/Rani Tonic;                    ; 1/25/2007

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 09/30/2009

Notes: Ranitone/Rani Tonic;                    ; 1/25/2007

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/16/2019

Notes: Ranitone/Rani Tonic;                    ; 1/25/2007

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Ranitone/Rani Tonic;                    ; 1/25/2007

61 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Ranitone/Rani Tonic;                    ; 1/25/2007

62 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Ranitone/Rani Tonic;                    ; 1/25/2007

63 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Ranitone/Rani Tonic;                    ; 1/25/2007

64 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Ranitone/Rani Tonic;                    ; 1/25/2007

65 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Ranitone/Rani Tonic;                    ; 1/25/2007

66 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Ranitone/Rani Tonic;                    ; 1/25/2007

Rave Overseas Pvt. Ltd
Date Published : 09/30/2009
P O Box No. 611, GPO , Indore, Mp INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/16/2019

Desc: ;"Diabet Guard" Granules "Himalaya Diabecon"
Notes:                        

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/16/2019

Desc: "Diabet Guard" Granules "Himalaya Diabecon"
Notes:                        

Reckitt Benckiser
Date Published : 03/22/2018
B-96, Eldeco SIDCUL Industrial , Sitangami , Uttarakhand, Uttaranchal INDIA
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 03/22/2018

Desc: Dettol Original Everyday Protection Hand Wash

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 03/22/2018

Desc: Dettol Skincare Everyday Protection ph-balanced Handwash

61 H - - 99 Anti-Bacterial, N.E.C.
Date Published: 03/22/2018

Desc: Dettol Skincare Everyday Protection ph-balanced Handwash

61 H - - 99 Anti-Bacterial, N.E.C.
Date Published: 03/22/2018

Desc: Dettol Original Everyday Protection Hand Wash

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/22/2018

Desc: Dettol Skincare Everyday Protection ph-balanced Handwash

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/22/2018

Desc: Dettol Original Everyday Protection Hand Wash

Reckitt Benckiser
Date Published : 05/30/2013
61-62 Hootagelli , Mysore, INDIA
64 A - - 99 Disinfectant N.E.C.
Date Published: 05/30/2013

Desc: Dettol Antiseptic Liquid
Notes: India

64 V - - 99 Ion-Exchange Resin N.E.C.
Date Published: 05/30/2013

Desc: Dettol Antiseptic Liquid
Notes: India

Reckitt Benckiser (India) Ltd
Date Published : 02/02/2015
48 Plot No , Gurgaon, Haryana INDIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 02/02/2015

Desc: Moov Pain Relief Specialists

60 Q - - 99 Anesthetic, N.E.C.
Date Published: 02/02/2015

Desc: Moov Pain Relief Specialists

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 02/02/2015

Desc: Moov Pain Relief Specialists

Reckitt Benckiser (India) Pvt. Ltd.
Date Published : 05/20/2019
Unit Ii , Ml No M 15/C/Ua/2015 , Sitarganj, Uttarakhand INDIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/20/2019

Desc: Dettol Original Protection Soap
Notes: The product appears to be an unapproved new drug as the product website includes claims such as; "Protects against a wide range of unseen germs...Anti-Bacteria". The product label includes claims such as; "Dettol fragrance provides trusted protection from wide range of germs...It cleanses and protects your skin..."

Reckitt Benckiser Healthcare
Date Published : 05/29/2014
No 701/534 Nalagrah Road , Baddi, Himachal Pradesh INDIA
21 C - - 99 Mixed Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 04/04/2018

Desc: Strepsils
Notes: Labeling and formulation do not comply with the OTC monograph

50 M - - 29 Zinc Oxide
Date Published: 05/29/2014

Desc: Itch Guard Cream

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/29/2014

Desc: MOOV ? The PAIN SPECIALIST

60 Q - - 99 Anesthetic, N.E.C.
Date Published: 05/29/2014

Desc: MOOV ? The PAIN SPECIALIST

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 05/29/2014

Desc: MOOV ? The PAIN SPECIALIST

66 F - - 99 Suppressant N.E.C.
Date Published: 04/04/2018

Desc: Strepsils
Notes: Labeling and formulation do not comply with the OTC monograph

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 04/04/2018

Desc: Strepsils
Notes: Labeling and formulation do not comply with the OTC monograph

Roar Code(T)
Date Published : 11/03/2010
1 Henkel Indian Ltd 28roy Road , Kalkata, INDIA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 11/03/2010

Desc: Neem Toothpaste
Notes: India

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 11/03/2010

Desc: Neem Toothpaste
Notes: India

63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic)
Date Published: 11/03/2010

Desc: Neem Toothpaste
Notes: India

SANSKAR AYUSH MEDICARE
Date Published : 11/21/2022
Khasra No 673 Imehera B , Hardiwar, INDIA
28 A - - 99 Whole Spice, N.E.C.
Date Published: 11/21/2022

Desc: Dabur Tulsi Drops

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 11/21/2022

Desc: Dabur Tulsi Drops

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/21/2022

Desc: Dabur Tulsi Drops

SBL Private Limited
Date Published : 12/22/2023
SBL House , 2, Commercial Complex, Shrestha Vihar , East Delhi, Delhi INDIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/22/2023

Desc: Cineraria Maritima Euphrasia Eye Drops

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 12/22/2023

Desc: Cineraria Maritima Euphrasia Eye Drops

SHREE BAIDYANATH LTD
Date Published : 06/04/2020
Gwlior Road , Karari, Uttar Pradesh INDIA
21 V - - 34 Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 12/09/2020

Desc: Baidyanath Asli Ayurved Giloy Juice Immunity Booster
Notes: The product appears to be an unapproved new drug as the product's label includes disease claims such as (not an all-inclusive list): '...treat chronic and recurrent infections and fever. It boost's the immune system and body's resistance against infections by increased bacterial clearance and phagocytic activity by neutrophils. Helpful in controlling skin allergies, joint pain . protection from frequent cold and flu, liver disorders and convalescence from severe illness."

22 K - - 99 Other Fruits and Fruit Products, Other Fruit Juices or Concentrates, N.E.C.
Date Published: 12/09/2020

Desc: Baidyanath Asli Ayurved Giloy Juice Immunity Booster
Notes: The product appears to be an unapproved new drug as the product's label includes disease claims such as (not an all-inclusive list): '...treat chronic and recurrent infections and fever. It boost's the immune system and body's resistance against infections by increased bacterial clearance and phagocytic activity by neutrophils. Helpful in controlling skin allergies, joint pain . protection from frequent cold and flu, liver disorders and convalescence from severe illness."

30 B - - 06 Beverage Base, Subtropical or Tropical Fruit, Liquid
Date Published: 12/09/2020

Desc: Baidyanath Asli Ayurved Giloy Juice Immunity Booster
Notes: The product appears to be an unapproved new drug as the product's label includes disease claims such as (not an all-inclusive list): '...treat chronic and recurrent infections and fever. It boost's the immune system and body's resistance against infections by increased bacterial clearance and phagocytic activity by neutrophils. Helpful in controlling skin allergies, joint pain . protection from frequent cold and flu, liver disorders and convalescence from severe illness."

30 B - - 99 Fruit Beverage Bases, Liquid, N.E.C.
Date Published: 12/09/2020

Desc: Baidyanath Asli Ayurved Giloy Juice Immunity Booster
Notes: The product appears to be an unapproved new drug as the product's label includes disease claims such as (not an all-inclusive list): '...treat chronic and recurrent infections and fever. It boost's the immune system and body's resistance against infections by increased bacterial clearance and phagocytic activity by neutrophils. Helpful in controlling skin allergies, joint pain . protection from frequent cold and flu, liver disorders and convalescence from severe illness."

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/09/2020

Desc: Baidyanath Asli Ayurved Giloy Juice Immunity Booster
Notes: The product appears to be an unapproved new drug as the product's label includes disease claims such as (not an all-inclusive list): '...treat chronic and recurrent infections and fever. It boost's the immune system and body's resistance against infections by increased bacterial clearance and phagocytic activity by neutrophils. Helpful in controlling skin allergies, joint pain . protection from frequent cold and flu, liver disorders and convalescence from severe illness."

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/09/2020

Desc: Baidyanath Asli Ayurved Giloy Juice Immunity Booster
Notes: The product appears to be an unapproved new drug as the product's label includes disease claims such as (not an all-inclusive list): '...treat chronic and recurrent infections and fever. It boost's the immune system and body's resistance against infections by increased bacterial clearance and phagocytic activity by neutrophils. Helpful in controlling skin allergies, joint pain . protection from frequent cold and flu, liver disorders and convalescence from severe illness."

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/04/2020

Desc: Manmath Ras (Ayurvedic Medicine)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/04/2020

Desc: Arogyawardhini Bati (Ayurvedic Medicine)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/04/2020

Desc: Puspadhanwa Ras (Ayurvedic Medicine)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/04/2020

Desc: Shukramatrika Bati (Ayurvedic Medicine)

SHREE DHANWANTRI HERBALS
Date Published : 10/17/2022
Village Nag Kalan , Punjab, INDIA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 10/17/2022

Desc: Divisa Natural Laxative Granules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/17/2022

Desc: Divisa Natural Laxative Granules

SMB Corporation of India
Date Published : 09/30/2009
13 34 35 Prem Industrial Estate , Gupha Road , Mumbai, Maharashtra INDIA
65 J - - 36 Intrauterine Copper (Progestin)
Date Published: 09/30/2009

Notes: 5/28/2008 All Models Intrauterine Device (IUD) Copper T. IUDS for the purpose of contraception are regulated as medical devices; however; IUDs for the purpose of contraception that incorporate heavy metals; such as copper; drugs; or otherwise active substances are regulated as drugs. The SMB IUDS are new drugs requiring approval applications (see 21 CFR 310.502)

85 H - - DT Device, Intrauterine, Contraceptive and Introducer
Date Published: 09/30/2009

Notes: 5/28/2008 All Models Intrauterine Device (IUD) Copper T. IUDS for the purpose of contraception are regulated as medical devices; however; IUDs for the purpose of contraception that incorporate heavy metals; such as copper; drugs; or otherwise active substances are regulated as drugs. The SMB IUDS are new drugs requiring approval applications (see 21 CFR 310.502)

SOULGENIE HEALTH PATHWAYS LLP
Date Published : 03/25/2016
B-36, SECTOR 31 , NOIDA, Uttar Pradesh INDIA
45 T - - 99 All Other Products, Non-Nutritive Sweeteners
Date Published: 03/25/2016

Desc: Stevia Leaves
Notes: Claims found on labeling and websites

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/25/2016

Desc: Stevia Leaves
Notes: Claims found on labeling and websites

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/25/2016

Desc: Stevia Leaves
Notes: Claims found on labeling and websites

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/25/2016

Desc: Stevia Leaves
Notes: Claims found on labeling and websites

Sami-Sabinsa Group Limited
Date Published : 01/05/2023
PLOT NO. 12A, MN Science & Technology Park , GENOME VALLEY, TURKAPALLY VILLAGE, SHAMEERPET MANDAL, , MEDCHAL-MALKAJGIRI DT, Telangana INDIA
20 B - - 08 Gooseberries, Dried or Paste
Date Published: 01/05/2023

Desc: Amla Extract (Emblica officinalis) (Saberry with Gum Acacia)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

20 B - - 08 Gooseberries, Dried or Paste
Date Published: 01/05/2023

Desc: Amala Extract (Emblica officinalis) (Saberry with Maltodextrin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

20 B - - 21 Barberry, Dried or Paste
Date Published: 01/05/2023

Desc: Berberis Aristata Extract (Berberis aristata) (Rebersa)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

22 B - - 05 Bitter Melon, Dried or Paste
Date Published: 01/05/2023

Desc: Momordica Extract (Momordica charantia) (Momordicin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

24 B - - 07 Kidney Bean, Dried or paste
Date Published: 01/05/2023

Desc: White Kidney Bean Extract (Phaseolus vulgaris) (Fabenol)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

24 U - - 45 Sugar Cane, Dried or Paste (Leaf & Stem Vegetable)
Date Published: 01/05/2023

Desc: Sugarcane Peel Extract (Policosanol) (Sacharum officinarum)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

25 L - - 24 Ginger Root, Dried or Paste
Date Published: 01/05/2023

Desc: Ginger Dry Extract 40 mesh (Zingiber officinale)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

28 A - - 67 Black Cumin
Date Published: 01/05/2023

Desc: Black Cumin Seed SCF Extract PEARL 20% (Nigella sativa) (Nigellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

28 A - - 67 Black Cumin
Date Published: 01/05/2023

Desc: Black Cumin Seed SCF Extract ONYX 20% (Nigella sativa) (Nigellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

28 A - - 67 Black Cumin
Date Published: 01/05/2023

Desc: Black Cumin Seed SCF Extract AMBER (Nigella sativa) (Nigellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

28 A - - 67 Black Cumin
Date Published: 01/05/2023

Desc: Black Cumin Seed SCF Extract ONYX (Nigella sativa) (Nigellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

28 A - - 67 Black Cumin
Date Published: 01/05/2023

Desc: Black Cumin Seed SCF dExtract PEARL (Nigella sativa) (Nigellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

28 C - - 49 Turmeric, Natural Extract or Flavor (Spice)
Date Published: 01/05/2023

Desc: Curcuma Longa Extract (Curcuma longa) (Curcumin C3 Complex)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

28 C - - 49 Turmeric, Natural Extract or Flavor (Spice)
Date Published: 01/05/2023

Desc: Tetrahydrocurcuminoids ODN (Curcuma longa) (Curcumin C3 Reduct)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

28 C - - 49 Turmeric, Natural Extract or Flavor (Spice)
Date Published: 01/05/2023

Desc: Curcumin C3 Special (Curcuma longa)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

28 C - - 49 Turmeric, Natural Extract or Flavor (Spice)
Date Published: 01/05/2023

Desc: Curcumin C3 Dispersible (Curcuma longa)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

28 C - - 49 Turmeric, Natural Extract or Flavor (Spice)
Date Published: 01/05/2023

Desc: Curcuma Longa Extract DC (Curcuma longa) (Curcumin C3 Complex)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

28 C - - 49 Turmeric, Natural Extract or Flavor (Spice)
Date Published: 01/05/2023

Desc: Curcuma Longa Extract HBD (Curcuma longa) (Curcumin C3 Complex)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

28 C - - 49 Turmeric, Natural Extract or Flavor (Spice)
Date Published: 01/05/2023

Desc: Curcuma Longa Extract Beadlets (Curcuma longa) (Curcumin C3 Complex)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

28 C - - 49 Turmeric, Natural Extract or Flavor (Spice)
Date Published: 01/05/2023

Desc: Curcumin Longa Extract W5 (Curcuma longa) (uC3 Clear)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

28 C - - 49 Turmeric, Natural Extract or Flavor (Spice)
Date Published: 01/05/2023

Desc: Turmeric Starch (Curcuma longa)(Starmeric)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

28 C - - 53 Rosemary, Natural Extract or Flavor (Spice)
Date Published: 01/05/2023

Desc: Rosmarinic Acid 50% (Rosmarinus officinalis)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

28 C - - 53 Rosemary, Natural Extract or Flavor (Spice)
Date Published: 01/05/2023

Desc: Rosmarinic Acid 90% (Coleus forskohlii)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

28 C - - 53 Rosemary, Natural Extract or Flavor (Spice)
Date Published: 01/05/2023

Desc: Rosemary Extract (Rosmarinus officinalis)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

31 K - - 02 Tea, Green
Date Published: 01/05/2023

Desc: Green Tea Extract 40% (Camellia sinensis)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

31 K - - 02 Tea, Green
Date Published: 01/05/2023

Desc: Green Tea Extract 75% (Camellia sinensis)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

31 L - - 02 Tea, Green, Decaffeinated
Date Published: 01/05/2023

Desc: Green Tea Extract (Decaf) (Camellia sinensis)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

50 L - - 29 Turmeric
Date Published: 01/05/2023

Desc: Curcuma Longa Extract Beadlets (Curcuma longa) (Curcumin C3 Complex)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

50 L - - 29 Turmeric
Date Published: 01/05/2023

Desc: Curcuma Longa Extract HBD (Curcuma longa) (Curcumin C3 Complex)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

50 L - - 29 Turmeric
Date Published: 01/05/2023

Desc: Curcumin C3 Dispersible (Curcuma longa)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

50 L - - 29 Turmeric
Date Published: 01/05/2023

Desc: Tetrahydrocurcuminoids ODN (Curcuma longa) (Curcumin C3 Reduct)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

50 L - - 29 Turmeric
Date Published: 01/05/2023

Desc: Curcuma Longa Extract (Curcuma longa) (Curcumin C3 Complex)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

50 L - - 29 Turmeric
Date Published: 01/05/2023

Desc: Curcumin Longa Extract W5 (Curcuma longa) (uC3 Clear)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

50 L - - 29 Turmeric
Date Published: 01/05/2023

Desc: Curcuma Longa Extract DC (Curcuma longa) (Curcumin C3 Complex)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

50 L - - 29 Turmeric
Date Published: 01/05/2023

Desc: Curcumin C3 Special (Curcuma longa)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 E - - 16 Licorice (Herbal & Botanical Teas)
Date Published: 01/05/2023

Desc: Deglycyrrhizinated Licorice (DGL) (Glycyrrhiza glabra)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 E - - 16 Licorice (Herbal & Botanical Teas)
Date Published: 01/05/2023

Desc: Licorice Dry Extract (Glycyrrhiza glaba)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 E - - 16 Licorice (Herbal & Botanical Teas)
Date Published: 01/05/2023

Desc: MonoAmmonium Glycyrrhizinate (Glycyrrhiza glaba)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 E - - 45 Fenugreek (Herbal & Botanical Teas)
Date Published: 01/05/2023

Desc: Fenugreek Fibers (Trigonella foenum-graecum) (Fenufibers)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 E - - 45 Fenugreek (Herbal & Botanical Teas)
Date Published: 01/05/2023

Desc: Fenugreek Fibers (Trigonella foenum-graecum) (Fenumannan)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 E - - 45 Fenugreek (Herbal & Botanical Teas)
Date Published: 01/05/2023

Desc: Fenugreek Extract (Trigonella foenum-graecum) (FenuSterols)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 E - - 88 Gymnema sylvestre (Herbal & Botanical Teas)
Date Published: 01/05/2023

Desc: Gymnema Extract 75% (Gymnema sylvestre) (GS4PLUS)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 E - - 88 Gymnema sylvestre (Herbal & Botanical Teas)
Date Published: 01/05/2023

Desc: Gymnema Extract 25% (Gymnema sylvestre) (GS4PLUS)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 E - - 91 Boswellia (Herbal & Botanical Teas)
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract PS (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 E - - 91 Boswellia (Herbal & Botanical Teas)
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract WS (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 E - - 91 Boswellia (Herbal & Botanical Teas)
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract Forte (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 E - - 91 Boswellia (Herbal & Botanical Teas)
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract Super (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 E - - 91 Boswellia (Herbal & Botanical Teas)
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract HBD (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 E - - 91 Boswellia (Herbal & Botanical Teas)
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 E - - 91 Boswellia (Herbal & Botanical Teas)
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract Polysaccharides (Boswellia serrata) (Polybos)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 E - - 91 Boswellia (Herbal & Botanical Teas)
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract HBD DC (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 45 Fenugreek (Herbal & Botanicals, not Teas)
Date Published: 01/05/2023

Desc: Fenugreek Extract (Trigonella foenum-graecum) (FenuSterols)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 45 Fenugreek (Herbal & Botanicals, not Teas)
Date Published: 01/05/2023

Desc: Fenugreek Fibers (Trigonella foenum-graecum) (Fenumannan)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 45 Fenugreek (Herbal & Botanicals, not Teas)
Date Published: 01/05/2023

Desc: Fenugreek Fibers (Trigonella foenum-graecum) (Fenufibers)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 75 Cocculus
Date Published: 01/05/2023

Desc: Paniculata Extract 90% (Andrographis paniculata) (Panicin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 75 Cocculus
Date Published: 01/05/2023

Desc: Paniculata Extract 50% (Andrographis paniculata) (Panicin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 88 Gymnema sylvestre (Herbal & Botanicals, not Teas)
Date Published: 01/05/2023

Desc: Gymnema Extract 75% (Gymnema sylvestre) (GS4PLUS)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 88 Gymnema sylvestre (Herbal & Botanicals, not Teas)
Date Published: 01/05/2023

Desc: Gymnema Extract 25% (Gymnema sylvestre) (GS4PLUS)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Adhatoda Vasica Extract (Adhatoda vasica)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Tetrahydrocurcuminoids ODN (Curcuma longa) (Curcumin C3 Reduct)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Varuna Extract 1.5% (Crataeva nurvala) (Cratavin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Curcuma Longa Extract DC (Curcuma longa) (Curcumin C3 Complex)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract Polysaccharides (Boswellia serrata) (Polybos)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract WS (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract HBD DC (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Vitex Negundo Extract (Vitex negundo)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Cirpusins (Cyperus rotundus)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Black Cumin Seed SCF Extract ONYX (Nigella sativa) (Nigellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: MonoAmmonium Glycyrrhizinate (Glycyrrhiza glaba)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Paniculata Extract 50% (Andrographis paniculata) (Panicin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Oroxylum Indicum Extract (Oroxylum indicum) (Sabroxy)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Black Cumin Seed SCF Extract AMBER (Nigella sativa) (Nigellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Curcumin C3 Special (Curcuma longa)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Curcumin Longa Extract W5 (Curcuma longa) (uC3 Clear)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Moringa Leaf Extract (Moringa oleifa) (Samoringa)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract Forte (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Tulsi Extract (Holy Basil) (Ocimum sanctum) (ThulCin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Curcuma Longa Extract Beadlets (Curcuma longa) (Curcumin C3 Complex)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Fenugreek Extract (Trigonella foenum-graecum) (FenuSterols)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Turmeric Starch (Curcuma longa)(Starmeric)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Sugarcane Peel Extract (Policosanol) (Sacharum officinarum)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Pterocarpus Extract WS (Pterocarpus marsupium) (pTeroSol)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Black Cumin Seed SCF dExtract PEARL (Nigella sativa) (Nigellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Andrographis Paniculata Extract 10% (Andrographis paniculata) (Panicin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract PS (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Paniculata Extract 90% (Andrographis paniculata) (Panicin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Peanut Shell Extract (Arachis hypogaea)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Gymnema Extract 75% (Gymnema sylvestre) (GS4PLUS)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract HBD (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Curcuma Longa Extract HBD (Curcuma longa) (Curcumin C3 Complex)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Curcumin C3 Dispersible (Curcuma longa)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Fenugreek Fibers (Trigonella foenum-graecum) (Fenumannan)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Deglycyrrhizinated Licorice (DGL) (Glycyrrhiza glabra)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Green Tea Extract 75% (Camellia sinensis)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Amla Extract (Emblica officinalis) (Saberry with Gum Acacia)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Momordica Extract (Momordica charantia) (Momordicin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Terminalia Arjuna Extract (Terminalia arjuna) (3% Arjunoglucoside)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Black Cumin Seed SCF Extract PEARL 20% (Nigella sativa) (Nigellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Green Tea Extract 40% (Camellia sinensis)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Rosmarinic Acid 50% (Rosmarinus officinalis)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Ginger Dry Extract 40 mesh (Zingiber officinale)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Amala Extract (Emblica officinalis) (Saberry with Maltodextrin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Berberis Aristata Extract (Berberis aristata) (Rebersa)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Sesame Extract Natural Seasamin Complex (Seasmum indicum)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Fenugreek Fibers (Trigonella foenum-graecum) (Fenufibers)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Licorice Dry Extract (Glycyrrhiza glaba)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract Super (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Black Cumin Seed SCF Extract ONYX 20% (Nigella sativa) (Nigellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Neem Leaf Extract (Melia azadirachta)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Gymnema Extract 25% (Gymnema sylvestre) (GS4PLUS)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Rosemary Extract (Rosmarinus officinalis)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Curcuma Longa Extract (Curcuma longa) (Curcumin C3 Complex)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Olive Leaf Extract (Olea europaea)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Rosmarinic Acid 90% (Coleus forskohlii)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Green Tea Extract (Decaf) (Camellia sinensis)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: White Kidney Bean Extract (Phaseolus vulgaris) (Fabenol)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 J - - 06 Holy Basil (Herbal & Botanicals II)
Date Published: 01/05/2023

Desc: Tulsi Extract (Holy Basil) (Ocimum sanctum) (ThulCin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued)
Date Published: 01/05/2023

Desc: Moringa Leaf Extract (Moringa oleifa) (Samoringa)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 K - - 06 Holy Basil (Herbal & Botanicals, not Teas II)
Date Published: 01/05/2023

Desc: Tulsi Extract (Holy Basil) (Ocimum sanctum) (ThulCin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd
Date Published: 01/05/2023

Desc: Moringa Leaf Extract (Moringa oleifa) (Samoringa)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Peanut Shell Extract (Arachis hypogaea)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Fenugreek Fibers (Trigonella foenum-graecum) (Fenufibers)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Varuna Extract 1.5% (Crataeva nurvala) (Cratavin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/06/2023

Desc: Curcuma Longa Extract HBD (Curcuma longa) (Curcumin C3 Complex)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Rosemary Extract (Rosmarinus officinalis)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Curcumin C3 Dispersible (Curcuma longa)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Olive Leaf Extract (Olea europaea)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Green Tea Extract 40% (Camellia sinensis)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Ginger Dry Extract 40 mesh (Zingiber officinale)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Neem Leaf Extract (Melia azadirachta)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Green Tea Extract 75% (Camellia sinensis)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Amla Extract (Emblica officinalis) (Saberry with Gum Acacia)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Curcuma Longa Extract (Curcuma longa) (Curcumin C3 Complex)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Vitex Negundo Extract (Vitex negundo)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: White Kidney Bean Extract (Phaseolus vulgaris) (Fabenol)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Sesame Extract Natural Seasamin Complex (Seasmum indicum)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Deglycyrrhizinated Licorice (DGL) (Glycyrrhiza glabra)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Gymnema Extract 25% (Gymnema sylvestre) (GS4PLUS)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Terminalia Arjuna Extract (Terminalia arjuna) (3% Arjunoglucoside)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Andrographis Paniculata Extract 10% (Andrographis paniculata) (Panicin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Sugarcane Peel Extract (Policosanol) (Sacharum officinarum)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Tulsi Extract (Holy Basil) (Ocimum sanctum) (ThulCin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Paniculata Extract 50% (Andrographis paniculata) (Panicin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Gymnema Extract 75% (Gymnema sylvestre) (GS4PLUS)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Rosmarinic Acid 90% (Coleus forskohlii)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract WS (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Pterocarpus Extract WS (Pterocarpus marsupium) (pTeroSol)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract HBD (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Momordica Extract (Momordica charantia) (Momordicin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Curcuma Longa Extract DC (Curcuma longa) (Curcumin C3 Complex)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: MonoAmmonium Glycyrrhizinate (Glycyrrhiza glaba)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Rosmarinic Acid 50% (Rosmarinus officinalis)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Curcuma Longa Extract Beadlets (Curcuma longa) (Curcumin C3 Complex)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract PS (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Berberis Aristata Extract (Berberis aristata) (Rebersa)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Curcumin C3 Special (Curcuma longa)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Adhatoda Vasica Extract (Adhatoda vasica)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Black Cumin Seed SCF Extract ONYX (Nigella sativa) (Nigellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract Forte (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Licorice Dry Extract (Glycyrrhiza glaba)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Amala Extract (Emblica officinalis) (Saberry with Maltodextrin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Oroxylum Indicum Extract (Oroxylum indicum) (Sabroxy)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Turmeric Starch (Curcuma longa)(Starmeric)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Fenugreek Extract (Trigonella foenum-graecum) (FenuSterols)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Paniculata Extract 90% (Andrographis paniculata) (Panicin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract Super (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract HBD DC (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Black Cumin Seed SCF Extract AMBER (Nigella sativa) (Nigellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Curcumin Longa Extract W5 (Curcuma longa) (uC3 Clear)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Black Cumin Seed SCF dExtract PEARL (Nigella sativa) (Nigellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Green Tea Extract (Decaf) (Camellia sinensis)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract Polysaccharides (Boswellia serrata) (Polybos)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Cirpusins (Cyperus rotundus)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Fenugreek Fibers (Trigonella foenum-graecum) (Fenumannan)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Moringa Leaf Extract (Moringa oleifa) (Samoringa)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Tetrahydrocurcuminoids ODN (Curcuma longa) (Curcumin C3 Reduct)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/05/2023

Desc: Black Cumin Seed SCF Extract ONYX 20% (Nigella sativa) (Nigellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Gymnema Extract 25% (Gymnema sylvestre) (GS4PLUS)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Fenugreek Extract (Trigonella foenum-graecum) (FenuSterols)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Ginger Dry Extract 40 mesh (Zingiber officinale)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract PS (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Amla Extract (Emblica officinalis) (Saberry with Gum Acacia)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Paniculata Extract 90% (Andrographis paniculata) (Panicin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Fenugreek Fibers (Trigonella foenum-graecum) (Fenumannan)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Green Tea Extract (Decaf) (Camellia sinensis)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Curcuma Longa Extract Beadlets (Curcuma longa) (Curcumin C3 Complex)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract HBD (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract Forte (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract Polysaccharides (Boswellia serrata) (Polybos)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Olive Leaf Extract (Olea europaea)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Neem Leaf Extract (Melia azadirachta)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Terminalia Arjuna Extract (Terminalia arjuna) (3% Arjunoglucoside)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Rosmarinic Acid 90% (Coleus forskohlii)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Gymnema Extract 75% (Gymnema sylvestre) (GS4PLUS)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Rosmarinic Acid 50% (Rosmarinus officinalis)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Oroxylum Indicum Extract (Oroxylum indicum) (Sabroxy)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Tetrahydrocurcuminoids ODN (Curcuma longa) (Curcumin C3 Reduct)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Peanut Shell Extract (Arachis hypogaea)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Turmeric Starch (Curcuma longa)(Starmeric)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Adhatoda Vasica Extract (Adhatoda vasica)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Sesame Extract Natural Seasamin Complex (Seasmum indicum)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Andrographis Paniculata Extract 10% (Andrographis paniculata) (Panicin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Curcuma Longa Extract DC (Curcuma longa) (Curcumin C3 Complex)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Tulsi Extract (Holy Basil) (Ocimum sanctum) (ThulCin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Curcumin C3 Dispersible (Curcuma longa)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract WS (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Green Tea Extract 75% (Camellia sinensis)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: MonoAmmonium Glycyrrhizinate (Glycyrrhiza glaba)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract Super (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Curcuma Longa Extract (Curcuma longa) (Curcumin C3 Complex)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Curcumin Longa Extract W5 (Curcuma longa) (uC3 Clear)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Curcuma Longa Extract HBD (Curcuma longa) (Curcumin C3 Complex)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Cirpusins (Cyperus rotundus)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Licorice Dry Extract (Glycyrrhiza glaba)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Rosemary Extract (Rosmarinus officinalis)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Black Cumin Seed SCF Extract PEARL 20% (Nigella sativa) (Nigellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Boswellia Serrata Extract HBD DC (Boswellia serrata) (Boswellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Paniculata Extract 50% (Andrographis paniculata) (Panicin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Pterocarpus Extract WS (Pterocarpus marsupium) (pTeroSol)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Curcumin C3 Special (Curcuma longa)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Deglycyrrhizinated Licorice (DGL) (Glycyrrhiza glabra)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Green Tea Extract 40% (Camellia sinensis)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Berberis Aristata Extract (Berberis aristata) (Rebersa)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Black Cumin Seed SCF Extract AMBER (Nigella sativa) (Nigellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Black Cumin Seed SCF Extract ONYX (Nigella sativa) (Nigellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Fenugreek Fibers (Trigonella foenum-graecum) (Fenufibers)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Amala Extract (Emblica officinalis) (Saberry with Maltodextrin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Black Cumin Seed SCF Extract ONYX 20% (Nigella sativa) (Nigellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Momordica Extract (Momordica charantia) (Momordicin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: White Kidney Bean Extract (Phaseolus vulgaris) (Fabenol)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Vitex Negundo Extract (Vitex negundo)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Sugarcane Peel Extract (Policosanol) (Sacharum officinarum)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Black Cumin Seed SCF dExtract PEARL (Nigella sativa) (Nigellin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Moringa Leaf Extract (Moringa oleifa) (Samoringa)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2023

Desc: Varuna Extract 1.5% (Crataeva nurvala) (Cratavin)
Notes: These products appear to be unapproved new drugs, as their promotional website includes statements such as: “Anti-allergy support”, “Antibacterial support”, “Anti-inflammatory support”, “Antimicrobial support”, “Blood sugar support”, “Cholesterol support”, “Cold and cough support”, “Glycemic index support” and “Hypertension support”.                                                  

Sha Maganlal Chunilal Gandhi
Date Published : 05/28/2013
Mota Bazar , Valsad, INDIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/28/2013

Desc: Ayurvedic Dharasna Malis Tel Massage Oil

Shahnaz Ayurvedics
Date Published : 01/13/2016
Khasra No.1394 Langha Road , Uttaraanchal, INDIA
53 A - - 02 Lotions, Oils, Powders and Creams (Baby Products)
Date Published: 01/13/2016

Desc: Oxygen Skin Cream
Notes: Products labeling makes structure or function of the body claims

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 01/13/2016

Desc: Oxygen Skin Cream
Notes: Products labeling makes structure or function of the body claims

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 01/13/2016

Desc: Oxygen Skin Cream
Notes: Products labeling makes structure or function of the body claims

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 01/13/2016

Desc: Oxygen Skin Cream
Notes: Products labeling makes structure or function of the body claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/13/2016

Desc: Oxygen Skin Cream
Notes: Products labeling makes structure or function of the body claims

Shahnaz Husain Group
Date Published : 01/13/2016
M 84 A Greater Kailash Part Ii , New Dehli, INDIA
53 A - - 02 Lotions, Oils, Powders and Creams (Baby Products)
Date Published: 01/13/2016

Desc: Oxygen Skin Cream
Notes: Products labeling makes structure or function of the body claims

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 01/13/2016

Desc: Oxygen Skin Cream
Notes: Products labeling makes structure or function of the body claims.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 01/13/2016

Desc: Oxygen Skin Cream
Notes: Products labeling makes structure or function of the body claims.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 01/13/2016

Desc: Oxygen Skin Cream
Notes: Products labeling makes structure or function of the body claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/13/2016

Desc: Oxygen Skin Cream
Notes: Products labeling makes structure or function of the body claims

Shalina Laboratories Limited
Date Published : 04/23/2015
96 Maker Chamber V , Mumbai, Maharashtra INDIA
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/23/2015

Desc: Diproson Lotion

56 D - - 21 Gentamicin Sulfate (Aminoglycosides)
Date Published: 10/01/2021

Desc: Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline)
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “…indicated for the treatment of following: Mixed bacterial and fungal infections, Tinea infections of the skin (ringworm), Otitis externa, Seborrheic dermatitis, Contact dermatitis, Eczemas, Psoriasis, Athlete’s foot, Anal & vulval pruritis.” and “…is a combination of anti-fungal, anti-bacterial & anti-inflammatory drugs, which provide synergetic action in treatment of mix bacterial & fungal infections.”

61 A - - 11 Iodochlorhydroxyquin (Anti-Amebic)
Date Published: 10/01/2021

Desc: Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline)
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “…indicated for the treatment of following: Mixed bacterial and fungal infections, Tinea infections of the skin (ringworm), Otitis externa, Seborrheic dermatitis, Contact dermatitis, Eczemas, Psoriasis, Athlete’s foot, Anal & vulval pruritis.” and “…is a combination of anti-fungal, anti-bacterial & anti-inflammatory drugs, which provide synergetic action in treatment of mix bacterial & fungal infections.”

61 W - - 31 Tolnaftate (Anti-Fungal) (Not Antibiotic)
Date Published: 10/01/2021

Desc: Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline)
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “…indicated for the treatment of following: Mixed bacterial and fungal infections, Tinea infections of the skin (ringworm), Otitis externa, Seborrheic dermatitis, Contact dermatitis, Eczemas, Psoriasis, Athlete’s foot, Anal & vulval pruritis.” and “…is a combination of anti-fungal, anti-bacterial & anti-inflammatory drugs, which provide synergetic action in treatment of mix bacterial & fungal infections.”

61 X - - 14 Cyproheptadine HCl (Anti-Histaminic)
Date Published: 09/15/2021

Desc: Super Apeti (Cyproheptadine 4 mg Tablets)
Notes: The product appears to be a drug, as per Section 201(g)(1) of the FD&C Act, 21 § 321(g)(1) because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Labeling statements documenting the intended use of the product include, but may not be limited to, the following: “Super Apeti is an antihistaminic and antiserotonergic agent.” and “Super Apeti is indicated for the treatment of loss of appetite and allergy & pruritus.”

61 X - - 99 Anti-Histaminic N.E.C.
Date Published: 09/15/2021

Desc: Super Apeti (Cyproheptadine 4 mg Tablets)
Notes: The product appears to be a drug, as per Section 201(g)(1) of the FD&C Act, 21 § 321(g)(1) because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Labeling statements documenting the intended use of the product include, but may not be limited to, the following: “Super Apeti is an antihistaminic and antiserotonergic agent.” and “Super Apeti is indicated for the treatment of loss of appetite and allergy & pruritus.”

64 A - - 05 Cresol (Disinfectant)
Date Published: 10/01/2021

Desc: Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline)
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “…indicated for the treatment of following: Mixed bacterial and fungal infections, Tinea infections of the skin (ringworm), Otitis externa, Seborrheic dermatitis, Contact dermatitis, Eczemas, Psoriasis, Athlete’s foot, Anal & vulval pruritis.” and “…is a combination of anti-fungal, anti-bacterial & anti-inflammatory drugs, which provide synergetic action in treatment of mix bacterial & fungal infections.”

64 L - - 06 Betamethasone Dipropionate (Glucocorticoid)
Date Published: 09/16/2019

Desc: Diproson Lotion
Notes: 4/23/2015

64 L - - 06 Betamethasone Dipropionate (Glucocorticoid)
Date Published: 10/01/2021

Desc: Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline)
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “…indicated for the treatment of following: Mixed bacterial and fungal infections, Tinea infections of the skin (ringworm), Otitis externa, Seborrheic dermatitis, Contact dermatitis, Eczemas, Psoriasis, Athlete’s foot, Anal & vulval pruritis.” and “…is a combination of anti-fungal, anti-bacterial & anti-inflammatory drugs, which provide synergetic action in treatment of mix bacterial & fungal infections.”

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/01/2021

Desc: Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline)
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “…indicated for the treatment of following: Mixed bacterial and fungal infections, Tinea infections of the skin (ringworm), Otitis externa, Seborrheic dermatitis, Contact dermatitis, Eczemas, Psoriasis, Athlete’s foot, Anal & vulval pruritis.” and “…is a combination of anti-fungal, anti-bacterial & anti-inflammatory drugs, which provide synergetic action in treatment of mix bacterial & fungal infections.”

Sheth Brothers
Date Published : 11/28/2012
30-31 G.I.D.C. Vithalwadi , Bhavnagar, INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/28/2012

Desc: Kayam Churna Digestive
Notes: Note; Manufacturer per product label ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/28/2012

Desc: Kayam Churna Digestive
Notes: Note; Manufacturer per product label

Shree Baidyanath Ayurved Bhanan
Date Published : 01/20/2011
100 Great Nag Road , Nagpornagpor, INDIA
54 E - - 94 Ashwagandha (Herbal & Botanical Teas)
Date Published: 01/20/2011

Desc: Garbhapal Ras (Ros Yog Sagar)
Notes: India

54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas)
Date Published: 01/20/2011

Desc: Garbhapal Ras (Ros Yog Sagar)
Notes: India

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/20/2011

Desc: Garbhapal Ras (Ros Yog Sagar)
Notes: India

Shree Baidyanath Ayurved Bhawan Ltd
Date Published : 09/17/2019
172 Gusainpura , Jhansi, INDIA
62 Q B Y 99 Anti-Rheumatic N.E.C., Human - Non/Rx Combination Ingredient, NEC
Date Published: 09/17/2019

Desc: Herbal Ayurvedic Medicine
Notes: 8/25/2006

Shree Dhoot Apapeshwar Limited
Date Published : 09/16/2019
135 Nanubhai Desai Road Khetwadi , Mumbai, INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/16/2019

Desc: Pushpadhanwa tablets
Notes: 5/4/2006

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/16/2019

Desc: Pushpadhanwa tablets
Notes: 5/4/2006

Shree Marwal Sevashram
Date Published : 08/24/2012
4 - 5 A B Industrial Est , Plot No; Baolia Khurd , Indore, Madhya Pradesh INDIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/24/2012

Desc: Sandhi Sudha Ayuevedic Joint Pain Reliever Oil
Notes: India

Siddhi Vinayak Herbals
Date Published : 09/27/2012
23 Bj Vihar , Colony Near Shiv , Indore, INDIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/27/2012

Desc: Tummy Fit Ayurvedic Medicated Slimming Oil

Socomed Pharma Pvt. Ltd.
Date Published : 11/07/2011
CBD Belapur , Navi , Mumbai, INDIA
61 B - - 02 Cyproterone Acetate (Anti-Androgen)
Date Published: 11/07/2011

Desc: Cyproterone Acetate
Notes: India

Sonark Pharmaceuticals Private Limited
Date Published : 10/30/2015
j 13/17 Additional Midc , Satara, Maharashtra INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/30/2015

Desc: Six-Way Neem Capsules
Notes: There are drug claims on product associated website.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/30/2015

Desc: Six-Way Neem Capsules
Notes: There are drug claims on product associated website.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/30/2015

Desc: Six-Way Neem Capsules
Notes: There are drug claims on product associated website

South India Research Institute Pvt. Ltd
Date Published : 11/20/2023
Sirinagar , Vijayawada, Andhra Pradesh INDIA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 11/20/2023

Desc: WOODWARD'S GRIPE WATER (200 ml)
Notes: The product appears to be an unapproved new drug, as its label includes claims such as: "Gives instant relief to infants and babies ... due to gripe", "Relieve stomach pain caused by acidity and indigestion" and "Gentle antacid..."

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 11/20/2023

Desc: WOODWARD'S GRIPE WATER (200 ml)
Notes: The product appears to be an unapproved new drug, as its label includes claims such as: "Gives instant relief to infants and babies ... due to gripe", "Relieve stomach pain caused by acidity and indigestion" and "Gentle antacid..."

60 - - - -- Human and Animal Drugs
Date Published: 11/20/2023

Desc: WOODWARD'S GRIPE WATER (200 ml)
Notes: The product appears to be an unapproved new drug, as its label includes claims such as: "Gives instant relief to infants and babies ... due to gripe", "Relieve stomach pain caused by acidity and indigestion" and "Gentle antacid..."

61 - - - -- Human and Animal Drugs
Date Published: 11/20/2023

Desc: WOODWARD'S GRIPE WATER (200 ml)
Notes: The product appears to be an unapproved new drug, as its label includes claims such as: "Gives instant relief to infants and babies ... due to gripe", "Relieve stomach pain caused by acidity and indigestion" and "Gentle antacid..."

62 - - - -- Human and Animal Drugs
Date Published: 11/20/2023

Desc: WOODWARD'S GRIPE WATER (200 ml)
Notes: The product appears to be an unapproved new drug, as its label includes claims such as: "Gives instant relief to infants and babies ... due to gripe", "Relieve stomach pain caused by acidity and indigestion" and "Gentle antacid..."

63 - - - -- Human and Animal Drugs
Date Published: 11/20/2023

Desc: WOODWARD'S GRIPE WATER (200 ml)
Notes: The product appears to be an unapproved new drug, as its label includes claims such as: "Gives instant relief to infants and babies ... due to gripe", "Relieve stomach pain caused by acidity and indigestion" and "Gentle antacid..."

64 - - - -- Human and Animal Drugs
Date Published: 11/20/2023

Desc: WOODWARD'S GRIPE WATER (200 ml)
Notes: The product appears to be an unapproved new drug, as its label includes claims such as: "Gives instant relief to infants and babies ... due to gripe", "Relieve stomach pain caused by acidity and indigestion" and "Gentle antacid..."

65 - - - -- Human and Animal Drugs
Date Published: 11/20/2023

Desc: WOODWARD'S GRIPE WATER (200 ml)
Notes: The product appears to be an unapproved new drug, as its label includes claims such as: "Gives instant relief to infants and babies ... due to gripe", "Relieve stomach pain caused by acidity and indigestion" and "Gentle antacid..."

66 - - - -- Human and Animal Drugs
Date Published: 11/20/2023

Desc: WOODWARD'S GRIPE WATER (200 ml)
Notes: The product appears to be an unapproved new drug, as its label includes claims such as: "Gives instant relief to infants and babies ... due to gripe", "Relieve stomach pain caused by acidity and indigestion" and "Gentle antacid..."

TAPOVAN IMPEX PRIVATE LIMITED
Date Published : 06/11/2019
9/31-32 Ground Floor , Subhash Nagar , New Delhi, INDIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/11/2019

Desc: Organic Smokes Roll Your Own

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/11/2019

Desc: Organic Smokes Mild

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/11/2019

Desc: Organic Smokes Menthol

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/11/2019

Desc: Organic Smokes Regular

98 - - - -- Tobacco Products
Date Published: 06/11/2019

Desc: Organic Smokes Menthol

98 - - - -- Tobacco Products
Date Published: 06/11/2019

Desc: Organic Smokes Regular

98 - - - -- Tobacco Products
Date Published: 06/11/2019

Desc: Organic Smokes Roll Your Own

98 - - - -- Tobacco Products
Date Published: 06/11/2019

Desc: Organic Smokes Mild

THE HIMALAYA DRUG COMPANY
Date Published : 09/10/2021
Plot No 56, Sector Idcie Sidsul Pa , Ntnagar Dist-Us Nagar , Uttarakhand, INDIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/10/2021

Desc: HIMALAYA AGE DEFYING HAND CREAM

THE HIMALAYA DRUG COMPANY
Date Published : 01/30/2020
KHASRA NO 190 , KAIPUR INDUSTRIAL AREA , UTTRAKHAND, INDIA
53 E - - -- Hair Preps(Non-Coloring)
Date Published: 01/30/2020

Desc: Anti-Hair Fall Hair Oil
Notes: The product appears to be an unapproved new drug as the product's label and promotional website include claims such as (not an all-inclusive list): 'Promotes hair growth'; 'Prevents hair fall'; 'Anti-Hair Fall'; '...prevent scalp infections'.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/10/2021

Desc: HIMALAYA CLEAR COMPLEXION BRIGHTENING FACE WASH

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/10/2021

Desc: HIMALAYA MEN POWER GLOW LICORICE FACE WASH

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 03/18/2020

Desc: Himalaya Gentle Exfoliating Apricot Scrub
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list); 'Help stimulate fresh cell growth'.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 03/18/2020

Desc: Himalaya Purifying Neem Scrub
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Neem, well-known for its purifying and antibacterial properties, kills problem-causing bacteria ...'; 'Purifying Neem Scrub with Antibacterial Properties'.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/10/2021

Desc: HIMALAYA GENTLE EXFOLIATING WALNUT SCRUB (WALNUT APPLE)

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/18/2020

Desc: Himalaya Gentle Exfoliating Apricot Scrub
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list); 'Help stimulate fresh cell growth'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/18/2020

Desc: Himalaya Purifying Neem Scrub
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Neem, well-known for its purifying and antibacterial properties, kills problem-causing bacteria ...'; 'Purifying Neem Scrub with Antibacterial Properties'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/10/2021

Desc: HIMALAYA GENTLE EXFOLIATING WALNUT SCRUB (WALNUT APPLE)

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/10/2021

Desc: HIMALAYA AGE DEFYING HAND CREAM

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/10/2021

Desc: HIMALAYA REVITALIZING NIGHT CREAM

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/18/2020

Desc: Himalaya Gentle Exfoliating Apricot Scrub
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list); 'Help stimulate fresh cell growth'.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/18/2020

Desc: Himalaya Purifying Neem Scrub
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Neem, well-known for its purifying and antibacterial properties, kills problem-causing bacteria ...'; 'Purifying Neem Scrub with Antibacterial Properties'.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/10/2021

Desc: HIMALAYA GENTLE EXFOLIATING WALNUT SCRUB (WALNUT APPLE)

53 L - - 07 Night (Skin Care Preparations)
Date Published: 09/10/2021

Desc: HIMALAYA REVITALIZING NIGHT CREAM

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/10/2021

Desc: HIMALAYA GENTLE EXFOLIATING WALNUT SCRUB (WALNUT APPLE)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/18/2020

Desc: Himalaya Purifying Neem Scrub
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Neem, well-known for its purifying and antibacterial properties, kills problem-causing bacteria ...'; 'Purifying Neem Scrub with Antibacterial Properties'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/30/2020

Desc: Anti-Hair Fall Hair Oil
Notes: The product appears to be an unapproved new drug as the product's label and promotional website include claims such as (not an all-inclusive list): 'Promotes hair growth'; 'Prevents hair fall'; 'Anti-Hair Fall'; '...prevent scalp infections'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/18/2020

Desc: Himalaya Gentle Exfoliating Apricot Scrub
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list); 'Help stimulate fresh cell growth'.

THE HIMALAYA DRUG COMPANY
Date Published : 06/12/2023
Plot No 79 A & 79 B, Epip Phase 2 , Village Thana Tehsil Baddi , Solan, INDIA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 06/12/2023

Desc: Himalaya Purifying Neem Face Scrub

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/12/2023

Desc: Himalaya Purifying Neem Face Scrub

TIL HEALTHCARE PVT LTD
Date Published : 02/24/2017
100, Sri City Sez , Irugulam Post, Andhra Pradesh INDIA
54 A - - 02 Vitamin B1 (Thiamine)
Date Published: 12/13/2021

Desc: Apetamin Tablets
Notes: The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”.                                                                                       

54 A - - 04 Vitamin B6 (Pyridoxine)
Date Published: 12/13/2021

Desc: Apetamin Tablets
Notes: The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”.                                                                                       

54 A - - 07 Nicotinamide (Niacinamide) (Vitamin)
Date Published: 12/13/2021

Desc: Apetamin Tablets
Notes: The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”.                                                                                       

54 A - - -- Vitamin
Date Published: 03/06/2024

Desc: Astymin Amino Acids & Multivitamins Syrup
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

54 A - - -- Vitamin
Date Published: 11/23/2021

Desc: Apetamin Capsules
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…in the treatment of acute and chronic allergies and pruritis, such as dermatitis, including neurodermatitis, and neurodermatosis circumscripta, eczema, eczematoid dermatitis, dermatographism, mild, local allergic reactions to insect bites, hay fever, and other seasonal rhinitis, perennial allergic and vasomotor rhinitis, allergic conjunctivitis…’.

54 A - - -- Vitamin
Date Published: 02/24/2017

Desc: Apetamin Syrup
Notes: The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Indications: Loss of appetite and poor eating habits; Anorexia after a brief illness; Patients experiencing loss of appetite during convalescence following surgery or after any major illness'.

54 C - - 13 L-Lysine (Protein)
Date Published: 12/13/2021

Desc: Apetamin Tablets
Notes: The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”.                                                                                       

54 C - - -- Protein
Date Published: 03/06/2024

Desc: Astymin Amino Acids & Multivitamins Syrup
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 02/24/2017

Desc: Apetamin Syrup
Notes: The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Indications: Loss of appetite and poor eating habits; Anorexia after a brief illness; Patients experiencing loss of appetite during convalescence following surgery or after any major illness'.

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 11/23/2021

Desc: Apetamin Capsules
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…in the treatment of acute and chronic allergies and pruritis, such as dermatitis, including neurodermatitis, and neurodermatosis circumscripta, eczema, eczematoid dermatitis, dermatographism, mild, local allergic reactions to insect bites, hay fever, and other seasonal rhinitis, perennial allergic and vasomotor rhinitis, allergic conjunctivitis…’.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/13/2021

Desc: Apetamin Tablets
Notes: The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”.                                                                                       

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 11/23/2021

Desc: Apetamin Capsules
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…in the treatment of acute and chronic allergies and pruritis, such as dermatitis, including neurodermatitis, and neurodermatosis circumscripta, eczema, eczematoid dermatitis, dermatographism, mild, local allergic reactions to insect bites, hay fever, and other seasonal rhinitis, perennial allergic and vasomotor rhinitis, allergic conjunctivitis…’.

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 02/24/2017

Desc: Apetamin Syrup
Notes: The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Indications: Loss of appetite and poor eating habits; Anorexia after a brief illness; Patients experiencing loss of appetite during convalescence following surgery or after any major illness'.

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 03/06/2024

Desc: Astymin Amino Acids & Multivitamins Syrup
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

61 X - - 14 Cyproheptadine HCl (Anti-Histaminic)
Date Published: 11/23/2021

Desc: Apetamin Capsules
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…in the treatment of acute and chronic allergies and pruritis, such as dermatitis, including neurodermatitis, and neurodermatosis circumscripta, eczema, eczematoid dermatitis, dermatographism, mild, local allergic reactions to insect bites, hay fever, and other seasonal rhinitis, perennial allergic and vasomotor rhinitis, allergic conjunctivitis…’.

61 X - - 14 Cyproheptadine HCl (Anti-Histaminic)
Date Published: 12/13/2021

Desc: Apetamin Tablets
Notes: The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”.                                                                                       

61 X - - 14 Cyproheptadine HCl (Anti-Histaminic)
Date Published: 02/24/2017

Desc: Apetamin Syrup
Notes: The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Indications: Loss of appetite and poor eating habits; Anorexia after a brief illness; Patients experiencing loss of appetite during convalescence following surgery or after any major illness'.

61 - - - -- Human and Animal Drugs
Date Published: 03/06/2024

Desc: Astymin Amino Acids & Multivitamins Syrup
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

63 N - - 04 Dexpanthenol (Cholinergic)
Date Published: 12/13/2021

Desc: Apetamin Tablets
Notes: The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”.                                                                                       

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/13/2021

Desc: Apetamin Tablets
Notes: The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”.                                                                                       

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/23/2021

Desc: Apetamin Capsules
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…in the treatment of acute and chronic allergies and pruritis, such as dermatitis, including neurodermatitis, and neurodermatosis circumscripta, eczema, eczematoid dermatitis, dermatographism, mild, local allergic reactions to insect bites, hay fever, and other seasonal rhinitis, perennial allergic and vasomotor rhinitis, allergic conjunctivitis…’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/24/2017

Desc: Apetamin Syrup
Notes: The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Indications: Loss of appetite and poor eating habits; Anorexia after a brief illness; Patients experiencing loss of appetite during convalescence following surgery or after any major illness'.

66 V - - -- Patent Medicines, Etc
Date Published: 03/06/2024

Desc: Astymin Amino Acids & Multivitamins Syrup
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

TIRUPATI LIFESCIENCES
Date Published : 09/15/2022
Nahan Road, Dist Sirmou , Paonta Sahib, INDIA
46 - - - -- Food Additives (Human Use)
Date Published: 09/15/2022

Desc: Vedicinals 9

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/15/2022

Desc: Vedicinals 9

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/15/2022

Desc: Vedicinals 9

Telesky Shopping P
Date Published : 08/14/2012
22 Morya House , Mumbai, INDIA
66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 08/14/2012

Desc: Musli Power X-Tra
Notes: India

Tevapharm India Pvt Ltd
Date Published : 04/04/2018
Plot No Sm-46 Industrial Estate , Ahnedabad, INDIA
21 C - - 99 Mixed Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 04/04/2018

Desc: Vicks cough drops
Notes: Labeling and formulation do not comply with the OTC monograph

66 F - - 99 Suppressant N.E.C.
Date Published: 04/04/2018

Desc: Vicks cough drops
Notes: Labeling and formulation do not comply with the OTC monograph

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 04/04/2018

Desc: Vicks cough drops
Notes: Labeling and formulation do not comply with the OTC monograph

The Himalaya Drug Company
Date Published : 10/25/2010
Survey No. 11/2 Makali Village, Dasahapura Hobli , Madanayakanahalli, Tumkur Road , Bangalore, Karnataka INDIA
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 01/30/2015

Desc: Neem Face Wash

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 01/30/2015

Desc: Neem Face Wash

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 10/19/2015

Desc: Anti-Hair Fall Hair Oil

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/25/2010

Desc: Diaget Guard Granules Himalaya Diabecon
Notes: India; 1/23/2007

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/25/2010

Desc: Diaget Guard Granules Himalaya Diabecon
Notes: India; 1/23/2007

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/30/2015

Desc: Neem Face Wash

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/19/2015

Desc: Anti-Hair Fall Hair Oil

The Himalaya Drug Company
Date Published : 08/05/2015
A-3/3, UPSIDC Industrial Area , Bhimtal ¿¿¿¿¿¿¿¿¿¿¿¿ 263 136. , Distt. Nainital., Uttarakhand INDIA
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 08/05/2015

Desc: Himalaya Herbals Purifying Neem Pack

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 08/05/2015

Desc: Himalaya Herbals Purifying Neem Pack

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/05/2015

Desc: Himalaya Herbals Purifying Neem Pack

The Himalaya Drug Company
Date Published : 08/05/2015
No. 546, AA 1 & AA 2 Nandigam , Kuthar Mandal , Mehaboob Nagar, Andhra Pradesh INDIA
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 08/05/2015

Desc: Himalaya Anti-Dandruff Shampoo

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 08/05/2015

Desc: Anti-Hair Fall Shampoo

53 E - - -- Hair Preps(Non-Coloring)
Date Published: 01/30/2020

Desc: Anti-Hair Fall Hair Oil
Notes: The product appears to be an unapproved new drug as the product's label and promotional website include claims such as (not an all-inclusive list): 'Promotes hair growth'; 'Prevents hair fall'; 'Anti-Hair Fall'; '...prevent scalp infections'.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/10/2021

Desc: HIMALAYA CLEAR COMPLEXION BRIGHTENING FACE WASH

62 S - - 99 Anti-Seborrheic N.E.C.
Date Published: 08/05/2015

Desc: Himalaya Anti-Dandruff Shampoo

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/30/2020

Desc: Anti-Hair Fall Hair Oil
Notes: The product appears to be an unapproved new drug as the product's label and promotional website include claims such as (not an all-inclusive list): 'Promotes hair growth'; 'Prevents hair fall'; 'Anti-Hair Fall'; '...prevent scalp infections'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/05/2015

Desc: Himalaya Anti-Dandruff Shampoo

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/05/2015

Desc: Anti-Hair Fall Shampoo

The Himalaya Drug Company
Date Published : 07/21/2015
No. 182 Village Gurumajra , Kishanpura , Tehsil, Nalagarh, Himachal Pradesh INDIA
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 07/21/2015

Desc: Himalaya Purifying Neem Face Wash

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 08/05/2015

Desc: Himalaya Herbals Purifying Neem Pack

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/21/2015

Desc: Himalaya Purifying Neem Face Wash

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 08/05/2015

Desc: Himalaya Herbals Purifying Neem Pack

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/05/2015

Desc: Himalaya Herbals Purifying Neem Pack

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/21/2015

Desc: Himalaya Purifying Neem Face Wash

The Himalaya Drug Company
Date Published : 07/29/2015
Plot. No. 16/A, Phase Iv , Ida , Jeedimetla, Andhra Pradesh INDIA
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 08/05/2015

Desc: Himalaya Herbals Purifying Neem Pack

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 07/29/2015

Desc: Himalaya Refreshing Fruit Pack (Face Wash)

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 08/05/2015

Desc: Himalaya Herbals Purifying Neem Pack

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/05/2015

Desc: Himalaya Herbals Purifying Neem Pack

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/29/2015

Desc: Himalaya Refreshing Fruit Pack (Face Wash)

The Himalaya Drug Company
Date Published : 07/30/2015
No. 292 & 294, 4th Phase , Peenya Industrial Area , Bangalore, Karnataka INDIA
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 07/30/2015

Desc: Himalaya Herbals Anti Wrinkle Cream

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/30/2015

Desc: Himalaya Herbals Anti Wrinkle Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/30/2015

Desc: Himalaya Herbals Anti Wrinkle Cream

Three N Products Pvt. Ltd.
Date Published : 11/19/2014
3030 Partap Street , New Delhi, Delhi INDIA
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 11/19/2014

Desc: Ayur Herbal Coconut Shampoo for Dry Hair
Notes: Problem; Unapproved New Drug

Three N Products Pvt.Ltd
Date Published : 11/19/2014
24a, Shivaji Marg, Najafgarh Road , New Delhi, INDIA
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 11/19/2014

Desc: Ayur Herbal Coconut Shampoo for Dry Hair
Notes: Problem; Unapproved New Drug

Three-N-Produucts (P) LTD
Date Published : 11/19/2014
Po Box No 6032 , New Delhi, Delhi INDIA
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 11/19/2014

Desc: Ayur Herbal Coconut Shampoo for Dry Hair
Notes: Problem; Unapproved New Drug

Time Laboratories
Date Published : 08/19/2012
201, Mahavir Ind.Estate, Chandansar rd. , Virar ( East ) , Thane, Maharashtra INDIA
63 H - - 22 Senna (Cathartic)
Date Published: 08/19/2012

Desc: Kamyab Powder
Notes: India

63 H - - 99 Cathartic N.E.C.
Date Published: 08/19/2012

Desc: Kamyab Powder
Notes: India

66 C - - 99 Stool Softener N.E.C.
Date Published: 08/19/2012

Desc: Kamyab Powder
Notes: India

Time Laboratories
Date Published : 08/28/2012
I Parekh Road , Mumbai, Maharashtra INDIA
63 H - - 22 Senna (Cathartic)
Date Published: 08/28/2012

Desc: Kamyab Powder
Notes: Country; India

63 H - - 99 Cathartic N.E.C.
Date Published: 08/28/2012

Desc: Kamyab Powder
Notes: Country; India

66 C - - 99 Stool Softener N.E.C.
Date Published: 08/28/2012

Desc: Kamyab Powder
Notes: Country; India

Tirupati Medicare Ltd.
Date Published : 10/19/2022
Dist. Sirmour (H.P.) , Nahan, Himachal Pradesh INDIA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 10/19/2022

Desc: Divisa Natural Laxative Tablets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/19/2022

Desc: Divisa Natural Laxative Tablets

Udaan International
Date Published : 04/04/2018
Maruti Co Op Society , Near Old Water Tank , Ahmedabad, Gujarat INDIA
21 C - - 99 Mixed Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 04/04/2018

Desc: Vicks cough drops
Notes: Labeling and formulation do not comply with the OTC monograph

21 C - - 99 Mixed Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 04/04/2018

Desc: Strepsils
Notes: Labeling and formulation do not comply with the OTC monograph

66 F - - 99 Suppressant N.E.C.
Date Published: 04/04/2018

Desc: Vicks cough drops
Notes: Labeling and formulation do not comply with the OTC monograph

66 F - - 99 Suppressant N.E.C.
Date Published: 04/04/2018

Desc: Strepsils
Notes: Labeling and formulation do not comply with the OTC monograph

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 04/04/2018

Desc: Vicks cough drops
Notes: Labeling and formulation do not comply with the OTC monograph

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 04/04/2018

Desc: Strepsils
Notes: Labeling and formulation do not comply with the OTC monograph

Ultratech India Ltd.
Date Published : 01/14/2014
113 J K Chambers Sector - 17 , Vashi, Navi Mumbai, Maharashtra INDIA
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 01/14/2014

Desc: 18 Again Gel Vaginal Tightening and Rejuvenation
Notes: DWPE date 12/16/13

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 01/14/2014

Desc: 18 Again Gel Vaginal Tightening and Rejuvenation
Notes: DWPE date 12/16/13

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/14/2014

Desc: 18 Again Gel Vaginal Tightening and Rejuvenation
Notes: DWPE date 12/16/13

Unilever India Export Ltd.
Date Published : 03/19/2014
Plot 253-257, Sector-Iv , Kandla Special Economic Zone , Gandhidham, INDIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/19/2014

Desc: Fair & Lovely Advanced Multi-Vitman Daily Fairness Expert Cream

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/19/2014

Desc: Fair & Lovely Advanced Multi-Vitman Daily Fairness Expert Cream

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 03/19/2014

Desc: Fair & Lovely Advanced Multi-Vitman Daily Fairness Expert Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/19/2014

Desc: Fair & Lovely Advanced Multi-Vitman Daily Fairness Expert Cream

Unique Fragrances
Date Published : 08/25/2017
1 Plot No 21 , Road No , New Delhi, Delhi INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/25/2017

Desc: CHYAWANPRASH
Notes: Disease claims made on product labeling.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/25/2017

Desc: CHYAWANPRASH
Notes: Disease claims made on product labeling.

Unique Fragrances
Date Published : 03/10/2017
B- 63,2 nd Floor, Prashat Vihar. , New Delhi, Delhi INDIA
21 D - - 13 Berries and Subtropica/Tropical Fruits, Mixed, Juices or Concentrates
Date Published: 03/10/2017

Desc: "Uniayurveda" Triphala Juice (Amla; Haritaki & Vibhitaki)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

21 K - - 14 Plum, Juice, Pit Fruit Juices or Concentrates
Date Published: 03/10/2017

Desc: "Uniayurveda" Jamun Juice (Black Plum)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

21 V - - 34 Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 03/10/2017

Desc: "Uniayurveda" Amla Juice (Indian Gooseberry)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

22 D - - 05 Bitter Melon, Juice, Vine Fruit Juices or Concentrates
Date Published: 03/10/2017

Desc: "Uniayurveda" Karela Juice (Bitter Gourd)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

29 - - - -- Soft Drinks/Water
Date Published: 03/10/2017

Desc: "Uniayurveda" Aloe Vera Juice Dietary Supplement
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper

29 - - - -- Soft Drinks/Water
Date Published: 03/10/2017

Desc: "Uniayurveda" Karela Juice (Bitter Gourd)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

29 - - - -- Soft Drinks/Water
Date Published: 03/10/2017

Desc: "Uniayurveda" Amla Juice (Indian Gooseberry)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper

29 - - - -- Soft Drinks/Water
Date Published: 03/10/2017

Desc: "Uniayurveda" Jamun Juice (Black Plum)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

29 - - - -- Soft Drinks/Water
Date Published: 03/10/2017

Desc: "Uniayurveda" Triphala Juice (Amla; Haritaki & Vibhitaki)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued))
Date Published: 03/10/2017

Desc: "Uniayurveda" Aloe Vera Juice Dietary Supplement
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/10/2017

Desc: "Uniayurveda" Triphala Juice (Amla; Haritaki & Vibhitaki)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/10/2017

Desc: "Uniayurveda" Jamun Juice (Black Plum)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/10/2017

Desc: "Uniayurveda" Karela Juice (Bitter Gourd)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/10/2017

Desc: "Uniayurveda" Amla Juice (Indian Gooseberry)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/10/2017

Desc: "Uniayurveda" Aloe Vera Juice Dietary Supplement
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

Unique Fragrances
Date Published : 03/10/2017
395 Food Park , Rai Industrial Estate , Sonepat, Haryana INDIA
21 D - - 13 Berries and Subtropica/Tropical Fruits, Mixed, Juices or Concentrates
Date Published: 03/10/2017

Desc: "Uniayurveda" Triphala Juice (Amla; Haritaki & Vibhitaki)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

21 K - - 14 Plum, Juice, Pit Fruit Juices or Concentrates
Date Published: 03/10/2017

Desc: "Uniayurveda" Jamun Juice (Black Plum)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

21 V - - 34 Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 03/10/2017

Desc: "Uniayurveda" Amla Juice (Indian Gooseberry)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

22 D - - 05 Bitter Melon, Juice, Vine Fruit Juices or Concentrates
Date Published: 03/10/2017

Desc: "Uniayurveda" Karela Juice (Bitter Gourd)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

29 - - - -- Soft Drinks/Water
Date Published: 03/10/2017

Desc: "Uniayurveda" Karela Juice (Bitter Gourd)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

29 - - - -- Soft Drinks/Water
Date Published: 03/10/2017

Desc: "Uniayurveda" Triphala Juice (Amla; Haritaki & Vibhitaki)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

29 - - - -- Soft Drinks/Water
Date Published: 03/10/2017

Desc: "Uniayurveda" Jamun Juice (Black Plum)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

29 - - - -- Soft Drinks/Water
Date Published: 03/10/2017

Desc: "Uniayurveda" Aloe Vera Juice Dietary Supplement
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

29 - - - -- Soft Drinks/Water
Date Published: 03/10/2017

Desc: "Uniayurveda" Amla Juice (Indian Gooseberry)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued))
Date Published: 03/10/2017

Desc: "Uniayurveda" Aloe Vera Juice Dietary Supplement
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/10/2017

Desc: "Uniayurveda" Karela Juice (Bitter Gourd)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/10/2017

Desc: "Uniayurveda" Amla Juice (Indian Gooseberry)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/10/2017

Desc: "Uniayurveda" Jamun Juice (Black Plum)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper. ;

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/10/2017

Desc: "Uniayurveda" Triphala Juice (Amla; Haritaki & Vibhitaki)
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/10/2017

Desc: "Uniayurveda" Aloe Vera Juice Dietary Supplement
Notes: Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.

Unjha Ayurvedic Pharmacy
Date Published : 09/13/2019
Unknown Street , Unknown, INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/13/2019

Desc: Navratna Rasa
Notes: 5/4/2006

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/13/2019

Desc: Navratna Rasa
Notes: 5/4/2006

Uttarkashi Minerals Corporation
Date Published : 04/20/2011
Vill-Aungi, P.O.Maneri , Gangotri Valley,Uttarkashi , Uttarakhand, INDIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/20/2011

Desc: Ganjal (The Holy Water)
Notes: Country; India

VAHDAM TEAS PVT LT
Date Published : 01/25/2023
C 12 3 , Noida, Uttar Pradesh INDIA
31 K - - 01 Tea, Black
Date Published: 01/25/2023

Desc: Turmeric Spiced Herbal Tea
Notes: Based on review of the product labeling, Turmeric Moringa Herbal Tea, Turmeric Ashwagandha Herbal Tea, Turmeric Spiced Herbal Tea, Turmeric Ginger Herbal Tea, Turmeric Chamomile Herbal Tea, and Turmeric Pepper Herbal Tea products appear to be unapproved new drugs within the meaning of section 505(a) of the Act.

31 K - - 01 Tea, Black
Date Published: 01/25/2023

Desc: Turmeric Ginger Herbal Tea
Notes: Based on review of the product labeling, Turmeric Moringa Herbal Tea, Turmeric Ashwagandha Herbal Tea, Turmeric Spiced Herbal Tea, Turmeric Ginger Herbal Tea, Turmeric Chamomile Herbal Tea, and Turmeric Pepper Herbal Tea products appear to be unapproved new drugs within the meaning of section 505(a) of the Act.

31 K - - 01 Tea, Black
Date Published: 01/25/2023

Desc: Turmeric Moringa Herbal Tea
Notes: Based on review of the product labeling, Turmeric Moringa Herbal Tea, Turmeric Ashwagandha Herbal Tea, Turmeric Spiced Herbal Tea, Turmeric Ginger Herbal Tea, Turmeric Chamomile Herbal Tea, and Turmeric Pepper Herbal Tea products appear to be unapproved new drugs within the meaning of section 505(a) of the Act.

31 K - - 01 Tea, Black
Date Published: 01/25/2023

Desc: Turmeric Pepper Herbal Tea
Notes: Based on review of the product labeling, Turmeric Moringa Herbal Tea, Turmeric Ashwagandha Herbal Tea, Turmeric Spiced Herbal Tea, Turmeric Ginger Herbal Tea, Turmeric Chamomile Herbal Tea, and Turmeric Pepper Herbal Tea products appear to be unapproved new drugs within the meaning of section 505(a) of the Act.

31 K - - 01 Tea, Black
Date Published: 01/25/2023

Desc: Turmeric Ashwagandha Herbal Tea
Notes: Based on review of the product labeling, Turmeric Moringa Herbal Tea, Turmeric Ashwagandha Herbal Tea, Turmeric Spiced Herbal Tea, Turmeric Ginger Herbal Tea, Turmeric Chamomile Herbal Tea, and Turmeric Pepper Herbal Tea products appear to be unapproved new drugs within the meaning of section 505(a) of the Act.

31 K - - 01 Tea, Black
Date Published: 01/25/2023

Desc: Turmeric Chamomile Herbal Tea
Notes: Based on review of the product labeling, Turmeric Moringa Herbal Tea, Turmeric Ashwagandha Herbal Tea, Turmeric Spiced Herbal Tea, Turmeric Ginger Herbal Tea, Turmeric Chamomile Herbal Tea, and Turmeric Pepper Herbal Tea products appear to be unapproved new drugs within the meaning of section 505(a) of the Act.

31 P - - 04 Tea, Camomille, Chamomile (Tea Substitute)
Date Published: 01/25/2023

Desc: Turmeric Chamomile Herbal Tea
Notes: Based on review of the product labeling, Turmeric Moringa Herbal Tea, Turmeric Ashwagandha Herbal Tea, Turmeric Spiced Herbal Tea, Turmeric Ginger Herbal Tea, Turmeric Chamomile Herbal Tea, and Turmeric Pepper Herbal Tea products appear to be unapproved new drugs within the meaning of section 505(a) of the Act.

54 E - - 94 Ashwagandha (Herbal & Botanical Teas)
Date Published: 01/25/2023

Desc: Turmeric Ashwagandha Herbal Tea
Notes: Based on review of the product labeling, Turmeric Moringa Herbal Tea, Turmeric Ashwagandha Herbal Tea, Turmeric Spiced Herbal Tea, Turmeric Ginger Herbal Tea, Turmeric Chamomile Herbal Tea, and Turmeric Pepper Herbal Tea products appear to be unapproved new drugs within the meaning of section 505(a) of the Act.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 01/25/2023

Desc: Turmeric Ginger Herbal Tea
Notes: Based on review of the product labeling, Turmeric Moringa Herbal Tea, Turmeric Ashwagandha Herbal Tea, Turmeric Spiced Herbal Tea, Turmeric Ginger Herbal Tea, Turmeric Chamomile Herbal Tea, and Turmeric Pepper Herbal Tea products appear to be unapproved new drugs within the meaning of section 505(a) of the Act.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 01/25/2023

Desc: Turmeric Ashwagandha Herbal Tea
Notes: Based on review of the product labeling, Turmeric Moringa Herbal Tea, Turmeric Ashwagandha Herbal Tea, Turmeric Spiced Herbal Tea, Turmeric Ginger Herbal Tea, Turmeric Chamomile Herbal Tea, and Turmeric Pepper Herbal Tea products appear to be unapproved new drugs within the meaning of section 505(a) of the Act.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 01/25/2023

Desc: Turmeric Spiced Herbal Tea
Notes: Based on review of the product labeling, Turmeric Moringa Herbal Tea, Turmeric Ashwagandha Herbal Tea, Turmeric Spiced Herbal Tea, Turmeric Ginger Herbal Tea, Turmeric Chamomile Herbal Tea, and Turmeric Pepper Herbal Tea products appear to be unapproved new drugs within the meaning of section 505(a) of the Act.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 01/25/2023

Desc: Turmeric Pepper Herbal Tea
Notes: Based on review of the product labeling, Turmeric Moringa Herbal Tea, Turmeric Ashwagandha Herbal Tea, Turmeric Spiced Herbal Tea, Turmeric Ginger Herbal Tea, Turmeric Chamomile Herbal Tea, and Turmeric Pepper Herbal Tea products appear to be unapproved new drugs within the meaning of section 505(a) of the Act.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 01/25/2023

Desc: Turmeric Moringa Herbal Tea
Notes: Based on review of the product labeling, Turmeric Moringa Herbal Tea, Turmeric Ashwagandha Herbal Tea, Turmeric Spiced Herbal Tea, Turmeric Ginger Herbal Tea, Turmeric Chamomile Herbal Tea, and Turmeric Pepper Herbal Tea products appear to be unapproved new drugs within the meaning of section 505(a) of the Act.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 01/25/2023

Desc: Turmeric Chamomile Herbal Tea
Notes: Based on review of the product labeling, Turmeric Moringa Herbal Tea, Turmeric Ashwagandha Herbal Tea, Turmeric Spiced Herbal Tea, Turmeric Ginger Herbal Tea, Turmeric Chamomile Herbal Tea, and Turmeric Pepper Herbal Tea products appear to be unapproved new drugs within the meaning of section 505(a) of the Act.

54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued)
Date Published: 01/25/2023

Desc: Turmeric Moringa Herbal Tea
Notes: Based on review of the product labeling, Turmeric Moringa Herbal Tea, Turmeric Ashwagandha Herbal Tea, Turmeric Spiced Herbal Tea, Turmeric Ginger Herbal Tea, Turmeric Chamomile Herbal Tea, and Turmeric Pepper Herbal Tea products appear to be unapproved new drugs within the meaning of section 505(a) of the Act.

VEDICINALS INDIA PRIVATE LIMITED
Date Published : 09/15/2022
Building J Flat No 204 , Pune, INDIA
46 - - - -- Food Additives (Human Use)
Date Published: 09/15/2022

Desc: Vedicinals 9

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/15/2022

Desc: Vedicinals 9

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/15/2022

Desc: Vedicinals 9

Vaidya Nutraceutical
Date Published : 07/18/2022
Barotiwala Ind Area , Tehsil-kasouli, INDIA
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/18/2022

Desc: Mahanarayan Tel
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “THE RENOWNED OIL FOR JOINTS AND MUSCULAR PAINS” and “Indications - Joints Pain, Backache, Groin and Calf Pain, Paralysis”.                                                                                                                                                                                                                                                                                           

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/18/2022

Desc: Mahanarayan Tel
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “THE RENOWNED OIL FOR JOINTS AND MUSCULAR PAINS” and “Indications - Joints Pain, Backache, Groin and Calf Pain, Paralysis”.                                                                                                                                                                                                                                                                                           

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/18/2022

Desc: Mahanarayan Tel
Notes: A label/labeling statement documenting the intended use of the product include, but may not be limited to the following: “THE RENOWNED OIL FOR JOINTS AND MUSCULAR PAINS” and “Indications - Joints Pain, Backache, Groin and Calf Pain, Paralysis”.                                                                                                                                                                                                                                                                                           

Vee Excel
Date Published : 09/30/2009
2, Veer Sawarkar Block , Triveni Comp. Shakarpur , Delhi, INDIA
65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 09/30/2009

Vee Excel
Date Published : 09/30/2009
G-16 3rd Floor , Preet Vihar, Vikas Marg , Delhi, INDIA
65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 09/30/2009

Notes: 9/16/2004

Vee Excel Drugs & Pharmaceutical
Date Published : 09/30/2009
R-23-B, 1/F, Rita Block , Delhi, INDIA
65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 09/30/2009

Vicco Laboratories
Date Published : 11/08/2010
Plot No 24 1d-2 Mologa De Orora , Panaji Goa, North Goa Goa INDIA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 04/10/2012

Desc: Vicco Vajradanthi Toothpaste (100g; 150g; and 200g)
Notes: India

53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 04/23/2012

Desc: Vicco Vajradanti Toothpowder
Notes: India; Note: Vicco Vajradanti Toothpowder is being promoted for prevention of tooth decay and cure of pyorrhea, bleeding, swollen and inflamed gums.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 11/08/2010

Desc: Vicco Vajradanti Paste
Notes: Inida

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 11/08/2010

Desc: Vicco Turmeric Skin Cream
Notes: India

63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic)
Date Published: 04/23/2012

Desc: Vicco Vajradanti Toothpowder
Notes: India;Note: Vicco Vajradanti Toothpowder is being promoted for prevention of tooth decay and cure of pyorrhea, bleeding, swollen and inflamed gums

63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic)
Date Published: 04/10/2012

Desc: Vicco Vajradanthi Toothpaste (100g; 150g; and 200g)
Notes: India

63 S - - 99 Dental Protectant N.E.C.
Date Published: 11/08/2010

Desc: Vicco Vajradanti Paste
Notes: India

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 11/08/2010

Desc: Vicco Turmeric Skin Cream
Notes: India

Vicco laboratories
Date Published : 08/26/2010
Factory S-89. M.I.D.C. , Hinga, Maharashtra INDIA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 11/03/2010

Desc: Vicco VAJRADANTI Ayurvedic Medicine for Gums and Teeth Toothpaste
Notes: india

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 11/03/2010

Desc: Vicco VAJRADANTI Ayurvedic Medicine for Gums and Teeth Toothpaste
Notes: India

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 11/08/2010

Desc: Per Product Labeling; Vicco Vajradanti Paste
Notes: India

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/26/2010

Desc: Vicco Tumeric Skin Cream
Notes: India

63 S - - 99 Dental Protectant N.E.C.
Date Published: 11/08/2010

Desc: Per Product Labeling; Vicco Vajradanti Paste
Notes: India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/26/2010

Desc: Vicco Tumeric Skin Cream
Notes: India

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/03/2010

Desc: Vicco VAJRADANTI Ayurvedic Medicine for Gums and Teeth Toothpaste
Notes: India

Vinicare Intl Llp
Date Published : 07/26/2016
No 43 Bc , 1st Floor; Tamilnadutamilnadu , Chennai, Tamil Nadu INDIA
21 T - - 34 Amla, Subtropical and Tropical Fruit, Dried or Paste
Date Published: 07/26/2016

Desc: Amla Powder

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/26/2016

Desc: Amla Powder

Vita Biopharma Private Limited
Date Published : 05/30/2013
141, 143 Panchal Udyog Nagar , Bhimpore, Nani Daman , Nani Daman, 396210 INDIA
64 A - - 99 Disinfectant N.E.C.
Date Published: 05/30/2013

Desc: Dettol Antiseptic Liquid
Notes: India

64 V - - 99 Ion-Exchange Resin N.E.C.
Date Published: 05/30/2013

Desc: Dettol Antiseptic Liquid
Notes: India

WIPRO ENTERPRISES LTD
Date Published : 08/03/2017
SURYA LABORATRIES PLOT , BELWADI INDL AREA , MYSORE, INDIA
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 08/03/2017

Desc: Chandrika Ayurvedic Soap
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; 'has more than double the amount of coconut oil and ayurvedic herbs; which gently treat skin problems... Removes blemishes Treats acne/pimples protects from common skin problems like pimples; dark spots; rashes; pigmentation etc'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/03/2017

Desc: Chandrika Ayurvedic Soap
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; 'has more than double the amount of coconut oil and ayurvedic herbs; which gently treat skin problems... Removes blemishes Treats acne/pimples protects from common skin problems like pimples; dark spots; rashes; pigmentation etc'.

WIPRO LTD.
Date Published : 08/03/2017
4 Antharasanahalli Industrial Area , Ahobala Agrahara, Karnataka INDIA
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 08/03/2017

Desc: Chandrika Ayurvedic Soap
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; 'has more than double the amount of coconut oil and ayurvedic herbs; which gently treat skin problems... Removes blemishes Treats acne/pimples? protects from common skin problems like pimples; dark spots; rashes; pigmentation etc'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/03/2017

Desc: Chandrika Ayurvedic Soap
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; 'has more than double the amount of coconut oil and ayurvedic herbs; which gently treat skin problems... Removes blemishes Treats acne/pimples protects from common skin problems like pimples; dark spots; rashes; pigmentation etc'.

Wellous Pharma Pvt. Ltd.
Date Published : 03/19/2021
7/62-B, Villianur Road , Perambai Village, INDIA
60 S - - 99 Antacid, N.E.C.
Date Published: 03/19/2021

Desc: Woodward's Celebrated "Gripe Water"; Gentle Antacid Safe for Infants
Notes: The product appears to be an unapproved new drug, as its promotional website includes claims such as: "Gives instant relief to infants and babies ... due to gripe", "Relieve stomach pain caused by acidity and indigestion" and "Gentle antacid...".

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/19/2021

Desc: Woodward's Celebrated "Gripe Water"; Gentle Antacid Safe for Infants
Notes: The product appears to be an unapproved new drug, as its promotional website includes claims such as: "Gives instant relief to infants and babies ... due to gripe", "Relieve stomach pain caused by acidity and indigestion" and "Gentle antacid...".

Wf Limited
Date Published : 12/12/2011
No 28 C N Roy Road , Kolkata, West Bengal INDIA
63 R - - 05 Sodium Monofluorophosphate (Dental Caries Prophylactic)
Date Published: 05/28/2013

Desc: Neem Toothpaste
Notes: India

63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic)
Date Published: 12/12/2011

Desc: Neem Toothpaste
Notes: India

Wf Limited
Date Published : 04/20/2015
No 28 C N Roy Road , Kolkata, West Bengal INDIA
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 04/20/2015

Desc: Neem Active Toothpaste

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 04/20/2015

Desc: Neem Active Toothpaste

63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic)
Date Published: 04/20/2015

Desc: Neem Active Toothpaste

63 S - - 99 Dental Protectant N.E.C.
Date Published: 04/20/2015

Desc: Neem Active Toothpaste

YDIK NATURE CARE PRODUCTS
Date Published : 12/09/2021
Rambhai Estate, Block # 944 , Aslali , Ahmedabad, Gujarat INDIA
31 K - - -- Tea
Date Published: 12/09/2021

Desc: Kulo Cough Syrup
Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

31 K - - -- Tea
Date Published: 12/09/2021

Desc: Varman's Moor Health Syrups
Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

31 L - - -- Tea, Decaffeinated
Date Published: 12/09/2021

Desc: Varman's Moor Health Syrups
Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

31 L - - -- Tea, Decaffeinated
Date Published: 12/09/2021

Desc: Kulo Cough Syrup
Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

31 P - - -- Tea Substitutes
Date Published: 12/09/2021

Desc: Kulo Cough Syrup
Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

31 P - - -- Tea Substitutes
Date Published: 12/09/2021

Desc: Varman's Moor Health Syrups
Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 12/09/2021

Desc: Kulo Cough Syrup
Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 12/09/2021

Desc: Varman's Moor Health Syrups
Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/09/2021

Desc: Varman's Moor Health Syrups
Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/09/2021

Desc: Kulo Cough Syrup
Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued)
Date Published: 12/09/2021

Desc: Varman's Moor Health Syrups
Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued)
Date Published: 12/09/2021

Desc: Kulo Cough Syrup
Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd
Date Published: 12/09/2021

Desc: Varman's Moor Health Syrups
Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd
Date Published: 12/09/2021

Desc: Kulo Cough Syrup
Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/09/2021

Desc: Kulo Cough Syrup
Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/09/2021

Desc: Varman's Moor Health Syrups
Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

Zandu Pharmaceutical Works Ltd.
Date Published : 09/04/2019
GIDC, Plot No. 82 , Gujarat, INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/04/2019

Desc: Bala Guti Maha Sudarshan Churna
Notes: 5/4/2006

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/04/2019

Desc: Bala Guti Maha Sudarshan Churna
Notes: 5/4/2006

Zee Laboratories
Date Published : 03/11/2015
47 Industrial Area , Paorida Sahib, INDIA
62 C - - 41 Minoxidil (Anti-Hypertensive)
Date Published: 03/11/2015

Desc: Bio Aqua Minoxytop Solution Hair Regrowth Treatment

american Style Products
Date Published : 09/30/2009
F-131/1 Mohammad Pur , Bhikaji Cama PL New Delhi, INDIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All products. 2/6/2004. The agency received information about an overseas internet site selling counterfeit contraceptive patches that contain no active ingrediants. The countefeit contraceptive patches were promoted as Ortho Evra transdermal patches, Othro Evra Transdermal patches, a Johnson and Johnson's Othro-McNeil Pharmaceutical, Inc product. This internet sites domain name is www.rxpharmacy.ws

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

onlinesolution4u.com
Date Published : 09/30/2009
Easystore4u , Ravi Jain, 10/12/ Modul Town , Ludhiana PU, 56632, INDIA
65 V - - 13 Clozapine (Sedative)
Date Published: 09/30/2009

Notes: 2/8/2007                           

shree baidyanath ayurved bhawan pvt ltd
Date Published : 06/26/2019
P-83, Benaras Road , Howrah-8 , Weat Bengal, INDIA
53 - - - -- Cosmetics
Date Published: 06/26/2019

Desc: Kapiva Herbals Mahanarayan Oil

53 - - - -- Cosmetics
Date Published: 06/26/2019

Desc: Kapiva Herbals Brahmi Amla Hair Oil

53 - - - -- Cosmetics
Date Published: 06/26/2019

Desc: Kapiva Herbals Mahamas Oil (Niramis)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/26/2019

Desc: Kapiva Herbals Mahanarayan Oil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/26/2019

Desc: Kapiva Herbals Mahamas Oil (Niramis)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/26/2019

Desc: Kapiva Herbals Brahmi Amla Hair Oil

southern drugs pharmaceuticals
Date Published : 06/07/2010
door no 19-584,NH-5 , dowlaishwaram , andhra pradesh, Andhra Pradesh INDIA
60 S - - 99 Antacid, N.E.C.
Date Published: 06/07/2010

Desc: Eno Fruit Salt
Notes: India

60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 06/07/2010

Desc: Eno Fruit Salt
Notes: India


INDONESIA


AMC LINE EXPRESS
Date Published : 07/09/2019
Jl Selang Cironggeng , Bekasi, Jabotabek INDONESIA
31 K - - 02 Tea, Green
Date Published: 07/09/2019

Desc: Green Tea Powder Material for Herbal (Kratom)
Notes:                                                                                                                                                                                                                                                                                                                                                                                   

31 K - - 99 Tea, N.E.C.
Date Published: 07/09/2019

Desc: Green Tea Powder Material for Herbal (Kratom)
Notes:                                                                                                                                                                                                                                                                                                                                                                                   

53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 07/09/2019

Desc: Green Tea Powder Material for Herbal (Kratom)
Notes:                                                                                                                                                                                                                                                                                                                                                                                   

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/09/2019

Desc: Green Tea Powder Material for Herbal (Kratom)
Notes:                                                                                                                                                                                                                                                                                                                                                                                   

54 J - - 12 Kratom (Herbal and Botanical Teas II, continued)
Date Published: 07/09/2019

Desc: Green Tea Powder Material for Herbal (Kratom)
Notes:                                                                                                                                                                                                                                                                                                                                                                                   

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 07/09/2019

Desc: Green Tea Powder Material for Herbal (Kratom)
Notes:                                                                                                                                                                                                                                                                                                                                                                                   

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/09/2019

Desc: Green Tea Powder Material for Herbal (Kratom)
Notes:                                                                                                                                                                                                                                                                                                                                                                                   

Adi Dharma Putra
Date Published : 02/28/2017
Jongkong Kabupaten Kapuas Hulu , Putussibau, Kalimantan Barat INDONESIA
54 J - - 12 Kratom (Herbal and Botanical Teas II, continued)
Date Published: 02/28/2017

Desc: Mitragyna Speciosa (Kratom)
Notes: Pursuant to sections 502(f)(1) and 801(a)(3) of the Act because the article appears to be a drug within the meaning of section 201(g) and it appears to lack adequate directions for use.;                                                    ;                                            

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 02/28/2017

Desc: Mitragyna Speciosa (Kratom)
Notes: Pursuant to sections 502(f)(1) and 801(a)(3) of the Act because the article appears to be a drug within the meaning of section 201(g) and it appears to lack adequate directions for use.;                                                    ;                                             ;

Amc Line Express
Date Published : 07/09/2019
Rt 001 , Jl Perum Griya Yasa Blok A 3 No 8 , Bekasi, Jabotabek INDONESIA
31 K - - 02 Tea, Green
Date Published: 07/09/2019

Desc: Green Tea Powder Material for Herbal (Kratom)
Notes:                                                                                                                                                                                                                                                                                                                                                                                   

31 K - - 99 Tea, N.E.C.
Date Published: 07/09/2019

Desc: Green Tea Powder Material for Herbal (Kratom)
Notes:                                                                                                                                                                                                                                                                                                                                                                                   

53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 07/09/2019

Desc: Green Tea Powder Material for Herbal (Kratom)
Notes:                                                                                                                                                                                                                                                                                                                                                                                   

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/09/2019

Desc: Green Tea Powder Material for Herbal (Kratom)
Notes:                                                                                                                                                                                                                                                                                                                                                                                   

54 J - - 12 Kratom (Herbal and Botanical Teas II, continued)
Date Published: 07/09/2019

Desc: Green Tea Powder Material for Herbal (Kratom)
Notes:                                                                                                                                                                                                                                                                                                                                                                                   

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 07/09/2019

Desc: Green Tea Powder Material for Herbal (Kratom)
Notes:                                                                                                                                                                                                                                                                                                                                                                                   

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/09/2019

Desc: Green Tea Powder Material for Herbal (Kratom)
Notes:                                                                                                                                                                                                                                                                                                                                                                                   

CV MELDA FAMILY
Date Published : 01/18/2022
Rt 001 Rw 022 , Jln. Husein Mamzah No 35; Gangmelda , Pontianak, Kalimantan Barat INDONESIA
53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 01/18/2022

Desc: Mitragyna Speciosa Powder

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 01/18/2022

Desc: Mitragyna Speciosa Powder

54 E - - 12 Ginseng (Herbal & Botanical Teas)
Date Published: 01/18/2022

Desc: Mitragyna Speciosa Powder

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 01/18/2022

Desc: Mitragyna Speciosa Powder

54 J - - 12 Kratom (Herbal and Botanical Teas II, continued)
Date Published: 01/18/2022

Desc: Mitragyna Speciosa Powder

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 01/18/2022

Desc: Mitragyna Speciosa Powder

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/18/2022

Desc: Mitragyna Speciosa Powder

CV TRITOP BORNEO KENCANA
Date Published : 02/12/2024
Jl Trans Kalimantan Km7 3 No 55-56 Sungai Ambawang Kuala , West Kalimantan, INDONESIA
54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 02/12/2024

Desc: Royal Borneo White Vein Kratom Capsules

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 02/12/2024

Desc: Royal Borneo Green Vein Kratom Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/12/2024

Desc: Royal Borneo White Vein Kratom Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/12/2024

Desc: Royal Borneo Green Vein Kratom Capsules

Eagle Indo Pharma, PT
Date Published : 05/18/2017
Km. 1.1 Alam Jaya , Jl Raya Prabu Siliwangi , Tangerang, Jabotabek INDONESIA
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/18/2017

Desc: Cap Lang Telon Oil (Telon Lang or Warisan Budaya Leluhur)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/18/2017

Desc: Cap Lang Telon Oil (Telon Lang or Warisan Budaya Leluhur)

Enggang Borneo
Date Published : 07/16/2015
JL DR WAHION , Sepakat 8 No. 23 , Pontianak, INDONESIA
53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 07/16/2015

Desc: Mitragyna Speciosa Tea

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 07/16/2015

Desc: Mitragyna Speciosa Tea

54 J - - 12 Kratom (Herbal and Botanical Teas II, continued)
Date Published: 01/26/2016

Desc: Mitragyna Speciosa Tea
Notes: Drug/disease claims associated with mfg. in the entry.

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 01/26/2016

Desc: Mitragyna Speciosa Tea
Notes: Drug/disease claims associated with mfg. in the entry.

66 B - - 99 Stimulant N.E.C.
Date Published: 07/16/2015

Desc: Mitragyna Speciosa Tea

Kelly International Cosmetics
Date Published : 09/30/2009
unknown , unknown, INDONESIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Desc: Kelly Face Cream (Pearl Cream)
Notes: Reason for Alert; The Kelly Pearl Creams are unapproved drugs based upon their skin claims. The immediate container label states for removing the freckles; pimples; blotches; sunburn; wrinkles. SHIPPER; Hamil Al Musk Factory Phase 4 Industrial City Jeddah; Saudia Arabia FEI# 3004127278 10/6/08

M. Ridho Rizki Maulufi Alk
Date Published : 10/16/2015
11 Jalan Tabrani Achmad Kimplex Gbk D , Pontianak, INDONESIA
53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 10/16/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with mfg. in the entry.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/16/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with mfg. in the entry.

54 J - - 12 Kratom (Herbal and Botanical Teas II, continued)
Date Published: 01/26/2016

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with mfg. in the entry.

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 01/26/2016

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with mfg. in the entry.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/16/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with mfg. in the entry.

M. Ridho Rizki Maulufi Alk
Date Published : 10/16/2015
11 Jalan Tabrani Achmad Kimplex Gbk D , Pontianak, INDONESIA
53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 10/16/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with mfg. in the entry.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/16/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with mfg. in the entry.

54 J - - 12 Kratom (Herbal and Botanical Teas II, continued)
Date Published: 01/26/2016

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with mfg. in the entry

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 01/26/2016

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with mfg. in the entry

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/16/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with mfg. in the entry.

P T Eagle Indo Pharmaceuticallaboratories
Date Published : 05/18/2017
Unknown Street , Jakarta, INDONESIA
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/18/2017

Desc: Cap Lang Telon Oil (Telon Lang or Warisan Budaya Leluhur)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/18/2017

Desc: Cap Lang Telon Oil (Telon Lang or Warisan Budaya Leluhur)

PT INTEGRATED HEALTHCARE
Date Published : 03/16/2020
K-Link Tower Lt 12 Zona , Jln. Jendral Gatot Subroto 59A , Jakarta, Jabotabek INDONESIA
66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 03/16/2020

Desc: Listerine Cool Mint Mouthwash
Notes: Labeling appears to contain statements which appear to make health claims that would render the product a "drug" within the meaning of the FD&C Act. It also appears to contain active ingredients commonly seen in over-the-counter drug products intended for oral healthcare, but the label fails to include a "Drug Facts" panel and lacks adequate directions for use.

PT. POS INDONESIA (PERSERO)
Date Published : 12/20/2016
Medan Branch , Jl. Pos No. 1 Medan , North Sumatera, MEDAN INDONESIA
53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 12/20/2016

Desc: Herbal Speciasa (Kratom)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/20/2016

Desc: Herbal Speciasa (Kratom)

54 J - - 12 Kratom (Herbal and Botanical Teas II, continued)
Date Published: 12/20/2016

Desc: Herbal Speciasa (Kratom)

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 12/20/2016

Desc: Herbal Speciasa (Kratom)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/20/2016

Desc: Herbal Speciasa (Kratom)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/20/2016

Desc: Herbal Speciasa (Kratom)

PT. Surya Donasin
Date Published : 07/21/2017
Km. 8 , Jalan Jendral Sudirman No 128 , Cirebon, Jawa Barat INDONESIA
53 L - - -- Skin Care Prep
Date Published: 07/21/2017

Desc: Cap Lang Cajuput Oil
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; Help to relieve stomachache; flatulence; nausea; and itches by insect / mosquito bites

60 L - - 99 Analgesic, N.E.C.
Date Published: 07/21/2017

Desc: Cap Lang Cajuput Oil
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; Help to relieve stomachache; flatulence; nausea; and itches by insect / mosquito bites

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/21/2017

Desc: Cap Lang Cajuput Oil
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; Help to relieve stomachache; flatulence; nausea; and itches by insect / mosquito bites

PT. Tempo Scan Pacific
Date Published : 09/29/2014
Unknown , Jakarta, INDONESIA
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/29/2014

Desc: Tempovate Cream (Clobetasol Proprioate)

64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 09/29/2014

Desc: Tempovate Cream (Clobetasol Proprioate)

PT. Yasulor Indonesia
Date Published : 07/28/2014
Jl.Jababeka IV Blok V No. 10-33 & 44-63 , Kawasan Industri Jababeka , Cikarang, Bekasi INDONESIA
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/28/2014

Desc: L?Oreal White Perfect Fairness Control Moisturizing Day Cream SPF17

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 07/28/2014

Desc: L?Oreal White Perfect Fairness Control Moisturizing Day Cream SPF17

Rama Yogaswara
Date Published : 06/11/2012
37 Jln Embong , Bandung, Jawa Barat INDONESIA
66 B - - 99 Stimulant N.E.C.
Date Published: 06/11/2012

Desc: Kratom Leaf (Mitragyna Speciosa)
Notes: Indonesia

Rudi Hartona
Date Published : 10/07/2015
Jln. Tanjung Harapan , Pontianak, Kalimantan Barat INDONESIA
53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 10/07/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with mfg. in the entry.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/07/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with mfg. in the entry.

54 J - - 12 Kratom (Herbal and Botanical Teas II, continued)
Date Published: 01/26/2016

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with mfg in the entry.

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 01/26/2016

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with mfg in the entry.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/07/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with mfg. in the entry.

adi dharma putra
Date Published : 02/28/2017
Komplek Ari Karya Ndah 1 , Pontianak, None of the above INDONESIA
54 J - - 12 Kratom (Herbal and Botanical Teas II, continued)
Date Published: 02/28/2017

Desc: Mitragyna Speciosa (Kratom)
Notes: Pursuant to sections 502(f)(1) and 801(a)(3) of the Act because the article appears to be a drug within the meaning of section 201(g) and it appears to lack adequate directions for use.;                                                    ;                                            

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 02/28/2017

Desc: Mitragyna Speciosa (Kratom)
Notes: Pursuant to sections 502(f)(1) and 801(a)(3) of the Act because the article appears to be a drug within the meaning of section 201(g) and it appears to lack adequate directions for use.;                                                    ;                                             ;


IRELAND


Europharma Concepts Limited
Date Published : 03/09/2018
Kilbeggan Road , Clara, Offaly IRELAND
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/09/2018

Desc: Nuby All Natural Teething Gel with Gum-eez Teether

53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 03/09/2018

Desc: Nuby All Natural Teething Gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/09/2018

Desc: Nuby All Natural Teething Gel with Gum-eez Teether

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/09/2018

Desc: Nuby All Natural Teething Gel

76 K - - KO Ring, Teething, Fluid-Filled
Date Published: 03/09/2018

Desc: Nuby All Natural Teething Gel with Gum-eez Teether

Genesis II Church of Health and Healing
Date Published : 08/11/2014
Unknown , Unknown, IRELAND
53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations)
Date Published: 08/19/2014

Desc: MMS Bath Tablets
Notes: MMS Bath Tablets appear to be an unapproved new drug as product label states; A World Without Disease and product label references a website (http;//jimhumble.com) which lists structure/function claims to include; Bathing in MMS water enables cleansing of pathogens that are on the skin?s surface or just under it.

54 B - - 99 Mineral N.E.C.
Date Published: 08/11/2014

Desc: MMS
Notes: MMS & MMS2 appear to be unapproved new drugs as product labels reference a website (http;//jimhumble.com) that lists multiple structure/function claims to include; Two clients who had tested positive for HIV; reported testing negative after taking the solution. In addition; both products are misbranded because they lack adequate directions for use.

54 B - - 99 Mineral N.E.C.
Date Published: 08/11/2014

Desc: MMS2
Notes: MMS & MMS2 appear to be unapproved new drugs as product labels reference a website (http;//jimhumble.com) that lists multiple structure/function claims to include; Two clients who had tested positive for HIV; reported testing negative after taking the solution. In addition; both products are misbranded because they lack adequate directions for use.

60 L - - 99 Analgesic, N.E.C.
Date Published: 08/19/2014

Desc: Magnesium Oil Spray
Notes: Magnesium Oil Spray appears to be an unapproved new drug as structure/function claims listed on product label include; Muscle Pain Relief; Muscle Cramps ? Sore joints Stiff Muscles also helps relieve Arthritic pains.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/19/2014

Desc: MMS Bath Tablets
Notes: MMS Bath Tablets appear to be an unapproved new drug as product label states; A World Without Disease and product label references a website (http;//jimhumble.com) which lists structure/function claims to include; Bathing in MMS water enables cleansing of pathogens that are on the skin?s surface or just under it.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/11/2014

Desc: MMS2
Notes: MMS & MMS2 appear to be unapproved new drugs as product labels reference a website (http;//jimhumble.com) that lists multiple structure/function claims to include; Two clients who had tested positive for HIV; reported testing negative after taking the solution. In addition; both products are misbranded because they lack adequate directions for use.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/11/2014

Desc: MMS
Notes: MMS & MMS2 appear to be unapproved new drugs as product labels reference a website (http;//jimhumble.com) that lists multiple structure/function claims to include; Two clients who had tested positive for HIV; reported testing negative after taking the solution. In addition; both products are misbranded because they lack adequate directions for use.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/19/2014

Desc: Magnesium Oil Spray
Notes: Magnesium Oil Spray appears to be an unapproved new drug as structure/function claims listed on product label include; Muscle Pain Relief; Muscle Cramps - Sore joints Stiff Muscles also helps relieve Arthritic pains.

STIEFEL MANUFACTURING (IRELAND)LTD
Date Published : 04/01/2019
Finiskiln Industrial Estate , Sligo , Co Sligo, Co Sligo IRELAND
62 W - - 17 Aluminum Chloride Astringent/Anti-Perspirant)
Date Published: 04/01/2019

Desc: Drichlor Antiperspirant

62 W - - 99 Astringent/Anti-Perspirant N.E.C.
Date Published: 04/01/2019

Desc: Drichlor Antiperspirant

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/01/2019

Desc: Drichlor Antiperspirant

Stiefel Laboratories, Ltd.
Date Published : 04/01/2019
Finisklin Industrial Estate , Sligo, IRELAND
62 W - - 17 Aluminum Chloride Astringent/Anti-Perspirant)
Date Published: 04/01/2019

Desc: Drichlor Antiperspirant

62 W - - 99 Astringent/Anti-Perspirant N.E.C.
Date Published: 04/01/2019

Desc: Drichlor Antiperspirant

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/01/2019

Desc: Drichlor Antiperspirant


ISRAEL


CHIC COSMETIC IND. LTD.
Date Published : 12/26/2018
2, Ha-Prat , Yavne, IL-M ISRAEL
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/26/2018

Desc: Charcoal Purifying Face Wash

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/26/2018

Desc: Charcoal Exfoliating Cleansing Gel

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 12/26/2018

Desc: Charcoal Exfoliating Cleansing Gel

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 12/26/2018

Desc: Charcoal Purifying Face Wash

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/26/2018

Desc: Charcoal Exfoliating Cleansing Gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/26/2018

Desc: Charcoal Purifying Face Wash

Cts Novis
Date Published : 01/08/2019
10 Peker Street , Kiryat Malachi, ISRAEL
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 01/08/2019

Desc: Brightol Total Care Ice Mint Mouthwash

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 01/08/2019

Desc: Brightol Total Care Fresh Mint Mouthwash

63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic)
Date Published: 01/08/2019

Desc: Brightol Total Care Ice Mint Mouthwash

63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic)
Date Published: 01/08/2019

Desc: Brightol Total Care Fresh Mint Mouthwash

63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic)
Date Published: 01/08/2019

Desc: Brightol Total Care Ice Mint Mouthwash

63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic)
Date Published: 01/08/2019

Desc: Brightol Total Care Fresh Mint Mouthwash

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/08/2019

Desc: Brightol Total Care Ice Mint Mouthwash

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/08/2019

Desc: Brightol Total Care Fresh Mint Mouthwash

Dead Sea Cosmetics Inc
Date Published : 05/07/2014
33, Betsal'el , Arad, ISRAEL
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 05/07/2014

Desc: Collagen Boost Eye Serum Treatment (Sachet)

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/07/2014

Desc: Collagen Boost Eye Serum Treatment (Sachet)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/07/2014

Desc: Collagen Boost Eye Serum Treatment (Sachet)

Dead Sea Premier Cosmetics Lab
Date Published : 05/29/2013
21 Hashaked St , Shoham Industry Park , HaMerkaz, ISRAEL
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 08/27/2013

Desc: Moisture Complex
Notes: Israel

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 02/22/2017

Desc: ERA ORGANICS POWERFUL DEEP WRINKLE FILLER
Notes: Product does not meet OTC monograph for skin bleaching products Medical claims made on product label and website

53 L - - 07 Night (Skin Care Preparations)
Date Published: 05/29/2013

Desc: Premier Night Cream Complex

65 Q - - 02 Botox
Date Published: 02/22/2017

Desc: ERA ORGANICS POWERFUL DEEP WRINKLE FILLER
Notes: Product does not meet OTC monograph for skin bleaching products Medical claims made on product label and website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/22/2017

Desc: ERA ORGANICS POWERFUL DEEP WRINKLE FILLER
Notes: Product does not meet OTC monograph for skin bleaching products Medical claims made on product label and website

E.M.B YARDEN AGRICULTURAL FARM LTD
Date Published : 11/28/2011
1, Ha-Oman , Beit Shemesh, Hamerkaz ISRAEL
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/01/2011

Desc: Heimlich Natural Clear Cream for Dry & Delicate Skin
Notes: Israel

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/28/2011

Desc: Heimlich Natural Clear Cream for Dry & Delicate Skin
Notes: Israel

64 L - - 99 Glucocorticoid N.E.C.
Date Published: 12/01/2011

Desc: Heimlich Natural Clear Cream for Dry & Delicate Skin
Notes: Israel

Frigor And Chemicals Ltd
Date Published : 09/30/2009
Po Box 12053 Industrial Area , Hefer, ISRAEL
61 H - - 99 Anti-Bacterial, N.E.C.
Date Published: 09/30/2009

Notes: 5/16/2006 Salusil and Tetrasil

HEKMA CENTER
Date Published : 02/03/2023
Almaskah Street , Ar'Ara, ISRAEL
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: Zinc (Zinc Picolinate) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: NOR (Olive Leaves) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: Mera (Sage) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: M. Reishi (Reishi Ganoderma Mushroom Extract) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: M. Trame (Turkey Tail Mushroom) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: TKR (Curcumin) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: S.G.1 (Siberian Ginseng) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: Magic.1 (Moringa Oleifera) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: AK (Propolis) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: M. Shiita (Shiitake Mushroom Extract) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: E-Ech (Echinacea Extract) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: Astro (Astragalus Membranaceus) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: Cam1 (Milk Thistle) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: Spiru (Spirulina) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: MSM (Methyl Sulfonyl Methane) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: Magic.1 (Moringa Oleifera) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: Cam1 (Milk Thistle) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: TKR (Curcumin) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: Astro (Astragalus Membranaceus) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: NOR (Olive Leaves) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: Spiru (Spirulina) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: S.G.1 (Siberian Ginseng) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: M. Trame (Turkey Tail Mushroom) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: E-Ech (Echinacea Extract) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: M. Shiita (Shiitake Mushroom Extract) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: AK (Propolis) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: Zinc (Zinc Picolinate) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: MSM (Methyl Sulfonyl Methane) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: Mera (Sage) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: M. Reishi (Reishi Ganoderma Mushroom Extract) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

Hekma Center
Date Published : 02/03/2023
Ara , 1, El-Masqa St. , Ar'Ara, Ha Zafon ISRAEL
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: Spiru (Spirulina) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: Magic.1 (Moringa Oleifera) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: TKR (Curcumin) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: Mera (Sage) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: Astro (Astragalus Membranaceus) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: M. Reishi (Reishi Ganoderma Mushroom Extract) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: M. Shiita (Shiitake Mushroom Extract) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: E-Ech (Echinacea Extract) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: Zinc (Zinc Picolinate) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: S.G.1 (Siberian Ginseng) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: M. Trame (Turkey Tail Mushroom) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: AK (Propolis) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: Cam1 (Milk Thistle) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: NOR (Olive Leaves) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/03/2023

Desc: MSM (Methyl Sulfonyl Methane) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: TKR (Curcumin) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: M. Shiita (Shiitake Mushroom Extract) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: E-Ech (Echinacea Extract) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: Magic.1 (Moringa Oleifera) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: NOR (Olive Leaves) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: Zinc (Zinc Picolinate) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: M. Reishi (Reishi Ganoderma Mushroom Extract) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: M. Trame (Turkey Tail Mushroom) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: Astro (Astragalus Membranaceus) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: Cam1 (Milk Thistle) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: S.G.1 (Siberian Ginseng) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: MSM (Methyl Sulfonyl Methane) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: AK (Propolis) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: Spiru (Spirulina) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2023

Desc: Mera (Sage) Capsules
Notes: When marketed as part of the HSV Formula, either through website listed on product label or pamphlet contained with product at time of shipment, DWPE under this alert is applicable. HSV Formula includes the following individual products: MSM (Methyl Sulfonyl Methane), AK (Propolis), E-Ech (echinacea Extract), Astro (Astragalus membranaceus), Cam1 (Milk Thistle), Magic.1 (Moringa Oleifera), Spiru (Spirulina), M. Trame (Turkey Tail Mushroom), M. Shiita (Shiitake Mushroom Extract), M. Reishi (Reishi Ganoderma Mushroom Exract), TKR (Curcumin), Mera (Sage), NOR (Olive Leaves), Zinc (Zinc Picolinate), and S.G.1 (Siberian Ginseng).

Israel Pharmacy Ltd
Date Published : 04/18/2016
Unknown , Petah Tikva, ISRAEL
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/18/2016

Desc: Naltrexone 4.5mg Capsules

60 M - - 28 Naltrexone Hydrochloride (Analgesic, Narcotic)
Date Published: 04/18/2016

Desc: Naltrexone 4.5mg Capsules

60 T - - 15 Naltrexone (Antagonist)
Date Published: 04/18/2016

Desc: Naltrexone 4.5mg Capsules

Israel Post Co
Date Published : 08/04/2017
217, Jaffa Ro , Jerusalem, ISRAEL
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 08/04/2017

Desc: Royal Sea Arthritis Cream

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 08/04/2017

Desc: Royal Sea Arthritis Cream

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 08/04/2017

Desc: Royal Sea Arthritis Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/04/2017

Desc: Royal Sea Arthritis Cream

KATOM QP LTD
Date Published : 11/15/2021
36, Giv'On , Ganei Tikva, ISRAEL
60 C - - 48 Oxymetazoline HCl (Adrenergic)
Date Published: 11/15/2021

Desc: Enovid Nasal Spray
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘… Nasal Spray TO PROTECT AGAINST VIRUSES . . . Scientifically tested and proven to kill 99.9% of viruses within 2 minutes …’.

61 X - - 99 Anti-Histaminic N.E.C.
Date Published: 11/15/2021

Desc: Enovid Nasal Spray
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘… Nasal Spray TO PROTECT AGAINST VIRUSES . . . Scientifically tested and proven to kill 99.9% of viruses within 2 minutes …’.

64 J - - 02 Nitric Oxide (Medicinal Gas)
Date Published: 11/15/2021

Desc: Enovid Nasal Spray
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘… Nasal Spray TO PROTECT AGAINST VIRUSES . . . Scientifically tested and proven to kill 99.9% of viruses within 2 minutes …’.

65 R - - 19 Sodium Chloride (Replenisher)
Date Published: 11/15/2021

Desc: Enovid Nasal Spray
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘… Nasal Spray TO PROTECT AGAINST VIRUSES . . . Scientifically tested and proven to kill 99.9% of viruses within 2 minutes …’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/15/2021

Desc: Enovid Nasal Spray
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘… Nasal Spray TO PROTECT AGAINST VIRUSES . . . Scientifically tested and proven to kill 99.9% of viruses within 2 minutes …’.

Nezah Israel Pharmacy
Date Published : 04/18/2016
11 Nezah Israel St , Tel Aviv, ISRAEL
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/18/2016

Desc: Naltrexone 4.5mg Capsules

60 M - - 28 Naltrexone Hydrochloride (Analgesic, Narcotic)
Date Published: 04/18/2016

Desc: Naltrexone 4.5mg Capsules

60 T - - 15 Naltrexone (Antagonist)
Date Published: 04/18/2016

Desc: Naltrexone 4.5mg Capsules

Royal Sea
Date Published : 08/04/2017
Kehilat Lodge 18 , Tel Aviv, ISRAEL
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 08/04/2017

Desc: Royal Sea Arthritis Cream

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 08/04/2017

Desc: Royal Sea Arthritis Cream

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 08/04/2017

Desc: Royal Sea Arthritis Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/04/2017

Desc: Royal Sea Arthritis Cream

Sasa Cosmetics ACS Ltd
Date Published : 01/16/2020
Industrial Zone Benei Yehuda , Moshavyo Av , Giv'At Oz, Golan Heights ISRAEL
66 P - - 05 Homosalate (Ultraviolet Screen/Sunscreen)
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Lotion Broad Spectrum SPF 50

66 P - - 05 Homosalate (Ultraviolet Screen/Sunscreen)
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Spray Broad Spectrum SPF 40

66 P - - 05 Homosalate (Ultraviolet Screen/Sunscreen)
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Lotion for Kids Broad Spectrum SPF 50

66 P - - 11 Avobenzone (Ultraviolet Screen/Sunscreen)
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Lotion Broad Spectrum SPF 50

66 P - - 11 Avobenzone (Ultraviolet Screen/Sunscreen)
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Spray Broad Spectrum SPF 40

66 P - - 11 Avobenzone (Ultraviolet Screen/Sunscreen)
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Lotion for Kids Broad Spectrum SPF 50

66 P - - 14 Octinoxate (Ultraviolet Screen/Sunscreen)
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Spray Broad Spectrum SPF 40

66 P - - 14 Octinoxate (Ultraviolet Screen/Sunscreen)
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Lotion Broad Spectrum SPF 50

66 P - - 14 Octinoxate (Ultraviolet Screen/Sunscreen)
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Lotion for Kids Broad Spectrum SPF 50

66 P - - 15 Octisalate (Ultraviolet Screen/Sunscreen)
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Spray Broad Spectrum SPF 40

66 P - - 15 Octisalate (Ultraviolet Screen/Sunscreen)
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Lotion for Kids Broad Spectrum SPF 50

66 P - - 15 Octisalate (Ultraviolet Screen/Sunscreen)
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Lotion Broad Spectrum SPF 50

66 P - - 16 Octocrylene (Ultraviolet Screen/Sunscreen)
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Lotion Broad Spectrum SPF 50

66 P - - 16 Octocrylene (Ultraviolet Screen/Sunscreen)
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Spray Broad Spectrum SPF 40

66 P - - 16 Octocrylene (Ultraviolet Screen/Sunscreen)
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Lotion for Kids Broad Spectrum SPF 50

66 P - - 18 Zinc Oxide (Ultraviolet Screen/Sunscreen)
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Spray Broad Spectrum SPF 40

66 P - - 18 Zinc Oxide (Ultraviolet Screen/Sunscreen)
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Lotion for Kids Broad Spectrum SPF 50

66 P - - 18 Zinc Oxide (Ultraviolet Screen/Sunscreen)
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Lotion Broad Spectrum SPF 50

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Spray Broad Spectrum SPF 40

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Lotion for Kids Broad Spectrum SPF 50

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Lotion Broad Spectrum SPF 50

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Lotion Broad Spectrum SPF 50

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Spray Broad Spectrum SPF 40

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/16/2020

Desc: SAFE SEA Sunscreen & Jellyfish Sting Protective Lotion for Kids Broad Spectrum SPF 50

Shavit Import & Export
Date Published : 12/01/2011
64 Pinchas Rosen St , Tel Aviv, ISRAEL
61 H B L 05 Zinc Pyrithione (Anti-Bacterial), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 12/01/2011

Desc: Sea Buckthorn Anti Dandruff Shampoo Dandruff Treatment Shampoo
Notes: Israel

61 H B L 05 Zinc Pyrithione (Anti-Bacterial), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 12/01/2011

Desc: Tea Tree Anti Dandruff Shampoo

63 R B Y 05 Sodium Monofluorophosphate (Dental Caries Prophylactic), Human - Non/Rx Combination Ingredient, NEC
Date Published: 12/01/2011

Desc: Sea Buckthor Toothpaste S.L.S. Free Toothpaste
Notes: Israel

Shavit Natural Quality Product
Date Published : 12/01/2011
Pinchas Rozen 64 , Tel Aviv, ISRAEL
61 H B L 05 Zinc Pyrithione (Anti-Bacterial), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 12/01/2011

Desc: Tea Tree Anti Dandruff Shampoo
Notes: Israel

61 H B L 05 Zinc Pyrithione (Anti-Bacterial), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 12/01/2011

Desc: Sea Buckthorn Anti Dandruff Shampoo Dandruff Treatment Shampoo
Notes: Israel

63 R B Y 05 Sodium Monofluorophosphate (Dental Caries Prophylactic), Human - Non/Rx Combination Ingredient, NEC
Date Published: 12/01/2011

Desc: Sea Buckthor Toothpaste S.L.S. Free Toothpaste
Notes: Israel

Tradis Gat Ltd.
Date Published : 09/01/2022
32 Hashacham St. , Petach Tikvah, ISRAEL
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/01/2022

Desc: Enovid Nasal Spray

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/01/2022

Notes: Enovid Nasal Spray

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 09/01/2022

Notes: Enovid Nasal Spray

60 - - - -- Human and Animal Drugs
Date Published: 09/01/2022

Notes: Enovid Nasal Spray

61 - - - -- Human and Animal Drugs
Date Published: 09/01/2022

Notes: Enovid Nasal Spray

62 - - - -- Human and Animal Drugs
Date Published: 09/01/2022

Notes: Enovid Nasal Spray

63 - - - -- Human and Animal Drugs
Date Published: 09/01/2022

Notes: Enovid Nasal Spray

64 - - - -- Human and Animal Drugs
Date Published: 09/01/2022

Notes: Enovid Nasal Spray

65 - - - -- Human and Animal Drugs
Date Published: 09/01/2022

Notes: Enovid Nasal Spray

66 - - - -- Human and Animal Drugs
Date Published: 09/01/2022

Notes: Enovid Nasal Spray

77 - - - -- Ear,Nose And Throat
Date Published: 09/01/2022

Desc: Enovid Nasal Spray

80 Q - - IY Nasal spray, systemic delivery, CDER or CBER led
Date Published: 09/01/2022

Desc: Enovid Nasal Spray


ITALY


Alcina Cosmetic Belus BVBA/SPRL Spaoi s r l
Date Published : 09/30/2009
unknown , Genoa, ITALY
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Beltapharm SPA
Date Published : 05/03/2018
Via Stelvio 66 , Cusano Milanino, Milan ITALY
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/03/2018

Desc: Beneks Fashion Fair Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/03/2018

Desc: Beneks Fashion Fair Cream

Cosmec Spa
Date Published : 04/30/2014
Via della Posta 9 , Milan, Milan ITALY
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 04/30/2014

Desc: Hergen Hair Loss Shampoo

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 04/30/2014

Desc: Hergen Hair Loss Lotion

Dermedical Skin Sciences
Date Published : 01/23/2017
Via K Marx,18 Noverasco di Opera , MI, ITALY
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 01/23/2017

Desc: Glutax 5GS Micro Advance (ANTICELLULITE ANTI AGING POWDER KIT)
Notes: Medical claims made on product label

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/23/2017

Desc: Glutax 5GS Micro Advance (ANTICELLULITE ANTI AGING POWDER KIT)
Notes: Medical claims made on product label

Esapharma SpA
Date Published : 08/01/2011
Via Alcide De Gasperi 13 , Melzo, Milan ITALY
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/25/2021

Desc: Esapharma Lemonvate Cream
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “it helps to reduce swelling and irritation. Esapharma [Movate/Lemonvate] is used to help reduce redness and itchiness of certain skin problems. These skin problems include: ***psoriasis***frequently relapsing eczema***lichen planus***discord lupus***."                                                     

64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 08/01/2011

Desc: Movate Cream Plus
Notes: Italy

64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 10/25/2021

Desc: Esapharma Lemonvate Cream
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “it helps to reduce swelling and irritation. Esapharma [Movate/Lemonvate] is used to help reduce redness and itchiness of certain skin problems. These skin problems include: ***psoriasis***frequently relapsing eczema***lichen planus***discord lupus***."                                                     

65 L - - 11 Titanium Dioxide (Protectant)
Date Published: 10/25/2021

Desc: Esapharma Lemonvate Cream
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “it helps to reduce swelling and irritation. Esapharma [Movate/Lemonvate] is used to help reduce redness and itchiness of certain skin problems. These skin problems include: ***psoriasis***frequently relapsing eczema***lichen planus***discord lupus***."                                                     

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/25/2021

Desc: Esapharma Lemonvate Cream
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “it helps to reduce swelling and irritation. Esapharma [Movate/Lemonvate] is used to help reduce redness and itchiness of certain skin problems. These skin problems include: ***psoriasis***frequently relapsing eczema***lichen planus***discord lupus***."                                                     

I-BEAUTY SRL
Date Published : 12/05/2017
Via Quattro Novembre 11 , Alzano Lombardo, Bergamo ITALY
53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 12/05/2017

Desc: Spot Corrector & Whitening Mask
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: "[R]educe and progressively eliminate cutaneous spots of melanin origin located at the epidermal level", "Ascorbil Glucoside [an ingredient in the product]: …stimulates skin immune system, suppress melanin production", and "Acetyl Glycyl Beta-Alanine [an ingredient in the product]: advanced whitening peptide able to regenerate damaged skin tissues."

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 12/05/2017

Desc: Spot Corrector & Whitening Cream (Jar)
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: "Kojic Acid [an ingredient in the product]: whitening… skin lightening agent", "Phytic Acid [an ingredient in the product]: whitening…", "Arbutin [an ingredient in the product]: strong inhibitor of melanin (skin pigment) production", "Focus on: Spot on, whitening, lightening", and "Skin concern: hyperpigmentation."

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 12/05/2017

Desc: Spot Out & Whitening Kit
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: "[R]educe and progressively eliminate cutaneous spots localized at the epidermal level and common hyperpigmentation problems", "Focus on: Spot on, whitening, lightening", and "Skin concern: hyperpigmentation…"

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 12/05/2017

Desc: Spot Corrector & Whitening Cream (Sachet)
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: "Kojic Acid [an ingredient in the product]: whitening… skin lightening agent", "Phytic Acid [an ingredient in the product]: whitening…", "Arbutin [an ingredient in the product]: strong inhibitor of melanin (skin pigment) production", "Focus on: Spot on, whitening, lightening", and "Skin concern: hyperpigmentation."

Indaco S.p.A.
Date Published : 07/27/2021
S.S. 87 Zona Ind. Pascarola , Caivano, Naples ITALY
33 U - - 02 Chewing Gum (without Chocolate)
Date Published: 07/27/2021

Desc: Sugar Free Peppermint Gum with Organic Gynnema
Notes: Claims found on product website.

33 U - - 99 Chewing Gum, N.E.C. (without Chocolate)
Date Published: 07/27/2021

Desc: Sugar Free Peppermint Gum with Organic Gynnema
Notes: Claims found on product website.

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 07/27/2021

Desc: Sugar Free Peppermint Gum with Organic Gynnema
Notes: Claims found on product website.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/27/2021

Desc: Sugar Free Peppermint Gum with Organic Gynnema
Notes: Claims found on product website.

Ischia Thermae Srl
Date Published : 08/01/2011
Via Monsignor Schioppa 17 , Foriana, ITALY
53 - - - -- Cosmetics
Date Published: 08/01/2011

Notes: Thermal Anti-Aging Complex Eyes Cream; Active Vita System Thermal Vitamin Anti-Age Cream SPF; For Men After Shave Ultra-Protection Thermal SPF-15; For Men All Day Face Care SFF 8; Thermal Sebum Balancing Emulsion; Country; Italy

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/01/2011

Notes: Thermal Anti-Aging Complex Eyes Cream; Active Vita System Thermal Vitamin Anti- Age Cream SPF; For Men After Shave Ultra-Protection Thermal SPF-15; For Men All Day Face Care SFF 8; Thermal Sebum Balancing Emulsion; Country; Italy

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 08/01/2011

Notes: Thermal Anti-Aging Complex Eyes Cream; Active Vita System Thermal Vitamin Anti- Age Cream SPF; For Men After Shave Ultra-Protection Thermal SPF-15; For Men All Day Face Care SFF 8; Thermal Sebum Balancing Emulsion; Country; Italy

61 - - - -- Human and Animal Drugs
Date Published: 08/01/2011

Notes: Thermal Anti-Aging Complex Eyes Cream; Active Vita System Thermal Vitamin Anti- Age Cream SPF; For Men After Shave Ultra-Protection Thermal SPF-15; For Men All Day Face Care SFF 8; Thermal Sebum Balancing Emulsion; Country; Italy

62 - - - -- Human and Animal Drugs
Date Published: 08/01/2011

Notes: Thermal Anti-Aging Complex Eyes Cream; Active Vita System Thermal Vitamin Anti- Age Cream SPF; For Men After Shave Ultra-Protection Thermal SPF-15; For Men All Day Face Care SFF 8; Thermal Sebum Balancing Emulsion; Country; Italy

63 - - - -- Human and Animal Drugs
Date Published: 08/01/2011

Notes: Thermal Anti-Aging Complex Eyes Cream; Active Vita System Thermal Vitamin Anti- Age Cream SPF; For Men After Shave Ultra-Protection Thermal SPF-15; For Men All Day Face Care SFF 8; Thermal Sebum Balancing Emulsion; Country; Italy

64 - - - -- Human and Animal Drugs
Date Published: 08/01/2011

Notes: Thermal Anti-Aging Complex Eyes Cream; Active Vita System Thermal Vitamin Anti- Age Cream SPF; For Men After Shave Ultra-Protection Thermal SPF-15; For Men All Day Face Care SFF 8; Thermal Sebum Balancing Emulsion; Country; Italy

65 - - - -- Human and Animal Drugs
Date Published: 08/01/2011

Notes: Thermal Anti-Aging Complex Eyes Cream; Active Vita System Thermal Vitamin Anti- Age Cream SPF; For Men After Shave Ultra-Protection Thermal SPF-15; For Men All Day Face Care SFF 8; Thermal Sebum Balancing Emulsion; Country; Italy

66 - - - -- Human and Animal Drugs
Date Published: 08/01/2011

Notes: Thermal Anti-Aging Complex Eyes Cream; Active Vita System Thermal Vitamin Anti- Age Cream SPF; For Men After Shave Ultra-Protection Thermal SPF-15; For Men All Day Face Care SFF 8; Thermal Sebum Balancing Emulsion; Country; Italy

Italiani Selex
Date Published : 09/30/2009
20063 Cassina De Pecchi , Milano, ITALY
53 L C - 99 Other Skin Care Preparations, N.E.C., Cream
Date Published: 09/30/2009

Notes: 4/23/2003 "Busto-Lift" capsules and cream for growth enlargement of the female bust.

66 V A - 99 Miscellaneous Patent Medicines, Etc., Human - Non/Rx Single Ingredient
Date Published: 09/13/2019

Desc: "Busto-Lift" capsules and cream for growth enlargement of the female bust.
Notes: 4/24/2003

66 V B - 99 Miscellaneous Patent Medicines, Etc., Human - Non/Rx Combination Ingredient
Date Published: 09/13/2019

Desc: "Busto-Lift" capsules and cream for growth enlargement of the female bust.
Notes: 4/24/2003

Kan Productions Sarl
Date Published : 05/27/2016
Via Ventitre Marzo 1848 9 , Melegnano, Milan ITALY
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/26/2017

Desc: Fiftys Acne & Blackheads Facial Lotion

64 X - - 06 Salicylic Acid (Keratolytic)
Date Published: 05/26/2017

Desc: Fiftys Acne & Blackheads Facial Lotion

Lachifarma S.r.l.
Date Published : 02/04/2015
Zona Ind.le , Zollino (LE), ITALY
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 02/04/2015

Desc: Neo-Vate White Cream Plus; Clobetasol 0.05%

53 M - - 01 Suntan Gels, Creams, Liquids (not Sunscreen) (Suntan Preparations)
Date Published: 02/04/2015

Desc: Neo-Vate White Cream Plus; Clobetasol 0.05%

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 02/04/2015

Desc: Neo-Vate White Cream Plus; Clobetasol 0.05%

64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 02/04/2015

Desc: Neo-Vate White Cream Plus; Clobetasol 0.05%

64 L - - 99 Glucocorticoid N.E.C.
Date Published: 02/04/2015

Desc: Neo-Vate White Cream Plus; Clobetasol 0.05%

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/04/2015

Desc: Neo-Vate White Cream Plus; Clobetasol 0.05%

M Movate Industries, Inc
Date Published : 09/30/2009
Unknown , Milan, ITALY
53 L C - -- Skin Care Prep, Cream
Date Published: 09/30/2009

Notes: 10/15/1999

64 L - - 99 Glucocorticoid N.E.C.
Date Published: 09/30/2009

Notes: 10/15/1999 Movate Cream-M

MCA Medical And Chemical Agency S.R.L.
Date Published : 09/30/2009
Via Parini, 13 , San Vittore Olona, MI ITALY
53 L C - -- Skin Care Prep, Cream
Date Published: 09/30/2009

Notes: Prosone Gel MCA and Top-Gel Plus MCA

64 L - - 06 Betamethasone Dipropionate (Glucocorticoid)
Date Published: 09/30/2009

Notes: Prosone Gel MCA 10/15/1999

64 L - - 28 Fluocinonide (Glucocorticoid)
Date Published: 09/30/2009

Notes: Top Gel Plus MCA 10/15/1999

64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 08/05/2011

Desc: Tenovate Cream Plus
Notes: Italy; OASIS Declared Manufacturer

Medical and Chemical Agency S.p.A.
Date Published : 08/05/2011
Viale Teodorico 19/2 , Milano, MI ITALY
64 L - - 28 Fluocinonide (Glucocorticoid)
Date Published: 08/10/2011

Desc: Top-Gel MCA
Notes: Label declared manufacturer

64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 08/05/2011

Desc: Tenovate Cream Plus
Notes: Italy; Label Declared Manufacturer

Muster & Dikson Service -Spa-
Date Published : 01/10/2018
V Kennedy , Cerro Maggiore, ITALY
53 E - - 02 Hair Sprays (Aerosol Fixatives) (Hair Preparations, Non-coloring)
Date Published: 01/10/2018

Desc: Keiras Strengthening Energising Treatment For Hair
Notes: The product appears to be an unapproved new drug as the product includes claims such as: (product label): '… Combats hair loss …'; '… A intensive strengthening … treatment … which acts on the factors which control each hair life cycle …'; '… [E]ncourages the cell metabolism, stimulating growth …'; (website – www.muster-dikson.com): '… ANTI-HAIR LOSS …'; '… Helps prevent hair loss …'.

53 E - - 05 Rinses (Hair Preparations, Non-coloring)
Date Published: 01/10/2018

Desc: Keiras Strengthening Energising Treatment For Hair
Notes: The product appears to be an unapproved new drug as the product includes claims such as: (product label): '… Combats hair loss …'; '… A intensive strengthening … treatment … which acts on the factors which control each hair life cycle …'; '… [E]ncourages the cell metabolism, stimulating growth …'; (website – www.muster-dikson.com): '… ANTI-HAIR LOSS …'; '… Helps prevent hair loss …'.

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 01/10/2018

Desc: Keiras Strengthening Energising Treatment For Hair
Notes: The product appears to be an unapproved new drug as the product includes claims such as: (product label): '… Combats hair loss …'; '… A intensive strengthening … treatment … which acts on the factors which control each hair life cycle …'; '… [E]ncourages the cell metabolism, stimulating growth …'; (website – www.muster-dikson.com): '… ANTI-HAIR LOSS …'; '… Helps prevent hair loss …'.

N P Italiana srl
Date Published : 09/30/2009
unknown , Napoli, ITALY
53 L C - -- Skin Care Prep, Cream
Date Published: 09/30/2009

Notes: 10/15/1999 Top gel with special sunsceen agents.

64 L - - 28 Fluocinonide (Glucocorticoid)
Date Published: 09/30/2009

Notes: Top-Gel with Special Sunscreen Agent 10/15/1999

P C Products Srl
Date Published : 07/22/2021
Via Molinara 1 , Desio, Monza E della Brianza ITALY
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 08/30/2021

Desc: 3 Days No Taches Cream Lemon (CLOBETASOL PROPIONATE CREAM)

64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 07/22/2021

Desc: Haloderm (Clobetasol Proprionate 0.05%)

64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 08/30/2021

Desc: 3 Days No Taches Cream Lemon (CLOBETASOL PROPIONATE CREAM)

P&C PRODUCTS
Date Published : 10/01/2021
DESIO , MILAN, ITALY
64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 10/01/2021

Desc: Neoprosone-Gel Forte
Notes: The product appears to be an unapproved new drug as the product’s informational insert includes claims such as (not an all-inclusive list): ‘is a pharmaceutical product effective against acute dermatitis: eczema, psoriasis, itchiness, local inflammations and allergic reactions…’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/01/2021

Desc: Neoprosone-Gel Forte
Notes: The product appears to be an unapproved new drug as the product’s informational insert includes claims such as (not an all-inclusive list): ‘is a pharmaceutical product effective against acute dermatitis: eczema, psoriasis, itchiness, local inflammations and allergic reactions…’.

PHARMA GREEN S.R.L.
Date Published : 09/28/2018
Strada Degli Angariari,25 , Falciano, ITALY
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/28/2018

Desc: Cep Food Supplement
Notes: FDA analysis found the product to contain antiretroviral drugs Efavirenz and Tenofovir Disoproxil

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/28/2018

Desc: Cep Food Supplement
Notes: FDA analysis found the product to contain antiretroviral drugs Efavirenz and Tenofovir Disoproxil.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2018

Desc: Cep Food Supplement
Notes: FDA analysis found the product to contain antiretroviral drugs Efavirenz and Tenofovir Disoproxil

Pemadema
Date Published : 08/01/2012
Via Ferri Vecchi 1 , Napoli, Na ITALY
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);Italy

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);Italy

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);Italy

62 C - - 41 Minoxidil (Anti-Hypertensive)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);Italy

62 C - - 99 Anti-Hypertensive N.E.C.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);Italy

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);Italy

Pramil Srl
Date Published : 09/30/2009
Unknown , Milan, ITALY
53 L C - -- Skin Care Prep, Cream
Date Published: 09/13/2019

Desc: Movate Cream Esapharma .05 Clobetasol Propionate
Notes: 10/15/1999

53 L C - -- Skin Care Prep, Cream
Date Published: 09/30/2009

Notes: Regge Lemon Gel .05% Betamethasone dipropionate ;10/15/1999

53 L C - -- Skin Care Prep, Cream
Date Published: 09/13/2019

Desc: Topvate cream .05 clobetasol propionate
Notes: 10/15/1999

53 L C - -- Skin Care Prep, Cream
Date Published: 09/13/2019

Desc: Omic Gel Espharma .025 g Fluocinonide
Notes: 10/15/1999

64 L - - 06 Betamethasone Dipropionate (Glucocorticoid)
Date Published: 09/30/2009

Notes: Regge Lemon Gel .05% Betamethasone dipropionate ; 11/15/1999

64 L - - 28 Fluocinonide (Glucocorticoid)
Date Published: 09/30/2009

Notes: Omic Gel Espharma .025 g Fluocinonide; 10/15/1999

64 L - - 99 Glucocorticoid N.E.C.
Date Published: 09/30/2009

Notes: Movate Cream Esapharma .05% Clobetasol Propionate; 10/15/1999

64 L - - 99 Glucocorticoid N.E.C.
Date Published: 09/13/2019

Desc: Topvate cream .05 clobetasol propionate
Notes: 10/15/1999

Regi International
Date Published : 08/10/2011
Via M.Bucnaract 2/4/6 , Crema, ITALY
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 08/10/2011

Desc: Mascara; Cargo Lash Activator Duo
Notes: Country; Italy

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/10/2011

Desc: Mascara; Cargo Lash Activator Duo
Notes: Country; Italy

Revivre Cosmetiques
Date Published : 09/30/2009
Via Vallina Orticella 34 , Borsa Del Grappa, ITALY
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/30/2009

Notes: Dermopura Acneiche Treatment against acne and scarring. 12/3/1998 CDER has determined this product to be marketed over the internet and promoted for use as a treatment against "acne and scarring." The active ingrediants include "azelaic acid". That ingrediant offered as an OTC acne treatment, is a new drug, requiring an NDA to obtain marketing authorization and should not be promoted as an OTC product. This product also appears to be in violation of the final rule (21 CFR section 333.301) covering acne products. Questions regarding this product or other similar products should be addressed to Constance E. Bulawka, OTC Compliance Branch, Division of Drug Labeling and Non- Prescription Drug Compliance, HFD-312, 301-594-1065.

64 X - - 07 Tretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: Dermopura Acneiche Treatment against acne and scarring. 12/3/1998 CDER has determined this product to be marketed over the internet and promoted for use as a treatment against "acne and scarring." The active ingrediants include "azelaic acid". That ingrediant offered as an OTC acne treatment, is a new drug, requiring an NDA to obtain marketing authorization and should not be promoted as an OTC product. This product also appears to be in violation of the final rule (21 CFR section 333.301) covering acne products. Questions regarding this product or other similar products should be addressed to Constance E. Bulawka, OTC Compliance Branch, Division of Drug Labeling and Non- Prescription Drug Compliance, HFD-312, 301-594-1065.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: Dermopura Acneiche Treatment against acne and scarring. 12/3/1998 CDER has determined this product to be marketed over the internet and promoted for use as a treatment against "acne and scarring." The active ingrediants include "azelaic acid". That ingrediant offered as an OTC acne treatment, is a new drug, requiring an NDA to obtain marketing authorization and should not be promoted as an OTC product. This product also appears to be in violation of the final rule (21 CFR section 333.301) covering acne products. Questions regarding this product or other similar products should be addressed to Constance E. Bulawka, OTC Compliance Branch, Division of Drug Labeling and Non- Prescription Drug Compliance, HFD-312, 301-594-1065.

Sinerga S.p.A.
Date Published : 06/08/2010
Via Della Pacciarna 67 , Gorla Maggiore, Varese ITALY
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 06/08/2010

Desc: Anit-Hair Loss Lotion
Notes: Italy

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 10/04/2013

Desc: Kevis Shampoo
Notes: Structure/function claims found on package labeling and website. ITALY.

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 06/08/2010

Desc: Anit-Hair Loss Lotion
Notes: Italy

53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 06/08/2010

Desc: Anit-Hair Loss Lotion
Notes: Italy

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/04/2013

Desc: Kevis Shampoo
Notes: Structure/function claims found on package labeling and website. ITALY.

Spumador SpA
Date Published : 10/22/2012
Via Alla Fonte 13 , Cadorago, Como ITALY
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 10/22/2012

Desc: Venga Calorie Burn Orange Flavor

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 10/22/2012

Desc: Venga Calorie Burn Cranberry Flavor

Spumador Spa
Date Published : 10/22/2012
Via Dordone 43vimodrone , Felegarafelegara, ITALY
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 10/22/2012

Desc: Venga Calorie Burn Orange Flavor

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 10/22/2012

Desc: Venga Calorie Burn Cranberry Flavor

TECMOMED s.r.l.
Date Published : 09/30/2009
Viale San Gimignano 2 , Milan, Milan ITALY
53 L C - -- Skin Care Prep, Cream
Date Published: 09/30/2009

Notes: Dermo-Gel plus Techmomed; 10/15/1999

53 L C - -- Skin Care Prep, Cream
Date Published: 09/17/2019

Desc: Neoproson-Gel Forte
Notes: 10/15/1999

53 L C - -- Skin Care Prep, Cream
Date Published: 09/17/2019

Desc: Lemonvate Cream
Notes: 10/15/1999

64 L - - 06 Betamethasone Dipropionate (Glucocorticoid)
Date Published: 09/30/2009

Notes: Neoproson-Gel Forte ; 10/15/1999

64 L - - 28 Fluocinonide (Glucocorticoid)
Date Published: 09/30/2009

Notes: Dermo-Gel Plus 11/15/1999

64 L - - 28 Fluocinonide (Glucocorticoid)
Date Published: 09/17/2019

Desc: Dermo-Gel plus Techmomed
Notes: 10/15/1999

64 L - - 99 Glucocorticoid N.E.C.
Date Published: 09/30/2009

Notes: 10/15/1999 Lemonvate Cream

Vinco Corporation
Date Published : 09/29/2014
Unknown Street , Milan, ITALY
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/13/2019

Desc: Visible Difference Cream (Clobetasol Propionate)
Notes: 10/2/2014

64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 09/29/2014

Desc: Visible Difference Cream (Clobetasol Propionate)
Notes: 10/2/2014

vitus pharm co ltd
Date Published : 08/27/2019
clobetasol propionate 0,05% , milan, ITALY
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/27/2019

Notes: Aloe Vera Cream (Clobetasol Propionate) ; 11/18/08

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 08/27/2019

Notes: Aloe Vera Cream (Clobetasol Propionate) ; 11/18/08

61 - - - -- Human and Animal Drugs
Date Published: 08/27/2019

Notes: Aloe Vera Cream (Clobetasol Propionate) ; 11/18/08

62 - - - -- Human and Animal Drugs
Date Published: 08/27/2019

Notes: Aloe Vera Cream (Clobetasol Propionate) ; 11/18/08

63 - - - -- Human and Animal Drugs
Date Published: 08/27/2019

Notes: Aloe Vera Cream (Clobetasol Propionate) ; 11/18/08

64 - - - -- Human and Animal Drugs
Date Published: 08/27/2019

Notes: Aloe Vera Cream (Clobetasol Propionate) ; 11/18/08

65 - - - -- Human and Animal Drugs
Date Published: 08/27/2019

Notes: Aloe Vera Cream (Clobetasol Propionate) ; 11/18/08

66 - - - -- Human and Animal Drugs
Date Published: 08/27/2019

Notes: Aloe Vera Cream (Clobetasol Propionate) ; 11/18/08


IVORY COAST


Attote
Date Published : 02/18/2021
Ouattara Djakaridja a Korhogo , Korhogo, Republique de Cote d'Ivoire IVORY COAST
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/01/2021

Desc: La Paix
Notes: The product appears to be an unapproved new drug as the product’s label includes claims such as (not an all-inclusive list): ‘constipation.’

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/01/2021

Desc: ATTOTE Diabete
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): ‘Diabetes, blood pressure, fever, sexual weakness, hernia . . .’.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/18/2021

Desc: ATTOTE Original
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Diabetes, blood pressure, visual blurring, stomach ache, fever general fatigue, sexual weakness, sinusitis, ulcer, painful menstruation, vaginal discharge... kidney trouble, hemorrhoids, bloated stomach, constipation, typhoid fever... impotence, hernia, cyst, fibroma...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/01/2021

Desc: ATTOTE Diabete
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): ‘Diabetes, blood pressure, fever, sexual weakness, hernia . . .’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/18/2021

Desc: ATTOTE Original
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Diabetes, blood pressure, visual blurring, stomach ache, fever general fatigue, sexual weakness, sinusitis, ulcer, painful menstruation, vaginal discharge... kidney trouble, hemorrhoids, bloated stomach, constipation, typhoid fever... impotence, hernia, cyst, fibroma...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/01/2021

Desc: La Paix
Notes: The product appears to be an unapproved new drug as the product’s label includes claims such as (not an all-inclusive list): ‘constipation.’

DREAM COSMETICS
Date Published : 12/02/2016
Zone Industrielle Yopougon 23 , Abigian, IVORY COAST
53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations)
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Soap

53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations)
Date Published: 02/28/2024

Desc: Caro White Lightening Scrub Shower Gel Carrot Oil and Apricot

53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations)
Date Published: 02/28/2024

Desc: Paw Paw Lightening Shower Gel

53 D - - 03 Powders (Dusting and Talcum, excluding Aftershave Talc) (Fragrance Preparations)
Date Published: 04/21/2021

Desc: CAROTONE Black Spot Corrector CREAM
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'LIGHT & NATURAL . . . MAXI EFFECT CONCENTRATED FORMULA . . . Sun Protection . . . Black Spot Corrector'.

53 D - - 03 Powders (Dusting and Talcum, excluding Aftershave Talc) (Fragrance Preparations)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . protection against UV and sun rays'.

53 D - - 03 Powders (Dusting and Talcum, excluding Aftershave Talc) (Fragrance Preparations)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Cream
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

53 D - - 03 Powders (Dusting and Talcum, excluding Aftershave Talc) (Fragrance Preparations)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Soap
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

53 D - - 03 Powders (Dusting and Talcum, excluding Aftershave Talc) (Fragrance Preparations)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Body Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Provides protection against UV and sun rays'.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 02/28/2024

Desc: Paw Paw Lightening Shower Gel

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 02/28/2024

Desc: Pretty White Lightening Body Lotion

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 06/22/2021

Desc: Clear Therapy Extra Lightening Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "Reduces pigmentation;" "skin lightening therapy%u2026targeting pigmentation spots"

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/18/2022

Desc: Clear Therapy Intensive Lightening Serum
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘INTENSIVE LIGHTENING SERUM’; ‘Reduces pigmentation’; ‘Minimizes dark spots’; ‘INGREDIENTS…HYDROQUINONE MAX. 2%’.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/21/2018

Desc: Caro White Lightening Shower Gel with Carrot Oil

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/01/2019

Desc: CT Clear Therapy Lightening Purifying Soap with Plant Extracts

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Body Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Provides protection against UV and sun rays'.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 02/28/2024

Desc: Perfect White Lightening Serum

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Cream

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/21/2021

Desc: CAROTONE Black Spot Corrector CREAM
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'LIGHT & NATURAL . . . MAXI EFFECT CONCENTRATED FORMULA . . . Sun Protection . . . Black Spot Corrector'.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Oil

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Cream
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 06/22/2021

Desc: Caro White Lightening Beauty Soap with Carrot Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "in order to make your skin light"

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 10/25/2023

Desc: PAW PAW DSR Dark Spot Remover

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 02/28/2024

Desc: Pretty White Intensive Clarifying Cream

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 02/28/2024

Desc: Caro White Lightening Scrub Shower Gel Carrot Oil and Apricot

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/01/2019

Desc: CT Clear Therapy Lightening Purifying Soap with Carrot Oil

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Soap

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . protection against UV and sun rays'.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Soap
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/01/2019

Desc: Citrolight with Citrus Oil-Lightening Beauty Soap

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 02/28/2024

Desc: Pretty White Lightening Body Lotion

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 06/22/2021

Desc: Caro White Lightening Beauty Soap with Carrot Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "in order to make your skin light"

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 06/22/2021

Desc: Clear Therapy Extra Lightening Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "Reduces pigmentation;" "skin lightening therapy%u2026targeting pigmentation spots"

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Oil

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 02/28/2024

Desc: Caro White Lightening Scrub Shower Gel Carrot Oil and Apricot

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 02/28/2024

Desc: Perfect White Lightening Serum

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 02/28/2024

Desc: Paw Paw Lightening Shower Gel

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 04/18/2022

Desc: Clear Therapy Intensive Lightening Serum
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘INTENSIVE LIGHTENING SERUM’; ‘Reduces pigmentation’; ‘Minimizes dark spots’; ‘INGREDIENTS…HYDROQUINONE MAX. 2%’.

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Soap

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/29/2017

Desc: Clean Therapy Extra Lightening Lotion with Carrot Oil

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Pretty White Lightening Body Lotion

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 06/22/2021

Desc: Caro White Lightening Beauty Soap with Carrot Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "in order to make your skin light"

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Perfect White Lightening Serum

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 06/22/2021

Desc: Clear Therapy Extra Lightening Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "Reduces pigmentation;" "skin lightening therapy%u2026targeting pigmentation spots"

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Cream

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Oil

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 12/21/2018

Desc: Caro White Lightening Shower Gel with Carrot Oil

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/29/2017

Desc: Citrolight Lightening Beauty Lotion with Citrus Oil

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Pretty White Intensive Clarifying Cream

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Caro White Lightening Scrub Shower Gel Carrot Oil and Apricot

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Paw Paw Lightening Shower Gel

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/29/2017

Desc: Caro White Lightening Oil

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Soap

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/29/2017

Desc: Caro White Lightening Beauty Cream

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 04/18/2022

Desc: Clear Therapy Intensive Lightening Serum
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘INTENSIVE LIGHTENING SERUM’; ‘Reduces pigmentation’; ‘Minimizes dark spots’; ‘INGREDIENTS…HYDROQUINONE MAX. 2%’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/02/2016

Desc: Caro White Lightening Beauty Lotion
Notes: Medical claims on product labels

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/18/2022

Desc: Clear Therapy Intensive Lightening Serum
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘INTENSIVE LIGHTENING SERUM’; ‘Reduces pigmentation’; ‘Minimizes dark spots’; ‘INGREDIENTS…HYDROQUINONE MAX. 2%’.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 06/22/2021

Desc: Caro White Lightening Beauty Soap with Carrot Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "in order to make your skin light"

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . protection against UV and sun rays'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/21/2021

Desc: CAROTONE Black Spot Corrector CREAM
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'LIGHT & NATURAL . . . MAXI EFFECT CONCENTRATED FORMULA . . . Sun Protection . . . Black Spot Corrector'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Cream
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Pretty White Lightening Body Lotion

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 06/22/2021

Desc: Clear Therapy Extra Lightening Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "Reduces pigmentation;" "skin lightening therapy%u2026targeting pigmentation spots"

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Cream

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Soap
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Body Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Provides protection against UV and sun rays'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Oil

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Paw Paw Lightening Shower Gel

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Caro White Lightening Scrub Shower Gel Carrot Oil and Apricot

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Perfect White Lightening Serum

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Pretty White Intensive Clarifying Cream

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/03/2018

Desc: Perfect White Lightening Beauty Cream without Hydroquinone

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Soap

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/21/2018

Desc: Caro White Lightening Shower Gel with Carrot Oil

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Pretty White Lightening Body Lotion

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Perfect White Lightening Serum

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 05/03/2018

Desc: Clairman Lightening Program for Men

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Cream

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 06/22/2021

Desc: Clear Therapy Extra Lightening Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "Reduces pigmentation;" "skin lightening therapy...targeting pigmentation spots"

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Paw Paw Lightening Shower Gel

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 04/18/2022

Desc: Clear Therapy Intensive Lightening Serum
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘INTENSIVE LIGHTENING SERUM’; ‘Reduces pigmentation’; ‘Minimizes dark spots’; ‘INGREDIENTS…HYDROQUINONE MAX. 2%’.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/25/2023

Desc: PAW PAW DSR Dark Spot Remover

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Oil

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Pretty White Intensive Clarifying Cream

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/21/2018

Desc: Caro White Lightening Shower Gel with Carrot Oil

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Soap

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 06/22/2021

Desc: Caro White Lightening Beauty Soap with Carrot Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "in order to make your skin light"

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Caro White Lightening Scrub Shower Gel Carrot Oil and Apricot

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 02/28/2024

Desc: Caro White Lightening Scrub Shower Gel Carrot Oil and Apricot

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Cream

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Oil

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 06/22/2021

Desc: Clear Therapy Extra Lightening Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "Reduces pigmentation;" "skin lightening therapy...targeting pigmentation spots"

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Soap

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 02/28/2024

Desc: Pretty White Intensive Clarifying Cream

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 06/22/2021

Desc: Caro White Lightening Beauty Soap with Carrot Oil
Notes: Caro White Lightening Beauty Soap with Carrot Oil Notes; The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "in order to make your skin light"

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 02/28/2024

Desc: Paw Paw Lightening Shower Gel

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/02/2016

Desc: Caro White Lightening Beauty Lotion
Notes: Medical claims on product labels ;

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . protection against UV and sun rays'.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Cream
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/21/2018

Desc: Caro White Lightening Shower Gel with Carrot Oil

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Body Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Provides protection against UV and sun rays'.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/18/2022

Desc: Clear Therapy Intensive Lightening Serum
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘INTENSIVE LIGHTENING SERUM’; ‘Reduces pigmentation’; ‘Minimizes dark spots’; ‘INGREDIENTS…HYDROQUINONE MAX. 2%’.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/21/2021

Desc: CAROTONE Black Spot Corrector CREAM
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'LIGHT & NATURAL . . . MAXI EFFECT CONCENTRATED FORMULA . . . Sun Protection . . . Black Spot Corrector'.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Soap
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 02/28/2024

Desc: Perfect White Lightening Serum

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 02/28/2024

Desc: Pretty White Lightening Body Lotion

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 02/28/2024

Desc: Pretty White Lightening Body Lotion

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 02/28/2024

Desc: Paw Paw Lightening Shower Gel

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 02/28/2024

Desc: Pretty White Intensive Clarifying Cream

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 02/28/2024

Desc: Perfect White Lightening Serum

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Soap

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 02/28/2024

Desc: Caro White Lightening Scrub Shower Gel Carrot Oil and Apricot

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Cream

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Oil

60 - - - -- Human and Animal Drugs
Date Published: 10/25/2023

Desc: PAW PAW DSR Dark Spot Remover

61 - - - -- Human and Animal Drugs
Date Published: 10/25/2023

Desc: PAW PAW DSR Dark Spot Remover

62 - - - -- Human and Animal Drugs
Date Published: 10/25/2023

Desc: PAW PAW DSR Dark Spot Remover

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 09/29/2017

Desc: Caro White Lightening Oil

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 05/03/2018

Desc: Perfect White Lightening Beauty Cream without Hydroquinone

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . protection against UV and sun rays'.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 09/29/2017

Desc: Clean Therapy Extra Lightening Lotion with Carrot Oil

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Soap
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Body Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Provides protection against UV and sun rays'.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 12/02/2016

Desc: Caro White Lightening Beauty Lotion
Notes: Medical claims on product labels

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 09/29/2017

Desc: Caro White Lightening Beauty Cream

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Cream
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 09/29/2017

Desc: Citrolight Lightening Beauty Lotion with Citrus Oil

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 04/21/2021

Desc: CAROTONE Black Spot Corrector CREAM
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'LIGHT & NATURAL . . . MAXI EFFECT CONCENTRATED FORMULA . . . Sun Protection . . . Black Spot Corrector'.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 04/18/2022

Desc: Clear Therapy Intensive Lightening Serum
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘INTENSIVE LIGHTENING SERUM’; ‘Reduces pigmentation’; ‘Minimizes dark spots’; ‘INGREDIENTS…HYDROQUINONE MAX. 2%’.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 06/22/2021

Desc: Caro White Lightening Beauty Soap with Carrot Oil
Notes: Caro White Lightening Beauty Soap with Carrot Oil Notes; The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "in order to make your skin light"

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 12/21/2018

Desc: Caro White Lightening Shower Gel with Carrot Oil

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 06/22/2021

Desc: Clear Therapy Extra Lightening Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "Reduces pigmentation;" "skin lightening therapy...targeting pigmentation spots"

63 V - - 99 Depigmentor N.E.C.
Date Published: 09/29/2017

Desc: Clean Therapy Extra Lightening Lotion with Carrot Oil

63 V - - 99 Depigmentor N.E.C.
Date Published: 02/28/2024

Desc: Pretty White Intensive Clarifying Cream

63 V - - 99 Depigmentor N.E.C.
Date Published: 02/28/2024

Desc: Paw Paw Lightening Shower Gel

63 V - - 99 Depigmentor N.E.C.
Date Published: 04/01/2019

Desc: Citrolight with Citrus Oil-Lightening Beauty Soap

63 V - - 99 Depigmentor N.E.C.
Date Published: 12/02/2016

Desc: Caro White Lightening Beauty Lotion
Notes: Medical claims on product labels ;

63 V - - 99 Depigmentor N.E.C.
Date Published: 04/01/2019

Desc: CT Clear Therapy Lightening Purifying Soap with Carrot Oil

63 V - - 99 Depigmentor N.E.C.
Date Published: 02/28/2024

Desc: Pretty White Lightening Body Lotion

63 V - - 99 Depigmentor N.E.C.
Date Published: 02/28/2024

Desc: Perfect White Lightening Serum

63 V - - 99 Depigmentor N.E.C.
Date Published: 09/29/2017

Desc: Caro White Lightening Beauty Cream

63 V - - 99 Depigmentor N.E.C.
Date Published: 04/01/2019

Desc: CT Clear Therapy Lightening Purifying Soap with Plant Extracts

63 V - - 99 Depigmentor N.E.C.
Date Published: 09/29/2017

Desc: Citrolight Lightening Beauty Lotion with Citrus Oil

63 V - - 99 Depigmentor N.E.C.
Date Published: 06/22/2021

Desc: Clear Therapy Extra Lightening Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "Reduces pigmentation;" "skin lightening therapy...targeting pigmentation spots"

63 V - - 99 Depigmentor N.E.C.
Date Published: 12/21/2018

Desc: Caro White Lightening Shower Gel with Carrot Oil

63 V - - 99 Depigmentor N.E.C.
Date Published: 05/03/2018

Desc: Perfect White Lightening Beauty Cream without Hydroquinone

63 V - - 99 Depigmentor N.E.C.
Date Published: 02/28/2024

Desc: Caro White Lightening Scrub Shower Gel Carrot Oil and Apricot

63 V - - 99 Depigmentor N.E.C.
Date Published: 09/29/2017

Desc: Caro White Lightening Oil

63 V - - 99 Depigmentor N.E.C.
Date Published: 04/18/2022

Desc: Clear Therapy Intensive Lightening Serum
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘INTENSIVE LIGHTENING SERUM’; ‘Reduces pigmentation’; ‘Minimizes dark spots’; ‘INGREDIENTS…HYDROQUINONE MAX. 2%’.

63 V - - 99 Depigmentor N.E.C.
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Soap

63 V - - 99 Depigmentor N.E.C.
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Oil

63 V - - 99 Depigmentor N.E.C.
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Cream

63 V - - 99 Depigmentor N.E.C.
Date Published: 06/22/2021

Desc: Caro White Lightening Beauty Soap with Carrot Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "in order to make your skin light"

63 - - - -- Human and Animal Drugs
Date Published: 10/25/2023

Desc: PAW PAW DSR Dark Spot Remover

64 - - - -- Human and Animal Drugs
Date Published: 10/25/2023

Desc: PAW PAW DSR Dark Spot Remover

65 - - - -- Human and Animal Drugs
Date Published: 10/25/2023

Desc: PAW PAW DSR Dark Spot Remover

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Body Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Provides protection against UV and sun rays'.

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . protection against UV and sun rays'.

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 04/21/2021

Desc: CAROTONE Black Spot Corrector CREAM
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'LIGHT & NATURAL . . . MAXI EFFECT CONCENTRATED FORMULA . . . Sun Protection . . . Black Spot Corrector'.

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Cream
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Soap
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/28/2024

Desc: Pretty White Lightening Body Lotion

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . protection against UV and sun rays'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/22/2021

Desc: Clear Therapy Extra Lightening Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "Reduces pigmentation;" "skin lightening therapy...targeting pigmentation spots"

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/28/2024

Desc: Pretty White Intensive Clarifying Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Body Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Provides protection against UV and sun rays'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/28/2024

Desc: Perfect White Lightening Serum

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/28/2024

Desc: Caro White Lightening Scrub Shower Gel Carrot Oil and Apricot

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2017

Desc: Caro White Lightening Oil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Soap
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/01/2019

Desc: CT Clear Therapy Lightening Purifying Soap with Plant Extracts

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2017

Desc: Citrolight Lightening Beauty Lotion with Citrus Oil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/22/2021

Desc: Caro White Lightening Beauty Soap with Carrot Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "in order to make your skin light"

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/28/2024

Desc: Paw Paw Lightening Shower Gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Cream
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Oil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/01/2019

Desc: Citrolight with Citrus Oil-Lightening Beauty Soap

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2017

Desc: Clean Therapy Extra Lightening Lotion with Carrot Oil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/21/2021

Desc: CAROTONE Black Spot Corrector CREAM
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); 'LIGHT & NATURAL . . . MAXI EFFECT CONCENTRATED FORMULA . . . Sun Protection . . . Black Spot Corrector'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/03/2018

Desc: Perfect White Lightening Beauty Cream without Hydroquinone

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/01/2019

Desc: CT Clear Therapy Lightening Purifying Soap with Carrot Oil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2017

Desc: Caro White Lightening Beauty Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/28/2024

Desc: Paw Paw Clarifying Soap

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/03/2018

Desc: Clairman Lightening Program for Men

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/21/2018

Desc: Caro White Lightening Shower Gel with Carrot Oil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/18/2022

Desc: Clear Therapy Intensive Lightening Serum
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘INTENSIVE LIGHTENING SERUM’; ‘Reduces pigmentation’; ‘Minimizes dark spots’; ‘INGREDIENTS…HYDROQUINONE MAX. 2%’.

66 - - - -- Human and Animal Drugs
Date Published: 10/25/2023

Desc: PAW PAW DSR Dark Spot Remover

El Paradis Cosmetique
Date Published : 10/20/2017
12 Bp 2136 , Abidjan, IVORY COAST
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 05/03/2018

Desc: Eclat Whitening Soap

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 05/03/2018

Desc: Nature Secret Natural Exfoliating Care

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 05/03/2018

Desc: Eclat Whitening Soap

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 05/03/2018

Desc: Nature Secrete Carotte Lightening Serum Anti Ageing with Carrot Oil

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/20/2017

Desc: Nature Secrete with pure Argan oil Lightening Serum
Notes: Drug claims made on product labeling

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/27/2017

Desc: Nature Secrete Lightening Moisturizer Body Lotion
Notes: Drug claims made on product labeling

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 05/03/2018

Desc: Nature Secrete Precious Lightening Cream Dark Spot Corrector

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/27/2017

Desc: Nature Secrete Lightening Moisturizer Body Lotion
Notes: Drug claims made on product labeling

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/03/2018

Desc: Eclat Whitening Soap

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/20/2017

Desc: Nature Secrete with pure Argan oil Lightening Serum
Notes: Drug claims made on product labeling

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/03/2018

Desc: Nature Secret Natural Exfoliating Care

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/03/2018

Desc: Nature Secrete Carotte Lightening Serum Anti Ageing with Carrot Oil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/03/2018

Desc: Nature Secrete Precious Lightening Cream Dark Spot Corrector

Erhald Transit Import-Export
Date Published : 04/21/2021
05 Bp 2939 , Abidjan, IVORY COAST
53 D - - 03 Powders (Dusting and Talcum, excluding Aftershave Talc) (Fragrance Preparations)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Soap
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

53 D - - 03 Powders (Dusting and Talcum, excluding Aftershave Talc) (Fragrance Preparations)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . protection against UV and sun rays'.

53 D - - 03 Powders (Dusting and Talcum, excluding Aftershave Talc) (Fragrance Preparations)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Cream
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

53 D - - 03 Powders (Dusting and Talcum, excluding Aftershave Talc) (Fragrance Preparations)
Date Published: 04/21/2021

Desc: CAROTONE Black Spot Corrector CREAM
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'LIGHT & NATURAL . . . MAXI EFFECT CONCENTRATED FORMULA . . . Sun Protection . . . Black Spot Corrector'.

53 D - - 03 Powders (Dusting and Talcum, excluding Aftershave Talc) (Fragrance Preparations)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Body Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Provides protection against UV and sun rays'.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . protection against UV and sun rays'.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Soap
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/21/2021

Desc: CAROTONE Black Spot Corrector CREAM
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'LIGHT & NATURAL . . . MAXI EFFECT CONCENTRATED FORMULA . . . Sun Protection . . . Black Spot Corrector'.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Body Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Provides protection against UV and sun rays'.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Cream
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Body Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Provides protection against UV and sun rays'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Cream
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/21/2021

Desc: CAROTONE Black Spot Corrector CREAM
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'LIGHT & NATURAL . . . MAXI EFFECT CONCENTRATED FORMULA . . . Sun Protection . . . Black Spot Corrector'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . protection against UV and sun rays'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Soap
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Body Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Provides protection against UV and sun rays'.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Cream
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Soap
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . protection against UV and sun rays'.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/21/2021

Desc: CAROTONE Black Spot Corrector CREAM
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'LIGHT & NATURAL . . . MAXI EFFECT CONCENTRATED FORMULA . . . Sun Protection . . . Black Spot Corrector'.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Soap
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . protection against UV and sun rays'.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 04/21/2021

Desc: CAROTONE Black Spot Corrector CREAM
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'LIGHT & NATURAL . . . MAXI EFFECT CONCENTRATED FORMULA . . . Sun Protection . . . Black Spot Corrector'.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Cream
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 04/21/2021

Desc: CAROTONE Brightening Body Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Provides protection against UV and sun rays'.

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Body Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Provides protection against UV and sun rays'.

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Cream
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Soap
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . protection against UV and sun rays'.

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 04/21/2021

Desc: CAROTONE Black Spot Corrector CREAM
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'LIGHT & NATURAL . . . MAXI EFFECT CONCENTRATED FORMULA . . . Sun Protection . . . Black Spot Corrector'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . protection against UV and sun rays'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Cream
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/21/2021

Desc: CAROTONE Black Spot Corrector CREAM
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'LIGHT & NATURAL . . . MAXI EFFECT CONCENTRATED FORMULA . . . Sun Protection . . . Black Spot Corrector'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Soap
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Brighten up your skin complexion in just 3 weeks . . . Provides protection against UV and sun rays'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/21/2021

Desc: CAROTONE Brightening Body Lotion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Sun Protection . . . Formula rich in B-Carotene to lighten your skin . . . Provides protection against UV and sun rays'.

Ets Sanon Ami
Date Published : 05/03/2018
03 B.P. 216 Abidjan , Abidjan, IVORY COAST
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/30/2018

Desc: Bioclinic Lotion

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/03/2018

Desc: Flori?s Duo

54 F - - 13 Gotu Kola (Herbal & Botanicals, not Teas)
Date Published: 05/03/2018

Desc: Men?s VIP Increased

60 Q - - 07 Lidocaine
Date Published: 05/03/2018

Desc: Dragon?s Delay Super Dooz Spray

60 Q - - 07 Lidocaine
Date Published: 05/03/2018

Desc: Tightening 4 in 1 Sex Gel

60 Q - - 07 Lidocaine
Date Published: 05/03/2018

Desc: Perfect Smart Love Woman Gel

63 V - - 99 Depigmentor N.E.C.
Date Published: 07/30/2018

Desc: Bioclinic Lotion

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/03/2018

Desc: Flori?s Duo

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/03/2018

Desc: Men?s VIP Increased

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/03/2018

Desc: Perfect Smart Love Woman Gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/03/2018

Desc: Tightening 4 in 1 Sex Gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/03/2018

Desc: Dragon?s Delay Super Dooz Spray

Ets Sanon Ami
Date Published : 07/24/2018
03 B.P. 216 Abidjan , Abidjan, IVORY COAST
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/24/2018

Desc: Nature White Luxury Body Oil
Notes: The product appears to be an unapproved new drug as the product includes claims such as: '... Cleans Dark Stains ... Lightening ... Eliminates dark spots ...' In addition, the product contains undeclared hydroquinone and the product label includes photographs that depict darker skin in the 'Before' photograph and lighter skin in the 'After' photograph.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 07/24/2018

Desc: Nature White Luxury Body Oil
Notes: The product appears to be an unapproved new drug as the product includes claims such as: '... Cleans Dark Stains ... Lightening ... Eliminates dark spots ...' In addition, the product contains undeclared hydroquinone and the product label includes photographs that depict darker skin in the 'Before' photograph and lighter skin in the 'After' photograph.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/24/2018

Desc: Nature White Luxury Body Oil
Notes: The product appears to be an unapproved new drug as the product includes claims such as: '... Cleans Dark Stains ... Lightening ... Eliminates dark spots ...' In addition, the product contains undeclared hydroquinone and the product label includes photographs that depict darker skin in the 'Before' photograph and lighter skin in the 'After' photograph.

Fabrique par Rodis
Date Published : 12/21/2011
Bp 1282 , Abidjan, IVORY COAST
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/21/2011

Desc: Skin Light Cream
Notes: Ivory Coast

Fabrique Par Sivop-C.I.
Date Published : 07/16/2018
03 B.P 928 , Abidjan, IVORY COAST
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/16/2018

Desc: Caro-Light Lightening Body Oil
Notes: The product appears to be an unapproved new drug as the product includes claims such as; '... LIGHTENING BODY OIL ... Gradually eliminates dark spots ...'.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/16/2018

Desc: Caro-Light Lightening Body Oil
Notes: The product appears to be an unapproved new drug as the product includes claims such as; '... LIGHTENING BODY OIL ... Gradually eliminates dark spots ...'.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 07/16/2018

Desc: Caro-Light Lightening Body Oil
Notes: The product appears to be an unapproved new drug as the product includes claims such as; '... LIGHTENING BODY OIL ... Gradually eliminates dark spots ...'. ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/16/2018

Desc: Caro-Light Lightening Body Oil
Notes: The product appears to be an unapproved new drug as the product includes claims such as; '... LIGHTENING BODY OIL ... Gradually eliminates dark spots ...'. ;

H Cosmetics Ci Srl
Date Published : 05/03/2018
Bp 4657 , Abidjan, IVORY COAST
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 05/03/2018

Desc: H2O Jours Natural Whitening Papaya Soap

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 05/03/2018

Desc: Hyprogel Lightening and Gumming Soap

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 05/03/2018

Desc: Hyprogel Lightening and Gumming Soap

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 05/03/2018

Desc: Hyprogel Lightening and Gumming Soap

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/03/2018

Desc: Haloderm Huile Body Oil

53 L - - -- Skin Care Prep
Date Published: 10/15/2021

Desc: La Bamakoise Tamarin Huile Extra tonic oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); '... TAMARIND oil cleans dark stains; ...; Ingredients; ... - Hydroquinone ...'.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 10/15/2021

Desc: La Bamakoise Tamarin Huile Extra tonic oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); '... TAMARIND oil cleans dark stains; ...; Ingredients; ... - Hydroquinone ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/03/2018

Desc: H2O Jours Natural Whitening Papaya Soap

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/03/2018

Desc: Haloderm Huile Body Oil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/15/2021

Desc: La Bamakoise Tamarin Huile Extra tonic oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); '... TAMARIND oil cleans dark stains; ...; Ingredients; ... - Hydroquinone ...'.

H Cosmetiques CI
Date Published : 06/22/2021
75 ADJAME MAIRIE, RUE BANDAMA-Lot , Abidjan, IVORY COAST
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 06/22/2021

Desc: Janet Papaya Cream
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "It is effective against acute dermatitis; eczema; psoriasis; itchiness; local inflammations and allergic reactions"

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 06/22/2021

Desc: H2O Natural Papaya Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "It is effective against acute dermatitis; eczema; psoriasis; itchiness; local inflammations and allergic reactions"

64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 06/22/2021

Desc: Janet Papaya Cream
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "It is effective against acute dermatitis; eczema; psoriasis; itchiness; local inflammations and allergic reactions"

64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 06/22/2021

Desc: H2O Natural Papaya Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "It is effective against acute dermatitis; eczema; psoriasis; itchiness; local inflammations and allergic reactions"

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/22/2021

Desc: Janet Papaya Cream
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "It is effective against acute dermatitis; eczema; psoriasis; itchiness; local inflammations and allergic reactions"

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/22/2021

Desc: H2O Natural Papaya Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list); "It is effective against acute dermatitis; eczema; psoriasis; itchiness; local inflammations and allergic reactions"

H Cosmetiques CI
Date Published : 07/24/2018
75 ADJAME MAIRIE, RUE BANDAMA-Lot , Abidjan, IVORY COAST
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/24/2018

Desc: Nature White Luxury Body Oil
Notes: The product appears to be an unapproved new drug as the product includes claims such as: '... Cleans Dark Stains ... Lightening ... Eliminates dark spots ...' In addition, the product contains undeclared hydroquinone and the product label includes photographs that depict darker skin in the 'Before' photograph and lighter skin in the 'After' photograph.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 07/24/2018

Desc: Nature White Luxury Body Oil
Notes: The product appears to be an unapproved new drug as the product includes claims such as: '... Cleans Dark Stains ... Lightening ... Eliminates dark spots ...' In addition, the product contains undeclared hydroquinone and the product label includes photographs that depict darker skin in the 'Before' photograph and lighter skin in the 'After' photograph.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/24/2018

Desc: Nature White Luxury Body Oil
Notes: The product appears to be an unapproved new drug as the product includes claims such as: '... Cleans Dark Stains ... Lightening ... Eliminates dark spots ...' In addition, the product contains undeclared hydroquinone and the product label includes photographs that depict darker skin in the 'Before' photograph and lighter skin in the 'After' photograph.

LE BOUAKE
Date Published : 08/31/2020
Bp 423 , Abidjan, IVORY COAST
54 E - - -- Herbal and Botanical
Date Published: 08/31/2020

Desc: ATTOTE Original
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Diabetes, blood pressure, visual blurring, stomach ache, fever general fatigue, sexual weakness, sinusitis, ulcer, painful menstruation, vaginal discharge . . . kidney trouble, hemorrhoids, bloated stomach, constipation, typhoid fever . . . impotence, hernia, cyst, fibroma . . .'.

54 J - - -- Herbal and Botanical II
Date Published: 08/31/2020

Desc: ATTOTE Original
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Diabetes, blood pressure, visual blurring, stomach ache, fever general fatigue, sexual weakness, sinusitis, ulcer, painful menstruation, vaginal discharge . . . kidney trouble, hemorrhoids, bloated stomach, constipation, typhoid fever . . . impotence, hernia, cyst, fibroma . . .'.

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 08/31/2020

Desc: ATTOTE Original
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Diabetes, blood pressure, visual blurring, stomach ache, fever general fatigue, sexual weakness, sinusitis, ulcer, painful menstruation, vaginal discharge . . . kidney trouble, hemorrhoids, bloated stomach, constipation, typhoid fever . . . impotence, hernia, cyst, fibroma . . .'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/31/2020

Desc: ATTOTE Original
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Diabetes, blood pressure, visual blurring, stomach ache, fever general fatigue, sexual weakness, sinusitis, ulcer, painful menstruation, vaginal discharge . . . kidney trouble, hemorrhoids, bloated stomach, constipation, typhoid fever . . . impotence, hernia, cyst, fibroma . . .'.

Nouvelle Parfumeria Gandour
Date Published : 06/28/2013
01 Bp 4387 , Abidjan 01, IVORY COAST
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 08/31/2023

Desc: CAROTONE Brightening Body Lotion

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 06/28/2013

Desc: G
Notes: Ivory Coast

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 08/31/2023

Desc: CAROTONE Clarifying Cream

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 02/28/2024

Desc: Light & Natural Carotone Brightening Soap
Notes: This product appears to be an unapproved new drug, as the product’s labeling includes statements such as: “Provides protection against UV and sun rays… Brighten up your skin complexion in just 3 weeks.”

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/09/2019

Desc: BIO Claire Lightening Care Soap without Hydroquinone
Notes: Product label has statements; Lightening Care Soap without Hydroquinone and lightening soap.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 08/17/2017

Desc: Carotone TRIO B.S.C Black Spot Corrector Kit
Notes: The product is packaged as a kit that contains a lotion; serum; creme; and bar of soap.

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 02/28/2024

Desc: Light & Natural Carotone Brightening Soap
Notes: This product appears to be an unapproved new drug, as the product’s labeling includes statements such as: “Provides protection against UV and sun rays… Brighten up your skin complexion in just 3 weeks.”

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 08/17/2017

Desc: Carotone TRIO B.S.C Black Spot Corrector Kit
Notes: The product is packaged as a kit that contains a lotion; serum; creme; and bar of soap.

53 K - - 03 Men's Talcum (Shaving Preparations)
Date Published: 02/06/2015

Desc: Maxi Light Lightening

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 02/06/2015

Desc: Maxi Light Lightening & Purifying Body Lotion

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 03/25/2015

Desc: Immediat Claire Lightening Body Cream with Carrot Extract

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 05/29/2015

Desc: G&G Lightening Beauty Cream
Notes: Product label made medical claims and does not declare the hydroquinone ingredients and exceeds the 2% allowable limit.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 04/21/2015

Desc: Bio Claire Lightening Body Cream
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following; Lightening Body Cream without Hydroquinone; and The lightening cream Bio Claire without hydroquinone stimulates the lightening process in a natural way; ensures complete elimination of cutaneous defects and makes your complexion clear and even; with no mess. In addition; FDA analysis found the aforementioned product to contain Clobetasol Propionate; an active pharmaceutical ingredient.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/21/2015

Desc: Bio Claire Lightening Body Cream
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following; Lightening Body Cream without Hydroquinone; and The lightening cream Bio Claire without hydroquinone stimulates the lightening process in a natural way; ensures complete elimination of cutaneous defects and makes your complexion clear and even; with no mess. In addition; FDA analysis found the aforementioned product to contain Clobetasol Propionate; an active pharmaceutical ingredient.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 02/06/2015

Desc: Maxi Light Lightening & Purifying Body Lotion

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/25/2015

Desc: Immediat Claire Lightening Body Cream with Carrot Extract

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 02/28/2024

Desc: Light & Natural Carotone Serum B.S.C (Black Spot Corrector)
Notes: This product appears to be an unapproved new drug, as the product’s labeling includes statements such as: “Eliminates all spots and marks that are on hands, feet, elbows.”

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 02/11/2015

Desc: Pure Skin Vanishing Care Body Lotion
Notes: The aforementioned product appears to be an unapproved new drug as it contains an active pharmaceutical ingredient; Clobetasol Propionate; and the product label lists the intended uses for the product to include; but may not be limited to; the following; ?Moisturizing Anti-Spot?; and ?Pure Skin lightening care body lotion with pomegranate seeds and collagen; oxygenates the epidermis giving it; day after day; a radiant complexion?.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 02/06/2015

Desc: 'Maxi Light is an important element of a new generation of purifying and lightening care'; 'It clarifies; unifies and rids your skin of brown spots'; 'The beauty complex contains
Notes: The aforementioned product appears to be an unapproved new drug as the product label claims that the intended uses for the product include; but may not be limited to; the following

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 02/06/2015

Desc: Maxi Light Lightening & Purifying Body Lotion

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 08/25/2017

Desc: Dawny Lightening Body Lotion
Notes: Product contains undeclared Hydroquinone.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 05/04/2018

Desc: Carotene Brightening Cream

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 02/06/2015

Desc: Maxi Light Lightening & Purifying Body Creme
Notes: The aforementioned product appears to be an unapproved new drug as the product label claims that the intended uses for the product include; but may not be limited to; the following; Maxi Light is an important element of a new generation of purifying and lightening care; It clarifies; unifies and rids your skin of brown spots; The beauty complex contains; -vitamins A & E (to smooth; to rejuvenate and protect your skin against sun?s UV); Spot free and net skin.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/25/2015

Desc: Immediat Claire Lightening Body Cream with Carrot Extract

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/18/2017

Desc: Bronz Tone
Notes: The statement on label referring specifically to the function of "UV protection."

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 02/28/2024

Desc: Light & Natural Carotone Brightening Soap
Notes: This product appears to be an unapproved new drug, as the product’s labeling includes statements such as: “Provides protection against UV and sun rays… Brighten up your skin complexion in just 3 weeks.”

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 02/28/2024

Desc: Light & Natural Carotone Serum B.S.C (Black Spot Corrector)
Notes: This product appears to be an unapproved new drug, as the product’s labeling includes statements such as: “Eliminates all spots and marks that are on hands, feet, elbows.”

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/21/2015

Desc: Bio Claire Lightening Body Cream
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following; Lightening Body Cream without Hydroquinone; and The lightening cream Bio Claire without hydroquinone stimulates the lightening process in a natural way; ensures complete elimination of cutaneous defects and makes your complexion clear and even; with no mess. In addition; FDA analysis found the aforementioned product to contain Clobetasol Propionate; an active pharmaceutical ingredient.

53 L - - -- Skin Care Prep
Date Published: 08/31/2023

Desc: CAROTONE Clarifying Cream

53 L - - -- Skin Care Prep
Date Published: 08/17/2017

Desc: Carotone TRIO B.S.C Black Spot Corrector Kit
Notes: The product is packaged as a kit that contains a lotion; serum; creme; and bar of soap.

53 L - - -- Skin Care Prep
Date Published: 08/31/2023

Desc: CAROTONE Brightening Body Lotion

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 02/28/2024

Desc: Light & Natural Carotone Brightening Soap
Notes: This product appears to be an unapproved new drug, as the product’s labeling includes statements such as: “Provides protection against UV and sun rays… Brighten up your skin complexion in just 3 weeks.”

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 02/28/2024

Desc: Light & Natural Carotone Serum B.S.C (Black Spot Corrector)
Notes: This product appears to be an unapproved new drug, as the product’s labeling includes statements such as: “Eliminates all spots and marks that are on hands, feet, elbows.”

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 08/17/2017

Desc: Carotone TRIO B.S.C Black Spot Corrector Kit
Notes: The product is packaged as a kit that contains a lotion; serum; creme; and bar of soap.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 05/29/2015

Desc: G&G Lightening Beauty Cream
Notes: Product label made medical claims and does not declare the hydroquinone ingredients and exceeds the 2% allowable limit.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 02/06/2015

Desc: Maxi Light Lightening & Purifying Body Lotion

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 03/25/2015

Desc: Immediat Claire Lightening Body Cream with Carrot Extract

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 08/31/2023

Desc: CAROTONE Clarifying Cream

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 08/25/2017

Desc: Dawny Lightening Body Lotion
Notes: Product contains undeclared Hydroquinone.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 08/17/2017

Desc: Carotone TRIO B.S.C Black Spot Corrector Kit
Notes: The product is packaged as a kit that contains a lotion; serum; creme; and bar of soap.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 02/28/2024

Desc: Light & Natural Carotone Serum B.S.C (Black Spot Corrector)
Notes: This product appears to be an unapproved new drug, as the product’s labeling includes statements such as: “Eliminates all spots and marks that are on hands, feet, elbows.”

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 08/31/2023

Desc: CAROTONE Brightening Body Lotion

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 02/06/2015

Desc: Maxi Light Lightening & Purifying Body Creme
Notes: The aforementioned product appears to be an unapproved new drug as the product label claims that the intended uses for the product include; but may not be limited to; the following; Maxi Light is an important element of a new generation of purifying and lightening care; It clarifies; unifies and rids your skin of brown spots; The beauty complex contains; -vitamins A & E (to smooth; to rejuvenate and protect your skin against sun?s UV); Spot free and net skin.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 02/28/2024

Desc: Light & Natural Carotone Brightening Soap
Notes: This product appears to be an unapproved new drug, as the product’s labeling includes statements such as: “Provides protection against UV and sun rays… Brighten up your skin complexion in just 3 weeks.”

63 V - - 99 Depigmentor N.E.C.
Date Published: 02/28/2024

Desc: Light & Natural Carotone Serum B.S.C (Black Spot Corrector)
Notes: This product appears to be an unapproved new drug, as the product’s labeling includes statements such as: “Eliminates all spots and marks that are on hands, feet, elbows.”

63 V - - 99 Depigmentor N.E.C.
Date Published: 08/17/2017

Desc: Carotone TRIO B.S.C Black Spot Corrector Kit
Notes: The product is packaged as a kit that contains a lotion; serum; creme; and bar of soap.

63 V - - 99 Depigmentor N.E.C.
Date Published: 02/28/2024

Desc: Light & Natural Carotone Brightening Soap
Notes: This product appears to be an unapproved new drug, as the product’s labeling includes statements such as: “Provides protection against UV and sun rays… Brighten up your skin complexion in just 3 weeks.”

63 V - - 99 Depigmentor N.E.C.
Date Published: 02/11/2015

Desc: Pure Skin Vanishing Care Body Lotion
Notes: The aforementioned product appears to be an unapproved new drug as it contains an active pharmaceutical ingredient; Clobetasol Propionate; and the product label lists the intended uses for the product to include; but may not be limited to; the following; ?Moisturizing Anti-Spot?; and ?Pure Skin lightening care body lotion with pomegranate seeds and collagen; oxygenates the epidermis giving it; day after day; a radiant complexion?.

63 V - - 99 Depigmentor N.E.C.
Date Published: 08/25/2017

Desc: Dawny Lightening Body Lotion
Notes: Product contains undeclared Hydroquinone.

64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 04/21/2015

Desc: Bio Claire Lightening Body Cream
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following; Lightening Body Cream without Hydroquinone; and The lightening cream Bio Claire without hydroquinone stimulates the lightening process in a natural way; ensures complete elimination of cutaneous defects and makes your complexion clear and even; with no mess. In addition; FDA analysis found the aforementioned product to contain Clobetasol Propionate; an active pharmaceutical ingredient.

64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 02/11/2015

Desc: Pure Skin Vanishing Care Body Lotion
Notes: The aforementioned product appears to be an unapproved new drug as it contains an active pharmaceutical ingredient; Clobetasol Propionate; and the product label lists the intended uses for the product to include; but may not be limited to; the following; ?Moisturizing Anti-Spot?; and ?Pure Skin lightening care body lotion with pomegranate seeds and collagen; oxygenates the epidermis giving it; day after day; a radiant complexion?.

65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 02/28/2024

Desc: Light & Natural Carotone Brightening Soap
Notes: This product appears to be an unapproved new drug, as the product’s labeling includes statements such as: “Provides protection against UV and sun rays… Brighten up your skin complexion in just 3 weeks.”

65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 02/28/2024

Desc: Light & Natural Carotone Serum B.S.C (Black Spot Corrector)
Notes: This product appears to be an unapproved new drug, as the product’s labeling includes statements such as: “Eliminates all spots and marks that are on hands, feet, elbows.”

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 02/28/2024

Desc: Light & Natural Carotone Brightening Soap
Notes: This product appears to be an unapproved new drug, as the product’s labeling includes statements such as: “Provides protection against UV and sun rays… Brighten up your skin complexion in just 3 weeks.”

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/28/2024

Desc: Light & Natural Carotone Serum B.S.C (Black Spot Corrector)
Notes: This product appears to be an unapproved new drug, as the product’s labeling includes statements such as: “Eliminates all spots and marks that are on hands, feet, elbows.”

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/25/2017

Desc: Dawny Lightening Body Lotion
Notes: Product contains undeclared Hydroquinone.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/31/2023

Desc: CAROTONE Brightening Body Lotion

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/25/2015

Desc: Immediat Claire Lightening Body Cream with Carrot Extract

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/21/2015

Desc: Bio Claire Lightening Body Cream
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following; Lightening Body Cream without Hydroquinone; and The lightening cream Bio Claire without hydroquinone stimulates the lightening process in a natural way; ensures complete elimination of cutaneous defects and makes your complexion clear and even; with no mess. In addition; FDA analysis found the aforementioned product to contain Clobetasol Propionate; an active pharmaceutical ingredient

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/06/2015

Desc: Maxi Light Lightening & Purifying Body Lotion

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/04/2018

Desc: Carotene Brightening Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/17/2017

Desc: Carotone TRIO B.S.C Black Spot Corrector Kit
Notes: The product is packaged as a kit that contains a lotion; serum; creme; and bar of soap.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/31/2023

Desc: CAROTONE Clarifying Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/28/2013

Desc: G&G Purifying Beauty Soap
Notes: Ivory Coast

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/28/2024

Desc: Light & Natural Carotone Brightening Soap
Notes: This product appears to be an unapproved new drug, as the product’s labeling includes statements such as: “Provides protection against UV and sun rays… Brighten up your skin complexion in just 3 weeks.”

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 08/17/2017

Desc: Carotone TRIO B.S.C Black Spot Corrector Kit
Notes: The product is packaged as a kit that contains a lotion; serum; creme; and bar of soap.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 08/25/2017

Desc: Dawny Lightening Body Lotion
Notes: Product contains undeclared Hydroquinone.

Royale Distribution
Date Published : 04/25/2011
04 Bp 1282 , Abidjan, IVORY COAST
53 L - - -- Skin Care Prep
Date Published: 04/25/2011

Desc: Hermonie Reparateur Performance Multi-Action (Lightening Cream)
Notes: Ivory Coast

65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 04/25/2011

Desc: Hermonie Reparateur Performance Multi-Action (Lightening Cream)
Notes: Ivory Coast

66 - - - -- Human and Animal Drugs
Date Published: 04/25/2011

Desc: Hermonie Reparateur Performance Multi-Action (Lightening Cream)
Notes: Ivory Coast

SIVOP
Date Published : 07/16/2018
Cote d' Ivoire , Abidjan, IVORY COAST
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/16/2018

Desc: Caro-Light Lightening Body Oil
Notes: The product appears to be an unapproved new drug as the product includes claims such as; '... LIGHTENING BODY OIL ... Gradually eliminates dark spots ...'.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/16/2018

Desc: Caro-Light Lightening Body Oil
Notes: The product appears to be an unapproved new drug as the product includes claims such as; '... LIGHTENING BODY OIL ... Gradually eliminates dark spots ...'.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 07/16/2018

Desc: Caro-Light Lightening Body Oil
Notes: The product appears to be an unapproved new drug as the product includes claims such as; '... LIGHTENING BODY OIL ... Gradually eliminates dark spots ...'. ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/16/2018

Desc: Caro-Light Lightening Body Oil
Notes: The product appears to be an unapproved new drug as the product includes claims such as; '... LIGHTENING BODY OIL ... Gradually eliminates dark spots ...'. ;


JAMAICA


Delightful Gardens Enterprise Limited
Date Published : 06/15/2020
1027 Delightful District Po , Junction, Saint Elizabeth JAMAICA
28 A - - 49 Turmeric, Whole (Spice)
Date Published: 06/15/2020

Desc: Delightful Gardens Turmeric Root Capsule

28 B - - 49 Turmeric, Ground, Cracked (Spice)
Date Published: 06/15/2020

Desc: Delightful Gardens Turmeric Root Capsule

30 G - - 99 Beverage Base of Non-Fruit Origin, Liquid, N.E.C.
Date Published: 06/15/2020

Desc: Delightful Gardens Aloenoni Plus

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 06/15/2020

Desc: Delightful Gardens Moringa Plus Organic Vegetable Capsules

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 06/15/2020

Desc: Delightful Gardens Turmeric Root Capsule

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 06/15/2020

Desc: Delightful Gardens Aloenoni Plus

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 06/15/2020

Desc: Delightful Gardens Moringa Leaf Capsule

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/15/2020

Desc: Delightful Gardens Aloenoni Plus

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/15/2020

Desc: Delightful Gardens Moringa Leaf Capsule

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/15/2020

Desc: Delightful Gardens Turmeric Root Capsule

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/15/2020

Desc: Delightful Gardens Moringa Plus Organic Vegetable Capsules

54 J - - 08 Aloe (Herbal and Botanical Teas II, (continued))
Date Published: 06/15/2020

Desc: Delightful Gardens Aloenoni Plus

54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued)
Date Published: 06/15/2020

Desc: Delightful Gardens Moringa Plus Organic Vegetable Capsules

54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued)
Date Published: 06/15/2020

Desc: Delightful Gardens Moringa Leaf Capsule

54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued))
Date Published: 06/15/2020

Desc: Delightful Gardens Aloenoni Plus

54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd
Date Published: 06/15/2020

Desc: Delightful Gardens Moringa Leaf Capsule

54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd
Date Published: 06/15/2020

Desc: Delightful Gardens Moringa Plus Organic Vegetable Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/15/2020

Desc: Delightful Gardens Moringa Plus Organic Vegetable Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/15/2020

Desc: Delightful Gardens Aloenoni Plus

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/15/2020

Desc: Delightful Gardens Moringa Leaf Capsule

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/15/2020

Desc: Delightful Gardens Turmeric Root Capsule

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/15/2020

Desc: Delightful Gardens Moringa Leaf Capsule

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/15/2020

Desc: Delightful Gardens Aloenoni Plus

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/15/2020

Desc: Delightful Gardens Moringa Plus Organic Vegetable Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/15/2020

Desc: Delightful Gardens Turmeric Root Capsule

Immuno Venture Products Limited
Date Published : 04/20/2011
12 Manchester Avenue , May Pen, JAMAICA
41 G - - 99 Medical Foods, N.E.C.
Date Published: 04/20/2011

Desc: Immuno-gizer Fat Reducer
Notes: Country; Jamaica

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/20/2011

Desc: Immuno-gizer Fat Reducer
Notes: Country; Jamaica

Immuno Venture Products Limited
Date Published : 04/26/2011
12 Manchester Avenue , May Pen, JAMAICA
41 G - - 99 Medical Foods, N.E.C.
Date Published: 04/26/2011

Desc: Immuno-Gizer Fat Reducer
Notes: Jamaica

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/26/2011

Desc: Immuno-Gizer Fat Reducer
Notes: Jamaica

Immuno Venture Products Ltd
Date Published : 04/20/2011
Clarendon, Jamaica , May Pen, Clarendon JAMAICA
41 G - - 99 Medical Foods, N.E.C.
Date Published: 04/20/2011

Desc: Immuno-gizer Fat Reducer
Notes: Country; Jamaica

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/20/2011

Desc: Immuno-gizer Fat Reducer
Notes: Country; Jamaica

P.A. Benjamin Manufacturing Company Limited
Date Published : 07/01/2016
95-97 East Street , Kingston, JM-01 JAMAICA
31 K - - -- Tea
Date Published: 07/01/2016

Desc: Herbal Tea - Ginger Mint

31 K - - -- Tea
Date Published: 07/01/2016

Desc: Herbal Tea

31 K - - -- Tea
Date Published: 07/01/2016

Desc: Herbal Tea - Peppermint

31 K - - -- Tea
Date Published: 07/01/2016

Desc: Herbal Tea - Lemon Grass

31 K - - -- Tea
Date Published: 07/01/2016

Desc: Herbal Tea - Sorrel Ginger

54 E - - 52 Kava Kava (Herbal & Botanical Teas)
Date Published: 07/01/2016

Desc: Herbal Tea

54 E - - 52 Kava Kava (Herbal & Botanical Teas)
Date Published: 07/01/2016

Desc: Herbal Tea - Peppermint

54 E - - 52 Kava Kava (Herbal & Botanical Teas)
Date Published: 07/01/2016

Desc: Herbal Tea - Lemon Grass

54 E - - 52 Kava Kava (Herbal & Botanical Teas)
Date Published: 07/01/2016

Desc: Herbal Tea - Ginger Mint

54 E - - 52 Kava Kava (Herbal & Botanical Teas)
Date Published: 07/01/2016

Desc: Herbal Tea - Sorrel Ginger


JAPAN


8 Knot
Date Published : 09/13/2019
1339-1 , Shin'Asahichoshinjo , Takashima, Shiga JAPAN
29 W - - 01 Bottled Water
Date Published: 09/13/2019

Notes: Tokpela's Mist eliminates ROS* (Reactive Oxygen Species) is believed to cause conditions including cancer, high blood pressure, diabetes, kidney disease. Tokpela's Mist makes stressed erythrocytes "Red Blood Cells" (RBC's) more flexible. RBC's ... can then effortlessly pass smoothly through our capillaries . RBC's accordingly can quickly carry oxygen to our extremities. Although "Tokpela's Mist (Miracle Water)" appears to be sold as a food, in that its label bears a Nutrition Facts panel, the above claims cause the product to be a new drug.

29 W - - 02 Bottled Spring or Mineral Water
Date Published: 09/13/2019

Notes: Tokpela's Mist eliminates ROS* (Reactive Oxygen Species) is believed to cause conditions including cancer, high blood pressure, diabetes, kidney disease. Tokpela's Mist makes stressed erythrocytes "Red Blood Cells" (RBC's) more flexible. RBC's ... can then effortlessly pass smoothly through our capillaries . RBC's accordingly can quickly carry oxygen to our extremities. Although "Tokpela's Mist (Miracle Water)" appears to be sold as a food, in that its label bears a Nutrition Facts panel, the above claims cause the product to be a new drug.

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 09/13/2019

Notes: Tokpela's Mist eliminates ROS* (Reactive Oxygen Species) is believed to cause conditions including cancer, high blood pressure, diabetes, kidney disease. Tokpela's Mist makes stressed erythrocytes "Red Blood Cells" (RBC's) more flexible. RBC's ... can then effortlessly pass smoothly through our capillaries . RBC's accordingly can quickly carry oxygen to our extremities. Although "Tokpela's Mist (Miracle Water)" appears to be sold as a food, in that its label bears a Nutrition Facts panel, the above claims cause the product to be a new drug.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/13/2019

Notes: Tokpela's Mist eliminates ROS* (Reactive Oxygen Species) is believed to cause conditions including cancer, high blood pressure, diabetes, kidney disease. Tokpela's Mist makes stressed erythrocytes "Red Blood Cells" (RBC's) more flexible. RBC's ... can then effortlessly pass smoothly through our capillaries . RBC's accordingly can quickly carry oxygen to our extremities. Although "Tokpela's Mist (Miracle Water)" appears to be sold as a food, in that its label bears a Nutrition Facts panel, the above claims cause the product to be a new drug.

8 Knot Co Ltd
Date Published : 09/30/2009
3-7-21 Minamisuitasuita City , Osaka, JAPAN
29 W - - 01 Bottled Water
Date Published: 09/30/2009

Notes: 7/25/08. Tokpela's Mist Bottled Water. A pamphlet accompanying this product claims: "Tokpela's Mist eliminates ROS (Reactive Oxygen Species). It is believed to cause conditions including cancer, high blood pressure, diabetes and kidney disease" Also, "Tokpela's Mist makes stressed erythrocytes- Red Blood Cells - more flexible. RBCs can then effortlessly pass smoothly through our capillaries. RBC's accordingly can quickly carry oxygen to our extremities." Although the water appears to be sold as a food, in that its label bears a Nutrition Facts panel, the above claims cause the product to be a new drug.

29 W - - 02 Bottled Spring or Mineral Water
Date Published: 09/30/2009

Notes: 7/25/08. Tokpela's Mist Bottled Water. A pamphlet accompanying this product claims7/25/08. Tokpela's Mist Bottled Water. A pamphlet accompanying this product claims: "Tokpela's Mist eliminates ROS (Reactive Oxygen Species). It is believed to cause conditions including cancer, high blood pressure, diabetes and kidney disease" Also, "Tokpela's Mist makes stressed erythrocytes- Red Blood Cells - more flexible. RBCs can then effortlessly pass smoothly through our capillaries. RBC's accordingly can quickly carry oxygen to our extremities." Although the water appears to be sold as a food, in that its label bears a Nutrition Facts panel, the above claims cause the product to be a new drug.

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 09/30/2009

Notes: 7/25/08. Tokpela's Mist Bottled Water. A pamphlet accompanying this product claims: "Tokpela's Mist eliminates ROS (Reactive Oxygen Species). It is believed to cause conditions including cancer, high blood pressure, diabetes and kidney disease" Also, "Tokpela's Mist makes stressed erythrocytes- Red Blood Cells - more flexible. RBCs can then effortlessly pass smoothly through our capillaries. RBC's accordingly can quickly carry oxygen to our extremities." Although the water appears to be sold as a food, in that its label bears a Nutrition Facts panel, the above claims cause the product to be a new drug.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 7/25/08. Tokpela's Mist Bottled Water. A pamphlet accompanying this product claims: "Tokpela's Mist eliminates ROS (Reactive Oxygen Species). It is believed to cause conditions including cancer, high blood pressure, diabetes and kidney disease" Also, "Tokpela's Mist makes stressed erythrocytes- Red Blood Cells - more flexible. RBCs can then effortlessly pass smoothly through our capillaries. RBC's accordingly can quickly carry oxygen to our extremities." Although the water appears to be sold as a food, in that its label bears a Nutrition Facts panel, the above claims cause the product to be a new drug.

BIRDS & ARROWS INC
Date Published : 02/05/2020
6-16 Aokicho Kanagawa-Ku , Kanagawa, JAPAN
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 02/05/2020

Desc: WHITE CONC Body Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '...refines your skin surface and provides exotic white skin tones'; '...for whitening and massage'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/05/2020

Desc: WHITE CONC Body Oil
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '...refines your skin surface and provides exotic white skin tones'; '...for whitening and massage'.

Itoh Kanpo Pharmaceutical Co.,Ltd.
Date Published : 03/11/2015
Higashi Osaka , 2 Chome 4-1; Nagatahigashi , Higashiosaka, Osaka JAPAN
53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations)
Date Published: 03/11/2015

Desc: Hot Spring Series Arima (Relaxing Mineral Bath Soak)

53 B - - 99 Other Bath Preparations, N.E.C.
Date Published: 03/11/2015

Desc: Hot Spring Series Arima (Relaxing Mineral Bath Soak)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/11/2015

Desc: Hot Spring Series Arima (Relaxing Mineral Bath Soak)

Japan Hokkaido Cangye Pharmacy
Date Published : 09/25/2015
Katsushika-Ku, Shinkoiwa , Tokyo, JAPAN
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/25/2015

Desc: Pill for Weight Reduction
Notes: Found to contain undeclared Sildenafil and Phenolphthalein

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 09/25/2015

Desc: Pill for Weight Reduction
Notes: Found to contain undeclared Sildenafil and Phenolphthalein

63 H - - 17 Phenolphthalein (Cathartic)
Date Published: 09/25/2015

Desc: Pill for Weight Reduction
Notes: Found to contain undeclared Sildenafil and Phenolphthalein

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/25/2015

Desc: Pill for Weight Reduction
Notes: Found to contain undeclared Sildenafil and Phenolphthalein

Japanese Mayo Kaisha Pharmacy Export Ltd
Date Published : 09/30/2009
16F, Bi Fu Tong Bldg No. 88 , Gao Shi Da Dao , Tokyo, JAPAN
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/13/2019

Desc: Stree Overload Capsules
Notes: This product insert claims that the capsules can treat male impotence; prostatitis; and sexual impotence caused by diabetes. The product is also claimed to be superior to the erectile dysfunction drugs Viagra and Cialis. 8/10/2009

Kenrico LTD
Date Published : 01/13/2011
1796 6 , Kanaya; Sizuoka , Kanaya, JAPAN
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/13/2011

Desc: Bodi Detox Patch
Notes: Japan

Natsuko Enterprises
Date Published : 09/30/2009
362-10-1104 Kamiokuma , Kasuya-machi, Kasuya-Gun , Fukuoka 811-2301, JAPAN
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                          

Nizona Corporation
Date Published : 08/28/2014
107, Konan Chateau Bldg. , 5-1-13 Onoe-dori, Chuo-ku , Kobe, JAPAN
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 08/28/2014

Desc: Salasia Fiber Granules Dietary Supplement
Notes: Unapproved New Drug; Misbranded

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/28/2014

Desc: Salasia Fiber Granules Dietary Supplement
Notes: Unapproved New Drug; Misbranded

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/28/2014

Desc: Salasia Fiber Granules Dietary Supplement
Notes: Unapproved New Drug; Misbranded

O'will Corporation
Date Published : 09/30/2009
2-13-12, Hirakawa-cho, Chiyoda-ku , Tokyo, JP-13 JAPAN
53 - - - -- Cosmetics
Date Published: 09/30/2009

Notes: 12/5/2007. Nivea Goodbye. Product has been previously submitted for import misdeclared and product coded 53LF 06 as a moisturizing cosmetic. The product labeling states "continuous release one of it ingrediants into the fatty tissue of the skin." The OTC Monograph system does not include timed release or sustained release drug products, a dosage form that is designed to release the ingrediants over a prolonged period of time. All products in timed release dosage form are new drugs requiring approved applications.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 12/5/2007. Nivea Goodbye. Product has been previously submitted for import misdeclared and product coded 53LF 06 as a moisturizing cosmetic. The product labeling states "continuous release one of it ingrediants into the fatty tissue of the skin." The OTC Monograph system does not include timed release or sustained release drug products, a dosage form that is designed to release the ingrediants over a prolonged period of time. All products in timed release dosage form are new drugs requiring approved applications.

Otsuka Pharmaceutical Factory
Date Published : 08/14/2010
115 , Muyachokizu , Naruto, Tokushima JAPAN
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 08/14/2010

Desc: Oronine H Ointment
Notes: Japan

61 L - - 14 Chlorhexidine Gluconate
Date Published: 08/24/2010

Desc: Oronine H Ointment
Notes: Japan ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/14/2010

Desc: Oronine H Ointment
Notes: Japan

SANSHOKAKEN K.K.
Date Published : 11/05/2019
1 Chome 7-25 , Sugimoto; Sumiyoshi , Osaka, Osaka JAPAN
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/05/2019

Desc: Sanaderm Anti-Aging Serum
Notes: The product appears to be an unapproved new drug in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a), because it is intended to prevent, treat or cure disease conditions, and/or affect the structure or function of the body. Examples of claims observed on the firm's website, which identified product's label documenting the intended use of the product. These claims include, but are not limited to the following: "Prevent oxidation . . . whiten, and firm your skin. . ..". The product also appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended or suggested in its labeling.

Sujie Pharmaceutical Ltd
Date Published : 10/08/2013
Unknown , Tokyo, JAPAN
65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 10/08/2013

Desc: Tatiomax Lyophilized Powder for Injection
Notes: Japan

Yugen Kaisha Yamamoto Shoji
Date Published : 08/30/2021
Iwaya Nakamachi, Nada-Ku , 2 Chome 1-4; Iwayanaka-Machi; Nada , Kobe, Hyogo JAPAN
66 - - - -- Human and Animal Drugs
Date Published: 08/30/2021

Desc: Superior Fu Fang Jin Qian Chao Pill

66 - - - -- Human and Animal Drugs
Date Published: 08/30/2021

Desc: Moschus fel Ursi Chufeng Toukuwan


JORDAN


AMMAN PHARMACEUTICAL INDUSTRIES
Date Published : 09/12/2023
Building 108 , Street A3, King Abdullah Ii Industrial City , Amman, The Capital JORDAN
55 Q Y - 58 Glycerin (Pharmaceutic Necessity - Solvent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Dryness Relief PF

55 Q Y - 58 Glycerin (Pharmaceutic Necessity - Solvent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Eye Lid Relief PF

55 Q Y - 58 Glycerin (Pharmaceutic Necessity - Solvent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Floaters Relief

55 Q Y - 58 Glycerin (Pharmaceutic Necessity - Solvent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Pink Eye Relief PF

55 Q Y - 58 Glycerin (Pharmaceutic Necessity - Solvent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Stye Relief

55 Q Y - 58 Glycerin (Pharmaceutic Necessity - Solvent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Allergy Eyes Relief

55 Q Y - 58 Glycerin (Pharmaceutic Necessity - Solvent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Twitching Relief

55 Q Y - 58 Glycerin (Pharmaceutic Necessity - Solvent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Aging Eye Relief

55 Q Y - 58 Glycerin (Pharmaceutic Necessity - Solvent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Eye Strain Relief

55 Q Y - 58 Glycerin (Pharmaceutic Necessity - Solvent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Dryness Relief

55 Q Y - 58 Glycerin (Pharmaceutic Necessity - Solvent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Allergy Relief PF

55 Q Y - 58 Glycerin (Pharmaceutic Necessity - Solvent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Blur Relief

55 Q Y - 58 Glycerin (Pharmaceutic Necessity - Solvent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Eye Lid Relief

55 Q Y - 58 Glycerin (Pharmaceutic Necessity - Solvent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Pink Eye Relief

55 Q Y - 58 Glycerin (Pharmaceutic Necessity - Solvent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Red Eye Relief

55 R Y - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Dryness Relief PF

55 R Y - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Aging Eye Relief

55 R Y - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Pink Eye Relief

55 R Y - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Blur Relief

55 R Y - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Eye Strain Relief

55 R Y - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Allergy Relief PF

55 R Y - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Floaters Relief

55 R Y - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Stye Relief

55 R Y - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Allergy Eyes Relief

55 R Y - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Eye Lid Relief PF

55 R Y - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Red Eye Relief

55 R Y - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Eye Lid Relief

55 R Y - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Dryness Relief

55 R Y - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Pink Eye Relief PF

55 R Y - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Twitching Relief

55 R Y - 99 Pharmaceutic Necessities, N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Blur Relief

55 R Y - 99 Pharmaceutic Necessities, N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Dryness Relief PF

55 R Y - 99 Pharmaceutic Necessities, N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Floaters Relief

55 R Y - 99 Pharmaceutic Necessities, N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Pink Eye Relief

55 R Y - 99 Pharmaceutic Necessities, N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Twitching Relief

55 R Y - 99 Pharmaceutic Necessities, N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Eye Strain Relief

55 R Y - 99 Pharmaceutic Necessities, N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Eye Lid Relief PF

55 R Y - 99 Pharmaceutic Necessities, N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Allergy Relief PF

55 R Y - 99 Pharmaceutic Necessities, N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Pink Eye Relief PF

55 R Y - 99 Pharmaceutic Necessities, N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Aging Eye Relief

55 R Y - 99 Pharmaceutic Necessities, N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Dryness Relief

55 R Y - 99 Pharmaceutic Necessities, N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Stye Relief

55 R Y - 99 Pharmaceutic Necessities, N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Red Eye Relief

55 R Y - 99 Pharmaceutic Necessities, N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Allergy Eyes Relief

55 R Y - 99 Pharmaceutic Necessities, N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Eye Lid Relief

60 C D L 99 Adrenergic N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Floaters Relief

60 C D L 99 Adrenergic N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief PF

60 C D L 99 Adrenergic N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief

60 C D L 99 Adrenergic N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Allergy Eyes Relief

60 C D L 99 Adrenergic N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief

60 C D L 99 Adrenergic N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief PF

60 C D L 99 Adrenergic N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Allergy Relief PF

60 C D L 99 Adrenergic N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief

60 C D L 99 Adrenergic N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief PF

60 C D L 99 Adrenergic N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Blur Relief

60 C D L 99 Adrenergic N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Red Eye Relief

60 C D L 99 Adrenergic N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Aging Eye Relief

60 C D L 99 Adrenergic N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Twitching Relief

60 C D L 99 Adrenergic N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Stye Relief

60 C D L 99 Adrenergic N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Eye Strain Relief

63 H B L 15 Mineral Oil (Cathartic), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Blur Relief

63 H B L 15 Mineral Oil (Cathartic), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Eye Strain Relief

63 H B L 15 Mineral Oil (Cathartic), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief

63 H B L 15 Mineral Oil (Cathartic), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Twitching Relief

63 H B L 15 Mineral Oil (Cathartic), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief

63 H B L 15 Mineral Oil (Cathartic), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Red Eye Relief

63 H B L 15 Mineral Oil (Cathartic), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Floaters Relief

63 H B L 15 Mineral Oil (Cathartic), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief PF

63 H B L 15 Mineral Oil (Cathartic), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Allergy Eyes Relief

63 H B L 15 Mineral Oil (Cathartic), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief

63 H B L 15 Mineral Oil (Cathartic), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Stye Relief

63 H B L 15 Mineral Oil (Cathartic), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Allergy Relief PF

63 H B L 15 Mineral Oil (Cathartic), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Aging Eye Relief

63 H B L 15 Mineral Oil (Cathartic), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief PF

63 H B L 15 Mineral Oil (Cathartic), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief PF

64 D A K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief

64 D A K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief PF

64 D A K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief PF

64 D A K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief

64 D A K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Red Eye Relief

64 D A K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Twitching Relief

64 D A K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief

64 D A K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Floaters Relief

64 D A K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief PF

64 D A K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Allergy Relief PF

64 D A K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Blur Relief

64 D A K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Aging Eye Relief

64 D A K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Eye Strain Relief

64 D A K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Allergy Eyes Relief

64 D A K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Stye Relief

64 D A L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Twitching Relief

64 D A L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief PF

64 D A L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief

64 D A L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Red Eye Relief

64 D A L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Blur Relief

64 D A L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Allergy Eyes Relief

64 D A L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief PF

64 D A L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Allergy Relief PF

64 D A L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief

64 D A L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Floaters Relief

64 D A L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Eye Strain Relief

64 D A L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief

64 D A L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief PF

64 D A L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Aging Eye Relief

64 D A L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Single Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Stye Relief

64 D B K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Floaters Relief

64 D B K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Twitching Relief

64 D B K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief

64 D B K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief

64 D B K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Stye Relief

64 D B K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Allergy Relief PF

64 D B K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief

64 D B K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief PF

64 D B K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief PF

64 D B K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief PF

64 D B K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Allergy Eyes Relief

64 D B K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Aging Eye Relief

64 D B K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Red Eye Relief

64 D B K 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Blur Relief

64 D B L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief PF

64 D B L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Floaters Relief

64 D B L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Allergy Eyes Relief

64 D B L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief PF

64 D B L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Blur Relief

64 D B L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Red Eye Relief

64 D B L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Stye Relief

64 D B L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Eye Strain Relief

64 D B L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Twitching Relief

64 D B L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief

64 D B L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief

64 D B L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief PF

64 D B L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Aging Eye Relief

64 D B L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Allergy Relief PF

64 D B L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief

64 D B Y 02 Polyethylene Glycol, Emollient,Lubricant, Human - Non/Rx Combination Ingredient, NEC
Date Published: 09/12/2023

Desc: Dryness Relief

64 D B Y 02 Polyethylene Glycol, Emollient,Lubricant, Human - Non/Rx Combination Ingredient, NEC
Date Published: 09/12/2023

Desc: Eye Lid Relief PF

64 D B Y 02 Polyethylene Glycol, Emollient,Lubricant, Human - Non/Rx Combination Ingredient, NEC
Date Published: 09/12/2023

Desc: Blur Relief

64 D B Y 02 Polyethylene Glycol, Emollient,Lubricant, Human - Non/Rx Combination Ingredient, NEC
Date Published: 09/12/2023

Desc: Stye Relief

64 D B Y 02 Polyethylene Glycol, Emollient,Lubricant, Human - Non/Rx Combination Ingredient, NEC
Date Published: 09/12/2023

Desc: Eye Strain Relief

64 D B Y 02 Polyethylene Glycol, Emollient,Lubricant, Human - Non/Rx Combination Ingredient, NEC
Date Published: 09/12/2023

Desc: Allergy Relief PF

64 D B Y 02 Polyethylene Glycol, Emollient,Lubricant, Human - Non/Rx Combination Ingredient, NEC
Date Published: 09/12/2023

Desc: Pink Eye Relief

64 D B Y 02 Polyethylene Glycol, Emollient,Lubricant, Human - Non/Rx Combination Ingredient, NEC
Date Published: 09/12/2023

Desc: Eye Lid Relief

64 D B Y 02 Polyethylene Glycol, Emollient,Lubricant, Human - Non/Rx Combination Ingredient, NEC
Date Published: 09/12/2023

Desc: Aging Eye Relief

64 D B Y 02 Polyethylene Glycol, Emollient,Lubricant, Human - Non/Rx Combination Ingredient, NEC
Date Published: 09/12/2023

Desc: Red Eye Relief

64 D B Y 02 Polyethylene Glycol, Emollient,Lubricant, Human - Non/Rx Combination Ingredient, NEC
Date Published: 09/12/2023

Desc: Allergy Eyes Relief

64 D B Y 02 Polyethylene Glycol, Emollient,Lubricant, Human - Non/Rx Combination Ingredient, NEC
Date Published: 09/12/2023

Desc: Pink Eye Relief PF

64 D B Y 02 Polyethylene Glycol, Emollient,Lubricant, Human - Non/Rx Combination Ingredient, NEC
Date Published: 09/12/2023

Desc: Twitching Relief

64 D B Y 02 Polyethylene Glycol, Emollient,Lubricant, Human - Non/Rx Combination Ingredient, NEC
Date Published: 09/12/2023

Desc: Floaters Relief

64 D B Y 02 Polyethylene Glycol, Emollient,Lubricant, Human - Non/Rx Combination Ingredient, NEC
Date Published: 09/12/2023

Desc: Dryness Relief PF

64 D C K 02 Polyethylene Glycol, Emollient,Lubricant, Human - Rx/Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief

64 D C K 02 Polyethylene Glycol, Emollient,Lubricant, Human - Rx/Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief PF

64 D C K 02 Polyethylene Glycol, Emollient,Lubricant, Human - Rx/Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Twitching Relief

64 D C K 02 Polyethylene Glycol, Emollient,Lubricant, Human - Rx/Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Aging Eye Relief

64 D C K 02 Polyethylene Glycol, Emollient,Lubricant, Human - Rx/Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief PF

64 D C K 02 Polyethylene Glycol, Emollient,Lubricant, Human - Rx/Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Floaters Relief

64 D C K 02 Polyethylene Glycol, Emollient,Lubricant, Human - Rx/Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief

64 D C K 02 Polyethylene Glycol, Emollient,Lubricant, Human - Rx/Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Blur Relief

64 D C K 02 Polyethylene Glycol, Emollient,Lubricant, Human - Rx/Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Allergy Eyes Relief

64 D C K 02 Polyethylene Glycol, Emollient,Lubricant, Human - Rx/Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Allergy Relief PF

64 D C K 02 Polyethylene Glycol, Emollient,Lubricant, Human - Rx/Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief

64 D C K 02 Polyethylene Glycol, Emollient,Lubricant, Human - Rx/Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Eye Strain Relief

64 D C K 02 Polyethylene Glycol, Emollient,Lubricant, Human - Rx/Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Red Eye Relief

64 D C K 02 Polyethylene Glycol, Emollient,Lubricant, Human - Rx/Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Stye Relief

64 D C K 02 Polyethylene Glycol, Emollient,Lubricant, Human - Rx/Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief PF

65 F B K 99 Water N.E.C. (Pharmaceutic Aid), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Aging Eye Relief

65 F B K 99 Water N.E.C. (Pharmaceutic Aid), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Floaters Relief

65 F B K 99 Water N.E.C. (Pharmaceutic Aid), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Twitching Relief

65 F B K 99 Water N.E.C. (Pharmaceutic Aid), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Stye Relief

65 F B K 99 Water N.E.C. (Pharmaceutic Aid), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief PF

65 F B K 99 Water N.E.C. (Pharmaceutic Aid), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief PF

65 F B K 99 Water N.E.C. (Pharmaceutic Aid), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Eye Strain Relief

65 F B K 99 Water N.E.C. (Pharmaceutic Aid), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief

65 F B K 99 Water N.E.C. (Pharmaceutic Aid), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Allergy Eyes Relief

65 F B K 99 Water N.E.C. (Pharmaceutic Aid), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief

65 F B K 99 Water N.E.C. (Pharmaceutic Aid), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Red Eye Relief

65 F B K 99 Water N.E.C. (Pharmaceutic Aid), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief PF

65 F B K 99 Water N.E.C. (Pharmaceutic Aid), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief

65 F B K 99 Water N.E.C. (Pharmaceutic Aid), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Allergy Relief PF

65 F B K 99 Water N.E.C. (Pharmaceutic Aid), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Blur Relief

65 F B L 06 Water, Purified (Eyewash), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Stye Relief

65 F B L 06 Water, Purified (Eyewash), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Aging Eye Relief

65 F B L 06 Water, Purified (Eyewash), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Twitching Relief

65 F B L 06 Water, Purified (Eyewash), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief PF

65 F B L 06 Water, Purified (Eyewash), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Blur Relief

65 F B L 06 Water, Purified (Eyewash), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief

65 F B L 06 Water, Purified (Eyewash), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief PF

65 F B L 06 Water, Purified (Eyewash), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Eye Strain Relief

65 F B L 06 Water, Purified (Eyewash), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Allergy Relief PF

65 F B L 06 Water, Purified (Eyewash), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief

65 F B L 06 Water, Purified (Eyewash), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Floaters Relief

65 F B L 06 Water, Purified (Eyewash), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief

65 F B L 06 Water, Purified (Eyewash), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Red Eye Relief

65 F B L 06 Water, Purified (Eyewash), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Allergy Eyes Relief

65 F B L 06 Water, Purified (Eyewash), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief PF

65 F I L 06 Water, Purified (Eyewash), Human - Investigational, NonSterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief

65 F I L 06 Water, Purified (Eyewash), Human - Investigational, NonSterile Liquid
Date Published: 09/12/2023

Desc: Twitching Relief

65 F I L 06 Water, Purified (Eyewash), Human - Investigational, NonSterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief PF

65 F I L 06 Water, Purified (Eyewash), Human - Investigational, NonSterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief

65 F I L 06 Water, Purified (Eyewash), Human - Investigational, NonSterile Liquid
Date Published: 09/12/2023

Desc: Blur Relief

65 F I L 06 Water, Purified (Eyewash), Human - Investigational, NonSterile Liquid
Date Published: 09/12/2023

Desc: Allergy Relief PF

65 F I L 06 Water, Purified (Eyewash), Human - Investigational, NonSterile Liquid
Date Published: 09/12/2023

Desc: Eye Strain Relief

65 F I L 06 Water, Purified (Eyewash), Human - Investigational, NonSterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief

65 F I L 06 Water, Purified (Eyewash), Human - Investigational, NonSterile Liquid
Date Published: 09/12/2023

Desc: Allergy Eyes Relief

65 F I L 06 Water, Purified (Eyewash), Human - Investigational, NonSterile Liquid
Date Published: 09/12/2023

Desc: Floaters Relief

65 F I L 06 Water, Purified (Eyewash), Human - Investigational, NonSterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief PF

65 F I L 06 Water, Purified (Eyewash), Human - Investigational, NonSterile Liquid
Date Published: 09/12/2023

Desc: Stye Relief

65 F I L 06 Water, Purified (Eyewash), Human - Investigational, NonSterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief PF

65 F I L 06 Water, Purified (Eyewash), Human - Investigational, NonSterile Liquid
Date Published: 09/12/2023

Desc: Aging Eye Relief

65 F I L 06 Water, Purified (Eyewash), Human - Investigational, NonSterile Liquid
Date Published: 09/12/2023

Desc: Red Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Floaters Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Allergy Relief PF

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Stye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Blur Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Allergy Eyes Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Pink Eye Relief PF

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Eye Lid Relief PF

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Twitching Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Eye Strain Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Dryness Relief PF

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Aging Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Red Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Stye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Floaters Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Eye Lid Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Eye Strain Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Allergy Eyes Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Aging Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Allergy Relief PF

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Blur Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Dryness Relief PF

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Dryness Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Twitching Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Eye Lid Relief PF

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Red Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Pink Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Pink Eye Relief PF

Beauty Secrets For Dead Sea Products
Date Published : 09/03/2015
Gardens Street , Amman, JORDAN
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/28/2023

Desc: DARK AWAY WHITENING LOTION

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/13/2015

Desc: Whitening Cream

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/28/2023

Desc: GOOD BYE CELLULITE GEL-LOTION

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/13/2015

Desc: Night Repair Cream- Lux. Jar (50 ml)

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 09/08/2015

Desc: Paste Masks (Mud Packs) (Skin Care Preparations)
Notes: Whitening mask for Face Whitening mask for Body

65 L - - 11 Titanium Dioxide (Protectant)
Date Published: 09/03/2015

Desc: Protective Day Cream Lux Jar SPF 15
Notes: Specifically; the labels for Protective Day Cream- Lux Jar SPF 15 and Sunblock Beauty Secrets Sun Block SPF 45 do not distinguish between active and inactive ingredients. This causes all of the labeled ingredients to be represented as active ingredients for both products.

65 L - - 11 Titanium Dioxide (Protectant)
Date Published: 09/03/2015

Desc: Sunblock Beauty Secrets Sun Block SPF 45
Notes: Specifically; the labels for Protective Day Cream- Lux Jar SPF 15 and Sunblock Beauty Secrets Sun Block SPF 45 do not distinguish between active and inactive ingredients. This causes all of the labeled ingredients to be represented as active ingredients for both products.

Dead Sea Gift Enterprise
Date Published : 04/19/2013
137 Marj Al Hamam , Amman, The Capital JORDAN
53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations)
Date Published: 04/19/2013

Desc: Mud Facial Mask
Notes: Jordan

53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations)
Date Published: 04/19/2013

Desc: Bath Salts

53 G - - 01 Blushers (all Types) (Makeup Preparations, not for Eyes)
Date Published: 04/19/2013

Desc: Mud Mask

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/19/2013

Desc: Mineral Salt Soap

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/19/2013

Desc: Mud Soap

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 04/19/2013

Desc: Mud Mask

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 04/19/2013

Desc: Mud Facial Mask

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/19/2013

Desc: Mineral Salt Soap

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/19/2013

Desc: Mud Mask

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/19/2013

Desc: Bath Salts

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/19/2013

Desc: Mud Facial Mask

Jordan Co For Marketing Dead Sea Pr
Date Published : 04/03/2012
P.O. Box 212307 , Amman, The Capital JORDAN
53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations)
Date Published: 04/03/2012

Desc: Bath Salts and Tablets
Notes: Jordan

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 04/03/2012

Desc: Revitalising Mineral Shampoo
Notes: Jordan

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/03/2012

Desc: Anti-Cellulite Soap
Notes: Jordan

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/03/2012

Desc: Various Soaps- Mud; Black Seed; Scrub; Mineral Salt
Notes: Jordan

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 04/03/2012

Desc: Black Mud Mask
Notes: Jordan

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 04/03/2012

Desc: Black Mud
Notes: Jordan

53 L - - -- Skin Care Prep
Date Published: 04/03/2012

Desc: Facial Scrub Cream
Notes: Jordan

53 L - - -- Skin Care Prep
Date Published: 04/03/2012

Desc: Eye Cream
Notes: Jordan

53 L - - -- Skin Care Prep
Date Published: 04/03/2012

Desc: Night Cream
Notes: Jordan

53 L - - -- Skin Care Prep
Date Published: 04/03/2012

Desc: Moisturizing Cream
Notes: Jordan

53 L - - -- Skin Care Prep
Date Published: 04/03/2012

Desc: Day Cream; SPF 4
Notes: Jordan

53 L - - -- Skin Care Prep
Date Published: 04/03/2012

Desc: Whitening Cream
Notes: Jordan

53 L - - -- Skin Care Prep
Date Published: 04/03/2012

Desc: Body Scrub Cream
Notes: Jordan

65 L - - 99 Protectant N.E.C.
Date Published: 04/03/2012

Desc: Day Cream; SPF 4
Notes: Jordan

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 04/03/2012

Desc: Day Cream; SPF 4
Notes: Jordan

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 04/18/2012

Desc: Day Cream SPF4 Gift Set
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Bath Salts and Tablets
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Night Cream
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Day Cream; SPF 4
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Black Mud
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Facial Scrub Cream
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Body Scrub Cream
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/18/2012

Desc: Day Cream SPF4 Gift Set
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Revitalising Mineral Shampoo
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Anti-Cellulite Soap
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Whitening Cream
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Black Mud Mask
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Eye Cream
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Various Soaps- Mud; Black Seed; Scrub; Mineral Salt
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Moisturizing Cream
Notes: Jordan

Jordan Co., For Dead Sea Product
Date Published : 04/03/2012
Siqilya Street , Alshmisanee, JORDAN
53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations)
Date Published: 04/03/2012

Desc: Bath Salts and Tablets
Notes: Jordan

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 04/03/2012

Desc: Revitalising Mineral Shampoo
Notes: Jordan

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/03/2012

Desc: Various Soaps-Mud; Black Seed; Scrub; Mineral Salt
Notes: Jordan

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/03/2012

Desc: Anti-Cellulite Soap
Notes: Jordan ;

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 04/03/2012

Desc: Black Mud Mask
Notes: Jordan

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 04/03/2012

Desc: Black Mud
Notes: Jordan ;

53 L - - -- Skin Care Prep
Date Published: 04/03/2012

Desc: Night Cream & Night Cream Gift Pack
Notes: Jordan

53 L - - -- Skin Care Prep
Date Published: 04/03/2012

Desc: Facial Scrub Cream
Notes: Jordan

53 L - - -- Skin Care Prep
Date Published: 04/03/2012

Desc: Body Scrub Cream
Notes: Jordan

53 L - - -- Skin Care Prep
Date Published: 04/03/2012

Desc: Moisturizing Cream
Notes: Jordan

53 L - - -- Skin Care Prep
Date Published: 04/03/2012

Desc: Day Cream; SPF 4
Notes: Jordan

53 L - - -- Skin Care Prep
Date Published: 04/03/2012

Desc: Eye Cream
Notes: Jordan

53 L - - -- Skin Care Prep
Date Published: 04/03/2012

Desc: Whitening Cream
Notes: Jordan

65 L - - 99 Protectant N.E.C.
Date Published: 04/03/2012

Desc: Day Cream; SPF 4
Notes: Jordan

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 04/18/2012

Desc: Day Cream SPF4 Gift Set
Notes: Jordan

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 04/03/2012

Desc: Day Cream; SPF 4
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Body Scrub Cream
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Night Cream
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Bath Salts and Tablets
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Black Mud
Notes: Jordan ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Various Soaps-Mud; Black Seed; Scrub; Mineral Salt
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/18/2012

Desc: Day Cream SPF4 Gift Set
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Facial Scrub Cream
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Moisturizing Cream
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Anti-Cellulite Soap
Notes: Jordan ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Eye Cream
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Day Cream; SPF 4
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Whitening Cream
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Revitalising Mineral Shampoo
Notes: Jordan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/03/2012

Desc: Black Mud Mask
Notes: Jordan

Jordan Egypt Co Lt
Date Published : 07/31/2012
Amman , Amman, JORDAN
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 07/31/2012

Desc: Onital Acne Removal Cream Formula
Notes: Jordan

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/31/2012

Desc: Onital Acne Removal Cream Formula
Notes: Jordan

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/31/2012

Desc: Onital Acne Removal Cream Formula
Notes: Jordan

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 07/31/2012

Desc: Onital Acne Removal Cream Formula
Notes: Jordan

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/31/2012

Desc: Onital Acne Removal Cream Formula
Notes: Jordan

55 R - - 99 Pharmaceutic Necessities, N.E.C.
Date Published: 07/31/2012

Desc: Onital Acne Removal Cream Formula
Notes: Jordan

79 O - - ZC Over the counter acne treatment
Date Published: 07/31/2012

Desc: Onital Acne Removal Cream Formula
Notes: Jordan

Jothoor For Natural Products
Date Published : 06/04/2012
Sahab Altajamouat Ind. Esteat,Building B , Ammanjo, JORDAN
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 07/31/2012

Desc: Onital Acne Removal Cream Formula
Notes: Jordan; Note; Mfg per OASIS

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/31/2012

Desc: Onital Acne Removal Cream Formula
Notes: Jordan; Note; Mfg per OASIS

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/31/2012

Desc: Onital Acne Removal Cream Formula
Notes: Jordan; Note; Mfg per OASIS

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 07/31/2012

Desc: Onital Acne Removal Cream Formula
Notes: Jordan; Note; Mfg per OASIS

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/31/2012

Desc: Onital Acne Removal Cream Formula
Notes: Jordan; Note; Mfg per OASIS

55 R - - 99 Pharmaceutic Necessities, N.E.C.
Date Published: 07/31/2012

Desc: Onital Acne Removal Cream Formula
Notes: Jordan; Note; Mfg per OASIS

55 R - - 99 Pharmaceutic Necessities, N.E.C.
Date Published: 06/04/2012

Desc: Onidol Therapeutic Cream for Asthma

79 O - - ZC Over the counter acne treatment
Date Published: 07/31/2012

Desc: Onital Acne Removal Cream Formula
Notes: Jordan; Note; Mfg per OASIS


KENYA


FEYZO Limited
Date Published : 09/27/2023
Kenya Garden Plaza, Mombasa Road 1200519 , Mlolongo, Nairobi KENYA
09 A - - 02 Butter Oil
Date Published: 01/03/2024

Desc: SAAFI Goat Ghee
Notes: 09/29/2023

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/27/2023

Desc: SAAFI Goat Ghee


KOREA (THE REPUBLIC OF)


Adwin Korea Corp.
Date Published : 05/29/2015
4F Dong-A Bldg., , 769-7 Yoksam-dong , kangnam Gu, Seoul KOREA (THE REPUBLIC OF)
53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 06/19/2017

Desc: Masque Bar Anti-Blemish Prone Mud Mask

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 06/19/2017

Desc: Masque Bar Brightening Sheet Mask

62 S - - 99 Anti-Seborrheic N.E.C.
Date Published: 06/19/2017

Desc: Masque Bar Anti-Blemish Prone Mud Mask

63 V - - 99 Depigmentor N.E.C.
Date Published: 06/19/2017

Desc: Masque Bar Brightening Sheet Mask

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/19/2017

Desc: Masque Bar Anti-Blemish Prone Mud Mask

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/19/2017

Desc: Masque Bar Brightening Sheet Mask

Amorepacific Corporation - Daily Beauty Plant
Date Published : 04/24/2017
80, Daehwa-ro , Daedeok-gu , Daejeon, Daejeon KOREA (THE REPUBLIC OF)
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 04/24/2017

Desc: Amore Shampoo Set (Ryo Anti-Hair Loss Shampoo and Treatment)
Notes: Totra Co. Ltd. is the OASIS declared manufacturer.

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 04/24/2017

Desc: Amore Shampoo Set (Ryo Anti-Hair Loss Shampoo and Treatment)
Notes: Totra Co. Ltd. is the OASIS declared manufacturer.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2017

Desc: Amore Shampoo Set (Ryo Anti-Hair Loss Shampoo and Treatment)
Notes: Totra Co. Ltd. is the OASIS declared manufacturer.

Aromatica Company
Date Published : 02/04/2016
177 Sagimakgol-Lo; Jungwon , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF)
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 02/04/2016

Desc: Rose Absolute Vital Fluid Lotion

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 02/04/2016

Desc: Rose Absolute First Serum

BIO PORT KOREA,INC.
Date Published : 06/08/2015
#304 Marine Biotechnology Center San1-1 , Gwaebop-Dong , Sasang-Gu, PUSAN KOREA (THE REPUBLIC OF)
54 D - - -- Unconv Diet Spec (No Vit/Min Stmt)
Date Published: 06/08/2015

Desc: Pine Needle Extract
Notes: The above-listed product appears to be an unapproved new drug as the product website; www.qrapha.com; implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of claims on the website include; but are not limited to the following; "[P]ine needle helps to control gout; high blood pressure; prevents stroke..."; "Pine needle...control blood pressure; and reduce blood clots."; and "Silla University Food Chemistry Lab; Oct. 2006 had conducted in vivo testing that for six weeks Pine Needle extract supplemented at 100mg/kg bw/day to Sprague-Dawley; ovariectomized rats induced high cholesterol. The results stated that their total cholesterol...have decreased...".

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 06/08/2015

Desc: Pine Needle Extract
Notes: The above-listed product appears to be an unapproved new drug as the product website; www.qrapha.com; implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of claims on the website include; but are not limited to the following; "[P]ine needle helps to control gout; high blood pressure; prevents stroke..."; "Pine needle...control blood pressure; and reduce blood clots."; and "Silla University Food Chemistry Lab; Oct. 2006 had conducted in vivo testing that for six weeks Pine Needle extract supplemented at 100mg/kg bw/day to Sprague-Dawley; ovariectomized rats induced high cholesterol. The results stated that their total cholesterol...have decreased...".

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/08/2015

Desc: Pine Needle Extract
Notes: The above-listed product appears to be an unapproved new drug as the product website; www.qrapha.com; implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of claims on the website include; but are not limited to the following; "[P]ine needle helps to control gout; high blood pressure; prevents stroke..."; "Pine needle...control blood pressure; and reduce blood clots."; and "Silla University Food Chemistry Lab; Oct. 2006 had conducted in vivo testing that for six weeks Pine Needle extract supplemented at 100mg/kg bw/day to Sprague-Dawley; ovariectomized rats induced high cholesterol. The results stated that their total cholesterol...have decreased...". ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2015

Desc: Pine Needle Extract
Notes: The above-listed product appears to be an unapproved new drug as the product website; www.qrapha.com; implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of claims on the website include; but are not limited to the following; "[P]ine needle helps to control gout; high blood pressure; prevents stroke..."; "Pine needle...control blood pressure; and reduce blood clots."; and "Silla University Food Chemistry Lab; Oct. 2006 had conducted in vivo testing that for six weeks Pine Needle extract supplemented at 100mg/kg bw/day to Sprague-Dawley; ovariectomized rats induced high cholesterol. The results stated that their total cholesterol...have decreased...". ;

BTGIN Co., Ltd.
Date Published : 03/13/2023
125-6,Techno-2ro , Yuseong-Gu, Daejeon KOREA (THE REPUBLIC OF)
25 L - - 31 Ginseng, Dried or Paste (Root & Tuber Vegetable)
Date Published: 03/13/2023

Desc: BTGin Ginvichaek Saponin Hanppuri Fermented Korean Red Ginseng

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: BTGin Ginvichaek Saponin Hanppuri Fermented Korean Red Ginseng

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: BTGin Ginvichaek Saponin Hanppuri Fermented Korean Red Ginseng

Benton Inc.
Date Published : 07/07/2017
8 Yeouidaebang-Ro 24sa-Gil , Dongjak-Gu , Seoul, Seoul KOREA (THE REPUBLIC OF)
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/07/2017

Desc: Snail Bee High Content Mask Pack
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Glycerin 4% as an active ingredient; and Camellia Sinensis Leaf Water and Snail Secretion Filtrate; among others; as inactive ingredients; has functional ingredients such as Arbutin and Adenosine which helps brightening your skin and removes wrinkles

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/07/2017

Desc: Snail Bee High Content Steam Cream
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Glycerin 6.6% as an active ingredient and Snail Secretion Filtrate; among others; as an inactive ingredient ; has functional ingredients such as Niacinamide and Adenosine which helps brightening your skin and removes wrinkles.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/07/2017

Desc: Aloe BHA Skin Toner
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Salicylic Acid 0.5% as an active ingredient; and Aloe Barbadensis Leaf Water; BHA; and Snail Secretion Filtrate; among others; as inactive ingredients ; Anti-acne ; helps skin remain clear when used daily.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/07/2017

Desc: Aloe BHA Skin Toner
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Salicylic Acid 0.5% as an active ingredient; and Aloe Barbadensis Leaf Water; BHA; and Snail Secretion Filtrate; among others; as inactive ingredients ; Anti-acne ; helps skin remain clear when used daily.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/07/2017

Desc: Snail Bee High Content Steam Cream
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Glycerin 6.6% as an active ingredient and Snail Secretion Filtrate; among others; as an inactive ingredient ; has functional ingredients such as Niacinamide and Adenosine which helps brightening your skin and removes wrinkles.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/07/2017

Desc: Snail Bee High Content Mask Pack
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Glycerin 4% as an active ingredient; and Camellia Sinensis Leaf Water and Snail Secretion Filtrate; among others; as inactive ingredients; has functional ingredients such as Arbutin and Adenosine which helps brightening your skin and removes wrinkles

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/07/2017

Desc: Aloe BHA Skin Toner
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Salicylic Acid 0.5% as an active ingredient; and Aloe Barbadensis Leaf Water; BHA; and Snail Secretion Filtrate; among others; as inactive ingredients ; Anti-acne ; helps skin remain clear when used daily.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/07/2017

Desc: Snail Bee High Content Mask Pack
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Glycerin 4% as an active ingredient; and Camellia Sinensis Leaf Water and Snail Secretion Filtrate; among others; as inactive ingredients; has functional ingredients such as Arbutin and Adenosine which helps brightening your skin and removes wrinkles

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/07/2017

Desc: Snail Bee High Content Steam Cream
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Glycerin 6.6% as an active ingredient and Snail Secretion Filtrate; among others; as an inactive ingredient ; has functional ingredients such as Niacinamide and Adenosine which helps brightening your skin and removes wrinkles

53 L - - -- Skin Care Prep
Date Published: 05/08/2023

Desc: Goodbye Redness Centella Cica Mask Pack
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): Image of a red blemish with the text “GOODBYE REDNESS” from a megaphone next to it; “Relief from redness, irritation and inflamed blemishes”.

53 L - - -- Skin Care Prep
Date Published: 05/08/2023

Desc: Snail Bee High Content Steam Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): “promote collagen production”; “takes care of freckles and blemishes”; “heals injured skin”; “prevent skin damage”.

53 L - - -- Skin Care Prep
Date Published: 05/08/2023

Desc: Snail Bee High Content Essence
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): “collagen-boosting”; “CALMING ACNE”; “especially great for treating acne prone . . . skin”; “takes care of freckles and blemishes”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2023

Desc: Goodbye Redness Centella Cica Mask Pack
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): Image of a red blemish with the text “GOODBYE REDNESS” from a megaphone next to it; “Relief from redness, irritation and inflamed blemishes”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/07/2017

Desc: Aloe BHA Skin Toner
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Salicylic Acid 0.5% as an active ingredient; and Aloe Barbadensis Leaf Water; BHA; and Snail Secretion Filtrate; among others; as inactive ingredients ; Anti-acne ; helps skin remain clear when used daily.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/07/2017

Desc: Snail Bee High Content Mask Pack
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Glycerin 4% as an active ingredient; and Camellia Sinensis Leaf Water and Snail Secretion Filtrate; among others; as inactive ingredients; has functional ingredients such as Arbutin and Adenosine which helps brightening your skin and removes wrinkles

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/07/2017

Desc: Snail Bee High Content Steam Cream
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Glycerin 6.6% as an active ingredient and Snail Secretion Filtrate; among others; as an inactive ingredient ; has functional ingredients such as Niacinamide and Adenosine which helps brightening your skin and removes wrinkles. The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): “promote collagen production”; “takes care of freckles and blemishes”; “heals injured skin”; “prevent skin damage”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2023

Desc: Snail Bee High Content Essence
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): “collagen-boosting”; “CALMING ACNE”; “especially great for treating acne prone . . . skin”; “takes care of freckles and blemishes”.

Bioport Korea, Inc.
Date Published : 06/08/2015
#207 Marine Bio-industry , development center, 27 Hoenggye-ri , Ilgwang-myeon Gijang-gun, PUSAN KOREA (THE REPUBLIC OF)
54 D - - -- Unconv Diet Spec (No Vit/Min Stmt)
Date Published: 06/08/2015

Desc: Pine Needle Extract
Notes:                                                                                                                                                                                                                                                                          

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 06/08/2015

Desc: Pine Needle Extract
Notes:                                                                                                                                                                                                                                                                           

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/08/2015

Desc: Pine Needle Extract
Notes:                                                                                                                                                                                                                                                                           

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2015

Desc: Pine Needle Extract
Notes:                                                                                                                                                                                                                                                                           

Boryung Pharmaceutical Co Ltd
Date Published : 07/31/2019
Boryung Bldg 136, Changgyeonggung Ro , Seoul, KOREA (THE REPUBLIC OF)
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/31/2019

Desc: Younggaksan Powder
Notes: The product appears to be an unapproved new drug as the product's label includes disease claims such as (not an all-inclusive list): '...helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get sleep...'.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/31/2019

Desc: Younggaksan Powder
Notes: The product appears to be an unapproved new drug as the product's label includes disease claims such as (not an all-inclusive list): '...helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get sleep...'.

C T K Co Ltc
Date Published : 12/22/2014
Room 1907 Boutique Monaco Bldg , Seocho Ku, KOREA (THE REPUBLIC OF)
65 L - - 11 Titanium Dioxide (Protectant)
Date Published: 12/22/2014

Desc: CC Color Correcting Full Coverage Cream

65 L - - 99 Protectant N.E.C.
Date Published: 12/22/2014

Desc: CC Color Correcting Full Coverage Cream

CHANGJAE BENKO BIO
Date Published : 11/15/2021
Suseong , 149 Yonghak-Ro , Suseong, Daegu KOREA (THE REPUBLIC OF)
29 - - - -- Soft Drinks/Water
Date Published: 11/15/2021

Desc: Victory19 Virus Out (COVID 19 Virus Remedy)
Notes: Product label of “Victory 19 Virus Out” causes this product to be a drug under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is an article intended to diagnose, cure, mitigate, treat, or prevent disease. An example claim found on the product drug listing that documents the intended use of “Victory 19 Virus Out” includes, but may not be limited to, the following: “Prevention and treatment of COVID-19 infection”. “Victory 19 Virus Out” appears to be an unapproved new drug marketed under section 505(a) of the FD&C Act, 21 U.S.C 355(a).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 11/15/2021

Desc: Victory19 Virus Out (COVID 19 Virus Remedy)
Notes: Product label of “Victory 19 Virus Out” causes this product to be a drug under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is an article intended to diagnose, cure, mitigate, treat, or prevent disease. An example claim found on the product drug listing that documents the intended use of “Victory 19 Virus Out” includes, but may not be limited to, the following: “Prevention and treatment of COVID-19 infection”. “Victory 19 Virus Out” appears to be an unapproved new drug marketed under section 505(a) of the FD&C Act, 21 U.S.C 355(a).

66 - - - -- Human and Animal Drugs
Date Published: 11/15/2021

Desc: Victory19 Virus Out (COVID 19 Virus Remedy)
Notes: Product label of “Victory 19 Virus Out” causes this product to be a drug under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is an article intended to diagnose, cure, mitigate, treat, or prevent disease. An example claim found on the product drug listing that documents the intended use of “Victory 19 Virus Out” includes, but may not be limited to, the following: “Prevention and treatment of COVID-19 infection”. “Victory 19 Virus Out” appears to be an unapproved new drug marketed under section 505(a) of the FD&C Act, 21 U.S.C 355(a).

CHO-A Pharmaceutical Co., Ltd.
Date Published : 11/17/2022
318 Gwangjeong-Ro , Haman-Myeon , Haman, Gyeongsangnam KOREA (THE REPUBLIC OF)
64 D - - 99 Emollient, Lubricant, N.E.C.
Date Published: 11/17/2022

Desc: SeeClean-One Eye Drops
Notes: The product does not meet requirements of section 505G, under which a product is deemed to be GRASE and not a new drug. FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “SeeClean-1 Eye Drops” is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Accordingly, this product appears to be an unapproved new drug marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).

65 F - - 06 Water, Purified (Eyewash)
Date Published: 11/17/2022

Desc: SeeClean-One Eye Drops
Notes: The product does not meet requirements of section 505G, under which a product is deemed to be GRASE and not a new drug. FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “SeeClean-1 Eye Drops” is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Accordingly, this product appears to be an unapproved new drug marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 11/17/2022

Desc: SeeClean-One Eye Drops
Notes: The product does not meet requirements of section 505G, under which a product is deemed to be GRASE and not a new drug. FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “SeeClean-1 Eye Drops” is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Accordingly, this product appears to be an unapproved new drug marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).

COSMAX, INC.
Date Published : 06/04/2013
46 Jeyakgongdan2-Gil , Hyangnam-Eup , Hwaseong, Gyeonggi KOREA (THE REPUBLIC OF)
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple Mango
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Camellia
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Grape
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Lemon
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Rose
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Peppermint
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Lemon
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Peppermint
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Rose
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Camellia
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Grape
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple Mango
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Lemon
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Grape
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Peppermint
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple Mango
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Camellia
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Rose
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Grape
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Rose
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Peppermint
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Lemon
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Camellia
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple Mango
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Grape
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Lemon
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Peppermint
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Camellia
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Rose
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple Mango
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

53 L - - -- Skin Care Prep
Date Published: 08/06/2022

Desc: Vitapair C Dark Spot Cream

53 L - - -- Skin Care Prep
Date Published: 08/06/2022

Desc: Vitapair C Dark Spot Serum with Dark Spot Cream Special Set

53 L - - -- Skin Care Prep
Date Published: 06/04/2013

Desc: SUN SHIELD CAVA Sun Cream (SPF 50 ; PA)
Notes: Korea

62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Peppermint
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Grape
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Camellia
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple Mango
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Rose
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Lemon
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Rose
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Peppermint
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Lemon
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple Mango
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Camellia
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Grape
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

64 A - - 99 Disinfectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Grape
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

64 A - - 99 Disinfectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Rose
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

64 A - - 99 Disinfectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Camellia
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

64 A - - 99 Disinfectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Lemon
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

64 A - - 99 Disinfectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple Mango
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

64 A - - 99 Disinfectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Peppermint
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

64 A - - 99 Disinfectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

65 L - - 99 Protectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Camellia
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

65 L - - 99 Protectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Lemon
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

65 L - - 99 Protectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

65 L - - 99 Protectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Peppermint
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

65 L - - 99 Protectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Rose
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

65 L - - 99 Protectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Grape
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

65 L - - 99 Protectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple Mango
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

65 L - - 99 Protectant N.E.C.
Date Published: 06/04/2013

Desc: SUN SHIELD CAVA Sun Cream (SPF 50 ; PA)
Notes: Korea

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 06/04/2013

Desc: SUN SHIELD CAVA Sun Cream (SPF 50 ; PA )
Notes: Korea

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/06/2022

Desc: Vitapair C Dark Spot Serum with Dark Spot Cream Special Set

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/06/2022

Desc: Vitapair C Dark Spot Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Rose
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Lemon
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Peppermint
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Camellia
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple Mango
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Grape
Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/04/2013

Desc: SUN SHIELD CAVA Sun Cream (SPF 50 ; PA )
Notes: Korea

COSRX INC
Date Published : 04/20/2016
Bundangemtawo , 8 Gumi-Ro; Bundang , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF)
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 04/20/2021

Desc: AHA/BHA Clarifying Treatment Toner
Notes: The product appears to be an unapproved new drug as the product labeling and associated product website, www.cosrx.com, include disease claims such as: (product label) 'early prevention of whiteheads and blackheads', and (product website) indicates that the product is intended to 'stimulate cell regeneration'.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 05/03/2016

Desc: Salicylic Acid Exfoliating Cleanser

64 X - - 06 Salicylic Acid (Keratolytic)
Date Published: 05/03/2016

Desc: Salicylic Acid Exfoliating Cleanser

65 L - - 99 Protectant N.E.C.
Date Published: 04/20/2021

Desc: AHA/BHA Clarifying Treatment Toner
Notes: The product appears to be an unapproved new drug as the product labeling and associated product website, www.cosrx.com, include disease claims such as: (product label) 'early prevention of whiteheads and blackheads', and (product website) indicates that the product is intended to 'stimulate cell regeneration'.

CS LABS
Date Published : 11/15/2021
Gilju-Ro 77-37 Building , Gyeonggi-Do, KOREA (THE REPUBLIC OF)
15 B - - 07 Egg Extracts
Date Published: 11/15/2021

Desc: Lipo Lab PPC Solution (Phosphatidylcholine)
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “More efficacious and easier treatment than liposuction surgery”, “Lipo Lab PPC dissolves, destroys fat cells and exhausts them out of the body through sweat, urine and internal combustion . . ..”, “Solves the obesity of specific parts where exercises cannot do”, “Lipo Lab ppc solution treatment offer many benefits towards weight loss”, “PPC (PhosphatidylCholine) spotlighted as the latest solution to obesity, is being called ‘the 2ndbotox’.” and “The Main Use Site . . . Fat Back . . . Fat Abdominal region . . . Fat Hip . . . Fat Thighs . . .”

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/15/2021

Desc: Lipo Lab PPC Solution (Phosphatidylcholine)
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “More efficacious and easier treatment than liposuction surgery”, “Lipo Lab PPC dissolves, destroys fat cells and exhausts them out of the body through sweat, urine and internal combustion . . ..”, “Solves the obesity of specific parts where exercises cannot do”, “Lipo Lab ppc solution treatment offer many benefits towards weight loss”, “PPC (PhosphatidylCholine) spotlighted as the latest solution to obesity, is being called ‘the 2ndbotox’.” and “The Main Use Site . . . Fat Back . . . Fat Abdominal region . . . Fat Hip . . . Fat Thighs . . .”

Caregen Co., Ltd.
Date Published : 11/05/2015
270 Gongdan-Ro , Gunpo, Gyeonggi KOREA (THE REPUBLIC OF)
53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 11/27/2017

Desc: Dr. CYJ Hair Filler

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 11/27/2017

Desc: Dr. CYJ Hair Filler

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 11/05/2015

Desc: Dermaheal Anti-Wrinkle Cream
Notes: There are drug claims on the product label and on the manufacturer's website.

53 L - - 07 Night (Skin Care Preparations)
Date Published: 11/05/2015

Desc: Dermaheal Anti-Wrinkle Cream
Notes: There are drug claims on the product label and on the manufacturer's website.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 11/05/2015

Desc: Dermaheal Anti-Wrinkle Cream
Notes: There are drug claims on the product label and on the manufacturer's website.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/05/2015

Desc: Dermaheal Anti-Wrinkle Cream
Notes: There are drug claims on the product label and on the manufacturer's website.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/27/2017

Desc: Dr. CYJ Hair Filler

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/05/2015

Desc: Dermaheal Anti-Wrinkle Cream
Notes: There are drug claims on the product label and on the manufacturer's website.

Chemon Inc.
Date Published : 09/13/2019
4645 Chung-Ri , Kusung-Up Yongin-Si , Kyungki-Do, KOREA (THE REPUBLIC OF)
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/13/2019

Notes: Joint by Joint" supplement, 5/5/2003

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: Joint by Joint" supplement, 5/5/2003

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Joint by Joint" supplement, 5/5/2003

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Joint by Joint" supplement, 5/5/2003

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Joint by Joint" supplement, 5/5/2003

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Joint by Joint" supplement, 5/5/2003

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Joint by Joint" supplement, 5/5/2003

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Joint by Joint" supplement, 5/5/2003

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Joint by Joint" supplement, 5/5/2003

Ciracle
Date Published : 09/28/2016
19-3, Ugakgol-gil, Susin-myeon, , Dongnam-gu , Cheonan-si, Chungcheongnam-do KOREA (THE REPUBLIC OF)
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/28/2016

Desc: Ciracle Red Spot Cream

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/28/2016

Desc: Ciracle Red Spot Cream

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/28/2016

Desc: Ciracle Red Spot Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2016

Desc: Ciracle Red Spot Cream

Cosmecca Korea Co., Ltd.
Date Published : 06/24/2016
17-12 Daegeumro196beon-Gil , Daeso-Myeon , Eumseong, Chungcheongbuk KOREA (THE REPUBLIC OF)
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 06/24/2016

Desc: SRB 3 Lighting White Nutri-Cream

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 02/10/2021

Desc: AHA BHA PHA 30 DAYS MIRACLE SERUM
Notes: The product appears to be an unapproved new drug as the product's label and promotional website include claims such as (not an all-inclusive list): Label - 'Brightening; Skin soothing and strengthen barrier; stabilizing the skin turnover cycle'; Website - 'Treat and sooth sensitive and breakout-prone skin; This will aid in... promoting cell turnover which in turn help fade dark spots'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/30/2020

Desc: Repair Serum-Ginseng Snail Mucin (Face Serum)

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 06/24/2016

Desc: SRB 3 Lighting White Sun Cream

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 06/24/2016

Desc: SRB 3 Lighting White Sun Cream

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 06/24/2016

Desc: SRB 3 Lighting White Nutri-Cream

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 06/24/2016

Desc: SRB 3 Lighting White Nutri-Cream

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 06/24/2016

Desc: SRB 3 Lighting White Sun Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/10/2021

Desc: AHA BHA PHA 30 DAYS MIRACLE SERUM
Notes: The product appears to be an unapproved new drug as the product's label and promotional website include claims such as (not an all-inclusive list): Label - 'Brightening; Skin soothing and strengthen barrier; stabilizing the skin turnover cycle'; Website - 'Treat and sooth sensitive and breakout-prone skin; This will aid in... promoting cell turnover which in turn help fade dark spots'.

DONG HWAN PHARM IND.CO., LTD.
Date Published : 08/19/2010
189,Anyang7-Dong,Manan-Ku , Anyang-Si, KR-41 KOREA (THE REPUBLIC OF)
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

61 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

62 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

63 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

64 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

65 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

66 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

DONG SUNG BIO PHARM.CO.,LTD._Asan Factory
Date Published : 05/06/2021
45 Gwandaean-Gil , Dunpo-Myeon , Asan, Chungcheongnam KOREA (THE REPUBLIC OF)
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/06/2021

Desc: Cheong Ro Hwan -F Tablets
Notes: The product appears to be an unapproved new drug as the product’s associated website includes claims such as (not an all-inclusive list): “CheongRoHwan Dongsung *** OTC drug *** Gingival medication *** Diarrhea, dyspepsia ***Efficacy and effect Diarrhea, dyspepsia, watery stool, vomiting.”; In addition, the three cartoon characters on the Principal Display Panel showing parts of the gastrointestinal tract, including the stomach and intestines in great distress, imply disease claims by way of suggesting these products are intended to prevent, mitigate, cure, or treat medical conditions associated with the digestive system.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/06/2021

Desc: Cheong Ro Hwan -F Tablets
Notes: The product appears to be an unapproved new drug as the product’s associated website includes claims such as (not an all-inclusive list): “CheongRoHwan Dongsung *** OTC drug *** Gingival medication *** Diarrhea, dyspepsia ***Efficacy and effect Diarrhea, dyspepsia, watery stool, vomiting.”; In addition, the three cartoon characters on the Principal Display Panel showing parts of the gastrointestinal tract, including the stomach and intestines in great distress, imply disease claims by way of suggesting these products are intended to prevent, mitigate, cure, or treat medical conditions associated with the digestive system.

Dae Seung Co., Ltd.
Date Published : 03/29/2012
1696, Jochun-Ri, Jochun-Eup , Bukjeju-Gun, Jeju-Do, KOREA (THE REPUBLIC OF)
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/29/2012

Desc: Foot Sheets Adhesive Bandage (Detox foot Patches-Danaan foot Sheets)
Notes: S. Korea

80 F - - QM Bandage, Elastic
Date Published: 03/29/2012

Desc: Foot Sheets Adhesive Bandage (Detox foot Patches-Danaan foot Sheets)
Notes: S. Korea

Daraeworld Co., Ltd.
Date Published : 08/21/2020
96 Jinsangmiro1385beon-gil , Icheon, Gyeonggi KOREA (THE REPUBLIC OF)
62 H - - 99 Anti-Microbial N.E.C.
Date Published: 08/21/2020

Desc: Jeopureun Chowon Wiae Hand Sanitizer
Notes: The product appears to be an unapproved new drug as the product appears to be a topical antimicrobial drug product for over-the-counter human use that contains an active ingredient, tea tree oil, that is not in conformance with 'Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products' or associated current guidance.

Dong IL Pharm Co., Ltd.
Date Published : 06/04/2021
26 Rinosandan-Gil , Maengdong-Myeon , Eumseong, Chungcheongbuk KOREA (THE REPUBLIC OF)
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 06/04/2021

Desc: 100 Premium Brightening Toothpaste

53 R - - 09 Oral Hygiene Products, Cosmetic products containing animal by-products (bovine)
Date Published: 06/04/2021

Desc: 100 Premium Brightening Toothpaste

62 F - - 17 Hydrogen Peroxide (Sol) (Anti-Infective, Topical)
Date Published: 06/04/2021

Desc: 100 Premium Brightening Toothpaste

63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic)
Date Published: 06/04/2021

Desc: 100 Premium Brightening Toothpaste

Dong Sung Bio Pharm Co., Ltd.
Date Published : 05/06/2021
683 Dobong-ro , Dobong-gu, Seoulteugbyeol-si KOREA (THE REPUBLIC OF)
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/06/2021

Desc: Cheong Ro Hwan -F Tablets
Notes: The product appears to be an unapproved new drug as the product’s associated website includes claims such as (not an all-inclusive list): “CheongRoHwan Dongsung *** OTC drug *** Gingival medication *** Diarrhea, dyspepsia ***Efficacy and effect Diarrhea, dyspepsia, watery stool, vomiting.”; In addition, the three cartoon characters on the Principal Display Panel showing parts of the gastrointestinal tract, including the stomach and intestines in great distress, imply disease claims by way of suggesting these products are intended to prevent, mitigate, cure, or treat medical conditions associated with the digestive system.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/06/2021

Desc: Cheong Ro Hwan -F Tablets
Notes: The product appears to be an unapproved new drug as the product’s associated website includes claims such as (not an all-inclusive list): “CheongRoHwan Dongsung *** OTC drug *** Gingival medication *** Diarrhea, dyspepsia ***Efficacy and effect Diarrhea, dyspepsia, watery stool, vomiting.”; In addition, the three cartoon characters on the Principal Display Panel showing parts of the gastrointestinal tract, including the stomach and intestines in great distress, imply disease claims by way of suggesting these products are intended to prevent, mitigate, cure, or treat medical conditions associated with the digestive system.

Dong Wha Pharm Co., Ltd.
Date Published : 08/19/2010
19/F, 98 Huam-ro, Jung-gu , Seoul, KOREA (THE REPUBLIC OF)
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

61 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

62 U - - 99 Anti-Tussive/Cold N.E.C.
Date Published: 12/15/2016

Desc: Pancold S Oral Liquid
Notes: Product labels made disease claims and the labeling information not meeting the OTC Monograph.

62 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

63 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

64 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

65 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

66 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

Dong Wha Pharm. Co., Ltd.
Date Published : 12/15/2016
167 Chungjusandan 1-Ro , Chungju-Si,Chungcheongbuk-Do, KOREA (THE REPUBLIC OF)
62 U - - 99 Anti-Tussive/Cold N.E.C.
Date Published: 12/15/2016

Desc: Pancold S Oral Liquid
Notes: Product labels made disease claims and the labeling information not meeting the OTC Monograph.

Dong Wha Pharm. Ind. Co., Ltd. Anyang Plant
Date Published : 08/19/2010
189, Anyang-Dong, Manan-Ku , Anyang, KR-41 KOREA (THE REPUBLIC OF)
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

61 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

62 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

63 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

64 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

65 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

66 - - - -- Human and Animal Drugs
Date Published: 08/19/2010

Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

Dongseo Biopharm Co.
Date Published : 04/11/2013
96-2 Eobiri Edongmyun , Cheoingu , Yonginsi, KYONGGi KOREA (THE REPUBLIC OF)
54 Y - - 04 Ginseng Unconventional Dietary Speciality for Humans or Animals
Date Published: 04/11/2013

Desc: Affirm XL (Red Ginseng Dietary Supplement)
Notes: Note; This product was found to contain Sulfoaildenafil

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/11/2013

Desc: Affirm XL (Red Ginseng Dietary Supplement)
Notes: Note; This product was found to contain Sulfoaildenafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/11/2013

Desc: Affirm XL (Red Ginseng Dietary Supplement)
Notes: Note; This product was found to contain Sulfoaildenafil

Ens
Date Published : 02/23/2016
501 Hanam Venture Center 239 , Gyenonggi-do, KOREA (THE REPUBLIC OF)
53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 02/23/2016

Desc: Organic Facial Mask Pack Green Essence Lifting
Notes: The referenced product appears to be an unapproved new drug as the product labeling includes the following claims; Instant wrinkle improving; Improving Skin Brightening; Decreasing swollen face; and Pore Contraction.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 02/23/2016

Desc: Organic Facial Mask Pack Green Essence Lifting
Notes: The referenced product appears to be an unapproved new drug as the product labeling includes the following claims; Instant wrinkle improving; Improving Skin Brightening; Decreasing swollen face; and Pore Contraction.

Evercos Co., Ltd.
Date Published : 09/28/2020
13 Hakpyeongpungjeong-gil; Cheongwon , Naesu-eup, Cheongwon-gu , Cheongju, Chungcheongbuk KOREA (THE REPUBLIC OF)
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 09/28/2020

Desc: Pure Label Advanced Hand Sanitizer Gel Plus
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance.

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 09/28/2020

Desc: Pure Label Advanced Hand Sanitizer Gel Plus
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Pure Label Advanced Hand Sanitizer Gel Plus
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Pure Label Advanced Hand Sanitizer Gel Plus
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/28/2020

Desc: Pure Label Advanced Hand Sanitizer Gel Plus
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance.

62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 09/28/2020

Desc: Pure Label Advanced Hand Sanitizer Gel Plus
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance.

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 09/28/2020

Desc: Pure Label Advanced Hand Sanitizer Gel Plus
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance.

64 A - - 99 Disinfectant N.E.C.
Date Published: 09/28/2020

Desc: Pure Label Advanced Hand Sanitizer Gel Plus
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance.

65 L - - 99 Protectant N.E.C.
Date Published: 09/28/2020

Desc: Pure Label Advanced Hand Sanitizer Gel Plus
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2020

Desc: Pure Label Advanced Hand Sanitizer Gel Plus
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance.

Eyemee Beauty World
Date Published : 04/07/2014
Naegokdong 170 , Seoul, Seoul KOREA (THE REPUBLIC OF)
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 04/07/2014

Desc: Max2 Eyelash/Eyebrow Tonic Essence Gold
Notes: Problem(s); Unapproved New Drug

53 C - - 99 Other Eye Makeup Preparations, N.E.C.
Date Published: 04/07/2014

Desc: Max2 Eyelash/Eyebrow Tonic Essence Gold
Notes: Problem(s); Unapproved New Drug

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/07/2014

Desc: Max2 Eyelash/Eyebrow Tonic Essence Gold
Notes: Problem(s); Unapproved New Drug

Ezekiel Cosmetics Co.
Date Published : 10/14/2016
28-17 Namdongseo-ro 113beon-gil, Namdong-gu , Incheon, KOREA (THE REPUBLIC OF)
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/07/2017

Desc: Aloe BHA Skin Toner
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Salicylic Acid 0.5% as an active ingredient; and Aloe Barbadensis Leaf Water; BHA; and Snail Secretion Filtrate; among others; as inactive ingredients ; Anti-acne ; helps skin remain clear when used daily.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/07/2017

Desc: Snail Bee High Content Mask Pack
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Glycerin 4% as an active ingredient; and Camellia Sinensis Leaf Water and Snail Secretion Filtrate; among others; as inactive ingredients ; has functional ingredients such as Arbutin and Adenosine which helps brightening your skin and removes wrinkles.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/07/2017

Desc: Snail Bee High Content Steam Cream
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Glycerin 6.6% as an active ingredient and Snail Secretion Filtrate; among others; as an inactive ingredient ; has functional ingredients such as Niacinamide and Adenosine which helps brightening your skin and removes wrinkles

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/14/2016

Desc: Snail Bee High Content Essence

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/07/2017

Desc: Snail Bee High Content Steam Cream
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Glycerin 6.6% as an active ingredient and Snail Secretion Filtrate; among others; as an inactive ingredient ; has functional ingredients such as Niacinamide and Adenosine which helps brightening your skin and removes wrinkles

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/07/2017

Desc: Aloe BHA Skin Toner
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Salicylic Acid 0.5% as an active ingredient; and Aloe Barbadensis Leaf Water; BHA; and Snail Secretion Filtrate; among others; as inactive ingredients ; Anti-acne ; helps skin remain clear when used daily.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/14/2016

Desc: Snail Bee High Content Essence

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/07/2017

Desc: Snail Bee High Content Mask Pack
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Glycerin 4% as an active ingredient; and Camellia Sinensis Leaf Water and Snail Secretion Filtrate; among others; as inactive ingredients ; has functional ingredients such as Arbutin and Adenosine which helps brightening your skin and removes wrinkles.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/07/2017

Desc: Aloe BHA Skin Toner
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Salicylic Acid 0.5% as an active ingredient; and Aloe Barbadensis Leaf Water; BHA; and Snail Secretion Filtrate; among others; as inactive ingredients ; Anti-acne ; helps skin remain clear when used daily.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/07/2017

Desc: Snail Bee High Content Mask Pack
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Glycerin 4% as an active ingredient; and Camellia Sinensis Leaf Water and Snail Secretion Filtrate; among others; as inactive ingredients ; has functional ingredients such as Arbutin and Adenosine which helps brightening your skin and removes wrinkles. ;

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/07/2017

Desc: Snail Bee High Content Steam Cream
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Glycerin 6.6% as an active ingredient and Snail Secretion Filtrate; among others; as an inactive ingredient ; has functional ingredients such as Niacinamide and Adenosine which helps brightening your skin and removes wrinkles

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 10/14/2016

Desc: Snail Bee High Content Essence

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/07/2017

Desc: Snail Bee High Content Mask Pack
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Glycerin 4% as an active ingredient; and Camellia Sinensis Leaf Water and Snail Secretion Filtrate; among others; as inactive ingredients ; has functional ingredients such as Arbutin and Adenosine which helps brightening your skin and removes wrinkles. ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/07/2017

Desc: Aloe BHA Skin Toner
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Salicylic Acid 0.5% as an active ingredient; and Aloe Barbadensis Leaf Water; BHA; and Snail Secretion Filtrate; among others; as inactive ingredients ; Anti-acne ; helps skin remain clear when used daily.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/14/2016

Desc: Snail Bee High Content Essence

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/07/2017

Desc: Snail Bee High Content Steam Cream
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Contains Glycerin 6.6% as an active ingredient and Snail Secretion Filtrate; among others; as an inactive ingredient ; has functional ingredients such as Niacinamide and Adenosine which helps brightening your skin and removes wrinkles

EzekielCosmetic Co., Ltd.
Date Published : 07/27/2022
53 Hwanggeum3ro7beon-Gil , Yangchon-Eup , Gimpo, Gyeonggi KOREA (THE REPUBLIC OF)
53 L - - -- Skin Care Prep
Date Published: 07/27/2022

Desc: Benton Snail Bee High Content Mask Pack

53 U - - -- Cosmetic Prods Containing Animal By Prod (Other)
Date Published: 07/27/2022

Desc: Benton Snail Bee High Content Mask Pack

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/27/2022

Desc: Benton Snail Bee High Content Mask Pack

GMS
Date Published : 11/15/2021
113-2002 47 DAECHEON-RO , BUSAN, KOREA (THE REPUBLIC OF)
15 B - - 07 Egg Extracts
Date Published: 11/15/2021

Desc: Lipo Lab PPC Solution (Phosphatidylcholine)
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “More efficacious and easier treatment than liposuction surgery”, “Lipo Lab PPC dissolves, destroys fat cells and exhausts them out of the body through sweat, urine and internal combustion . . ..”, “Solves the obesity of specific parts where exercises cannot do”, “Lipo Lab ppc solution treatment offer many benefits towards weight loss”, “PPC (PhosphatidylCholine) spotlighted as the latest solution to obesity, is being called ‘the 2ndbotox’.” and “The Main Use Site . . . Fat Back . . . Fat Abdominal region . . . Fat Hip . . . Fat Thighs . . .”

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/15/2021

Desc: Lipo Lab PPC Solution (Phosphatidylcholine)
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “More efficacious and easier treatment than liposuction surgery”, “Lipo Lab PPC dissolves, destroys fat cells and exhausts them out of the body through sweat, urine and internal combustion . . ..”, “Solves the obesity of specific parts where exercises cannot do”, “Lipo Lab ppc solution treatment offer many benefits towards weight loss”, “PPC (PhosphatidylCholine) spotlighted as the latest solution to obesity, is being called ‘the 2ndbotox’.” and “The Main Use Site . . . Fat Back . . . Fat Abdominal region . . . Fat Hip . . . Fat Thighs . . .”

GMS
Date Published : 11/15/2021
Rm 102-1111 Bucheon Techno Park Ssangyong 3-cha , Bucheon, Gyeonggi KOREA (THE REPUBLIC OF)
15 B - - 07 Egg Extracts
Date Published: 11/15/2021

Desc: Lipo Lab PPC Solution (Phosphatidylcholine)
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “More efficacious and easier treatment than liposuction surgery”, “Lipo Lab PPC dissolves, destroys fat cells and exhausts them out of the body through sweat, urine and internal combustion . . ..”, “Solves the obesity of specific parts where exercises cannot do”, “Lipo Lab ppc solution treatment offer many benefits towards weight loss”, “PPC (PhosphatidylCholine) spotlighted as the latest solution to obesity, is being called ‘the 2ndbotox’.” and “The Main Use Site . . . Fat Back . . . Fat Abdominal region . . . Fat Hip . . . Fat Thighs . . .”

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/15/2021

Desc: Lipo Lab PPC Solution (Phosphatidylcholine)
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “More efficacious and easier treatment than liposuction surgery”, “Lipo Lab PPC dissolves, destroys fat cells and exhausts them out of the body through sweat, urine and internal combustion . . ..”, “Solves the obesity of specific parts where exercises cannot do”, “Lipo Lab ppc solution treatment offer many benefits towards weight loss”, “PPC (PhosphatidylCholine) spotlighted as the latest solution to obesity, is being called ‘the 2ndbotox’.” and “The Main Use Site . . . Fat Back . . . Fat Abdominal region . . . Fat Hip . . . Fat Thighs . . .”

GMS
Date Published : 11/15/2021
Rm 102-1111 Bucheon Techno Park Ssangyong 3-cha , Bucheon, Gyeonggi KOREA (THE REPUBLIC OF)
15 B - - 07 Egg Extracts
Date Published: 11/15/2021

Desc: Lipo Lab PPC Solution (Phosphatidylcholine)
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “More efficacious and easier treatment than liposuction surgery”, “Lipo Lab PPC dissolves, destroys fat cells and exhausts them out of the body through sweat, urine and internal combustion . . ..”, “Solves the obesity of specific parts where exercises cannot do”, “Lipo Lab ppc solution treatment offer many benefits towards weight loss”, “PPC (PhosphatidylCholine) spotlighted as the latest solution to obesity, is being called ‘the 2ndbotox’.” and “The Main Use Site . . . Fat Back . . . Fat Abdominal region . . . Fat Hip . . . Fat Thighs . . .”

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/15/2021

Desc: Lipo Lab PPC Solution (Phosphatidylcholine)
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “More efficacious and easier treatment than liposuction surgery”, “Lipo Lab PPC dissolves, destroys fat cells and exhausts them out of the body through sweat, urine and internal combustion . . ..”, “Solves the obesity of specific parts where exercises cannot do”, “Lipo Lab ppc solution treatment offer many benefits towards weight loss”, “PPC (PhosphatidylCholine) spotlighted as the latest solution to obesity, is being called ‘the 2ndbotox’.” and “The Main Use Site . . . Fat Back . . . Fat Abdominal region . . . Fat Hip . . . Fat Thighs . . .”

Gms
Date Published : 11/15/2021
36-1 Sam Jung Dong , Bucheon, KOREA (THE REPUBLIC OF)
15 B - - 07 Egg Extracts
Date Published: 11/15/2021

Desc: Lipo Lab PPC Solution (Phosphatidylcholine)
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “More efficacious and easier treatment than liposuction surgery”, “Lipo Lab PPC dissolves, destroys fat cells and exhausts them out of the body through sweat, urine and internal combustion . . ..”, “Solves the obesity of specific parts where exercises cannot do”, “Lipo Lab ppc solution treatment offer many benefits towards weight loss”, “PPC (PhosphatidylCholine) spotlighted as the latest solution to obesity, is being called ‘the 2ndbotox’.” and “The Main Use Site . . . Fat Back . . . Fat Abdominal region . . . Fat Hip . . . Fat Thighs . . .”

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/15/2021

Desc: Lipo Lab PPC Solution (Phosphatidylcholine)
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “More efficacious and easier treatment than liposuction surgery”, “Lipo Lab PPC dissolves, destroys fat cells and exhausts them out of the body through sweat, urine and internal combustion . . ..”, “Solves the obesity of specific parts where exercises cannot do”, “Lipo Lab ppc solution treatment offer many benefits towards weight loss”, “PPC (PhosphatidylCholine) spotlighted as the latest solution to obesity, is being called ‘the 2ndbotox’.” and “The Main Use Site . . . Fat Back . . . Fat Abdominal region . . . Fat Hip . . . Fat Thighs . . .”

Handok Pharmaceuticals Co., Ltd.
Date Published : 08/05/2019
unknown , Chungchongbuk, KOREA (THE REPUBLIC OF)
64 E - - 01 Cellulase (Enzyme)
Date Published: 08/05/2019

Desc: Festal Plus Tablets
Notes: The product appears to be an unapproved new drug as the product contains the active ingredient pancreatin and the product label notes the product's intended use as a digestive aid by listing (not an all-inclusive list); '...Uses; Digestion...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/05/2019

Desc: Festal Plus Tablets
Notes: The product appears to be an unapproved new drug as the product contains the active ingredient pancreatin and the product label notes the product's intended use as a digestive aid by listing (not an all-inclusive list); '...Uses; Digestion...'.

Hugel, Inc.
Date Published : 04/23/2020
61-20 Sinbuk-ro, Sinbuk-eup , Chuncheon-si, Gangwon-do KOREA (THE REPUBLIC OF)
65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Botulax 100 Botulinum Toxin Type A

Huons Global Co. Ltd
Date Published : 04/23/2020
50, Bio Valley 2-Ro , Jecheon-Si, Chungcheongbuk-do KOREA (THE REPUBLIC OF)
65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: HUTOX INJ. Clostridium Botulinum Toxin Type A

Hyundai Pharm. Co., Ltd.
Date Published : 04/06/2015
55, Jandari-Gil, Pungse-Myeon , Dongnam-Gu , Cheonan-Si, Chungcheongnam-do KOREA (THE REPUBLIC OF)
60 L - - 99 Analgesic, N.E.C.
Date Published: 04/06/2015

Desc: BUMOOLY-S Solution
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives?; ?Itching from insect bites'.

60 L - - 99 Analgesic, N.E.C.
Date Published: 04/06/2015

Desc: MOOLPAS-F Humectant with Tocopherol
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the product?s intended use from the product labeling includes but is not limited to the following;' 1) Antiinflammatory [sic] analgesic of the following symptoms; Sprain; contusion; myosalgia; backache; shoulder discomfort; neuralgia; rheumarthritis ... 2) Pernio'.

60 Q - - 35 Dibucaine HCl (Anesthetic)
Date Published: 04/06/2015

Desc: BUMOOLY-S Solution
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'.

61 X - - 18 Diphenhydramine HCl (Anti-Histaminic)
Date Published: 04/06/2015

Desc: BUMOOLY-S Solution
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'.

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 04/06/2015

Desc: BUMOOLY-S Solution
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'.

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 04/06/2015

Desc: MOOLPAS-F Humectant with Tocopherol
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the product?s intended use from the product labeling includes but is not limited to the following;' 1) Antiinflammatory [sic] analgesic of the following symptoms; Sprain; contusion; myosalgia; backache; shoulder discomfort; neuralgia; rheumarthritis ... 2) Pernio'.

62 M - - 01 Camphor (Anti-Pruritic)
Date Published: 04/06/2015

Desc: BUMOOLY-S Solution
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'.

62 M - - 08 Menthol (Anti-Pruritic)
Date Published: 04/06/2015

Desc: BUMOOLY-S Solution
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'.

62 M - - 99 Anti-Pruritic N.E.C.
Date Published: 04/06/2015

Desc: BUMOOLY-S Solution
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/06/2015

Desc: BUMOOLY-S Solution
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/06/2015

Desc: MOOLPAS-F Humectant with Tocopherol
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the product?s intended use from the product labeling includes but is not limited to the following;' 1) Antiinflammatory [sic] analgesic of the following symptoms; Sprain; contusion; myosalgia; backache; shoulder discomfort; neuralgia; rheumarthritis ... 2) Pernio'.

Ion Farms Co
Date Published : 09/30/2009
2f Donggyoung Bd , Incheon, KOREA (THE REPUBLIC OF)
79 K - - GX Tape And Bandage, Adhesive
Date Published: 02/04/2016

Notes: 5/12/2006

J&C Trading Co Ltd
Date Published : 03/12/2014
1263-1 Yeongdeokri , Chungcheongbu, KOREA (THE REPUBLIC OF)
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 03/12/2014

Desc: Detoxifying Herbal Food Pad Sachets and Adhesives

J&P International Co.Ltd
Date Published : 08/21/2015
292 #B05, 3f Garden5 Tool Munjeong2 Dong , Seoul, KOREA (THE REPUBLIC OF)
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 08/21/2015

Desc: SNP Animal Tiger Wrinkle Mask

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/06/2015

Desc: The Premium Snow White Milky Pack

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 08/21/2015

Desc: SNP Animal Tiger Wrinkle Mask

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/01/2015

Desc: Mediheal Labocare Melakill Sun Cream SPF 50 PA
Notes:                                                                                                                                                                                                                                                                                                          

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/21/2015

Desc: SNP Animal Tiger Wrinkle Mask

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/01/2015

Desc: Mediheal Labocare Melakill Sun Cream SPF 50 PA
Notes:                                                                                                                                                                                                                                                                                                          

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/21/2015

Desc: SNP Animal Tiger Wrinkle Mask

KEEBON COMMERCE INC
Date Published : 08/26/2022
8 Gangnamdaero69-Gil , Seocho, Seoul KOREA (THE REPUBLIC OF)
53 L - - -- Skin Care Prep
Date Published: 08/26/2022

Desc: Proot Butt & Thigh Scrub

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 08/26/2022

Desc: Proot Butt & Thigh Scrub

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/26/2022

Desc: Proot Butt & Thigh Scrub

KOLMAR BNH CO., LTD Eumseong Factory
Date Published : 11/08/2018
8 Daepungsandan1-Gil , Daeso-Myeon , Eumseong, Chungcheongbuk KOREA (THE REPUBLIC OF)
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/08/2018

Desc: Atomy Probiotics Packets
Notes: The product appears to be an unapproved new drug as the product's promotional website and/or product label includes claims such as: '... Restraining harmful bacteria ... [R]estraining the growth of harmful bacteria ... Bifidobacterium breve lower levels of harmful bacteria ... People who experience irritable bowel movements ...'.

Kim Jeong Moon Aloe Co., Ltd.
Date Published : 09/27/2010
Baekjae B/D. 1580-10, , Seoul, KOREA (THE REPUBLIC OF)
33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 09/27/2010

Desc: Propolis Candy
Notes: Korea, Republic of (South)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/13/2019

Desc: Super Green Vera (Dried Aloe Vera Gel Powder)
Notes: 9/27/2010, Korea, Republic of (South)

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/27/2010

Desc: Spigreen Plus
Notes: Korea, Republic of (South)

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/27/2010

Desc: Aloe Cens
Notes: Korea, Republic of (South)

63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic)
Date Published: 09/27/2010

Desc: Aloe Dental (Toothpaste)
Notes: Korea, Republic of (South)

63 X - - 99 Diagostic Aid (Drugs) N.E.C.
Date Published: 09/27/2010

Desc: Super Green Vera (Dried Aloe Vera Gel Powder)
Notes: Korea, Republic of (South)

63 X - - 99 Diagostic Aid (Drugs) N.E.C.
Date Published: 09/27/2010

Desc: Aloe Dental (Toothpaste)
Notes: Korea, Republic of (South)

63 X - - 99 Diagostic Aid (Drugs) N.E.C.
Date Published: 09/27/2010

Desc: Spigreen Plus
Notes: Korea, Republic of (South)

63 X - - 99 Diagostic Aid (Drugs) N.E.C.
Date Published: 09/27/2010

Desc: Propolis Candy
Notes: Korea, Republic of (South)

63 X - - 99 Diagostic Aid (Drugs) N.E.C.
Date Published: 09/27/2010

Desc: Aloe Cens
Notes: Korea, Republic of (South)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/27/2010

Desc: Spigreen Plus
Notes: Korea, Republic of (South)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/27/2010

Desc: Super Green Vera (Dried Aloe Vera Gel Powder)
Notes: Korea, Republic of (South)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/27/2010

Desc: Propolis Candy
Notes: Korea, Republic of (South)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/27/2010

Desc: Aloe Cens
Notes: Korea, Republic of (South)

Kolmar Korea Co., Ltd.
Date Published : 06/05/2013
1596-3, Seocho-Dong, Seocho-Gu , Seoul, KOREA (THE REPUBLIC OF)
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 06/05/2013

Desc: Super Plus Beblesh Balm Triple Functions
Notes: south korea

65 L - - 99 Protectant N.E.C.
Date Published: 06/05/2013

Desc: Super Plus Beblesh Balm Triple Functions
Notes: South Korea

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 06/05/2013

Desc: Super Plus Beblesh Balm Triple Functions
Notes: South Korea

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/05/2013

Desc: Super Plus Beblesh Balm Triple Functions
Notes: South Korea

Kyc Usa Cosmetics Korea
Date Published : 09/28/2016
11 Daeriro6beon-Gil , Yeonje-gu, Busangwangyeog-si KOREA (THE REPUBLIC OF)
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/28/2016

Desc: Ciracle Red Spot Cream

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/14/2016

Desc: Snail Bee High Content Essence

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/28/2016

Desc: Ciracle Red Spot Cream

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/14/2016

Desc: Snail Bee High Content Essence

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 10/14/2016

Desc: Snail Bee High Content Essence

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/28/2016

Desc: Ciracle Red Spot Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/14/2016

Desc: Snail Bee High Content Essence

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2016

Desc: Ciracle Red Spot Cream

LYCL INC
Date Published : 06/08/2020
Unpa 2f 28 Nonhyeon-Ro98-Gil, Gangnam-Gu , Seoul, KOREA (THE REPUBLIC OF)
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 06/08/2020

Desc: Cha Cha Toothpaste Regular
Notes:                                                                                                             

53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 06/08/2020

Desc: Cha Cha Energy Toothpaste
Notes:                                                                                                             

53 R - - 09 Oral Hygiene Products, Cosmetic products containing animal by-products (bovine)
Date Published: 06/08/2020

Desc: Cha Cha Energy Toothpaste
Notes:                                                                                                             

53 R - - 09 Oral Hygiene Products, Cosmetic products containing animal by-products (bovine)
Date Published: 06/08/2020

Desc: Cha Cha Toothpaste Regular
Notes:                                                                                                             

MEDIHUB CO LTD
Date Published : 11/15/2021
1F 178-25 HYOMOKDONG DO , JONGHO PARK, KOREA (THE REPUBLIC OF)
15 B - - 07 Egg Extracts
Date Published: 11/15/2021

Desc: Lipo Lab PPC Solution (Phosphatidylcholine)
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “More efficacious and easier treatment than liposuction surgery”, “Lipo Lab PPC dissolves, destroys fat cells and exhausts them out of the body through sweat, urine and internal combustion . . ..”, “Solves the obesity of specific parts where exercises cannot do”, “Lipo Lab ppc solution treatment offer many benefits towards weight loss”, “PPC (PhosphatidylCholine) spotlighted as the latest solution to obesity, is being called ‘the 2ndbotox’.” and “The Main Use Site . . . Fat Back . . . Fat Abdominal region . . . Fat Hip . . . Fat Thighs . . .”

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/15/2021

Desc: Lipo Lab PPC Solution (Phosphatidylcholine)
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “More efficacious and easier treatment than liposuction surgery”, “Lipo Lab PPC dissolves, destroys fat cells and exhausts them out of the body through sweat, urine and internal combustion . . ..”, “Solves the obesity of specific parts where exercises cannot do”, “Lipo Lab ppc solution treatment offer many benefits towards weight loss”, “PPC (PhosphatidylCholine) spotlighted as the latest solution to obesity, is being called ‘the 2ndbotox’.” and “The Main Use Site . . . Fat Back . . . Fat Abdominal region . . . Fat Hip . . . Fat Thighs . . .”

MEDIHUB CO., LTD.
Date Published : 11/15/2021
# 108 Sa Tower , Gunpo, Gyeonggido KOREA (THE REPUBLIC OF)
15 B - - 07 Egg Extracts
Date Published: 11/15/2021

Desc: Lipo Lab PPC Solution (Phosphatidylcholine)
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “More efficacious and easier treatment than liposuction surgery”, “Lipo Lab PPC dissolves, destroys fat cells and exhausts them out of the body through sweat, urine and internal combustion . . ..”, “Solves the obesity of specific parts where exercises cannot do”, “Lipo Lab ppc solution treatment offer many benefits towards weight loss”, “PPC (PhosphatidylCholine) spotlighted as the latest solution to obesity, is being called ‘the 2ndbotox’.” and “The Main Use Site . . . Fat Back . . . Fat Abdominal region . . . Fat Hip . . . Fat Thighs . . .”

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/15/2021

Desc: Lipo Lab PPC Solution (Phosphatidylcholine)
Notes: A labeling statement documenting the intended use of the product includes, but may not be limited to the following: “More efficacious and easier treatment than liposuction surgery”, “Lipo Lab PPC dissolves, destroys fat cells and exhausts them out of the body through sweat, urine and internal combustion . . ..”, “Solves the obesity of specific parts where exercises cannot do”, “Lipo Lab ppc solution treatment offer many benefits towards weight loss”, “PPC (PhosphatidylCholine) spotlighted as the latest solution to obesity, is being called ‘the 2ndbotox’.” and “The Main Use Site . . . Fat Back . . . Fat Abdominal region . . . Fat Hip . . . Fat Thighs . . .”

Medytox Inc.
Date Published : 04/23/2020
Osong-Eup, Heungdeok , 102 Osongsaengmyeong4-Ro; Heungdeok , Cheongju, Chungcheongbuk KOREA (THE REPUBLIC OF)
65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Meditoxin Botulinum Toxin Type A

Mizherb
Date Published : 10/03/2016
132-7 Floor, Ne-Dong, Ojeung Bucheon-Si , Kuyngki-do, KOREA (THE REPUBLIC OF)
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/03/2016

Desc: Doctorcos Snow White Water Glow Mask

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/03/2016

Desc: Doctorcos Snow White Water Glow Mask

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 10/03/2016

Desc: Doctorcos Snow White Water Glow Mask

NATURE REPUBLIC CO., LTD.
Date Published : 06/19/2015
534, Teheran-ro, Gangnam-gu , Seoul, Seoul KOREA (THE REPUBLIC OF)
53 C - - -- Eye Makeup Prep
Date Published: 02/12/2018

Desc: Ginseng Royal Silk Eye Cream
Notes: Medical claims made on product label

53 G - - -- Makeup Prep(Not For Eyes)
Date Published: 04/26/2017

Desc: Soothing & Moisture Aloe Vera 92% Soothing Gel

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Lemon
Notes:                                                                                                                                                                                                                                                                                                     

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Camellia
Notes:                                                                                                                                                                                                                                                                                                     

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Rose
Notes:                                                                                                                                                                                                                                                                                                     

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple
Notes:                                                                                                                                                                                                                                                                                                     

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Grape
Notes:                                                                                                                                                                                                                                                                                                     

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple Mango
Notes:                                                                                                                                                                                                                                                                                                     

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 09/28/2020

Desc: Pure Label Advanced Hand Sanitizer Gel Plus
Notes:                                                                                                                                                                                                                                                                                                                  

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Peppermint
Notes:                                                                                                                                                                                                                                                                                                     

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/26/2017

Desc: Soothing & Moisture Aloe Vera 92% Soothing Gel

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Grape
Notes:                                                                                                                                                                                                                                                                                                     

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Peppermint
Notes:                                                                                                                                                                                                                                                                                                     

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple
Notes:                                                                                                                                                                                                                                                                                                     

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Camellia
Notes:                                                                                                                                                                                                                                                                                                     

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Rose
Notes:                                                                                                                                                                                                                                                                                                     

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple Mango
Notes:                                                                                                                                                                                                                                                                                                     

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Lemon
Notes:                                                                                                                                                                                                                                                                                                     

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 09/28/2020

Desc: Pure Label Advanced Hand Sanitizer Gel Plus
Notes:                                                                                                                                                                                                                                                                                                                  

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Rose
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/08/2023

Desc: Snail Solution Skin Care Set
Notes: The set contains the following products; Snail Solution Skin Booster and Snail Solution Emulsion.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Pure Label Advanced Hand Sanitizer Gel Plus
Notes:                                                                                                                                                                                                                                                                                                                  

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Peppermint
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Camellia
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Lemon
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple Mango
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Grape
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/08/2023

Desc: Snail Solution Skin Care Set
Notes: The set contains the following products; Snail Solution Skin Booster and Snail Solution Emulsion.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 06/19/2015

Desc: Snail Solution Hydro Gel Mask

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 06/19/2015

Desc: Snail Solution Pearl Hydro Gel Mask

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 06/19/2015

Desc: Super Origin Complete Cover SPF 50 PA

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Rose
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple Mango
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Grape
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Pure Label Advanced Hand Sanitizer Gel Plus
Notes:                                                                                                                                                                                                                                                                                                                  

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Peppermint
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Lemon
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Camellia
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/08/2023

Desc: Snail Solution Skin Care Set
Notes: The set contains the following products; Snail Solution Skin Booster and Snail Solution Emulsion.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 09/08/2023

Desc: Snail Solution Skin Care Set
Notes: The set contains the following products; Snail Solution Skin Booster and Snail Solution Emulsion.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 09/08/2023

Desc: Snail Solution Skin Care Set
Notes: The set contains the following products; Snail Solution Skin Booster and Snail Solution Emulsion.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple Mango
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/28/2020

Desc: Pure Label Advanced Hand Sanitizer Gel Plus
Notes:                                                                                                                                                                                                                                                                                                                  

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 06/19/2015

Desc: Super Origin Complete Cover SPF 50 PA

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Lemon
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Grape
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 06/19/2015

Desc: Snail Solution Hydro Gel Mask

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 06/19/2015

Desc: Snail Solution Pearl Hydro Gel Mask

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/08/2023

Desc: Snail Solution Skin Care Set
Notes: The set contains the following products; Snail Solution Skin Booster and Snail Solution Emulsion.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Camellia
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Rose
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Peppermint
Notes:                                                                                                                                                                                                                                                                                                     

53 L - - -- Skin Care Prep
Date Published: 04/26/2017

Desc: Soothing & Moisture Aloe Vera 92% Soothing Gel

62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Grape
Notes:                                                                                                                                                                                                                                                                                                     

62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Lemon
Notes:                                                                                                                                                                                                                                                                                                     

62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Camellia
Notes:                                                                                                                                                                                                                                                                                                     

62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple
Notes:                                                                                                                                                                                                                                                                                                     

62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 09/28/2020

Desc: Pure Label Advanced Hand Sanitizer Gel Plus
Notes:                                                                                                                                                                                                                                                                                                                  

62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Peppermint
Notes:                                                                                                                                                                                                                                                                                                     

62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Rose
Notes:                                                                                                                                                                                                                                                                                                     

62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple Mango
Notes:                                                                                                                                                                                                                                                                                                     

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Grape
Notes:                                                                                                                                                                                                                                                                                                     

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple Mango
Notes:                                                                                                                                                                                                                                                                                                     

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Camellia
Notes:                                                                                                                                                                                                                                                                                                     

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Lemon
Notes:                                                                                                                                                                                                                                                                                                     

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 09/28/2020

Desc: Pure Label Advanced Hand Sanitizer Gel Plus
Notes:                                                                                                                                                                                                                                                                                                                  

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Peppermint
Notes:                                                                                                                                                                                                                                                                                                     

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple
Notes:                                                                                                                                                                                                                                                                                                     

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Rose
Notes:                                                                                                                                                                                                                                                                                                     

64 A - - 99 Disinfectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Rose
Notes:                                                                                                                                                                                                                                                                                                     

64 A - - 99 Disinfectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Lemon
Notes:                                                                                                                                                                                                                                                                                                     

64 A - - 99 Disinfectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Camellia
Notes:                                                                                                                                                                                                                                                                                                     

64 A - - 99 Disinfectant N.E.C.
Date Published: 09/28/2020

Desc: Pure Label Advanced Hand Sanitizer Gel Plus
Notes:                                                                                                                                                                                                                                                                                                                  

64 A - - 99 Disinfectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Peppermint
Notes:                                                                                                                                                                                                                                                                                                     

64 A - - 99 Disinfectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple
Notes:                                                                                                                                                                                                                                                                                                     

64 A - - 99 Disinfectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Grape
Notes:                                                                                                                                                                                                                                                                                                     

64 A - - 99 Disinfectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple Mango
Notes:                                                                                                                                                                                                                                                                                                     

65 L - - 99 Protectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Grape
Notes:                                                                                                                                                                                                                                                                                                     

65 L - - 99 Protectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Rose
Notes:                                                                                                                                                                                                                                                                                                     

65 L - - 99 Protectant N.E.C.
Date Published: 08/11/2017

Desc: Snail Solution Skin Booster

65 L - - 99 Protectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple
Notes:                                                                                                                                                                                                                                                                                                     

65 L - - 99 Protectant N.E.C.
Date Published: 09/28/2020

Desc: Pure Label Advanced Hand Sanitizer Gel Plus
Notes:                                                                                                                                                                                                                                                                                                                  

65 L - - 99 Protectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Lemon
Notes:                                                                                                                                                                                                                                                                                                     

65 L - - 99 Protectant N.E.C.
Date Published: 04/26/2017

Desc: Soothing & Moisture Aloe Vera 92% Soothing Gel

65 L - - 99 Protectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple Mango
Notes:                                                                                                                                                                                                                                                                                                     

65 L - - 99 Protectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Peppermint
Notes:                                                                                                                                                                                                                                                                                                     

65 L - - 99 Protectant N.E.C.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Camellia
Notes:                                                                                                                                                                                                                                                                                                     

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Camellia
Notes:                                                                                                                                                                                                                                                                                                     

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/19/2015

Desc: Snail Solution Pearl Hydro Gel Mask

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple Mango
Notes:                                                                                                                                                                                                                                                                                                     

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Lemon
Notes:                                                                                                                                                                                                                                                                                                     

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Peppermint
Notes:                                                                                                                                                                                                                                                                                                     

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/08/2023

Desc: Snail Solution Skin Care Set
Notes: The set contains the following products; Snail Solution Skin Booster and Snail Solution Emulsion.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Grape
Notes:                                                                                                                                                                                                                                                                                                     

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2020

Desc: Pure Label Advanced Hand Sanitizer Gel Plus
Notes:                                                                                                                                                                                                                                                                                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/26/2017

Desc: Soothing & Moisture Aloe Vera 92% Soothing Gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/19/2015

Desc: Snail Solution Hydro Gel Mask

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/12/2018

Desc: Ginseng Royal Silk Eye Cream
Notes: Medical claims made on product label

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Rose
Notes:                                                                                                                                                                                                                                                                                                     

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/11/2017

Desc: Snail Solution Skin Booster

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/19/2015

Desc: Super Origin Complete Cover SPF 50 PA

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2020

Desc: Hand&Nature Sanitizer Gel - Apple
Notes:                                                                                                                                                                                                                                                                                                     

NOVISBIO CO.,LTD.
Date Published : 09/25/2019
104 Wonseungdu-Gil , Gongdo-Eup , Anseong, Gyeonggi KOREA (THE REPUBLIC OF)
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/25/2019

Desc: Sejong Biotech SJ Pine Forte-dietary supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/25/2019

Desc: Sejong Biotech SJ Pine Forte-dietary supplement

Nowcos Co., Ltd
Date Published : 09/27/2010
220 Sandan-Gil , Jeonui-Myeon , Sejong, Sejong KOREA (THE REPUBLIC OF)
53 J - - 03 Douches (not Antiperspirant) (Personal Cleanliness)
Date Published: 09/27/2010

Desc: Inner Wash (Douche)
Notes: Korea; Republic of (South)

63 X - - 99 Diagostic Aid (Drugs) N.E.C.
Date Published: 09/27/2010

Desc: Cure Cream
Notes: ;Korea; Republic of (South) ;

63 X - - 99 Diagostic Aid (Drugs) N.E.C.
Date Published: 09/27/2010

Desc: Inner Wash (Douche)
Notes: Korea; Republic of (South)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/27/2010

Desc: Cure Cream
Notes: ;Korea; Republic of (South) ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/27/2010

Desc: Inner Wash (Douche)
Notes: Korea; Republic of (South)

Nutribiotech Co., Ltd.
Date Published : 07/19/2016
127-16 Deokpyeong-Ro 663 Beon-Gil , Iceon, Gyeonggi KOREA (THE REPUBLIC OF)
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 07/19/2016

Desc: Joint Salido (dietary supplement)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/19/2016

Desc: Joint Salido (dietary supplement)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/19/2016

Desc: Joint Salido (dietary supplement)

Oasis Trading
Date Published : 07/31/2019
39-13 Sugi-Ro , Gocheon-Eup , Gimpo, Gyeonggido KOREA (THE REPUBLIC OF)
64 E - - 01 Cellulase (Enzyme)
Date Published: 08/05/2019

Desc: Festal Plus Tablets
Notes: The product appears to be an unapproved new drug as the product contains the active ingredient pancreatin and the product label notes the product's intended use as a digestive aid by listing (not an all-inclusive list); '...Uses; Digestion...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/05/2019

Desc: Festal Plus Tablets
Notes: The product appears to be an unapproved new drug as the product contains the active ingredient pancreatin and the product label notes the product's intended use as a digestive aid by listing (not an all-inclusive list); '...Uses; Digestion...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/31/2019

Desc: Younggaksan Powder
Notes: The product appears to be an unapproved new drug as the product's label includes disease claims such as (not an all-inclusive list): '...helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get sleep...'.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/31/2019

Desc: Younggaksan Powder
Notes: The product appears to be an unapproved new drug as the product's label includes disease claims such as (not an all-inclusive list): '...helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get sleep...'.

PNP Biopharm Co., Ltd.
Date Published : 03/31/2017
33 11, Digital-ro , Gil, Guro-gu , Seoul, Seoul KOREA (THE REPUBLIC OF)
65 L - - 99 Protectant N.E.C.
Date Published: 03/31/2017

Desc: Cellcurin Hair ReGen Serum

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/31/2017

Desc: Cellcurin Hair ReGen Serum

PUREPLUS CO., LTD
Date Published : 05/10/2012
11 Sudongnonggong-Gil , Sudong-Myeon , Hamyang, Gyeongsangnam KOREA (THE REPUBLIC OF)
29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 05/10/2012

Desc: BOJO Nutrition Supplement Drink
Notes: Korea; Republic of South

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/10/2012

Desc: BOJO Nutrition Supplement Drink
Notes: Korea; Republic of South

Pharmcle Co., Ltd.
Date Published : 08/24/2020
106 Sandanro67beon-Gil; Danwon , Ansan, Gyeonggi KOREA (THE REPUBLIC OF)
62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 08/24/2020

Desc: ZAPS Sanitizer Spray
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Disinfection of hands and skin', and '99.9% Sterilization of bacteria and viruses'. In addition, the product's principal display panel contains a depiction of the novel coronavirus with a slash in the middle, which suggests that the product is effective in preventing infection or disease specifically from the novel coronavirus.

95 R - - GI Hand Washing Sanitizer, Ultraviolet Hygiene Products, Non-Medical
Date Published: 08/24/2020

Desc: ZAPS Sanitizer Spray
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Disinfection of hands and skin', and '99.9% Sterilization of bacteria and viruses'. In addition, the product's principal display panel contains a depiction of the novel coronavirus with a slash in the middle, which suggests that the product is effective in preventing infection or disease specifically from the novel coronavirus.

Prostemics Co., Ltd. Factory
Date Published : 10/26/2016
16-25 Dongbaekjungangro16beon-Gil , Giheung , Yongin, Gyeonggi KOREA (THE REPUBLIC OF)
53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 10/26/2016

Desc: AAPE Adipo Series III Hair Ampoule
Notes: Medical claims on product labels

66 U - - 04 Hair (Natural Body Parts, Invivo Only)
Date Published: 10/26/2016

Desc: AAPE Adipo Series III Hair Ampoule
Notes: Medical claims on product labels

Rainbow Beauty Co Ltd
Date Published : 04/24/2017
2F 17Dodam 5-ro, Seo-gu , Incheon, KR-28 KOREA (THE REPUBLIC OF)
53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 04/24/2017

Desc: Animal Cutie Mask Pack Relaxing Charcoal and Aloe
Notes: Structure and function claims made on product labels

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/24/2017

Desc: Animal Cutie Mask Pack Relaxing Charcoal and Aloe
Notes: Structure and function claims made on product labels

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2017

Desc: Animal Cutie Mask Pack Relaxing Charcoal and Aloe
Notes: Structure and function claims made on product labels

Rebom Cosmetics Co Ltd
Date Published : 09/19/2013
Myodong 442 48 , Seoul, Seoul KOREA (THE REPUBLIC OF)
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2013

Desc: Triple Crown BB Cream

Rocket Electric Co., Ltd.
Date Published : 07/27/2010
747-29 Yeoksam1-Dong , Gangnam-gu , Seoul, Seoul KOREA (THE REPUBLIC OF)
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/27/2010

Desc: AcneFree 1 Hour Pimple Patches with Benzoyl Peroxide
Notes: Country; Korea; Republic of (south)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/27/2010

Desc: AcneFree 1 Hour Pimple Patches with Benzoyl Peroxide
Notes: Country; Korea; Republic of (south)

SD Biotechnologies Co., Ltd.
Date Published : 09/04/2015
C-Dong 301, Seoul New Technology Venture Center , 61 29 Gonghang-Daero , Gangseo-gu, Seoul KOREA (THE REPUBLIC OF)
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/16/2015

Desc: SNP Bird's Nest Aqua Ampule Mask

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/10/2015

Desc: ANIMAL PANDA WHITENING MASK

53 L - - 07 Night (Skin Care Preparations)
Date Published: 09/04/2015

Desc: SNP Gold Collagen Sleeping Pack

53 L - - 07 Night (Skin Care Preparations)
Date Published: 09/16/2015

Desc: SNP Bird's Nest Aqua Ampule Mask

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 09/08/2015

Desc: SNP Diamond Brightening Ampoule Mask

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 09/04/2015

Desc: SNP Animal Dragon Soothing Mask

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 09/04/2015

Desc: SNP Animal Otter Aqua Mask

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 09/08/2015

Desc: SNP Diamond Brightening Ampoule Mask

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 09/04/2015

Desc: SNP Animal Dragon Soothing Mask

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 11/03/2015

Desc: SNP Birds Nest Revital Aqua Sun Screen SPF 35 PA

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/16/2015

Desc: SNP GOLD COLLAGEN AMPOULE MASK

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 09/16/2015

Desc: SNP Bird's Nest Aqua Ampule Mask

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/08/2015

Desc: SNP Diamond Brightening Ampoule Mask

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/03/2015

Desc: SNP Birds Nest Revital Aqua Sun Screen SPF 35 PA

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/04/2015

Desc: SNP Animal Dragon Soothing Mask

53 L - - -- Skin Care Prep
Date Published: 09/04/2015

Desc: SNP Animal Otter Aqua Mask

53 L - - -- Skin Care Prep
Date Published: 09/04/2015

Desc: SNP Gold Collagen Sleeping Pack

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 11/03/2015

Desc: SNP Birds Nest Revital Aqua Sun Screen SPF 35 PA

SOLEO CO., LTD.
Date Published : 08/15/2016
52 16 Beon-Gil, Sandan , Pyeongtack-si, KOREA (THE REPUBLIC OF)
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 08/15/2016

Desc: Folligen Shampoo
Notes: Medical claims on product labels & website

61 H - - 05 Zinc Pyrithione (Anti-Bacterial)
Date Published: 08/15/2016

Desc: Folligen Shampoo
Notes: Medical claims on product labels & website

Seoul Cosmetics Co., Ltd.
Date Published : 04/24/2017
12 Namdongdongro63beon-Gil , Namdong, Incheon KOREA (THE REPUBLIC OF)
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 05/09/2017

Desc: Suwall Luxury Oriental Shampoo
Notes: Drug claims made on product labels and company websites.

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 04/24/2017

Desc: Brown Rice Moisture Shampoo
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: (Label) 'It prevents generation of dandruff and inflammation by helping anti-inflammation and anti-fungal effects of your scalp'; and 'It stimulates blood circulation so that it will prevent hair loss and promote hair growth.' (Website) 'Helps with the anti-inflammation and anti-bacterial action of the scalp to inhibit the growth of dandruff and inflammation.'

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 05/09/2017

Desc: Suwall Luxury Oriental Shampoo
Notes: Drug claims made on product labels and company websites.

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 04/24/2017

Desc: Brown Rice Moisture Shampoo
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: (Label) 'It prevents generation of dandruff and inflammation by helping anti-inflammation and anti-fungal effects of your scalp'; and 'It stimulates blood circulation so that it will prevent hair loss and promote hair growth.' (Website) 'Helps with the anti-inflammation and anti-bacterial action of the scalp to inhibit the growth of dandruff and inflammation.'

53 G - - -- Makeup Prep(Not For Eyes)
Date Published: 04/26/2017

Desc: Soothing & Moisture Aloe Vera 92% Soothing Gel

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/26/2017

Desc: Soothing & Moisture Aloe Vera 92% Soothing Gel

53 L - - -- Skin Care Prep
Date Published: 04/26/2017

Desc: Soothing & Moisture Aloe Vera 92% Soothing Gel

65 L - - 99 Protectant N.E.C.
Date Published: 04/26/2017

Desc: Soothing & Moisture Aloe Vera 92% Soothing Gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/09/2017

Desc: Suwall Luxury Oriental Shampoo
Notes: Drug claims made on product labels and company websites.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2017

Desc: Brown Rice Moisture Shampoo
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: (Label) 'It prevents generation of dandruff and inflammation by helping anti-inflammation and anti-fungal effects of your scalp'; and 'It stimulates blood circulation so that it will prevent hair loss and promote hair growth.' (Website) 'Helps with the anti-inflammation and anti-bacterial action of the scalp to inhibit the growth of dandruff and inflammation.'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/26/2017

Desc: Soothing & Moisture Aloe Vera 92% Soothing Gel

Sewha P&C Inc.
Date Published : 05/22/2013
36 Eunam-Gil , Chopyeong-Myeon , Jincheon, Chungbuk KOREA (THE REPUBLIC OF)
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 05/22/2013

Desc: Henna Shampoo Henna Clinic Shampoo
Notes: Korea Republic of south

Sminiks
Date Published : 08/24/2013
(135-955) 5F-6F, 40, Dosan-daero, 81-gil , Gangnam-gu , Seoul, KOREA (THE REPUBLIC OF)
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 08/24/2013

Desc: Allisis Miracle Stem Cell Perfect One Ampoule
Notes: Note; Sminiks is dba Natural Works Co. Ltd. Drug claims found on firms website

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 08/24/2013

Desc: Allisis Miracle Stem Cell Perfect One Ampoule
Notes: Note; Sminiks is dba Natural Works Co. Ltd. Drug claims found on firms website

53 L - - 07 Night (Skin Care Preparations)
Date Published: 08/24/2013

Desc: Allisis Miracle Stem Cell Perfect One Ampoule
Notes: Note; Sminiks is dba Natural Works Co. Ltd. Drug claims found on firms website

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 08/24/2013

Desc: Allisis Miracle Stem Cell Perfect One Ampoule
Notes: Note; Sminiks is dba Natural Works Co. Ltd. Drug claims found on firms website

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/24/2013

Desc: Allisis Miracle Stem Cell Perfect One Ampoule
Notes: Note; Sminiks is dba Natural Works Co. Ltd. Drug claims found on firms website

57 L - - 03 Eye Tissue (Cornea, Sclera)
Date Published: 08/24/2013

Desc: Allisis Miracle Stem Cell Perfect One Ampoule
Notes: Note; Sminiks is dba Natural Works Co. Ltd. Drug claims found on firms website

57 M - - 01 Hematopoietic Progenitor Cells (HPC), Cord Blood
Date Published: 08/24/2013

Desc: Allisis Miracle Stem Cell Perfect One Ampoule
Notes: Note; Sminiks is dba Natural Works Co. Ltd. Drug claims found on firms website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/24/2013

Desc: Allisis Miracle Stem Cell Perfect One Ampoule
Notes: Note; Sminiks is dba Natural Works Co. Ltd. Drug claims found on firms website

Solco Biomedical Co., Ltd.
Date Published : 08/31/2016
154 Seotan-ro , Seotan-Myeon , Pyeongtaek, Gyeonggi KOREA (THE REPUBLIC OF)
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 08/31/2016

Desc: Solco Platino IonDenti Toothpaste

63 R - - 99 Dental Caries Prophylactic N.E.C.
Date Published: 08/31/2016

Desc: Solco Platino IonDenti Toothpaste

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/31/2016

Desc: Solco Platino IonDenti Toothpaste

Soleo
Date Published : 08/15/2016
(Ju)Solleocgpmgongjang , 24 Sandan-Ro , Pyeongtaek, Gyeonggi KOREA (THE REPUBLIC OF)
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 08/15/2016

Desc: Folligen Shampoo
Notes: Medical claims on product labels & website

61 H - - 05 Zinc Pyrithione (Anti-Bacterial)
Date Published: 08/15/2016

Desc: Folligen Shampoo
Notes: Medical claims on product labels & website

Synbio Co Ltd
Date Published : 06/20/2016
Dobyungwon Bldg., Wonchun-dong , 7 World Cup-ro 179beon-gil Ye , Suwon-si, Kyonggi KOREA (THE REPUBLIC OF)
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 06/20/2016

Desc: Ginseng Whitening Cream
Notes: The product appears to be an unapproved new drug as the product labeling include disease claims such as; containing Korean ginseng extracts and Niacinamide helps your skin whitening.

Totra Co., Ltd.
Date Published : 04/24/2017
248 Jeosantaeseong-Ro , Heungdeok , Cheongju, Chungcheongbuk KOREA (THE REPUBLIC OF)
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 04/24/2017

Desc: Brown Rice Moisture Shampoo
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: (Label) 'It prevents generation of dandruff and inflammation by helping anti-inflammation and anti-fungal effects of your scalp'; and 'It stimulates blood circulation so that it will prevent hair loss and promote hair growth.' (Website) 'Helps with the anti-inflammation and anti-bacterial action of the scalp to inhibit the growth of dandruff and inflammation.'

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 04/24/2017

Desc: Amore Shampoo Set (Ryo Anti-Hair Loss Shampoo and Treatment)
Notes: Totra Co. Ltd. is the OASIS declared manufacturer.

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 05/09/2017

Desc: Suwall Luxury Oriental Shampoo
Notes: Drug claims made on product labels and company websites.

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 04/24/2017

Desc: Amore Shampoo Set (Ryo Anti-Hair Loss Shampoo and Treatment)
Notes: Totra Co. Ltd. is the OASIS declared manufacturer.

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 05/09/2017

Desc: Suwall Luxury Oriental Shampoo
Notes: Drug claims made on product labels and company websites.

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 04/24/2017

Desc: Brown Rice Moisture Shampoo
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: (Label) 'It prevents generation of dandruff and inflammation by helping anti-inflammation and anti-fungal effects of your scalp'; and 'It stimulates blood circulation so that it will prevent hair loss and promote hair growth.' (Website) 'Helps with the anti-inflammation and anti-bacterial action of the scalp to inhibit the growth of dandruff and inflammation.'

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 04/24/2017

Desc: Animal Cutie Mask Pack Relaxing Charcoal and Aloe
Notes: Structure and function claims made on product labels

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/13/2019

Desc: Animal Cutie Mask Pack Relaxing Charcoal and Aloe
Notes: Structure and function claims made on product labels

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/09/2017

Desc: Suwall Luxury Oriental Shampoo
Notes: Drug claims made on product labels and company websites.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2017

Desc: Animal Cutie Mask Pack Relaxing Charcoal and Aloe
Notes: Structure and function claims made on product labels

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2017

Desc: Amore Shampoo Set (Ryo Anti-Hair Loss Shampoo and Treatment)
Notes: Totra Co. Ltd. is the OASIS declared manufacturer.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2017

Desc: Brown Rice Moisture Shampoo
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: (Label) 'It prevents generation of dandruff and inflammation by helping anti-inflammation and anti-fungal effects of your scalp'; and 'It stimulates blood circulation so that it will prevent hair loss and promote hair growth.' (Website) 'Helps with the anti-inflammation and anti-bacterial action of the scalp to inhibit the growth of dandruff and inflammation.'

WELLMADE HOUSEHOLD & HEALTH CARE CO., LTD.
Date Published : 05/08/2023
44 Jeongnamsandan 1-Gil , Jeongnam-Myeon , Hwaseong, Gyeonggido KOREA (THE REPUBLIC OF)
53 L - - -- Skin Care Prep
Date Published: 05/08/2023

Desc: Goodbye Redness Centella Cica Mask Pack
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): Image of a red blemish with the text “GOODBYE REDNESS” from a megaphone next to it; “Relief from redness, irritation and inflamed blemishes”.

53 L - - -- Skin Care Prep
Date Published: 05/08/2023

Desc: Snail Bee High Content Steam Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): “promote collagen production”; “takes care of freckles and blemishes”; “heals injured skin”; “prevent skin damage”.

53 L - - -- Skin Care Prep
Date Published: 05/08/2023

Desc: Snail Bee High Content Essence
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): “collagen-boosting”; “CALMING ACNE”; “especially great for treating acne prone . . . skin”; “takes care of freckles and blemishes”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2023

Desc: Snail Bee High Content Steam Cream
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): “promote collagen production”; “takes care of freckles and blemishes”; “heals injured skin”; “prevent skin damage”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2023

Desc: Goodbye Redness Centella Cica Mask Pack
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): Image of a red blemish with the text “GOODBYE REDNESS” from a megaphone next to it; “Relief from redness, irritation and inflamed blemishes”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2023

Desc: Snail Bee High Content Essence
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): “collagen-boosting”; “CALMING ACNE”; “especially great for treating acne prone . . . skin”; “takes care of freckles and blemishes”.

WILLIAM XYLITOL
Date Published : 10/02/2023
8 Geoma-Ro 77beon-Gil , Ulsan, KOREA (THE REPUBLIC OF)
28 C - - 36 Peppermint, Natural Extract or Flavor (Spice)
Date Published: 10/02/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)

33 C - - 06 Flavored Candy, Hard (Live Savers, Etc.), with Fruit (without Chocolate)
Date Published: 10/02/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)

33 C - - 11 Mint Candy, Hard, with Fruit (without Chocolate)
Date Published: 10/02/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)

33 E - - 06 Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 10/02/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)

33 E - - 11 Mint Candy, Hard, without Nuts and Fruit (without Chocolate)
Date Published: 10/02/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)

33 E - - 13 Rock Candy, Hard, without Nuts and Fruit (without Chocolate)
Date Published: 10/02/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)

33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 10/02/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 10/02/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)

33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 10/02/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)

54 B - - 99 Mineral N.E.C.
Date Published: 10/02/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/02/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)

WOOSHIN LABOTTACH CO.,LTD.
Date Published : 10/18/2023
# 1907 Daerung P-Toweri , Seoul, KOREA (THE REPUBLIC OF)
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/18/2023

Desc: NerveSpa Weight Control Dietary Supplement

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/18/2023

Desc: NerveSpa Gut Support With Probiotics Dietary Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/18/2023

Desc: NerveSpa Gut Support With Probiotics Dietary Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/18/2023

Desc: NerveSpa Weight Control Dietary Supplement

YANG WOO BIO CO. LTD.
Date Published : 12/30/2019
Dongsan-Myun , 175 Wonmudong-Gil; Dongsan-Myeon , Chuncheon, Gangwon KOREA (THE REPUBLIC OF)
54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 12/30/2019

Desc: Digest Soothe Granule Packs
Notes: This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): OUTER PACKAGE - 'The Fermented, high-enzyme fruits and soothing herbs gently coat the stomach and esophagus to relieve heartburn and acid reflux. . .'; 'Digest + Soothe immediately relieves Heartburn, Acid Reflux, Indigestion, Nausea, Stomach Ache. . .'; PRIMARY PACKAGE - 'Instant heartburn relief ... when experiencing heartburn or acid reflux...'.

54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 12/30/2019

Desc: Digest Soothe Granule Packs
Notes: This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): OUTER PACKAGE - 'The Fermented, high-enzyme fruits and soothing herbs gently coat the stomach and esophagus to relieve heartburn and acid reflux. . .'; 'Digest + Soothe immediately relieves Heartburn, Acid Reflux, Indigestion, Nausea, Stomach Ache. . .'; PRIMARY PACKAGE - 'Instant heartburn relief ... when experiencing heartburn or acid reflux...'.

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 12/30/2019

Desc: Digest Soothe Granule Packs
Notes: This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): OUTER PACKAGE - 'The Fermented, high-enzyme fruits and soothing herbs gently coat the stomach and esophagus to relieve heartburn and acid reflux. . .'; 'Digest + Soothe immediately relieves Heartburn, Acid Reflux, Indigestion, Nausea, Stomach Ache. . .'; PRIMARY PACKAGE - 'Instant heartburn relief ... when experiencing heartburn or acid reflux...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/30/2019

Desc: Digest Soothe Granule Packs
Notes: This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): OUTER PACKAGE - 'The Fermented, high-enzyme fruits and soothing herbs gently coat the stomach and esophagus to relieve heartburn and acid reflux. . .'; 'Digest + Soothe immediately relieves Heartburn, Acid Reflux, Indigestion, Nausea, Stomach Ache. . .'; PRIMARY PACKAGE - 'Instant heartburn relief ... when experiencing heartburn or acid reflux...'.

YESTOTOM CO LTD.
Date Published : 04/26/2019
Rm 117, 32 Dongguk-Ro Ilsandong-Gu Gyeonggi-Do , Goyang, KOREA (THE REPUBLIC OF)
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/26/2019

Desc: Ultra V Idebenone Cream

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/26/2019

Desc: Ultra V Idebenone Cream

YESTOTOM CO., LTD.
Date Published : 04/26/2019
15-10 Shinhang Ro , Seoul, KOREA (THE REPUBLIC OF)
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/26/2019

Desc: Ultra V Idebenone Cream

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/26/2019

Desc: Ultra V Idebenone Cream


LATVIA


Joint Stock Company Grindeks
Date Published : 04/12/2012
Krustpils Iela 53 , Riga, Riga LATVIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/12/2012

Desc: Viprosal B Cream
Notes: Lativa

SIA "UNIVERSAL FINANCIAL GROUP LTD"
Date Published : 01/22/2013
IEROCU STREET 4-6 , Riga, LV-RIX LATVIA
31 K - - 01 Tea, Black
Date Published: 01/22/2013

Desc: Various Health Teas
Notes: NOTE: Includes Health Tea for Skin, Health Tea Menopause, Health Tea Diabetes, Health Tea for Immunity, Health Tea for Lungs, Health Tea Soft & Easy, etc.

31 K - - 04 Tea, Mixed (Green and Black, Etc.)
Date Published: 01/22/2013

Desc: Various Health Teas
Notes: NOTE; Includes Health Tea for Skin; Health Tea Menopause; Health Tea Diabetes; Health Tea for Immunity; Health Tea for Lungs; Health Tea Soft & Easy; etc.

31 K - - 99 Tea, N.E.C.
Date Published: 01/22/2013

Desc: Various Health Teas
Notes: NOTE: Includes Health Tea for Skin, Health Tea Menopause, Health Tea Diabetes, Health Tea for Immunity, Health Tea for Lungs, Health Tea Soft & Easy, etc.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 01/22/2013

Desc: Various Health Teas
Notes: NOTE: Includes Health Tea for Skin, Health Tea Menopause, Health Tea Diabetes, Health Tea for Immunity, Health Tea for Lungs, Health Tea Soft & Easy, etc.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/22/2013

Desc: Various Health Teas
Notes: NOTE: Includes Health Tea for Skin, Health Tea Menopause, Health Tea Diabetes, Health Tea for Immunity, Health Tea for Lungs, Health Tea Soft & Easy, etc.

SIA Vitolana
Date Published : 10/11/2022
131A Dzelzavas Iela , Riga, Riga LATVIA
26 - - - -- Vegetable Oils
Date Published: 10/11/2022

Desc: Siberian Pine Nut Oil

26 - - - -- Vegetable Oils
Date Published: 10/11/2022

Desc: Siberian Pine Nut Oil capsules

36 Y - - 99 Food Sweetners (Nutritive) N.E.C.
Date Published: 10/11/2022

Desc: Siberian Pine Nut Oil capsules

36 Y - - 99 Food Sweetners (Nutritive) N.E.C.
Date Published: 10/11/2022

Desc: Siberian Pine Nut Oil

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/11/2022

Desc: Siberian Pine Nut Oil

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/11/2022

Desc: Siberian Pine Nut Oil capsules

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 10/11/2022

Desc: Siberian Pine Nut Oil capsules

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 10/11/2022

Desc: Siberian Pine Nut Oil

54 H - - 99 Fats and Lipid Substances, N.E.C.
Date Published: 10/11/2022

Desc: Siberian Pine Nut Oil capsules

54 H - - 99 Fats and Lipid Substances, N.E.C.
Date Published: 10/11/2022

Desc: Siberian Pine Nut Oil

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/11/2022

Desc: Siberian Pine Nut Oil

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/11/2022

Desc: Siberian Pine Nut Oil capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/11/2022

Desc: Siberian Pine Nut Oil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/11/2022

Desc: Siberian Pine Nut Oil capsules


LEBANON


Ets Diana De Beaute
Date Published : 09/30/2009
Rue Riad El Solh , Beirut, Beirut LEBANON
53 G - - -- Makeup Prep(Not For Eyes)
Date Published: 02/01/2010

Desc: Diana Cream and Acne Soap
Notes: Country; Lebanon

53 L - - -- Skin Care Prep
Date Published: 02/01/2010

Desc: Diana Cream and Acne Soap
Notes: Country; Lebanon

53 L - - -- Skin Care Prep
Date Published: 09/30/2009

Notes: 9/5/2003

64 X - - -- Keratolytic
Date Published: 09/30/2009

Notes: 9/5/2003

64 X - - -- Keratolytic
Date Published: 02/01/2010

Desc: Diana Cream and Acne Soap
Notes: Country; Lebanon

66 V - - -- Patent Medicines, Etc
Date Published: 02/01/2010

Desc: Diana Cream and Acne Soap
Notes: Country; Lebanon

Exim
Date Published : 10/18/2011
Jdeideh Tower Bldg 7th Fl , Beirut, LEBANON
31 A - - 02 Coffee, Ground
Date Published: 10/18/2011

Desc: Magic Macho Coffee
Notes: Lebanon;Note: Product contains undeclared Sulfoaildenafil and Thiohomosildenafil.

31 A - - 03 Coffee, Instant
Date Published: 10/18/2011

Desc: Magic Macho Coffee
Notes: Lebanon;Note: Product contains undeclared Sulfoaildenafil and Thiohomosildenafil.

31 A - - 99 Coffee, N.E.C.
Date Published: 10/18/2011

Desc: Magic Macho Coffee
Notes: Lebanon;Note: Product contains undeclared Sulfoaildenafil and Thiohomosildenafil.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/18/2011

Desc: Magic Macho Coffee
Notes: Lebanon;Note: Product contains undeclared Sulfoaildenafil and Thiohomosildenafil.


MALAYSIA


A.M. Herbs (M) Pvt. Ltd.
Date Published : 09/30/2009
2-4 JLN 3/114 Kuchai Business Center , Kuala Lumpur, MY-14 MALAYSIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: Avicenna Pharma Brand Dietary Supplements Cholestemed; Glucosure; Gastro Balance; Renalife; Livtone; Respire.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2009

Desc: Cholestemed; Glucosure; Gastro Balance; Renalife; Livtone; Respire.
Notes: Avicenna Pharma Brand Dietary Supplements Cholestemed; Glucosure; Gastro Balance; Renalife; Livtone; Respire.

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 09/30/2009

Notes: Avicenna Pharma Brand Dietary Supplements Cholestemed; Glucosure; Gastro Balance; Renalife; Livtone; Respire.

Asian Secrets Sdn Bhd
Date Published : 04/11/2016
No. 5 Jalan 4 , C-11-4, 5&6, Wisma Goshen, Bangsar Tade Center, Plaza Pantai , Kuala Lumpur, Wp Kuala Lumpur MALAYSIA
21 A - - 20 Citrus and Other Fruits, Mixed
Date Published: 04/11/2016

Desc: TUNJUK LANGIT (FRUCTUS SWIETENIA MACROPHYLLA) - SKY FRUIT

21 S - - 99 Subtropical and Tropical Fruit, N.E.C.
Date Published: 04/11/2016

Desc: TUNJUK LANGIT (FRUCTUS SWIETENIA MACROPHYLLA) - SKY FRUIT

BIO-GULF SDN BHD
Date Published : 09/30/2009
Plaza Damansara , 24 2 Jalan , Kuala Lumpur, Wilayah Persekutuan MALAYSIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: Libidus is promoted on the websites                       and                    as an herbal male sexual stimulant and has been imported into the US as a dietary supplement. Analysis provided by CDERS Division of Pharmaceutical Analysis HFS-920 found that the capsules contain the undeclared chemical "acetildenafil," an analog of sildenafil. Sildenafil citrate is the active ingrediant in Viagras product manufactured by Pfizer for the treatment of erectile dysfunction. Acetildenafil is not declared as one of the ingrediants as one of the ingrediants on the Libidus' product lables and the pharmacology of this new drug is unknown.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2009

Notes: Libidus is promoted on the websites                       and                    as an herbal male sexual stimulant and has been imported into the US as a dietary supplement. Analysis provided by CDERS Division of Pharmaceutical Analysis HFS-920 found that the capsules contain the undeclared chemical "acetildenafil," an analog of sildenafil. Sildenafil citrate is the active ingrediant in Viagras product manufactured by Pfizer for the treatment of erectile dysfunction. Acetildenafil is not declared as one of the ingrediants as one of the ingrediants on the Libidus' product lables and the pharmacology of this new drug is unknown.

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 09/30/2009

Notes: Libidus is promoted on the websites                       and                    as an herbal male sexual stimulant and has been imported into the US as a dietary supplement. Analysis provided by CDERS Division of Pharmaceutical Analysis HFS-920 found that the capsules contain the undeclared chemical "acetildenafil," an analog of sildenafil. Sildenafil citrate is the active ingrediant in Viagras product manufactured by Pfizer for the treatment of erectile dysfunction. Acetildenafil is not declared as one of the ingrediants as one of the ingrediants on the Libidus' product lables and the pharmacology of this new drug is unknown.

BIO-GULF SDN BHD
Date Published : 09/13/2019
Plaza Damansara , 24 2 Jalan , Kuala Lumpur, Wilayah Persekutuan MALAYSIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/13/2019

Desc: Libidus
Notes: 6/29/2006

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/13/2019

Desc: Libidus
Notes: 6/29/2006

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 09/13/2019

Desc: Libidus
Notes: 6/29/2006

DRS SECRET WORLDWIDE MANUFACTURING SDN BHD
Date Published : 05/24/2016
No 42 Jalan Todak , 2 , Seberang Perai Tengah, Pulau Pinang MALAYSIA
36 C - - 04 Honey
Date Published: 05/24/2016

Desc: Royal King Honey (Food Supplement)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/24/2016

Desc: Royal King Honey (Food Supplement)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/24/2016

Desc: Men's Bio Honey Malaysia Recipe

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 05/24/2016

Desc: Royal King Honey (Food Supplement)

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 05/24/2016

Desc: Men's Bio Honey Malaysia Recipe

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/24/2016

Desc: Men's Bio Honey Malaysia Recipe

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/24/2016

Desc: Royal King Honey (Food Supplement)

DYNAMIC NUTRITION SDN BHD
Date Published : 05/10/2019
No 12c Hedgeford Innovation Park Ja , Jalan Tandang , Petaling Jaya, Selangor MALAYSIA
54 A - - 99 Vitamin, N.E.C.
Date Published: 05/10/2019

Desc: Ashiguard Capsules
Notes: The product appears to be an unapproved new drug as the firm's website includes disease claims such as (not an all-inclusive list): '... Reduces & prevent metabolic syndrome... Reduces LDL cholesterol ... Regulate Blood Sugar & Combat Metabolic Syndrome ... Regulates and stabilizes blood sugar ... Ashitaba chalcones are found to have blood glucose lowering properties ...'.

54 F - - 03 Angelica (Herbal & Botanicals, not Teas)
Date Published: 05/10/2019

Desc: Ashiguard Capsules
Notes: The product appears to be an unapproved new drug as the firm's website includes disease claims such as (not an all-inclusive list): '... Reduces & prevent metabolic syndrome... Reduces LDL cholesterol ... Regulate Blood Sugar & Combat Metabolic Syndrome ... Regulates and stabilizes blood sugar ... Ashitaba chalcones are found to have blood glucose lowering properties ...'.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/10/2019

Desc: Ashiguard Capsules
Notes: The product appears to be an unapproved new drug as the firm's website includes disease claims such as (not an all-inclusive list): '... Reduces & prevent metabolic syndrome... Reduces LDL cholesterol ... Regulate Blood Sugar & Combat Metabolic Syndrome ... Regulates and stabilizes blood sugar ... Ashitaba chalcones are found to have blood glucose lowering properties ...'.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/10/2019

Desc: Ashiguard Capsules
Notes: The product appears to be an unapproved new drug as the firm's website includes disease claims such as (not an all-inclusive list): '... Reduces & prevent metabolic syndrome... Reduces LDL cholesterol ... Regulate Blood Sugar & Combat Metabolic Syndrome ... Regulates and stabilizes blood sugar ... Ashitaba chalcones are found to have blood glucose lowering properties ...'.

Dr Foerster (M) Sdn Bhd
Date Published : 12/26/2019
No. 95 Jalan Nilam 1/2 , Taman Technologi Tinggi Subang , Shah Alam, Selangor MALAYSIA
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 12/26/2019

Desc: Dr Foerster Detox Plus Food Supplement
Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil, paynantheine and, mitragynine.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/26/2019

Desc: Dr Foerster Detox Plus Food Supplement
Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil, paynantheine and, mitragynine.

Dragonedge Resources
Date Published : 09/13/2019
1207 Jasmine Towers , Selangor, MALAYSIA
53 - - - -- Cosmetics
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

73 - - - -- Anesthesiology
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

74 - - - -- Cardiovascular
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

76 - - - -- Dental
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

77 - - - -- Ear,Nose And Throat
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

78 - - - -- Gastroenterological & Urological
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

79 - - - -- General & Plastic Surgery
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

80 - - - -- General Hospital/Personal Use
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

84 - - - -- Neurological
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

85 - - - -- Obstetrical & Gynecological
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

86 - - - -- Ophthalmic
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

87 - - - -- Orthopedic
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

89 - - - -- Physical Medicine
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

90 - - - -- Radiology
Date Published: 09/13/2019

Notes: Revitapatch, 11/14/2006

Dynamic Nutrition
Date Published : 05/10/2019
18 Jalan Industri , Subang Jaya, MALAYSIA
54 A - - 99 Vitamin, N.E.C.
Date Published: 05/10/2019

Desc: Ashiguard Capsules
Notes: The product appears to be an unapproved new drug as the firm's website includes disease claims such as (not an all-inclusive list): '... Reduces & prevent metabolic syndrome... Reduces LDL cholesterol ... Regulate Blood Sugar & Combat Metabolic Syndrome ... Regulates and stabilizes blood sugar ... Ashitaba chalcones are found to have blood glucose lowering properties ...'.

54 F - - 03 Angelica (Herbal & Botanicals, not Teas)
Date Published: 05/10/2019

Desc: Ashiguard Capsules
Notes: The product appears to be an unapproved new drug as the firm's website includes disease claims such as (not an all-inclusive list): '... Reduces & prevent metabolic syndrome... Reduces LDL cholesterol ... Regulate Blood Sugar & Combat Metabolic Syndrome ... Regulates and stabilizes blood sugar ... Ashitaba chalcones are found to have blood glucose lowering properties ...'.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/10/2019

Desc: Ashiguard Capsules
Notes: The product appears to be an unapproved new drug as the firm's website includes disease claims such as (not an all-inclusive list): '... Reduces & prevent metabolic syndrome... Reduces LDL cholesterol ... Regulate Blood Sugar & Combat Metabolic Syndrome ... Regulates and stabilizes blood sugar ... Ashitaba chalcones are found to have blood glucose lowering properties ...'.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/10/2019

Desc: Ashiguard Capsules
Notes: The product appears to be an unapproved new drug as the firm's website includes disease claims such as (not an all-inclusive list): '... Reduces & prevent metabolic syndrome... Reduces LDL cholesterol ... Regulate Blood Sugar & Combat Metabolic Syndrome ... Regulates and stabilizes blood sugar ... Ashitaba chalcones are found to have blood glucose lowering properties ...'.

Easy Pha-Max Marke
Date Published : 07/12/2013
60 Jalan Puteri 2 , Selangor, MALAYSIA
50 - - - -- Color Additiv Food/Drug/Cosmetic
Date Published: 07/12/2013

Notes: Insupro Forte; Note; FDA analysis found Glyburide in product.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/12/2013

Notes: Insupro Forte; Note; FDA analysis found Glyburide in product.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

61 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

62 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

63 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

64 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

65 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

66 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

Easy Pha-Max Marke
Date Published : 07/12/2013
60 Jalan Puteri 2 , Selangor, MALAYSIA
50 - - - -- Color Additiv Food/Drug/Cosmetic
Date Published: 07/12/2013

Notes: Insupro Forte; Note; FDA analysis found Glyburide in product.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/12/2013

Notes: Insupro Forte; Note; FDA analysis found Glyburide in product.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

61 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

62 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

63 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

64 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

65 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

66 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

Enhance Nutraceutical
Date Published : 07/16/2013
Suite #173, Mbe Puchong , No. 10 Persian Puteri 1 , Bandar Puteri, Puchong Selangor MALAYSIA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/16/2013

Notes: All Dietary Supplement Products; Malaysia;Note: All Dietary supplement and Topical products are subject to DWPE

Etumax
Date Published : 07/19/2013
102 Jalan Gasing , Petaling, Selangor MALAYSIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/23/2013

Desc: Phyto-Unilipid Capsules
Notes: Phyto-Unilipid Capsules are promoted as a 100% natural herbal food supplement to lower cholesterol and for slimming. FDA analysis found Sibutramine and Desmethylsibutramine in this product. Sibutramine is the active ingredient in the FDA approved drug Meridia which is used for reducing weight in obese persons.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/23/2013

Desc: Phyto Sukoon Capsules
Notes: Phyto Sukoon Capsules are promoted as a 100% natural herbal food supplement for relation and sleep. FDA analysis found Zolpidem in this product. Zolpidem is the active ingredient in the FDA approved drug Ambien for the short term treatment of insomnia.

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 07/23/2013

Notes: 9/16/2008 Phytoshape Capsules 11/12/2008 Etumax Tongkat Ali Power Plus. This product is promoted as a dietary supplemented for weight loss. FDA analysis found rimonabant in this product. Rimonabant is the active ingredient inZimulti. Zimulti is an anti-obesity drug not approved for use in the United States.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/23/2013

Desc: Phyto-Unilipid Capsules
Notes: Phyto-Unilipid Capsules are promoted as a 100% natural herbal food supplement to lower cholesterol and for slimming. FDA analysis found Sibutramine and Desmethylsibutramine in this product. Sibutramine is the active ingredient in the FDA approved drug Meridia which is used for reducing weight in obese persons.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/23/2013

Desc: Phyto Sukoon Capsules
Notes: Phyto Sukoon Capsules are promoted as a 100% natural herbal food supplement for relation and sleep. FDA analysis found Zolpidem in this product. Zolpidem is the active ingredient in the FDA approved drug Ambien for the short term treatment of insomnia.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/19/2013

Desc: Royal Honey for him
Notes: Note; FDA analysis found Tadalafil in product

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 07/23/2013

Notes: 9/16/2008 Phytoshape Capsules 11/12/2008 Etumax Tongkat Ali Power Plus. This product is promoted as a dietary supplemented for weight loss. FDA analysis found rimonabant in this product. Rimonabant is the active ingredient inZimulti. Zimulti is an anti-obesity drug not approved for use in the United States.

66 S - - 51 Tadalafil
Date Published: 07/19/2013

Desc: Royal Honey for him
Notes: Note; FDA analysis found Tadalafil in product

HLS International Sdn. Bhd.
Date Published : 07/12/2013
No. 60 Jalan Puteri 2/2 , Selangor, Puchong MALAYSIA
50 - - - -- Color Additiv Food/Drug/Cosmetic
Date Published: 07/12/2013

Notes: Insupro Forte; Note; FDA analysis found Glyburide in product.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/12/2013

Notes: Insupro Forte; Note; FDA analysis found Glyburide in product.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

61 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

62 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

63 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

64 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

65 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

66 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

Herbal Home Sdn Bhd
Date Published : 07/19/2013
No 102 Jalan Gasing Section 5 , Petaling Jaya, , Selangor, MALAYSIA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/19/2013

Desc: Royal Honey for him
Notes: Note; FDA analysis found Tadalafil in product

66 S - - 51 Tadalafil
Date Published: 07/19/2013

Desc: Royal Honey for him
Notes: Note; FDA analysis found Tadalafil in product

K-Link International Sdn Bhd
Date Published : 12/18/2013
45, Jalan Kuchai Maju 2,Off Jalan Kuchai , Kuala Lumpurkuala Lumpur, MALAYSIA
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 12/18/2013

Desc: Feminine Hygiene Gel

61 W - - 99 A-Fungal N.E.C.
Date Published: 12/18/2013

Desc: Feminine Hygiene Gel

65 X - - 04 Octoxynol 9 (Spermaticide)
Date Published: 12/18/2013

Desc: Feminine Hygiene Gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/18/2013

Desc: Feminine Hygiene Gel

Luoice Marketing Enterprise
Date Published : 09/13/2019
No 7 Off Jalan Bukit Bintang , Luala Lumpur, MALAYSIA
53 L C - 99 Other Skin Care Preparations, N.E.C., Cream
Date Published: 09/13/2019

Desc: "Busto-Lift" capsules and cream for growth/enlargement of the female bust
Notes: 4/24/2003

66 V A - 99 Miscellaneous Patent Medicines, Etc., Human - Non/Rx Single Ingredient
Date Published: 09/13/2019

Desc: "Busto-Lift" capsules and cream for growth/enlargement of the female bust
Notes: 4/24/2003

66 V B - 99 Miscellaneous Patent Medicines, Etc., Human - Non/Rx Combination Ingredient
Date Published: 09/13/2019

Desc: "Busto-Lift" capsules and cream for growth/enlargement of the female bust
Notes: 4/24/2003

Mellips SDN BHD
Date Published : 06/12/2013
Lot 28 , Jalan Tun , Melaka, Melaka MALAYSIA
54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 06/12/2013

Desc: Ginseng Plus
Notes: Malaysia

54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 06/12/2013

Desc: Ginseng Plus
Notes: Malaysia

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/12/2013

Desc: Ginseng Plus
Notes: Malaysia

ONECARE WELLNESS SDN BHD
Date Published : 03/07/2017
NO 23 3 The , Kuala Lumpur, Wilayah Persekutuan MALAYSIA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/07/2017

Desc: Ag-Factor Capsules
Notes: The product appears to be an unapproved new drug as the product website includes claims such as; '[P]rotecting us against cancer via cytokines production (natural cancer killer cells); Reduce Redness Associated With Inflammation; Whey Protein Hydrolysate (an ingredient in Ag-Factor) ...milk protein can reduce risk of cancer'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/07/2017

Notes: Praventac Capsules;The product appears to be an unapproved new drug as the product label and website include claims such as: 'The breakthrough solution for acne-prone skin; [I]t inhibits the growth of the propionibacterium, which is … responsible for acne; Praventac's anti-inflammatory properties mean that the size of spots is reduced and blemishes heal quicker; Clear acne and repair damage skin cells with Praventac – a leading acne-fighting formula'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/07/2017

Desc: Ag-Factor Capsules
Notes: The product appears to be an unapproved new drug as the product website includes claims such as; [P]rotecting us against cancer via cytokines production (natural cancer killer cells); Reduce Redness Associated With Inflammation; Whey Protein Hydrolysate (an ingredient in Ag-Factor) milk protein can reduce risk of cancer.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/07/2017

Desc: Praventac Capsules
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; The breakthrough solution for acne-prone skin; [I]t inhibits the growth of the propionibacterium; which is... responsible for acne; Praventac's anti-inflammatory properties mean that the size of spots is reduced and blemishes heal quicker; Clear acne and repair damage skin cells with Praventac - a leading acne-fighting formula'.

POLENS (M) Sdn Bhd
Date Published : 12/17/2012
No 1, Jalan Saham 23/3 , Section 23 , Shah Alam, MY-10 MALAYSIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/17/2012

Desc: Cosanova Cordyceps
Notes: NOTE; Product contains undeclared Tadalafil; an active ingredient for the treatment of erectile dysfunction.

66 S - - 01 Amyl Nitrite (Vasodilator)
Date Published: 12/17/2012

Desc: Cosanova Cordyceps
Notes: NOTE; Product contains undeclared Tadalafil; an active ingredient for the treatment of erectile dysfunction.

Reishilab Sdn Bhd
Date Published : 05/10/2019
No 5 Jalan P2/4 , Semenyih, Selangor MALAYSIA
54 A - - 99 Vitamin, N.E.C.
Date Published: 05/10/2019

Desc: Ashiguard Capsules
Notes: The product appears to be an unapproved new drug as the firm's website includes disease claims such as (not an all-inclusive list): '... Reduces & prevent metabolic syndrome... Reduces LDL cholesterol ... Regulate Blood Sugar & Combat Metabolic Syndrome ... Regulates and stabilizes blood sugar ... Ashitaba chalcones are found to have blood glucose lowering properties ...'.

54 F - - 03 Angelica (Herbal & Botanicals, not Teas)
Date Published: 05/10/2019

Desc: Ashiguard Capsules
Notes: The product appears to be an unapproved new drug as the firm's website includes disease claims such as (not an all-inclusive list): '... Reduces & prevent metabolic syndrome... Reduces LDL cholesterol ... Regulate Blood Sugar & Combat Metabolic Syndrome ... Regulates and stabilizes blood sugar ... Ashitaba chalcones are found to have blood glucose lowering properties ...'.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/10/2019

Desc: Ashiguard Capsules
Notes: The product appears to be an unapproved new drug as the firm's website includes disease claims such as (not an all-inclusive list): '... Reduces & prevent metabolic syndrome... Reduces LDL cholesterol ... Regulate Blood Sugar & Combat Metabolic Syndrome ... Regulates and stabilizes blood sugar ... Ashitaba chalcones are found to have blood glucose lowering properties ...'.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/10/2019

Desc: Ashiguard Capsules
Notes: The product appears to be an unapproved new drug as the firm's website includes disease claims such as (not an all-inclusive list): '... Reduces & prevent metabolic syndrome... Reduces LDL cholesterol ... Regulate Blood Sugar & Combat Metabolic Syndrome ... Regulates and stabilizes blood sugar ... Ashitaba chalcones are found to have blood glucose lowering properties ...'.

So Young Plus
Date Published : 08/09/2017
Pusat Perdagangan Bukit Serdang Jalan BS 14/1 , Suite #111, C-G-23 , Seri Kembangan, Selangor Darul Ehsan MALAYSIA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/09/2017

Notes: All Dietary Supplements

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/09/2017

Desc: All Dietary Supplements

Syarikat Wen Ken Drug Sdn Bhd
Date Published : 08/09/2017
Jalan A , Johor Bahru, Johor MALAYSIA
25 G - - 99 Mixed Vegetables, Juice or Drink, N.E.C.
Date Published: 08/09/2017

Desc: Three Legs Cooling Water

29 W - - 01 Bottled Water
Date Published: 08/09/2017

Desc: Three Legs Cooling Water

29 W - - 02 Bottled Spring or Mineral Water
Date Published: 08/09/2017

Desc: Three Legs Cooling Water

29 W - - 99 Water And Ice, N.E.C.
Date Published: 08/09/2017

Desc: Three Legs Cooling Water

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 08/09/2017

Desc: Three Legs Cooling Water

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/09/2017

Desc: Three Legs Cooling Water

Tachisan Enterprise (M) Sdn Bhd
Date Published : 11/29/2010
96-2 Jalan 491 Taman Shemelln Perka , Kuala Lumpur, MALAYSIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2010

Desc: Sanphan Fushigi Sheet (KawaseTakara Natural Plant Extracts Foot Patches)
Notes: Malaysia

80 K - - YS Insoles, Medical
Date Published: 11/29/2010

Desc: Sanphan Fushigi Sheet (KawaseTakara Natural Plant Extracts Foot Patches)
Notes: Malaysia

The Origin Foods Sdn Bhd
Date Published : 07/12/2013
LOT 1, JALAN INDUSTRI PBP 11 , TAMAN PERINDUSTRIAN PUSAT BANDAR PUCHONG , Puchong, Selangor MALAYSIA
50 - - - -- Color Additiv Food/Drug/Cosmetic
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/20/2013

Desc: Bio Balance sachet component of the So-Easy Nutri Supplement Dietary Supplement
Notes: Note; The Bio-Balance sachet was found to contain undeclared lovastatin

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/20/2013

Desc: Bio Balance sachet component of the So-Easy Nutri Supplement Dietary Supplement
Notes: Note; The Bio-Balance sachet was found to contain undeclared lovastatin

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/12/2013

Desc: Insupro Forte
Notes: Note; FDA analysis found Glyburide in product.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

61 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

62 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

63 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

64 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

65 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

66 - - - -- Human and Animal Drugs
Date Published: 07/12/2013

Notes: Insupro Forte; Note: FDA analysis found Glyburide in product.

Tony
Date Published : 06/30/2014
No. 42 Jalan Tpk 2/5 , Puchong, Selangor MALAYSIA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/30/2014

Desc: RigiRx Capsules
Notes: Product contains aminotadalafil

66 S - - 51 Tadalafil
Date Published: 06/30/2014

Desc: RigiRx Capsules
Notes: Product contains aminotadalafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/30/2014

Desc: RigiRx Capsules
Notes: Product contains aminotadalafil

Unifier Sdn bhd
Date Published : 09/30/2009
Lot 7.13. 7th Floor, , Imbi Plaza, Jalan Imbi, , Kuala Lumpur, MY-14 MALAYSIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: 7/6/2007. Han Palace Capsules.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2009

Notes: 7/6/2007. Han Palace Capsules.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 7/6/2007. Han Palace Capsules.

Unison Nutraceuticals Sdn. Bhd
Date Published : 04/13/2010
No. 13, Jalan TTU52, Taman Tasik Utama , Ayer Keroh, 75450, Malacca, Malaysia , Malacca, MY-04 MALAYSIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/13/2010

Desc: Bioflu Vital Dietary Supplements Capsules
Notes: Malaysia; Product name contains the term "Flu" and labeling declares it "may be useful as a preventive measure during the cold and flu seasons"

55 R - - 99 Pharmaceutic Necessities, N.E.C.
Date Published: 04/13/2010

Notes: Malaysia; Product name contains the term "Flu" and labeling declares it "may be useful as a preventive measure during the cold and flu seasons"

V-Shine Marketing Sdn Bhd
Date Published : 09/30/2009
Unknown Street , Jalan, MALAYSIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: 7/6/2007. Han Palace Capsules.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2009

Notes: 7/6/2007. Han Palace Capsules.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 7/6/2007. Han Palace Capsules.

Vall Boon Medical Factory
Date Published : 10/04/2013
No. 1 Lorong Menkudu , Penang, MALAYSIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/04/2013

Desc: Su Bi Lin
Notes: Unapproved

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/04/2013

Desc: Vail-Bon Jie Yang Wan
Notes: Unapproved

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/04/2013

Desc: Val Boon Lue Fong Zai Yang Lin Pills
Notes: Unapproved

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/04/2013

Desc: Vail-Bon Jie Yang Wan
Notes: Unapproved

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/04/2013

Desc: Val Boon Lue Fong Zai Yang Lin Pills
Notes: Unapproved

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/04/2013

Desc: Su Bi Lin
Notes: Unapproved

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/04/2013

Desc: Vail-Bon Jie Yang Wan
Notes: Unapproved

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/04/2013

Desc: Val Boon Lue Fong Zai Yang Lin Pills
Notes: Unapproved

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/04/2013

Desc: Su Bi Lin
Notes: Unapproved

Welip (M) Sdn Bhd
Date Published : 12/24/2013
Lot 1892 Riverview Arcade Kuchin , Sarawak, MALAYSIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/24/2013

Desc: Ceng Fui Yen

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/24/2013

Desc: Kian Pee Wah

Worldgate Vision Beverage Sdn Bhd
Date Published : 08/05/2016
95 Jalan Enggang , Sungai Petani, Kedah MALAYSIA
31 E - - 06 Herbal Coffee (Blend of herbs, grains, fruits and nuts)
Date Published: 08/05/2016

Desc: Natural Herbs Coffee

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/05/2016

Desc: Natural Herbs Coffee

Yee Hong Pharmaceutical SDN. BHD.
Date Published : 09/15/2016
39 Jalan Molek Bagan Ajam , Butterworth Penang, MALAYSIA
60 L - - 99 Analgesic, N.E.C.
Date Published: 09/15/2016

Desc: NHAN SAM TUYET LIEN TRUY PHONG VHOAN
Notes: Medical claims on product labels and product contains undeclared chlorpheniramine and dexamethasone

61 X - - 08 Chlorpheniramine Maleate (Anti-Histaminic)
Date Published: 09/15/2016

Desc: NHAN SAM TUYET LIEN TRUY PHONG VHOAN
Notes: Medical claims on product labels and product contains undeclared chlorpheniramine and dexamethasone

64 L - - 19 Dexamethasone (Glucocorticoid)
Date Published: 09/15/2016

Desc: NHAN SAM TUYET LIEN TRUY PHONG VHOAN
Notes: Medical claims on product labels and product contains undeclared chlorpheniramine and dexamethasone


MEXICO


A G E S Distributors & Imports (aka AGES DISTRIBUIDORA)
Date Published : 09/13/2019
Apartado Postal No Box 2603 , Tijuana, B C MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: Energy Complex

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Energy Complex

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Energy Complex

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Energy Complex

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Energy Complex

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Energy Complex

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Energy Complex

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Energy Complex

A.H. Robbins de Mexico
Date Published : 08/20/2019
Unknown Street , Unknown, MEXICO
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/20/2019

Notes: Redotex

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/20/2019

Notes: Redotex

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

61 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

62 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

63 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

64 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

65 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

66 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

Agaviotica S.A. De C.V.
Date Published : 10/01/2010
Distrito B 4 No 433 , Monterrey, MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/01/2010

Desc: Fiber Agave Inulina
Notes: Mexico

62 B - - 99 Anti-Hyperlipidemic N.E.C.
Date Published: 10/01/2010

Desc: Fiber Agave Inulina
Notes: Mexico

Amalia Sanchez Ramirez
Date Published : 10/08/2013
Calle Benito Juarez 1 , Col. Chihuahua, Tijuana , Tijuana, Baja California MEXICO
61 W - - 04 Clotrimazole (Anti-Fungal) (Not Antibiotic)
Date Published: 10/08/2013

Desc: Clotrimazole Vaginal Cream 2% (Canesten V)

Bayer de Mexico, S.A. de C.V.
Date Published : 09/17/2014
Carretera Mexico-Toluca Km. 52.5 , Lerma, Mexico MEXICO
60 C - - 09 Phenylephrine HCl (Adrenergic)
Date Published: 09/17/2014

Desc: Tabcin Effervescent Tablets (Cold and flu relief)
Notes: The product; as formulated and labeled; appears to be a an unapproved new drug because it does not meet the requirements of the final monograph for Cold; Cough; Allergy; Bronchodilator; and Antiasthmatic Drug Products for OTC use; 21 CFR Part 341. For example; product indications such as the relief of upset stomach; heartburn; acid indigestion; and sour stomach do not meet the indications outlined in the final monograph.

60 S - - 99 Antacid, N.E.C.
Date Published: 09/17/2014

Desc: Tabcin Effervescent Tablets (Cold and flu relief)
Notes: The product; as formulated and labeled; appears to be a an unapproved new drug because it does not meet the requirements of the final monograph for Cold; Cough; Allergy; Bronchodilator; and Antiasthmatic Drug Products for OTC use; 21 CFR Part 341. For example; product indications such as the relief of upset stomach; heartburn; acid indigestion; and sour stomach do not meet the indications outlined in the final monograph.

61 X - - 08 Chlorpheniramine Maleate (Anti-Histaminic)
Date Published: 09/17/2014

Desc: Tabcin Effervescent Tablets (Cold and flu relief)
Notes: The product; as formulated and labeled; appears to be a an unapproved new drug because it does not meet the requirements of the final monograph for Cold; Cough; Allergy; Bronchodilator; and Antiasthmatic Drug Products for OTC use; 21 CFR Part 341. For example; product indications such as the relief of upset stomach; heartburn; acid indigestion; and sour stomach do not meet the indications outlined in the final monograph.

Bestbuyinjectablehgh.com
Date Published : 09/30/2009
BIP Cancun S.A. de C.V. , Calle Azucenas SM. 22 M. 2, Lote 19 , Cancun, ZZ, MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                               

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Bio Ser Natural Sa De Cv
Date Published : 06/06/2013
Calle 18 No. 36 , Col. Olivar Del Conde 1a. Seccion, Alvaro Obregon , Ciudad De Mexico, Ciudad de Mexico MEXICO
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 06/06/2013

Desc: Teen Clean Exfoliating Bar Soap

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 06/06/2013

Desc: Teen Clean Exfoliating Astringent Bar Soap

64 X - - 99 Keratolytic N.E.C.
Date Published: 06/06/2013

Desc: Teen Clean Exfoliating Bar Soap

64 X - - 99 Keratolytic N.E.C.
Date Published: 06/06/2013

Desc: Teen Clean Exfoliating Astringent Bar Soap

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/06/2013

Desc: Teen Clean Exfoliating Astringent Bar Soap

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/06/2013

Desc: Teen Clean Exfoliating Bar Soap

Biofarma Natural CMD S.A. de C.V.
Date Published : 01/20/2022
Calle Industria Hulera # 97 , Industrial Zapopan Norte , Zapopan, Jalisco MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 01/20/2022

Desc: BroncoMiel Syrup Honey And Propolis
Notes: The product appears to be an unapproved new drug as the product’s promotional website includes statements such as (not an all-inclusive list): ‘Prevención de las afecciones de las vías respiratorias.’

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 01/25/2022

Desc: Broncolito Syrup Honey
Notes: The product appears to be an unapproved new drug as the product’s promotional website includes statements such as (not an all-inclusive list): ‘Prevención de las afecciones de las vías respiratorias.’; ‘Ayuda a protegerlos de enfermedades repiratorias todos los dias.’

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/20/2022

Desc: BroncoMiel Syrup Honey And Propolis
Notes: The product appears to be an unapproved new drug as the product’s promotional website includes statements such as (not an all-inclusive list): ‘Prevención de las afecciones de las vías respiratorias.’

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/25/2022

Desc: Broncolito Syrup Honey
Notes: The product appears to be an unapproved new drug as the product’s promotional website includes statements such as (not an all-inclusive list): ‘Prevención de las afecciones de las vías respiratorias.’; ‘Ayuda a protegerlos de enfermedades repiratorias todos los dias.’

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/20/2022

Desc: BroncoMiel Syrup Honey And Propolis
Notes: The product appears to be an unapproved new drug as the product’s promotional website includes statements such as (not an all-inclusive list): ‘Prevención de las afecciones de las vías respiratorias.’

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2022

Desc: Broncolito Syrup Honey
Notes: The product appears to be an unapproved new drug as the product’s promotional website includes statements such as (not an all-inclusive list): ‘Prevención de las afecciones de las vías respiratorias.’; ‘Ayuda a protegerlos de enfermedades repiratorias todos los dias.’

Bioxira Health Technologies, S.A. de C.V.
Date Published : 09/30/2009
Calle Zaragoza No 1 , Col. Cuajimalpa, Cuajimalpa De Morelos , Ciudad De Mexico, Ciudad de Mexico MEXICO
53 L - - -- Skin Care Prep
Date Published: 11/26/2019

Desc: Bioxira Skin Cream Impregnated Cloth
Notes: 12/7/2005                                  

53 L - - -- Skin Care Prep
Date Published: 11/26/2019

Desc: Bioxira PreventAge 1.0
Notes: 12/7/2005                                  

53 L - - -- Skin Care Prep
Date Published: 11/26/2019

Desc: Bioxira Defining 1.0
Notes: 12/7/2005                                  

66 S - - 99 Vasodilator N.E.C.
Date Published: 11/26/2019

Desc: Bioxira Skin Cream Impregnated Cloth
Notes: 12/7/2005                                  

66 S - - 99 Vasodilator N.E.C.
Date Published: 11/26/2019

Desc: Bioxira Defining 1.0
Notes: 12/7/2005                                  

66 S - - 99 Vasodilator N.E.C.
Date Published: 11/26/2019

Desc: Bioxira PreventAge 1.0
Notes: 12/7/2005                                  

Border Pharmacy
Date Published : 09/30/2009
26 Abasolo Y Reforma, C.p. , Unknown, MEXICO
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 08/20/2020

Desc: Abarelix
Notes:                         

64 R - - 21 Somatropin (Hormone)
Date Published: 08/20/2020

Notes:                         

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                         

Broncolin, S.A. de C.V.
Date Published : 01/10/2012
Calle Sur 16 No. 353 , Col. Agricola Oriental, Iztacalco , Ciudad De Mexico, Ciudad de Mexico MEXICO
31 P - - 99 Tea Substitutes, N.E.C.
Date Published: 01/17/2012

Desc: Tea
Notes: Mexico

31 P - - 99 Tea Substitutes, N.E.C.
Date Published: 01/10/2012

Desc: Herbacil Tea of St. John's Wort
Notes: Mexico

CADBURY ADAMS MEXICO, S DE R.L. DE C.V.
Date Published : 02/09/2012
Av Santa Fe No 485 , Col Cruz Manca , Delg Cuajimalpa De Morelos, Distrito Federal MEXICO
62 U - - 99 Anti-Tussive/Cold N.E.C.
Date Published: 02/09/2012

Desc: Halls Troat Lozenges (All Flavors)

COLGATE-PALMOLIVE S.A. DE C.V,.
Date Published : 12/10/2015
Av. Ejercito Nacional 843B , Granada, Miguel Hidalgo, , Mexico City, Distrito Federal MEXICO
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 12/10/2015

Desc: Caprice Hair Loss Protection Shampoo
Notes: Labeling on product makes drug claims

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 12/10/2015

Desc: Caprice Hair Loss and Restoration Shampoo
Notes: Labeling on product makes drug claims

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 12/10/2015

Desc: Caprice Hair Loss and Restoration Shampoo
Notes: Labeling on product makes drug claims

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 12/10/2015

Desc: Caprice Hair Loss Protection Shampoo
Notes: Labeling on product makes drug claims

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 12/10/2015

Desc: Caprice Hair Loss Protection Shampoo
Notes: Labeling on product makes drug claims

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 12/10/2015

Desc: Caprice Hair Loss and Restoration Shampoo
Notes: Labeling on product makes drug claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/10/2015

Desc: Caprice Hair Loss and Restoration Shampoo
Notes: Labeling on product makes drug claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/10/2015

Desc: Caprice Hair Loss Protection Shampoo
Notes: Labeling on product makes drug claims

Cafe del Pacifico
Date Published : 08/11/2017
Blvd. Enrique Mazon Lopez 626 Interior A , Col. Cuartel Xx Cafe Combate, Hermosillo , Hermosillo, Sonora MEXICO
30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 08/16/2017

Desc: De Leon Cafe Original Formula Cappuccino
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Helps minimize pain in joints …'; '… Assist in maintaining cholesterol & triglyceride levels …'.

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 08/11/2017

Desc: De Leon Cafe Weight Loss Formula Cappuccino
Notes: The product appears to be an unapproved new drug as the product website includes claims such as; '...[R]educe LDL cholesterol levels...'.

31 A - - 02 Coffee, Ground
Date Published: 08/16/2017

Desc: De Leon Cafe Original Formula Cappuccino
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Helps minimize pain in joints …'; '… Assist in maintaining cholesterol & triglyceride levels …'.

31 A - - 02 Coffee, Ground
Date Published: 08/11/2017

Desc: De Leon Cafe Weight Loss Formula Cappuccino
Notes: The product appears to be an unapproved new drug as the product website includes claims such as; '...[R]educe LDL cholesterol levels...'. ;

31 A - - 03 Coffee, Instant
Date Published: 08/11/2017

Desc: De Leon Cafe Weight Loss Formula Cappuccino
Notes: The product appears to be an unapproved new drug as the product website includes claims such as; '...[R]educe LDL cholesterol levels...'. ;

31 A - - 03 Coffee, Instant
Date Published: 08/16/2017

Desc: De Leon Cafe Original Formula Cappuccino
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Helps minimize pain in joints …'; '… Assist in maintaining cholesterol & triglyceride levels …'.

31 A - - 99 Coffee, N.E.C.
Date Published: 08/11/2017

Desc: De Leon Cafe Weight Loss Formula Cappuccino
Notes: The product appears to be an unapproved new drug as the product website includes claims such as; '...[R]educe LDL cholesterol levels...'.

31 A - - 99 Coffee, N.E.C.
Date Published: 08/16/2017

Desc: De Leon Cafe Original Formula Cappuccino
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Helps minimize pain in joints …'; '… Assist in maintaining cholesterol & triglyceride levels …'.

CarePluss Pharma S. de R.L. de C.V.
Date Published : 07/19/2013
Avenida Los Charros 5 A , Col. Jose Sandoval, Tijuana , Tijuana, Baja California MEXICO
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/19/2013

Desc: Simply firm non-surgical facelift eye creme
Notes: Note; mfg per product level

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/19/2013

Desc: Simply firm non-surgical face
Notes: Note; mfg per product level

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/19/2013

Desc: Simply firm non-surgical face
Notes: Note; mfg per product level

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/19/2013

Desc: Simply firm non-surgical facelift eye creme
Notes: Note; mfg per product level

64 D - - 99 Emollient, Lubricant, N.E.C.
Date Published: 07/19/2013

Desc: Simply firm non-surgical facelift eye creme
Notes: Note; mfg per product level

64 D - - 99 Emollient, Lubricant, N.E.C.
Date Published: 07/19/2013

Desc: Simply firm non-surgical face
Notes: Note; mfg per product level

65 L - - 99 Protectant N.E.C.
Date Published: 07/19/2013

Desc: Simply firm non-surgical face
Notes: Note; mfg per product level

65 L - - 99 Protectant N.E.C.
Date Published: 07/19/2013

Desc: Simply firm non-surgical facelift eye creme
Notes: Note; mfg per product level

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/19/2013

Desc: Simply firm non-surgical face
Notes: Note; mfg per product level

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/19/2013

Desc: Simply firm non-surgical facelift eye creme
Notes: Note; mfg per product level

Carepluss Pharma Sa De Cv
Date Published : 07/19/2013
Via Rapida Oriente No. 11812-2B , Col. Mineral de Santa Fe , Tijuana, Baja California MEXICO
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/23/2013

Desc: Simply Firm Non-Surgical Face & Neck Creme
Notes: Note; Mfg/shipper per invoice and oasis

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/19/2013

Desc: Simply Firm Non-Surgical Facelift Eye Creme
Notes: Note; mfg/shipper per invoice and OASIS

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/19/2013

Desc: Simply Firm Non-Surgical Facelift Eye Creme
Notes: Note; mfg/shipper per invoice and OASIS

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/23/2013

Notes: Simply Firm Non-Surgical Face & Neck Creme; Note; Mfg/shipper per invoice and oasis

64 D - - 99 Emollient, Lubricant, N.E.C.
Date Published: 07/23/2013

Desc: Simply Firm Non-Surgical Face & Neck Creme
Notes: Note: Mfg/shipper per invoice and oasis

64 D - - 99 Emollient, Lubricant, N.E.C.
Date Published: 07/19/2013

Desc: Simply Firm Non-Surgical Facelift Eye Creme
Notes: Note; mfg/shipper per invoice and OASIS

65 L - - 99 Protectant N.E.C.
Date Published: 07/19/2013

Desc: Simply Firm Non-Surgical Facelift Eye Creme
Notes: Note; mfg/shipper per invoice and OASIS

65 L - - 99 Protectant N.E.C.
Date Published: 07/23/2013

Desc: Simply Firm Non-Surgical Face & Neck Creme
Notes: Note; Mfg/shipper per invoice and oasis

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/19/2013

Desc: Simply Firm Non-Surgical Facelift Eye Creme
Notes: Note; mfg/shipper per invoice and OASIS

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/23/2013

Notes: Simply Firm Non-Surgical Face & Neck Creme; Note; Mfg/shipper per invoice and oasis

Carlos Alvear Lopez
Date Published : 06/17/2022
Domicilio Conocido S/N , Jalmolonga Malinalco, Mexico MEXICO
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/17/2022

Desc: Diabetless Plus (powder or capsule)
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘Diabetless’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/17/2022

Desc: Diabetless Plus (powder or capsule)
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘Diabetless’.

Centro Botanico Azteca SA
Date Published : 05/07/2012
Col. Merced Centro, Deleg V. Carranza , San Simon , Mexico, Df MEXICO
31 M - - 02 Tea With Extracts or Concentrates
Date Published: 09/19/2012

Desc: Te de Arnica

31 M - - 02 Tea With Extracts or Concentrates
Date Published: 09/19/2012

Desc: Tizana AD-TE Extracto

31 M - - 02 Tea With Extracts or Concentrates
Date Published: 09/19/2012

Desc: Pulmonaria

31 M - - 02 Tea With Extracts or Concentrates
Date Published: 09/19/2012

Desc: Te Riopan

31 M - - 99 Blended Teas, N.E.C.
Date Published: 09/19/2012

Desc: Diawerek

31 M - - 99 Blended Teas, N.E.C.
Date Published: 09/19/2012

Desc: Te Ervioxil

31 M - - 99 Blended Teas, N.E.C.
Date Published: 09/19/2012

Desc: Te Negro

31 M - - 99 Blended Teas, N.E.C.
Date Published: 09/19/2012

Desc: Te de Hierba Del Sapo

31 M - - 99 Blended Teas, N.E.C.
Date Published: 09/19/2012

Desc: Te Del Indio

31 M - - 99 Blended Teas, N.E.C.
Date Published: 09/19/2012

Desc: Te Estomacal

31 M - - 99 Blended Teas, N.E.C.
Date Published: 09/19/2012

Desc: Tizana Uva

31 M - - 99 Blended Teas, N.E.C.
Date Published: 09/19/2012

Desc: Te Circulsan

31 M - - 99 Blended Teas, N.E.C.
Date Published: 09/19/2012

Desc: Te de Masto

31 M - - 99 Blended Teas, N.E.C.
Date Published: 09/19/2012

Desc: Te de Pasilfora

54 F - - 43 Damiana (Herbal & Botanicals, not Teas)
Date Published: 07/24/2012

Desc: Damiana Tunera Difusa
Notes: mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/07/2012

Desc: Abango Herbal Tea
Notes: Mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2012

Desc: Te Riopan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2012

Desc: Te de Pasilfora

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/07/2012

Desc: Estomacal Herbal Tea
Notes: Mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/07/2012

Desc: Lollipop Abango
Notes: Mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/07/2012

Desc: Te Del Indio
Notes: Mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2012

Desc: Tizana Uva

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2012

Desc: Pulmonaria

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2012

Desc: Diawerek

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2012

Desc: Te Ervioxil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2012

Desc: Te de Masto

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/07/2012

Desc: Abango Jarabe 240 mL
Notes: Mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2012

Desc: Te de Arnica

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/07/2012

Desc: Arnica Herbal Tea
Notes: Mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/24/2012

Desc: Damiana Tunera Difusa
Notes: mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2012

Desc: Tizana AD-TE Extracto

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2012

Desc: Te Circulsan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2012

Desc: Te de Hierba Del Sapo

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/07/2012

Desc: Abango Jarabe Bee Honey Syrup
Notes: Mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/07/2012

Desc: Tizana Indio Herbal Teas
Notes: Mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2012

Desc: Te Negro

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2012

Desc: Te Estomacal

Centro Botanico Santiago
Date Published : 11/25/2013
Av. Benito Juarez # 8306 , Col. Centro C.P. 22000 , Tijuana Baja, California MEXICO
54 G - - 99 Animal By-Products and Extracts, N.E.C.
Date Published: 11/25/2013

Desc: Ortiga Dietary Supplement

Comercializadora Quality Health S.A
Date Published : 07/11/2012
Fermin G Riestra 43 , Zona Centro, Jal MEXICO
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 08/24/2013

Desc: Tiger Balm Ointment
Notes: Note: drug claims found on website;                               

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 08/24/2013

Desc: Viper & Bee Ointment
Notes: Note: drug claims found on website;                               

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 08/24/2013

Desc: Aloe Vera Sabila Ointment
Notes: Note: drug claims found on website;                               

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 08/24/2013

Desc: Arnica Flowers Ointment
Notes: Note: drug claims found on website;                               

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 07/11/2012

Desc: Ointment Milagro
Notes: Mexico

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 08/24/2013

Desc: Coyote Ointment
Notes: Note: drug claims found on website;                               

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 08/24/2013

Desc: Arnica Ointment
Notes: Note: drug claims found on website;                               

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 08/24/2013

Desc: Peyote Ointment
Notes: Note: drug claims found on website;                               

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 08/24/2013

Desc: Tepezcohuite Bark Ointment
Notes: Note: drug claims found on website;                               

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/24/2013

Desc: Coyote Ointment
Notes: Note: drug claims found on website;                               

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/24/2013

Desc: Tiger Balm Ointment
Notes: Note: drug claims found on website;                               

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/24/2013

Desc: Viper & Bee Ointment
Notes: Note: drug claims found on website;                               

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/11/2012

Desc: Ointment Milagro
Notes: mexico

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/24/2013

Desc: Aloe Vera Sabila Ointment
Notes: Note: drug claims found on website;                               

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/24/2013

Desc: Peyote Ointment
Notes: Note: drug claims found on website;                               

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/24/2013

Desc: Tepezcohuite Bark Ointment
Notes: Note: drug claims found on website;                               

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/24/2013

Desc: Arnica Ointment
Notes: Note: drug claims found on website;                               

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/24/2013

Desc: Arnica Flowers Ointment
Notes: Note: drug claims found on website;                               

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/11/2012

Desc: Ointment Milagro
Notes: mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/24/2013

Desc: Arnica Ointment
Notes: Note: drug claims found on website;                               

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/24/2013

Desc: Viper & Bee Ointment
Notes: Note: drug claims found on website;                               

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/24/2013

Desc: Tiger Balm Ointment
Notes: Note: drug claims found on website;                               

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/24/2013

Desc: Tepezcohuite Bark Ointment
Notes: Note: drug claims found on website;                               

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/24/2013

Desc: Coyote Ointment
Notes: Note: drug claims found on website;                               

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/24/2013

Desc: Peyote Ointment
Notes: Note: drug claims found on website;                               

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/24/2013

Desc: Arnica Flowers Ointment
Notes: Note: drug claims found on website;                               

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/11/2012

Desc: Ointment Milagro
Notes: Mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/24/2013

Desc: Aloe Vera Sabila Ointment
Notes: Note: drug claims found on website;                               

Comercializadora Quality Health Sa De Cv
Date Published : 10/10/2013
Tezozomoc #47 Ciudad Del Sol , Zapopan Jalisco, MEXICO
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 10/10/2013

Desc: Belladonna Ointment

55 R - - 99 Pharmaceutic Necessities, N.E.C.
Date Published: 10/10/2013

Desc: Belladonna Ointment

61 K - - 06 Belladonna (Ext) (Anti-Cholinergic)
Date Published: 10/10/2013

Desc: Belladonna ointment

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/10/2013

Desc: Belladonna Ointment

Corporativo Serysi, S. De R.L. De C.V.
Date Published : 04/24/2017
Avenida Paseo Royal Country No. 4596 , Col. Puerta De Hierro, Zapopan , Zapopan, Jalisco MEXICO
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/24/2017

Desc: Baba de Caracol Soap with Allantoin 0.5%

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/24/2017

Desc: Baba de Caracol Facial Lotion

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 04/24/2017

Desc: Baba de Caracol Facial Lotion

65 L - - 02 Allantoin (Protectant)
Date Published: 04/24/2017

Desc: Baba de Caracol Soap with Allantoin 0.5%

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2017

Desc: Baba de Caracol Soap with Allantoin 0.5%

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2017

Desc: Baba de Caracol Facial Lotion

Cosbel S.A de C.V.
Date Published : 04/24/2017
Prol. Divisi??n del Norte 5152 130 COLONIA XOCO , Col. Potrero De San Bernardino, Xochimilco , Ciudad De Mexico, Ciudad de Mexico MEXICO
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 04/24/2017

Desc: FRUCTIS SHAMPOO STOP CAIDA
Notes: The product appears to be an unapproved new drug as the product labeling and firms website declared in Spanish contain claims that indicate drug uses for the product including; Stop calda (English translation; Step loss); Fortifica la fibra del interior hasta las puntas 4x menos calda (English translation; Fortify the interior fibers down to 4x less loss).

Cosbel, S.A. de C.V.
Date Published : 06/19/2017
Oklahoma No. 14 Napoles, Benito Juarez , Mexico,Distrito Federal, C.P 03810 , Mexico, Distrito Federal MEXICO
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 06/19/2017

Desc: Fructis Grow Strong 2IN1 Shampoo & Conditioner (Stop Caida Crece Fuerte 2 En 1)
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ' ... Salva hasta 2000 cabellos al mes cabello fragil que se cae fortifica la fibra del interior hasta las puntas ...; ... Cabello 4X mas resistente contra la caida ...'

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 06/19/2017

Desc: Fructis Fortifying 2IN1 Shampoo
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ' ... Stop caida crece fuerte cabello dibilitados con tendencia a caerse" ...; ... Stop caida crece fuerte ...'

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 06/19/2017

Desc: Fructis Grow Strong Shampoo (Stop Caida Crece Fuerte)
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ' ... Stop caida crece fuerte cabello dibilitados con tendencia a caerse ...; ... Stop caida crece fuerte ...'

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 06/19/2017

Desc: Fructis Grow Strong 2IN1 Shampoo & Conditioner (Stop Caida Crece Fuerte 2 En 1)
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ' ... Salva hasta 2000 cabellos al mes cabello fragil que se cae fortifica la fibra del interior hasta las puntas ...; ... Cabello 4X mas resistente contra la caida ...'

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 06/19/2017

Desc: Fructis Grow Strong Shampoo (Stop Caida Crece Fuerte)
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ' ... Stop caida crece fuerte cabello dibilitados con tendencia a caerse ...; ... Stop caida crece fuerte ...'

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 06/19/2017

Desc: Fructis Fortifying 2IN1 Shampoo & Conditioner (Stop Caida 2 En 1)
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ' ... Stop caida crece fuerte cabello dibilitados con tendencia a caerse" ...; ... Stop caida crece fuerte ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/19/2017

Desc: Fructis Fortifying 2IN1 Shampoo & Conditioner (Stop Caida 2 En 1)
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ' ... Stop caida crece fuerte cabello dibilitados con tendencia a caerse" ...; ... Stop caida crece fuerte ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/19/2017

Desc: Fructis Grow Strong Shampoo (Stop Caida Crece Fuerte)
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ' ... Stop caida crece fuerte cabello dibilitados con tendencia a caerse ...; ... Stop caida crece fuerte ...'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/19/2017

Desc: Fructis Grow Strong 2IN1 Shampoo
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ' ... Salva hasta 2000 cabellos al mes cabello fragil que se cae fortifica la fibra del interior hasta las puntas ...; ... Cabello 4X mas resistente contra la caida ...'

DIBAR NUTRICIONALS S DE RL DE CV
Date Published : 01/08/2018
Eucalipto No. 20 Col. Puerto de Buenavista , Morelia, Michoacan MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 01/17/2018

Desc: "Crofibronix Plus" Dietary Supplement
Notes: Product labeling fails to bear adequate directions for use and includes claims, such as, "…designed to manage the symptoms of fibromyalgia and C.F.S." (Chronic Fatigue Sundrome).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/08/2018

Desc: Male Sexual Enhancement Dietary Herbal Supplement
Notes: The product appears to be an unapproved new drug as the product includes claims such as; " "[P]roduces dramatic health improvements for people with ED "; "[H]elping others who were faced with ED health concerns "; and "[A]ssist with premature ejaculation "

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/17/2018

Desc: "Crofibronix Plus" Dietary Supplement
Notes: Product labeling fails to bear adequate directions for use and includes claims, such as, "…designed to manage the symptoms of fibromyalgia and C.F.S." (Chronic Fatigue Sundrome).

DR VILLALPANDO
Date Published : 09/17/2019
UNKNOWN , UNKNOWN, MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/17/2019

Notes: Life Crystals, 5/22/2003

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Life Crystals, 5/22/2003

61 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Life Crystals, 5/22/2003

62 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Life Crystals, 5/22/2003

63 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Life Crystals, 5/22/2003

64 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Life Crystals, 5/22/2003

65 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Life Crystals, 5/22/2003

66 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Life Crystals, 5/22/2003

Discovery Experimental and Development Mexico N.A.
Date Published : 09/17/2019
Juan Carrisco No. 13 , Tijuana, Baja California MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/17/2019

Notes: Liquid Deprenyl Citrate

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Liquid Deprenyl Citrate

61 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Liquid Deprenyl Citrate

62 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Liquid Deprenyl Citrate

63 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Liquid Deprenyl Citrate

64 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Liquid Deprenyl Citrate

65 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Liquid Deprenyl Citrate

66 - - - -- Human and Animal Drugs
Date Published: 09/17/2019

Notes: Liquid Deprenyl Citrate

EMPACADORA THERBAL SA DE CV
Date Published : 08/13/2013
Espana 423 , Col. San Juan Xalpa, Iztapalapa , Ciudad De Mexico, Ciudad de Mexico MEXICO
31 K - - 99 Tea, N.E.C.
Date Published: 11/13/2015

Desc: Pu-Erh Red Tea (Tea Rojo)
Notes: Product labels make disease claims

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 11/13/2015

Desc: Pu-Erh Red Tea (Tea Rojo)
Notes: Product labels make disease claims

66 F - - 99 Suppressant N.E.C.
Date Published: 08/13/2013

Desc: Cough Drops AKA Caramelos Abango Con Propoleo
Notes: Product labels make disease claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/13/2015

Desc: Pu-Erh Red Tea (Tea Rojo)
Notes: Product labels make disease claims

ENAT INTERNATIONAL S.A. de C.V.
Date Published : 01/20/2012
Carretera Federal Tramo Salamanca-Irapuato Km 320 Interior B , Salamanca, Guanajuato MEXICO
20 U - - 06 Prickle Pear Cactus - Edible Stems or Pads (Core Fruit Purees)
Date Published: 04/24/2013

Desc: Prickly Pear Puree
Notes: Mexico

21 M - - 05 Subtropical Fruit Flavored Imitation Fruit
Date Published: 01/20/2012

Desc: Prickly Pear Puree Health Drink
Notes: Mexico

FABRICANTE EXPORTADORA Y COMERCIALIZADORA DE JARABE DE AGAVE
Date Published : 08/16/2013
CARRETERA INTERNACIONAL 720 , Tequila, Jal MEXICO
41 G - - 99 Medical Foods, N.E.C.
Date Published: 08/16/2013

Desc: Fiber Plus Cactus & Agave Fiber

54 I - - 99 Fiber, N.E.C.
Date Published: 08/16/2013

Desc: Fiber Plus Cactus & Agave Fiber

Farmaqro, S.A. de C.V.
Date Published : 10/04/2013
Calle 2 No. 42 , Parque Industrial Benito Juarez, Queretaro , Santiago De Queretaro, Queretaro MEXICO
61 W - - 39 Undecylenic Acid (Anti-Fungal) (Not Antibiotic)
Date Published: 10/04/2013

Desc: Ting Cream

61 W - - 41 Zinc Undecylenate (Anti-Fungal) (Not Antibiotic)
Date Published: 10/04/2013

Desc: Ting Cream

61 W - - 99 A-Fungal N.E.C.
Date Published: 10/04/2013

Desc: Ting Cream

Frabel Sa De Cv
Date Published : 06/11/2013
Cerrada Felix Cuevas 6 , Otro Tlacoquemecatl Del Valle, Benito Juarez , Ciudad De Mexico, Ciudad de Mexico MEXICO
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 06/19/2017

Desc: Fructis Grow Strong Shampoo (Stop Caida Crece Fuerte)
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ' ... Stop caida crece fuerte cabello dibilitados con tendencia a caerse ...; ... Stop caida crece fuerte ...'

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 06/19/2017

Desc: Fructis Grow Strong 2IN1 Shampoo
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ' ... Salva hasta 2000 cabellos al mes cabello fragil que se cae fortifica la fibra del interior hasta las puntas ...; ... Cabello 4X mas resistente contra la caida ...'.

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 06/19/2017

Desc: Fructis Fortifying 2IN1 Shampoo
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ' ... Stop caida crece fuerte cabello dibilitados con tendencia a caerse" ...; ... Stop caida crece fuerte ...'.

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 06/19/2017

Desc: Fructis Grow Strong 2IN1 Shampoo
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ' ... Salva hasta 2000 cabellos al mes cabello fragil que se cae fortifica la fibra del interior hasta las puntas ...; ... Cabello 4X mas resistente contra la caida ...'.

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 06/19/2017

Desc: Fructis Grow Strong Shampoo (Stop Caida Crece Fuerte)
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ' ... Stop caida crece fuerte cabello dibilitados con tendencia a caerse ...; ... Stop caida crece fuerte ...'

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 06/19/2017

Desc: Fructis Fortifying 2IN1 Shampoo
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ' ... Stop caida crece fuerte cabello dibilitados con tendencia a caerse" ...; ... Stop caida crece fuerte ...'.

53 J - - 02 Deodorants (underarm)(Not Antiperspirant) (Personal Cleanliness)
Date Published: 06/11/2013

Desc: Deodorant
Notes: Mexico

62 W - - 17 Aluminum Chloride Astringent/Anti-Perspirant)
Date Published: 06/11/2013

Desc: Deodorant
Notes: Mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/19/2017

Desc: Fructis Grow Strong 2IN1 Shampoo & Conditioner (Stop Caida Crece Fuerte 2 En 1)
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ' ... Salva hasta 2000 cabellos al mes cabello fragil que se cae fortifica la fibra del interior hasta las puntas ...; ... Cabello 4X mas resistente contra la caida ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/19/2017

Desc: Fructis Grow Strong Shampoo (Stop Caida Crece Fuerte)
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ' ... Stop caida crece fuerte cabello dibilitados con tendencia a caerse ...; ... Stop caida crece fuerte ...'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/19/2017

Desc: Fructis Fortifying 2IN1 Shampoo & Conditioner (Stop Caida 2 En 1)
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; ' ... Stop caida crece fuerte cabello dibilitados con tendencia a caerse" ...; ... Stop caida crece fuerte ...'.

Genomma Lab Internacional SAB de CV
Date Published : 10/02/2013
Mz 4 , Av Industrial Automotriz LT 3 y 5 , Estado de Mexico, Dona Rosa Lerma MEXICO
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 10/02/2013

Desc: Sulfur Cleansing Bar Soap

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 10/02/2013

Desc: Forte Cleansing Bar

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 10/02/2013

Desc: Herbal Cleansing Bar Soap

64 X - - 99 Keratolytic N.E.C.
Date Published: 10/02/2013

Desc: Forte Cleansing Bar

64 X - - 99 Keratolytic N.E.C.
Date Published: 10/02/2013

Desc: Herbal Cleansing Bar Soap

64 X - - 99 Keratolytic N.E.C.
Date Published: 10/02/2013

Desc: Sulfur Cleansing Bar Soap

Grupo Nutrivida
Date Published : 08/06/2010
Av De Las Americas , Del. Benito Juarez , Mexico, MX-DIF MEXICO
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 09/28/2010

Desc: Lipo Alcachofivida Reductive and Reaffirm Organic Soap
Notes: mexico

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 08/06/2010

Desc: Lipo Alcachofivida Redutive Cream
Notes: mexico

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/06/2010

Desc: Lipo Alcachofivida Redutive Cream
Notes: mexico

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/28/2010

Desc: Omega 3000
Notes: mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2010

Desc: Lipo Alcachofivida Reductive and Reaffirm Organic Soap
Notes: mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2010

Desc: Omega 3000
Notes: mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/06/2010

Desc: Lipo Alcachofivida Redutive Cream
Notes: mexico

Grupo Russellsa - Mexican Pharmaceutical Co.
Date Published : 08/20/2019
Unknown Street , Unknown, MEXICO
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/20/2019

Notes: Redotex

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/20/2019

Notes: Redotex

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

61 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

62 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

63 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

64 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

65 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

66 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

HGH Human Growth Hormone
Date Published : 09/30/2009
Laura Vadillo, Av. Sayil No. 24 , Cancun, Quintana Roo, MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                                   

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Healthy People Labs S de RL de CV
Date Published : 05/08/2013
Avenida Alvaro Obregon 145 , Col. Irapuato Centro, Irapuato , Irapuato, Guanajuato MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: Perfect Man Dietary Supplement
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: EverLax Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: EverSlim Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: Mince Belle Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: Acaiman Mangosteen Herbal Drink
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: EverSlim Shake-Strawberry & Chocolate flavors
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: EverSlim Shake-Strawberry & Chocolate flavors
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine ;

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: Mince Belle Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: Acaiman Mangosteen Herbal Drink
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: Perfect Man Dietary Supplement
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: EverSlim Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: EverLax Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: EverSlim Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: Mince Belle Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: Perfect Man Dietary Supplement
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: EverLax Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: Acaiman Mangosteen Herbal Drink
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: EverSlim Shake-Strawberry & Chocolate flavors
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine ;

Healthy People Labs S de RL de CV
Date Published : 05/08/2013
Avenida Alvaro Obregon 145 , Col. Irapuato Centro, Irapuato , Irapuato, Guanajuato MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: Mince Belle Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: Acaiman Mangosteen Herbal Drink
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: EverSlim Shake Strawberry
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: EverSlim Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: Perfect Man Dietary Supplement
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: EverLax Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: EverLax Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: Perfect Man Dietary Supplement
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: Acaiman Mangosteen Herbal Drink
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: Mince Belle Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: EverSlim Shake Strawberry
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: EverSlim Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: EverSlim Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: EverLax Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: EverSlim Shake Strawberry & Chocolate flavors
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: Acaiman Mangosteen Herbal Drink
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: Mince Belle Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: Perfect Man Dietary Supplement
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil

Healthy People Labs S de RL de CV
Date Published : 05/08/2013
Avenida Alvaro Obregon 145 , Col. Irapuato Centro, Irapuato , Irapuato, Guanajuato MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: EverSlim Shake Strawberry & Chocolate flavors
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: Mince Belle Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: EverLax Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: EverSlim Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: Perfect Man Dietary Supplement
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: Acaiman Mangosteen Herbal Drink
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/13/2018

Desc: Ever Lim Gel- firming gel

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 03/13/2018

Desc: Ever Lim Gel- firming gel

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: EverSlim Shake Strawberry
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: EverSlim Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: Mince Belle Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: Acaiman Mangosteen Herbal Drink
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: Perfect Man Dietary Supplement
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: EverLax Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: EverSlim Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2018

Desc: Ever Lim Gel- firming gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: Perfect Man Dietary Supplement
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: Mince Belle Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: EverLax Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: EverSlim Shake Strawberry & Chocolate flavors
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: Acaiman Mangosteen Herbal Drink
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil

Healthy People Labs S de RL de CV
Date Published : 05/08/2013
Avenida Alvaro Obregon 145 , Col. Irapuato Centro, Irapuato , Irapuato, Guanajuato MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/03/2022

Desc: Plata Coloidal Colloidal Silver Liquid Dietary Supplement

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: Mince Belle Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/03/2022

Desc: Plata Coloidal Colloidal Silver Spray Liquid Dietary Supplement

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 07/28/2014

Desc: Ever Lim Dietary Supplement Capsules
Notes: Problem -- Unapproved New Drug; Product contains undeclared Sibutramine and Fluoxetine. Firm's website also makes claims relating to this product's effect on the body's metabolism and fat.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: Perfect Man Dietary Supplement
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: EverLax Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: Acaiman Mangosteen Herbal Drink
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: EverSlim Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/08/2013

Desc: EverSlim Shake-Strawberry
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 07/28/2014

Desc: Ever Lim Dietary Supplement Capsules
Notes: Problem -- Unapproved New Drug; Product contains undeclared Sibutramine and Fluoxetine. Firm's website also makes claims relating to this product's effect on the body's metabolism and fat.

54 A - - 99 Vitamin, N.E.C.
Date Published: 07/28/2014

Desc: Ever Lim Dietary Supplement Capsules
Notes: Problem -- Unapproved New Drug; Product contains undeclared Sibutramine and Fluoxetine. Firm's website also makes claims relating to this product's effect on the body's metabolism and fat.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/28/2014

Desc: Ever Lim Dietary Supplement Capsules
Notes: Problem -- Unapproved New Drug; Product contains undeclared Sibutramine and Fluoxetine. Firm's website also makes claims relating to this product's effect on the body's metabolism and fat.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: EverSlim Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/28/2014

Desc: Ever Lim Dietary Supplement Capsules
Notes: Problem -- Unapproved New Drug; Product contains undeclared Sibutramine and Fluoxetine. Firm's website also makes claims relating to this product's effect on the body's metabolism and fat.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: EverSlim Shake-Strawberry
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: EverLax Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: Mince Belle Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: Perfect Man Dietary Supplement
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/08/2013

Desc: Acaiman Mangosteen Herbal Drink
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: Mince Belle Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/03/2022

Desc: Plata Coloidal Colloidal Silver Spray Liquid Dietary Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/28/2014

Desc: Ever Lim Dietary Supplement Capsules
Notes: Problem -- Unapproved New Drug; Product contains undeclared Sibutramine and Fluoxetine. Firm's website also makes claims relating to this product's effect on the body's metabolism and fat.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: EverLax Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: Perfect Man Dietary Supplement
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: EverSlim Capsules
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/03/2022

Desc: Plata Coloidal Colloidal Silver Liquid Dietary Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: EverSlim Shake-Strawberry & Chocolate flavors
Notes: NOTE; The Mince Belle Capsules; EverSlim Capsule; EverSlim Shake and Everlax Capsules were found to contain undeclared Sibutramine

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2013

Desc: Acaiman Mangosteen Herbal Drink
Notes: NOTE; Acaiman Mangosteen Herbal Drink and Perfect Man Dietary Supplement were found to contain undeclared Tadalafil.

Healthy People Labs S de RL de CV
Date Published : 10/03/2022
Avenida Alvaro Obregon 145 , Col. Irapuato Centro, Irapuato , Irapuato, Guanajuato MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/03/2022

Desc: Plata Coloidal Colloidal Silver Liquid Dietary Supplement

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/03/2022

Desc: Plata Coloidal Colloidal Silver Spray Liquid Dietary Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/03/2022

Desc: Plata Coloidal Colloidal Silver Liquid Dietary Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/03/2022

Desc: Plata Coloidal Colloidal Silver Spray Liquid Dietary Supplement

Healthy People S de R.L. de CV
Date Published : 03/13/2018
Calle Luis Alcantara No. 674 , Col. Los Eucaliptos , Irapuato, Guanajuato MEXICO
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/13/2018

Desc: Ever Lim Gel- firming gel

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 03/13/2018

Desc: Ever Lim Gel- firming gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2018

Desc: Ever Lim Gel- firming gel

Healthylab Mexicana, S.A. de C.V.
Date Published : 06/29/2018
Blvd. Parque Industrial # 4057-B , Parque Industrial Ramos Arizpe , Ramos Arizpe, Coahuila MEXICO
31 A - - 99 Coffee, N.E.C.
Date Published: 06/29/2018

Desc: Stevy Concentrate (60-01 Stevy)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/29/2018

Desc: Stevy Concentrate (60-01 Stevy)

Herbal Solution's Health S.A. de C.V.
Date Published : 12/14/2017
Calzada Insurgentes Poniente No. 322 , Barrio Barrio De Santa Anita, Irapuato , Irapuato, Guanajuato MEXICO
53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 01/16/2020

Desc: Herbal Solutions Fungi Lotion With Natural Extracts

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 01/16/2020

Desc: Herbal Solutions Fungi Lotion With Natural Extracts

54 F - - 08 Echinacea, Herbal & Botanicals (not teas)
Date Published: 12/14/2017

Desc: Pentreci Kids Syrup
Notes: Mecial claims made on the product?s labeling on the website

54 F - - 32 Arnica (Herbal & Botanicals, not Teas)
Date Published: 12/14/2017

Desc: Pentreci Kids Syrup
Notes: Mecial claims made on the product?s labeling on the website.

56 G - - 99 Antifungal N.E.C.
Date Published: 01/16/2020

Desc: Herbal Solutions Fungi Lotion With Natural Extracts

61 W - - 99 A-Fungal N.E.C.
Date Published: 01/16/2020

Desc: Herbal Solutions Fungi Lotion With Natural Extracts

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/16/2020

Desc: Herbal Solutions Fungi Lotion With Natural Extracts

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/14/2017

Desc: Pentreci Kids Syrup
Notes: Mecial claims made on the product?s labeling on the website

Herbal Solution's Health, S.A. de C.V.
Date Published : 09/30/2009
Comunidad Guadalupe De Paso , Blanco Lot 10 , Irapuato, Guanajuato MEXICO
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 09/30/2009

Notes: 11/12/2008 Clear and Balance Facial Gel and Acne Solutions Herbal Capsules

54 F - - 08 Echinacea, Herbal & Botanicals (not teas)
Date Published: 12/14/2017

Desc: Pentreci Kids Syrup
Notes: Mecial claims made on the product?s labeling on the website.

54 F - - 32 Arnica (Herbal & Botanicals, not Teas)
Date Published: 12/14/2017

Desc: Pentreci Kids Syrup
Notes: Mecial claims made on the product?s labeling on the website.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: 11/12/2008 Clear and Balance Facial Gel and Acne Solutions Herbal Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2009

Notes: 11/12/2008 Clear and Balance Facial Gel and Acne Solutions Herbal Capsules

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/04/2019

Notes: Acne Solutions Herbal Capsules and Clear and Balance Facial Gel; 11/12/2008

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Acne Solutions Herbal Capsules and Clear and Balance Facial Gel; 11/12/2008

61 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Acne Solutions Herbal Capsules and Clear and Balance Facial Gel; 11/12/2008

62 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Acne Solutions Herbal Capsules and Clear and Balance Facial Gel; 11/12/2008

63 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Acne Solutions Herbal Capsules and Clear and Balance Facial Gel; 11/12/2008

64 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Acne Solutions Herbal Capsules and Clear and Balance Facial Gel; 11/12/2008

65 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Acne Solutions Herbal Capsules and Clear and Balance Facial Gel; 11/12/2008

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 11/12/2008 Clear and Balance Facial Gel and Acne Solutions Herbal Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/14/2017

Desc: Pentreci Kids Syrup
Notes: Mecial claims made on the product?s labeling on the website.

66 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: Acne Solutions Herbal Capsules and Clear and Balance Facial Gel; 11/12/2008

Industria de Nutraceuticos S.A. de C.V.
Date Published : 01/30/2020
Privada Benjamin Eguiluz No. 125 , Col. Tetlan, Guadalajara , Guadalajara, Jalisco MEXICO
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/30/2020

Desc: Hierba Del Sapo Herbal Extract (Toad Herb Capsules)
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Diabetes control'; 'Lowers Uric Acid'; 'Fights Urinary Infections'; 'Toad Herb lowers blood glucose levels. "bad" cholesterol and uric acid'.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/30/2020

Desc: Palo Azul Herbal Extract (Blue Stick Oil Capsules)
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Joint Support'; 'Kidneywood helps prevent renal and hepatic cramps. It is anti-inflammatory. Stop diarrhea. Relieves joint pain (from rheumatism or arthritis). Fights urinary infection. Keeps cholesterol levels under control'.

54 K - - 03 Valerian (Herbal & Botanicals, not Teas II)
Date Published: 01/30/2020

Desc: Valeriana Reforzada Herbal Extract (Valerian Root Oil Capsules)
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Fights Anxiety'; 'Natural Insomnian treatment'; 'Valerian, Hops and Passionflower are plants that act as sedative agents, relaxing the nervous system and the brain, so they are highly recommended to people with sleep disorders, or to relieve anxiety'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/30/2020

Desc: Hierba Del Sapo Herbal Extract (Toad Herb Capsules)
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Diabetes control'; 'Lowers Uric Acid'; 'Fights Urinary Infections'; 'Toad Herb lowers blood glucose levels. "bad" cholesterol and uric acid'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/30/2020

Desc: Valeriana Reforzada Herbal Extract (Valerian Root Oil Capsules)
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Fights Anxiety'; 'Natural Insomnian treatment'; 'Valerian, Hops and Passionflower are plants that act as sedative agents, relaxing the nervous system and the brain, so they are highly recommended to people with sleep disorders, or to relieve anxiety'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/30/2020

Desc: Palo Azul Herbal Extract (Blue Stick Oil Capsules)
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Joint Support'; 'Kidneywood helps prevent renal and hepatic cramps. It is anti-inflammatory. Stop diarrhea. Relieves joint pain (from rheumatism or arthritis). Fights urinary infection. Keeps cholesterol levels under control'.

Industrializadora de Cacahuananche, S.A. de C.V.
Date Published : 11/10/2014
Calle Camino Arenero No. 20 , Pueblo San Juan de Ocotan , Zapopan, Jalisco MEXICO
53 R - - 12 Skin Care Preparations, Cosmetic products containing animal by-products (bovine)
Date Published: 11/10/2014

Desc: Collagen Cream with Vitamin E Tepezcohuite

Industrias Biologicas Sin Fin, Sa De Cv
Date Published : 09/30/2009
Edzna No# 106 Biscol. Independencia , Cd. De Mexico, MEXICO
54 H - - 06 Safflower Oil (Fats and Lipid Substances)
Date Published: 09/30/2009

Notes: 9/13/2007. Virus Sin Health. Sin Fin SA DE CV. This product which was entered as a dietary supplement to contain caustic liquid rayon and was found to have a very basic PH. There are also multiple drug claims for the product on the firm's website.

Industrias Quimicas Kemed
Date Published : 09/30/2009
Callejon de las Moras No.11901 , Colonia 20 de Noviembre , Tijuana, BC MEXICO
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/05/2011

Desc: Liposomal Resveratrol (Dietary Supplement)
Notes: Mexico

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/05/2011

Desc: Liposomal Resveratrol (Dietary Supplement)
Notes: Mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/05/2011

Desc: Liposomal Resveratrol (Dietary Supplement)
Notes: Mexico

Industrias T Taio Sa De Cv
Date Published : 12/09/2021
Av Hacienda La Escolastica 131 4 , Azcapotzalco, MEXICO
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 12/09/2021

Desc: ALOE-VERA SOAP-SPONGE
Notes: Product bears claims that cause it to be a drug under section 201(g)(1)(C) of the Federal Food, Drug and Cosmetic Act (the Act)Act in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or is intended to affect the structure or function of the human body: Product appears to be a new drug within the meaning of section 201 (p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)].

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/09/2021

Desc: ALOE-VERA SOAP-SPONGE
Notes: Product bears claims that cause it to be a drug under section 201(g)(1)(C) of the Federal Food, Drug and Cosmetic Act (the Act)Act in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or is intended to affect the structure or function of the human body: Product appears to be a new drug within the meaning of section 201 (p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)].

53 U - - 12 Skin Care Preparations, Cosmetic products containing animal by-products (other animal by-products)
Date Published: 12/09/2021

Desc: ALOE-VERA SOAP-SPONGE
Notes: Product bears claims that cause it to be a drug under section 201(g)(1)(C) of the Federal Food, Drug and Cosmetic Act (the Act)Act in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or is intended to affect the structure or function of the human body: Product appears to be a new drug within the meaning of section 201 (p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)].

53 Y - - 03 Sponges (Other Cosmetic and Cosmetic Products)
Date Published: 12/09/2021

Desc: ALOE-VERA SOAP-SPONGE
Notes: Product bears claims that cause it to be a drug under section 201(g)(1)(C) of the Federal Food, Drug and Cosmetic Act (the Act)Act in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or is intended to affect the structure or function of the human body: Product appears to be a new drug within the meaning of section 201 (p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)].

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 12/09/2021

Desc: ALOE-VERA SOAP-SPONGE
Notes: Product bears claims that cause it to be a drug under section 201(g)(1)(C) of the Federal Food, Drug and Cosmetic Act (the Act)Act in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or is intended to affect the structure or function of the human body: Product appears to be a new drug within the meaning of section 201 (p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)].

Industrias T Taio Sa De Cv
Date Published : 12/09/2021
Calzada De Las Armas # 134a , Pueblo Tlanepantla , Tlanepantla, Puebla MEXICO
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 12/09/2021

Desc: ALOE-VERA SOAP-SPONGE
Notes: Product bears claims that cause it to be a drug under section 201(g)(1)(C) of the Federal Food, Drug and Cosmetic Act (the Act)Act in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or is intended to affect the structure or function of the human body: Product appears to be a new drug within the meaning of section 201 (p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)].

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/09/2021

Desc: ALOE-VERA SOAP-SPONGE
Notes: Product bears claims that cause it to be a drug under section 201(g)(1)(C) of the Federal Food, Drug and Cosmetic Act (the Act)Act in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or is intended to affect the structure or function of the human body: Product appears to be a new drug within the meaning of section 201 (p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)].

53 U - - 12 Skin Care Preparations, Cosmetic products containing animal by-products (other animal by-products)
Date Published: 12/09/2021

Desc: ALOE-VERA SOAP-SPONGE
Notes: Product bears claims that cause it to be a drug under section 201(g)(1)(C) of the Federal Food, Drug and Cosmetic Act (the Act)Act in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or is intended to affect the structure or function of the human body: Product appears to be a new drug within the meaning of section 201 (p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)].

53 Y - - 03 Sponges (Other Cosmetic and Cosmetic Products)
Date Published: 12/09/2021

Desc: ALOE-VERA SOAP-SPONGE
Notes: Product bears claims that cause it to be a drug under section 201(g)(1)(C) of the Federal Food, Drug and Cosmetic Act (the Act)Act in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or is intended to affect the structure or function of the human body: Product appears to be a new drug within the meaning of section 201 (p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)].

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 12/09/2021

Desc: ALOE-VERA SOAP-SPONGE
Notes: Product bears claims that cause it to be a drug under section 201(g)(1)(C) of the Federal Food, Drug and Cosmetic Act (the Act)Act in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or is intended to affect the structure or function of the human body: Product appears to be a new drug within the meaning of section 201 (p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)].

Inter-Medica of Tijuana
Date Published : 09/13/2019
unknown , Tijuana, B C MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: All drugs; 10/23/1987

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 10/23/1987

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 10/23/1987

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 10/23/1987

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 10/23/1987

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 10/23/1987

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 10/23/1987

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 10/23/1987

International Trade
Date Published : 09/30/2009
Apartado Postal No 81 , Admon. de Correos Mesa De Otay, CP MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: Live cell therapy. 2/9/1996. Information submitted to DIOP by ATL-DO indicates the above firm is soliciting individuals to purchase live cell therapy. The product is currently on import alert from other shippers and under the name of Zellen Live Cell Therapy. The Live Cell Therapy is being promoted for numerous medical conditions, including aging problems, lack of energy, impotency, diabetes, degenerative brain disease, ect. Promotion is usually accompanied by a MEMO FRTOM DR. HANZ BYRON PREMATURE AGINNG SPEACIALIST, HOLISTIC HEALTH CENTER LONDON, ENGLAND, ZURICH, SWITZERLAND.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Jesus Mosiah Ramos
Date Published : 06/09/2014
Paseo Del Tec 702 L2 , 27000 Torreon , Torreon, Coah MEXICO
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 06/09/2014

Desc: Mr. Field Clasica Mezcla de Hierbas

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/09/2014

Desc: Mr. Field Clasica Mezcla de Hierbas

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/09/2014

Desc: Mr. Field Clasica Mezcla de Hierbas

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/09/2014

Desc: Mr. Field Clasica Mezcla de Hierbas

Juan Manuel Rayas Arvizu
Date Published : 05/22/2012
Av. 18 De Marzo No. 8 , Col. Ferrocarril, San Andres Tuxtla , San Andres Tuxtla, Veracruz MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/22/2012

Desc: Demograss Capsules Dietary Supplment
Notes: Mexico

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 05/22/2012

Desc: Demograss Capsules Dietary Supplment
Notes: Mexico

KAFESON AM SA DE CV
Date Published : 12/22/2015
Boulevard Adolfo Lopez Mateos 626 A , Col. Adolfo Lopez Mateos, Hermosillo , Hermosillo, Sonora MEXICO
31 A - - 02 Coffee, Ground
Date Published: 12/22/2015

Desc: Rx Smart Coffee Blends- Thin Blend and Fresh Breeze Blend
Notes: Product labeling found on website makes claims.

Karen Laboratorio, S.A. de C.V.
Date Published : 04/13/2020
Avenida Rio Chiquito No. 2 , Texcoco , Pueblo San Simon, Mexico MEXICO
41 E - - 99 Meal Replacements (Not labeled for treatment of disease)
Date Published: 04/13/2020

Desc: DITOXIFY Whole Body Detox System
Notes: The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and its labeling bears claim for is intended for use as a drug. Example of this claim from the product labeling includes: "Eliminates toxins and parasites from digestive, urinary, lymphatic, and hepatic systems of your body for a true whole body detox". The product appears to be a new drug, as per Section 201(p) of the Act [21 U.S.C. § 321(p)], and is not generally recognized as safe and effective for the intended uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval. The violative product was transmitted to FDA as "Food Supplement"; therefore, please verify the true identity of product shipments from this firm offered for entry into the US.

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 04/13/2020

Desc: DITOXIFY Whole Body Detox System
Notes: The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and its labeling bears claim for is intended for use as a drug. Example of this claim from the product labeling includes: "Eliminates toxins and parasites from digestive, urinary, lymphatic, and hepatic systems of your body for a true whole body detox". The product appears to be a new drug, as per Section 201(p) of the Act [21 U.S.C. § 321(p)], and is not generally recognized as safe and effective for the intended uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval. The violative product was transmitted to FDA as "Food Supplement"; therefore, please verify the true identity of product shipments from this firm offered for entry into the US.

54 A - - 99 Vitamin, N.E.C.
Date Published: 04/13/2020

Desc: DITOXIFY Whole Body Detox System
Notes: The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and its labeling bears claim for is intended for use as a drug. Example of this claim from the product labeling includes: "Eliminates toxins and parasites from digestive, urinary, lymphatic, and hepatic systems of your body for a true whole body detox". The product appears to be a new drug, as per Section 201(p) of the Act [21 U.S.C. § 321(p)], and is not generally recognized as safe and effective for the intended uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval. The violative product was transmitted to FDA as "Food Supplement"; therefore, please verify the true identity of product shipments from this firm offered for entry into the US.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/13/2020

Desc: DITOXIFY Whole Body Detox System
Notes: The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and its labeling bears claim for is intended for use as a drug. Example of this claim from the product labeling includes: "Eliminates toxins and parasites from digestive, urinary, lymphatic, and hepatic systems of your body for a true whole body detox". The product appears to be a new drug, as per Section 201(p) of the Act [21 U.S.C. § 321(p)], and is not generally recognized as safe and effective for the intended uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval. The violative product was transmitted to FDA as "Food Supplement"; therefore, please verify the true identity of product shipments from this firm offered for entry into the US.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/13/2020

Desc: DITOXIFY Whole Body Detox System
Notes: The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and its labeling bears claim for is intended for use as a drug. Example of this claim from the product labeling includes: "Eliminates toxins and parasites from digestive, urinary, lymphatic, and hepatic systems of your body for a true whole body detox". The product appears to be a new drug, as per Section 201(p) of the Act [21 U.S.C. § 321(p)], and is not generally recognized as safe and effective for the intended uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval. The violative product was transmitted to FDA as "Food Supplement"; therefore, please verify the true identity of product shipments from this firm offered for entry into the US.

LABORATORIOS PISA, S.A. DE C.V.
Date Published : 07/06/2022
Carretera San Isidro Mazatepec # 7000 , Santa Cruz de Las Flores , Tlajomulco de Zuniga, MEXICO
20 - - - -- Fruit/Fruit Products
Date Published: 07/06/2022

Desc: Electrolit (all flavors)
Notes: These products appear to be unapproved new drugs as the product labels include statements such as (not an all-inclusive list): ‘INDICACIONES: Electrolit es una solucion rehidratante para prevenir o tratar la deshidratacion ocasionada por el exceso de calor, desgaste fisico intenso, insolacion, resaca, vomito y/o diarrea.’ which translates to ‘INDICATIONS: Electrolit is a rehydrating solution to prevent or treat dehydration caused by…heatstroke, hangover, vomiting and/or diarrhea’.                                                                                                                                                                                                                                                                                                                                                                                                                                         

21 - - - -- Fruit/Fruit Products
Date Published: 07/06/2022

Desc: Electrolit (all flavors)
Notes: These products appear to be unapproved new drugs as the product labels include statements such as (not an all-inclusive list): ‘INDICACIONES: Electrolit es una solucion rehidratante para prevenir o tratar la deshidratacion ocasionada por el exceso de calor, desgaste fisico intenso, insolacion, resaca, vomito y/o diarrea.’ which translates to ‘INDICATIONS: Electrolit is a rehydrating solution to prevent or treat dehydration caused by…heatstroke, hangover, vomiting and/or diarrhea’.                                                                                                                                                                                                                                                                                                                                                                                                                                         

24 - - - -- Vegetables/Vegetable Products
Date Published: 07/06/2022

Desc: Electrolit (all flavors)
Notes: These products appear to be unapproved new drugs as the product labels include statements such as (not an all-inclusive list): ‘INDICACIONES: Electrolit es una solucion rehidratante para prevenir o tratar la deshidratacion ocasionada por el exceso de calor, desgaste fisico intenso, insolacion, resaca, vomito y/o diarrea.’ which translates to ‘INDICATIONS: Electrolit is a rehydrating solution to prevent or treat dehydration caused by…heatstroke, hangover, vomiting and/or diarrhea’.                                                                                                                                                                                                                                                                                                                                                                                                                                         

28 - - - -- Spices, Flavors And Salts
Date Published: 07/06/2022

Desc: Electrolit (all flavors)
Notes: These products appear to be unapproved new drugs as the product labels include statements such as (not an all-inclusive list): ‘INDICACIONES: Electrolit es una solucion rehidratante para prevenir o tratar la deshidratacion ocasionada por el exceso de calor, desgaste fisico intenso, insolacion, resaca, vomito y/o diarrea.’ which translates to ‘INDICATIONS: Electrolit is a rehydrating solution to prevent or treat dehydration caused by…heatstroke, hangover, vomiting and/or diarrhea’.                                                                                                                                                                                                                                                                                                                                                                                                                                         

29 - - - -- Soft Drinks/Water
Date Published: 07/06/2022

Desc: Electrolit (all flavors)
Notes: These products appear to be unapproved new drugs as the product labels include statements such as (not an all-inclusive list): ‘INDICACIONES: Electrolit es una solucion rehidratante para prevenir o tratar la deshidratacion ocasionada por el exceso de calor, desgaste fisico intenso, insolacion, resaca, vomito y/o diarrea.’ which translates to ‘INDICATIONS: Electrolit is a rehydrating solution to prevent or treat dehydration caused by…heatstroke, hangover, vomiting and/or diarrhea’.                                                                                                                                                                                                                                                                                                                                                                                                                                         

30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 07/06/2022

Desc: Electrolit (all flavors)
Notes: These products appear to be unapproved new drugs as the product labels include statements such as (not an all-inclusive list): ‘INDICACIONES: Electrolit es una solucion rehidratante para prevenir o tratar la deshidratacion ocasionada por el exceso de calor, desgaste fisico intenso, insolacion, resaca, vomito y/o diarrea.’ which translates to ‘INDICATIONS: Electrolit is a rehydrating solution to prevent or treat dehydration caused by…heatstroke, hangover, vomiting and/or diarrhea’.                                                                                                                                                                                                                                                                                                                                                                                                                                         

41 G - - 03 Oral Rehydration Products
Date Published: 07/06/2022

Desc: Electrolit (all flavors)
Notes: These products appear to be unapproved new drugs as the product labels include statements such as (not an all-inclusive list): ‘INDICACIONES: Electrolit es una solucion rehidratante para prevenir o tratar la deshidratacion ocasionada por el exceso de calor, desgaste fisico intenso, insolacion, resaca, vomito y/o diarrea.’ which translates to ‘INDICATIONS: Electrolit is a rehydrating solution to prevent or treat dehydration caused by…heatstroke, hangover, vomiting and/or diarrhea’.                                                                                                                                                                                                                                                                                                                                                                                                                                         

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 07/06/2022

Desc: Electrolit (all flavors)
Notes: These products appear to be unapproved new drugs as the product labels include statements such as (not an all-inclusive list): ‘INDICACIONES: Electrolit es una solucion rehidratante para prevenir o tratar la deshidratacion ocasionada por el exceso de calor, desgaste fisico intenso, insolacion, resaca, vomito y/o diarrea.’ which translates to ‘INDICATIONS: Electrolit is a rehydrating solution to prevent or treat dehydration caused by…heatstroke, hangover, vomiting and/or diarrhea’.                                                                                                                                                                                                                                                                                                                                                                                                                                         

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/06/2022

Desc: Electrolit (all flavors)
Notes: These products appear to be unapproved new drugs as the product labels include statements such as (not an all-inclusive list): ‘INDICACIONES: Electrolit es una solucion rehidratante para prevenir o tratar la deshidratacion ocasionada por el exceso de calor, desgaste fisico intenso, insolacion, resaca, vomito y/o diarrea.’ which translates to ‘INDICATIONS: Electrolit is a rehydrating solution to prevent or treat dehydration caused by…heatstroke, hangover, vomiting and/or diarrhea’.                                                                                                                                                                                                                                                                                                                                                                                                                                         

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/06/2022

Desc: Electrolit (all flavors)
Notes: These products appear to be unapproved new drugs as the product labels include statements such as (not an all-inclusive list): ‘INDICACIONES: Electrolit es una solucion rehidratante para prevenir o tratar la deshidratacion ocasionada por el exceso de calor, desgaste fisico intenso, insolacion, resaca, vomito y/o diarrea.’ which translates to ‘INDICATIONS: Electrolit is a rehydrating solution to prevent or treat dehydration caused by…heatstroke, hangover, vomiting and/or diarrhea’.                                                                                                                                                                                                                                                                                                                                                                                                                                         

La Tia Trini, S.A. de C.V.
Date Published : 05/16/2018
Camino A Los Capulines No. 8 , Pueblo Santa Anita, San Pedro Tlaquepaque , Tlaquepaque, Jalisco MEXICO
33 C - - 01 Caramel Candy Bar, Hard with Fruit (without Chocolate)
Date Published: 10/26/2018

Desc: Honey and Propolis Candy with Mint; Cherry Flavored (Caramelos de Miel y Propoloeo con Menta; Sabor Cereza)
Notes: The product appears to be an unapproved new drug, as its labeling statements document the intended uses, but are not limited to the following: "... Honey's Therapeutic Properties... A poultice of honey placed on burns and wounds provides fast relief from pain and itching... The bacteria trapped by it die from a lack of humidity. Its bactericide power is increased by its acid reaction and because it contains potassium, which makes it an unfavorable environment for the growth of bacteria... It works as a laxative ... it is antitoxic and antiseptic, antipyretic (lowers a fever)...".

33 E - - 02 Caramel Candy Pieces, Hard, without Nuts or Fruit (without Chocolate)
Date Published: 10/26/2018

Desc: Honey and Propolis Candy with Mint; Cherry Flavored (Caramelos de Miel y Propoloeo con Menta; Sabor Cereza)
Notes: The product appears to be an unapproved new drug, as its labeling statements document the intended uses, but are not limited to the following: "... Honey's Therapeutic Properties... A poultice of honey placed on burns and wounds provides fast relief from pain and itching... The bacteria trapped by it die from a lack of humidity. Its bactericide power is increased by its acid reaction and because it contains potassium, which makes it an unfavorable environment for the growth of bacteria... It works as a laxative ... it is antitoxic and antiseptic, antipyretic (lowers a fever)...".

33 E - - 05 Candy Bar or Pieces (not Caramel or Fondant), Hard, without Nuts and Fruit (without Chocolate)
Date Published: 10/26/2018

Desc: Honey and Propolis Candy with Mint; Cherry Flavored (Caramelos de Miel y Propoloeo con Menta; Sabor Cereza)
Notes: The product appears to be an unapproved new drug, as its labeling statements document the intended uses, but are not limited to the following: "... Honey's Therapeutic Properties... A poultice of honey placed on burns and wounds provides fast relief from pain and itching... The bacteria trapped by it die from a lack of humidity. Its bactericide power is increased by its acid reaction and because it contains potassium, which makes it an unfavorable environment for the growth of bacteria... It works as a laxative ... it is antitoxic and antiseptic, antipyretic (lowers a fever)...".

33 E - - 06 Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 10/26/2018

Desc: Honey and Propolis Candy with Mint; Cherry Flavored (Caramelos de Miel y Propoloeo con Menta; Sabor Cereza)
Notes: The product appears to be an unapproved new drug, as its labeling statements document the intended uses, but are not limited to the following: "... Honey's Therapeutic Properties... A poultice of honey placed on burns and wounds provides fast relief from pain and itching... The bacteria trapped by it die from a lack of humidity. Its bactericide power is increased by its acid reaction and because it contains potassium, which makes it an unfavorable environment for the growth of bacteria... It works as a laxative ... it is antitoxic and antiseptic, antipyretic (lowers a fever)...".

33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 10/26/2018

Desc: Honey and Propolis Candy with Mint; Cherry Flavored (Caramelos de Miel y Propoloeo con Menta; Sabor Cereza)
Notes: The product appears to be an unapproved new drug, as its labeling statements document the intended uses, but are not limited to the following: "... Honey's Therapeutic Properties... A poultice of honey placed on burns and wounds provides fast relief from pain and itching... The bacteria trapped by it die from a lack of humidity. Its bactericide power is increased by its acid reaction and because it contains potassium, which makes it an unfavorable environment for the growth of bacteria... It works as a laxative ... it is antitoxic and antiseptic, antipyretic (lowers a fever)...".

33 H - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Coconut (without Chocolate)
Date Published: 10/26/2018

Desc: Honey and Propolis Candy with Mint; Cherry Flavored (Caramelos de Miel y Propoloeo con Menta; Sabor Cereza)
Notes: The product appears to be an unapproved new drug, as its labeling statements document the intended uses, but are not limited to the following: "... Honey's Therapeutic Properties... A poultice of honey placed on burns and wounds provides fast relief from pain and itching... The bacteria trapped by it die from a lack of humidity. Its bactericide power is increased by its acid reaction and because it contains potassium, which makes it an unfavorable environment for the growth of bacteria... It works as a laxative ... it is antitoxic and antiseptic, antipyretic (lowers a fever)...".

33 L - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, without Nuts and Fruit (without Chocolate)
Date Published: 10/26/2018

Desc: Honey and Propolis Candy with Mint; Cherry Flavored (Caramelos de Miel y Propoloeo con Menta; Sabor Cereza)
Notes: The product appears to be an unapproved new drug, as its labeling statements document the intended uses, but are not limited to the following: "... Honey's Therapeutic Properties... A poultice of honey placed on burns and wounds provides fast relief from pain and itching... The bacteria trapped by it die from a lack of humidity. Its bactericide power is increased by its acid reaction and because it contains potassium, which makes it an unfavorable environment for the growth of bacteria... It works as a laxative ... it is antitoxic and antiseptic, antipyretic (lowers a fever)...".

33 S - - 06 Lollipop (without Chocolate)
Date Published: 10/26/2018

Desc: Honey and Propolis Candy with Mint; Cherry Flavored (Caramelos de Miel y Propoloeo con Menta; Sabor Cereza)
Notes: The product appears to be an unapproved new drug, as its labeling statements document the intended uses, but are not limited to the following: "... Honey's Therapeutic Properties... A poultice of honey placed on burns and wounds provides fast relief from pain and itching... The bacteria trapped by it die from a lack of humidity. Its bactericide power is increased by its acid reaction and because it contains potassium, which makes it an unfavorable environment for the growth of bacteria... It works as a laxative ... it is antitoxic and antiseptic, antipyretic (lowers a fever)...".

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 10/26/2018

Desc: Honey and Propolis Candy with Mint; Cherry Flavored (Caramelos de Miel y Propoloeo con Menta; Sabor Cereza)
Notes: The product appears to be an unapproved new drug, as its labeling statements document the intended uses, but are not limited to the following: "... Honey's Therapeutic Properties... A poultice of honey placed on burns and wounds provides fast relief from pain and itching... The bacteria trapped by it die from a lack of humidity. Its bactericide power is increased by its acid reaction and because it contains potassium, which makes it an unfavorable environment for the growth of bacteria... It works as a laxative ... it is antitoxic and antiseptic, antipyretic (lowers a fever)...".

36 C - - 04 Honey
Date Published: 05/16/2018

Desc: Tia Trini Syrup
Notes: The product appears to be an unapproved new drug as the product includes claims such as; '... [A]ntitoxic; anesthetic; bacteriostatic; bactericide; antiseptic and healing properties ...'; '... [A]ntifungal effect ...'; '... [A]ntibacterial action ...'; '... [A]ntiviral action includes; the herpes virus; the polio virus; the A and B cold virus ...'; '... [I]ncreases the production of antibodies ...'.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/26/2018

Desc: Honey and Propolis Candy with Mint; Cherry Flavored (Caramelos de Miel y Propoloeo con Menta; Sabor Cereza)
Notes: The product appears to be an unapproved new drug, as its labeling statements document the intended uses, but are not limited to the following: "... Honey's Therapeutic Properties... A poultice of honey placed on burns and wounds provides fast relief from pain and itching... The bacteria trapped by it die from a lack of humidity. Its bactericide power is increased by its acid reaction and because it contains potassium, which makes it an unfavorable environment for the growth of bacteria... It works as a laxative ... it is antitoxic and antiseptic, antipyretic (lowers a fever)...".

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/16/2018

Desc: Tia Trini Syrup
Notes: The product appears to be an unapproved new drug as the product includes claims such as; '... [A]ntitoxic; anesthetic; bacteriostatic; bactericide; antiseptic and healing properties ...'; '... [A]ntifungal effect ...'; '... [A]ntibacterial action ...'; '... [A]ntiviral action includes; the herpes virus; the polio virus; the A and B cold virus ...'; '... [I]ncreases the production of antibodies ...'.

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 10/26/2018

Desc: Honey and Propolis Candy with Mint; Cherry Flavored (Caramelos de Miel y Propoloeo con Menta; Sabor Cereza)
Notes: The product appears to be an unapproved new drug, as its labeling statements document the intended uses, but are not limited to the following: "... Honey's Therapeutic Properties... A poultice of honey placed on burns and wounds provides fast relief from pain and itching... The bacteria trapped by it die from a lack of humidity. Its bactericide power is increased by its acid reaction and because it contains potassium, which makes it an unfavorable environment for the growth of bacteria... It works as a laxative ... it is antitoxic and antiseptic, antipyretic (lowers a fever)...".

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/16/2018

Desc: Tia Trini Syrup
Notes: The product appears to be an unapproved new drug as the product includes claims such as; '... [A]ntitoxic; anesthetic; bacteriostatic; bactericide; antiseptic and healing properties ...'; '... [A]ntifungal effect ...'; '... [A]ntibacterial action ...'; '... [A]ntiviral action includes; the herpes virus; the polio virus; the A and B cold virus ...'; '... [I]ncreases the production of antibodies ...'.

Laboratorios Bremer, S.A.
Date Published : 11/08/2012
Cd Industrial Mitras , Omicron 8116; Garcia , Garcia, Nuevo Leon MEXICO
53 L C - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations), Cream
Date Published: 11/08/2012

Desc: Ointment Arnica De La Abuela

53 L C - 99 Other Skin Care Preparations, N.E.C., Cream
Date Published: 11/08/2012

Desc: Ointment Arnica De La Abuela

55 R - - 99 Pharmaceutic Necessities, N.E.C.
Date Published: 11/08/2012

Desc: Ointment Arnica De La Abuela

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2012

Desc: Ointment Arnica De La Abuela

Laboratorios Ener Green, S.A. De C.V.
Date Published : 07/31/2012
Calle Platon Sanchez #826 Norte , Monterrey, Nuevo Leon, MEXICO
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 07/31/2012

Desc: Hongo Fin H-FIN Soap
Notes: Mexico

56 G - - 99 Antifungal N.E.C.
Date Published: 07/31/2012

Desc: Hongo Fin H-FIN Soap
Notes: Mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/31/2012

Desc: Hongo Fin H-FIN Soap
Notes: Mexico

Laboratorios Rodaquina S.A.
Date Published : 02/06/2020
Unknown Street , Ensenada, Baja California MEXICO
66 - - - -- Human and Animal Drugs
Date Published: 02/06/2020

Desc: Rodaquin
Notes: Original DWPE date of 06/06/89

Laboratorios Sophia, S.A. De C.V.
Date Published : 09/12/2023
Av. Paseo Del Norte No. 5255 , Guadalajara Technology Park , Zapopan, Jalisco MEXICO
60 C B K 51 Tetrahydrozoline HCl (Adrenergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Manzanilla Sophia Chamomile Herbal Eye Drops

60 C C L 46 Naphazoline HCl (Adrenergic), Human - Rx/Single Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Manzanilla Sophia Chamomile Herbal Eye Drops

60 C C Y 46 Naphazoline HCl (Adrenergic), Human - Rx/Single Ingredient, NEC
Date Published: 09/12/2023

Desc: Manzanilla Sophia Chamomile Herbal Eye Drops

60 C D T 46 Naphazoline HCl (Adrenergic), Human - Rx/Combination Ingredient, Active Pharm Ingred/Chems for Rx Compounding
Date Published: 09/12/2023

Desc: Manzanilla Sophia Chamomile Herbal Eye Drops

62 A C L 02 Sodium Sulfate (Anti-Hypercalcemic), Human - Rx/Single Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Manzanilla Sophia Chamomile Herbal Eye Drops

64 D C L 99 Emollient, Lubricant, N.E.C., Human - Rx/Single Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Manzanilla Sophia Chamomile Herbal Eye Drops

65 F A L 06 Water, Purified (Eyewash), Human - Non/Rx Single Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Manzanilla Sophia Chamomile Herbal Eye Drops

65 F C K 06 Water, Purified (Eyewash), Human - Rx/Single Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Manzanilla Sophia Chamomile Herbal Eye Drops

65 F D K 06 Water, Purified (Eyewash), Human - Rx/Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Manzanilla Sophia Chamomile Herbal Eye Drops

66 V D L 99 Miscellaneous Patent Medicines, Etc., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Manzanilla Sophia Chamomile Herbal Eye Drops

66 V D Y 99 Miscellaneous Patent Medicines, Etc., Human - Rx/Combination Ingredient, NEC
Date Published: 09/12/2023

Desc: Manzanilla Sophia Chamomile Herbal Eye Drops

Los Rancheros Comercializadora SA de CV
Date Published : 04/12/2019
State Highway 26 La Punta Km 4. 5 , Valle De Las Delicias Community , Cosio, Aguascalientes MEXICO
25 J - - 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 04/12/2019

Desc: Diamante Negro Black Garlic
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '... [C]onsidered a drug/medicine ... Ally against depression ... Prevents certain types of cancer ...'.

28 A - - 11 Garlic, Whole (Spice)
Date Published: 04/12/2019

Desc: Diamante Negro Black Garlic
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '... [C]onsidered a drug/medicine ... Ally against depression ... Prevents certain types of cancer ...'.

28 B - - 11 Garlic, Ground, Cracked (Spice)
Date Published: 04/12/2019

Desc: Diamante Negro Black Garlic
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '... [C]onsidered a drug/medicine ... Ally against depression ... Prevents certain types of cancer ...'.

MARCAS NESTLE SA DE CV
Date Published : 12/08/2022
Torre Sur Pb Granada , Avenida Miguel De Cervantes Saavedra 301; Col. Granada, Miguel Hidalgo , Ciudad De Mexico, Ciudad de Mexico MEXICO
09 C - - 16 Milk, Dried
Date Published: 12/08/2022

Desc: Nestle Nido Kinder Nutritional Toddler Drink

09 Y - - 99 Fluid/Dry Milk Products Not Elsewhere Mentioned, N.E.C.
Date Published: 12/08/2022

Desc: Nestle Nido Kinder Nutritional Toddler Drink

40 P - - 01 Milk Base Infant Formula Product (0-12 months), Powder Formula
Date Published: 12/08/2022

Desc: Nestle Nido Kinder Nutritional Toddler Drink

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 12/08/2022

Desc: Nestle Nido Kinder Nutritional Toddler Drink

41 G - - 99 Medical Foods, N.E.C.
Date Published: 12/08/2022

Desc: Nestle Nido Kinder Nutritional Toddler Drink

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/08/2022

Desc: Nestle Nido Kinder Nutritional Toddler Drink

Malabar Productos Naturales S.A. de C.V.
Date Published : 09/21/2018
Calle Licenciado Francisco de , Barbadillo 416 N;Col. CENTRO DE GUADALUP , Guadalupe, Nuevo Leon MEXICO
31 M - - 02 Tea With Extracts or Concentrates
Date Published: 09/21/2018

Desc: ALTAPRESS Plus Capsules
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '... Natural hypertensive, [h]elps normalizing high blood pressure ... Its diuretic properties help diminish high blood pressure ... Diminishes cholesterol and triglycerides ... Prevent formations of blood clots ...'.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 09/21/2018

Desc: ALTAPRESS Plus Capsules
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '... Natural hypertensive, [h]elps normalizing high blood pressure ... Its diuretic properties help diminish high blood pressure ... Diminishes cholesterol and triglycerides ... Prevent formations of blood clots ...'.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/21/2018

Desc: ALTAPRESS Plus Capsules
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '... Natural hypertensive, [h]elps normalizing high blood pressure ... Its diuretic properties help diminish high blood pressure ... Diminishes cholesterol and triglycerides ... Prevent formations of blood clots ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/21/2018

Desc: ALTAPRESS Plus Capsules
Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '... Natural hypertensive, [h]elps normalizing high blood pressure ... Its diuretic properties help diminish high blood pressure ... Diminishes cholesterol and triglycerides ... Prevent formations of blood clots ...'.

Mas Natural Salud Y Bienestar
Date Published : 01/25/2011
Calle Escuadron 201 24la Moderna , Col. Moderna, Irapuato , Irapuato, Guanajuato MEXICO
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 01/25/2011

Desc: Destellos de Luz Pain Reliever Ointment
Notes: Mexico

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/25/2011

Notes: Destellos de Luz Pain Reliever Ointment; Mexico

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 01/25/2011

Notes: Destellos de Luz Pain Reliever Ointment; Mexico

61 - - - -- Human and Animal Drugs
Date Published: 01/25/2011

Notes: Destellos de Luz Pain Reliever Ointment; Mexico

62 - - - -- Human and Animal Drugs
Date Published: 01/25/2011

Notes: Destellos de Luz Pain Reliever Ointment; Mexico

63 - - - -- Human and Animal Drugs
Date Published: 01/25/2011

Notes: Destellos de Luz Pain Reliever Ointment; Mexico

64 - - - -- Human and Animal Drugs
Date Published: 01/25/2011

Notes: Destellos de Luz Pain Reliever Ointment; Mexico

65 - - - -- Human and Animal Drugs
Date Published: 01/25/2011

Notes: Destellos de Luz Pain Reliever Ointment; Mexico

66 - - - -- Human and Animal Drugs
Date Published: 01/25/2011

Notes: Destellos de Luz Pain Reliever Ointment; Mexico

Merck Sharp & Dohme Mexico
Date Published : 08/20/2019
Av Division Del Norte 3377 , Col Xotepingo , Coyoacan, MEXICO
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/20/2019

Notes: Redotex

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/20/2019

Notes: Redotex

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

61 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

62 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

63 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

64 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

65 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

66 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

Merck, S.A. de C.V.
Date Published : 12/18/2014
Calle 5 No. 7 , Zona Industrial Alce Blanco, Naucalpan De Juarez , Naucalpan De Juarez, Mexico MEXICO
62 G - - 18 Diclofenac Sodium (Anti-Inflammatory)
Date Published: 12/18/2014

Desc: Dolo-Neurobion N
Notes: The reference product appears to be an unapproved new drug due to labeling claims

Micrometrix,
Date Published : 03/12/2014
Avenida San Lorenzo No. 97 , Paraje San Juan, Iztapalapa , Ciudad De Mexico, Ciudad de Mexico MEXICO
54 A - - 01 Vitamin A
Date Published: 03/12/2014

Desc: Sucanon Insulin Sensitizer Supplement

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/12/2014

Desc: Sucanon Insulin Sensitizer Supplement

61 P - - 99 Anti-Diabetic N.E.C.
Date Published: 03/12/2014

Desc: Sucanon Insulin Sensitizer Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/12/2014

Desc: Sucanon Insulin Sensitizer Supplement

Natura-Lexa
Date Published : 01/19/2012
Calle Rio Suchiate #9447 Col Marron , Tijuana, MEXICO
66 P - - 04 Dioxybenzone (Ultraviolet Screen/Sunscreen)
Date Published: 01/19/2012

Desc: Facial Day Cream Myryam
Notes: mexico

Nestle Mexico, S.A. de C.V. Lagos Polvos
Date Published : 12/08/2022
Frente Estacion Ff.Cc. S/N , Pueblo De Moya , Lagos E Moreno, Jalisco MEXICO
09 C - - 16 Milk, Dried
Date Published: 12/08/2022

Desc: Nestle Nido Kinder Nutritional Toddler Drink

09 Y - - 99 Fluid/Dry Milk Products Not Elsewhere Mentioned, N.E.C.
Date Published: 12/08/2022

Desc: Nestle Nido Kinder Nutritional Toddler Drink

40 P - - 01 Milk Base Infant Formula Product (0-12 months), Powder Formula
Date Published: 12/08/2022

Desc: Nestle Nido Kinder Nutritional Toddler Drink

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 12/08/2022

Desc: Nestle Nido Kinder Nutritional Toddler Drink

41 G - - 99 Medical Foods, N.E.C.
Date Published: 12/08/2022

Desc: Nestle Nido Kinder Nutritional Toddler Drink

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/08/2022

Desc: Nestle Nido Kinder Nutritional Toddler Drink

New Age Nutrition
Date Published : 09/30/2009
Discount Nutrition S.A. , Sayil , Cancun, Quintana Roo, MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: Al drugs. GPI = DR.                                        

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Nutri-Mail
Date Published : 09/30/2009
Apartado Postal 8 F , Tijuana, BC MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/24/2019

Notes: Energy Complex; 6/19/1996

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 07/24/2019

Notes: Energy Complex; 6/19/1996

61 - - - -- Human and Animal Drugs
Date Published: 07/24/2019

Notes: Energy Complex; 6/19/1996

62 - - - -- Human and Animal Drugs
Date Published: 07/24/2019

Notes: Energy Complex; 6/19/1996

63 - - - -- Human and Animal Drugs
Date Published: 07/24/2019

Notes: Energy Complex; 6/19/1996

64 - - - -- Human and Animal Drugs
Date Published: 07/24/2019

Notes: Energy Complex; 6/19/1996

65 - - - -- Human and Animal Drugs
Date Published: 07/24/2019

Notes: Energy Complex; 6/19/1996

66 - - - -- Human and Animal Drugs
Date Published: 07/24/2019

Notes: Energy Complex; 6/19/1996

ORBELL
Date Published : 12/02/2019
Av El Olivo 114 Int C 1-401 , Colonia Bosques De Las Lomas , Delegacion Cuajimalpade Morelos, MEXICO
53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes)
Date Published: 12/10/2019

Desc: Purifying Facial Cream
Notes: This product appears to be an unapproved new drug as the product label includes claims such as: "[I]t will help to decongest your skin and kill bacterial aliviating (sic) signs of redness and irritation. . .Say goodbye to blemishes and hello to a healthy looking skin. . ." and "It will help your skin to regenerate ... eliminate bacterial minimize irritation and redness."

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/17/2019

Desc: ANTI-AGING NIGHT CREAM
Notes: This product appears to be an unapproved new drug as the product label includes claims such as: "...help your skin regenerate...encouraging the cells of the dermis and epidermis..."

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/10/2019

Desc: Purifying Facial Cream
Notes: This product appears to be an unapproved new drug as the product label includes claims such as: "[I]t will help to decongest your skin and kill bacterial aliviating (sic) signs of redness and irritation. . .Say goodbye to blemishes and hello to a healthy looking skin. . ." and "It will help your skin to regenerate ... eliminate bacterial minimize irritation and redness."

53 L - - 07 Night (Skin Care Preparations)
Date Published: 12/10/2019

Desc: Purifying Facial Cream
Notes: This product appears to be an unapproved new drug as the product label includes claims such as: "[I]t will help to decongest your skin and kill bacterial aliviating (sic) signs of redness and irritation. . .Say goodbye to blemishes and hello to a healthy looking skin. . ." and "It will help your skin to regenerate ... eliminate bacterial minimize irritation and redness."

53 L - - 07 Night (Skin Care Preparations)
Date Published: 12/17/2019

Desc: ANTI-AGING NIGHT CREAM
Notes: This product appears to be an unapproved new drug as the product label includes claims such as: "...help your skin regenerate...encouraging the cells of the dermis and epidermis..."

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 12/10/2019

Desc: Purifying Facial Cream
Notes: This product appears to be an unapproved new drug as the product label includes claims such as: "[I]t will help to decongest your skin and kill bacterial aliviating (sic) signs of redness and irritation. . .Say goodbye to blemishes and hello to a healthy looking skin. . ." and "It will help your skin to regenerate ... eliminate bacterial minimize irritation and redness."

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 12/17/2019

Desc: ANTI-AGING NIGHT CREAM
Notes: This product appears to be an unapproved new drug as the product label includes claims such as: "...help your skin regenerate...encouraging the cells of the dermis and epidermis..."

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/10/2019

Desc: Purifying Facial Cream
Notes: This product appears to be an unapproved new drug as the product label includes claims such as: "[I]t will help to decongest your skin and kill bacterial aliviating (sic) signs of redness and irritation. . .Say goodbye to blemishes and hello to a healthy looking skin. . ." and "It will help your skin to regenerate ... eliminate bacterial minimize irritation and redness."

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/17/2019

Desc: ANTI-AGING NIGHT CREAM
Notes: This product appears to be an unapproved new drug as the product label includes claims such as: "...help your skin regenerate...encouraging the cells of the dermis and epidermis..."

53 L - - -- Skin Care Prep
Date Published: 12/02/2019

Desc: ORBELL Facial Serum Hyaluronic Acid
Notes: This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): '[T]o deeply repair the skin and eliminate lines and wrinkles. . .'; '[A] restorative facial serum. . .It will help skin regenerate and deeply repair, eliminating fine lines and wrinkles. . .'.

53 L - - -- Skin Care Prep
Date Published: 12/03/2019

Desc: OR'BELL Facial Moisturizer
Notes: This product appears to be an unapproved new drug as the product label (outer box) includes disease claims such as (not an all-inclusive list): 'Created to excert (sic) a protective effect on harmful agents sucha (sic) as toxins and enviromental (sic) pollution. . . helps . . .rejuvenerate (sic) and healing effect. . .'

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 12/10/2019

Desc: Purifying Facial Cream
Notes: This product appears to be an unapproved new drug as the product label includes claims such as: "[I]t will help to decongest your skin and kill bacterial aliviating (sic) signs of redness and irritation. . .Say goodbye to blemishes and hello to a healthy looking skin. . ." and "It will help your skin to regenerate ... eliminate bacterial minimize irritation and redness."

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 12/17/2019

Desc: ANTI-AGING NIGHT CREAM
Notes: This product appears to be an unapproved new drug as the product label includes claims such as: "...help your skin regenerate...encouraging the cells of the dermis and epidermis..."

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 12/02/2019

Desc: ORBELL Facial Serum Hyaluronic Acid
Notes: This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): '[T]o deeply repair the skin and eliminate lines and wrinkles. . .'; '[A] restorative facial serum. . .It will help skin regenerate and deeply repair, eliminating fine lines and wrinkles. . .'.

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 12/03/2019

Desc: OR'BELL Facial Moisturizer
Notes: This product appears to be an unapproved new drug as the product label (outer box) includes disease claims such as (not an all-inclusive list): 'Created to excert (sic) a protective effect on harmful agents sucha (sic) as toxins and enviromental (sic) pollution. . . helps . . .rejuvenerate (sic) and healing effect. . .'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/03/2019

Desc: OR'BELL Facial Moisturizer
Notes: This product appears to be an unapproved new drug as the product label (outer box) includes disease claims such as (not an all-inclusive list): 'Created to excert (sic) a protective effect on harmful agents sucha (sic) as toxins and enviromental (sic) pollution. . . helps . . .rejuvenerate (sic) and healing effect. . .'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/02/2019

Desc: ORBELL Facial Serum Hyaluronic Acid
Notes: This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): '[T]o deeply repair the skin and eliminate lines and wrinkles. . .'; '[A] restorative facial serum. . .It will help skin regenerate and deeply repair, eliminating fine lines and wrinkles. . .'.

Offenbach Mexicana, S.A. De C.V.
Date Published : 09/30/2009
Acueducto No. 15 , Col Reforma Social , Mexico City, MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/03/2019

Notes: Artrilan Tablets

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 12/03/2019

Notes: Artrilan Tablets

61 - - - -- Human and Animal Drugs
Date Published: 12/03/2019

Notes: Artrilan Tablets

62 - - - -- Human and Animal Drugs
Date Published: 12/03/2019

Notes: Artrilan Tablets

63 - - - -- Human and Animal Drugs
Date Published: 12/03/2019

Notes: Artrilan Tablets

64 - - - -- Human and Animal Drugs
Date Published: 12/03/2019

Notes: Artrilan Tablets

65 - - - -- Human and Animal Drugs
Date Published: 12/03/2019

Notes: Artrilan Tablets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/03/2019

Desc: Artrilan Tablets

66 - - - -- Human and Animal Drugs
Date Published: 12/03/2019

Notes: Artrilan Tablets

Olnatura, S. A. de C. V.
Date Published : 11/13/2015
Sur, Mnz. 40 Pb 8 , Civac , Jiutepec, Morelos MEXICO
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/13/2015

Desc: Vita Estres and Biogaxtric

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/13/2015

Desc: Olmodin and Vita Estres

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/13/2015

Desc: Biogaxtric/Vitaestres

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/13/2015

Desc: Biofiberex

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/13/2015

Desc: Vitaestres

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/13/2015

Desc: Digerol

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/13/2015

Desc: Vita Estres and Digerol

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/13/2015

Desc: Olmodin

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/13/2015

Desc: Biogaxtric

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/13/2015

Desc: Olmodin and Digerol

Ouro Productos Sa De Cv
Date Published : 11/09/2021
Prolongacion Matamoros # 84 , Tlajomulco De Zuniga , Pueblo Cajititlan, Jalisco MEXICO
53 E - - 03 Hair Straighteners (Hair Preparations, Non-coloring)
Date Published: 11/09/2021

Desc: OURO SLIM-AID Belly-suck Effect Gel; OURO Gel Reductor SLIM-AID
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “Thermogenic gel (cold) that isapplied [sic] directly to the skin for the disintegration of the cells.” and “Together with a healthy diet and exercise, it helps to:…Reduce stomach swelling | Helps eliminate fluid retention | Flashes out toxins.”.                                                                                             

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 11/09/2021

Desc: OURO SLIM-AID Belly-suck Effect Gel; OURO Gel Reductor SLIM-AID
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “Thermogenic gel (cold) that isapplied [sic] directly to the skin for the disintegration of the cells.” and “Together with a healthy diet and exercise, it helps to:…Reduce stomach swelling | Helps eliminate fluid retention | Flashes out toxins.”.                                                                                             

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/09/2021

Desc: OURO SLIM-AID Belly-suck Effect Gel; OURO Gel Reductor SLIM-AID
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “Thermogenic gel (cold) that isapplied [sic] directly to the skin for the disintegration of the cells.” and “Together with a healthy diet and exercise, it helps to:…Reduce stomach swelling | Helps eliminate fluid retention | Flashes out toxins.”.                                                                                             

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/09/2021

Desc: OURO SLIM-AID Belly-suck Effect Gel; OURO Gel Reductor SLIM-AID
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “Thermogenic gel (cold) that isapplied [sic] directly to the skin for the disintegration of the cells.” and “Together with a healthy diet and exercise, it helps to:…Reduce stomach swelling | Helps eliminate fluid retention | Flashes out toxins.”.                                                                                             

PLANTAS MEDICINALES DE MEXICO
Date Published : 08/09/2019
MELCHOR OCAMPO 55 LOCAL D , DELEGACION XOCHIMILCO C.P, MEXICO
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/16/2019

Desc: Ajo King Brand Vision
Notes: The product appears to be an unapproved new drug; because its label includes claims such as; "Vision Borrosa" (blurred vision) and "Inflamacion de Parpados" (eyelid inflammation). The product also appears to not be GRAS and effective for the referenced uses.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/01/2021

Desc: Ajo King Gastritis Colitis
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Gastritis, Reflux, Ulcers, Inflammation, Burning in the pit of the stomach'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/01/2021

Desc: Ajo King Jengibre
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Anti-ulcer, It is used to prevent cardiovascular diseases, Fight migraines'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/01/2021

Desc: Ajo King Mujer (Frasco 1 & Frasco 2)
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Colic, Inflammation of the Belly, Abdominal pain, Anxiety, Insomnia'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/01/2021

Desc: Ajo King Presion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'High pressure, Anxiety, Headache, Ringing in the Ears, Migranas'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/01/2021

Desc: Ajo King Mejora Tu Vision
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Blurry vision, Inflammation of the eyelids'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/01/2021

Desc: Ajo King Diabetes
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Frequent Urination, Sores on the body, Allergies, Kidney problems'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/01/2021

Desc: Ajo King Curcuma
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Relieves pain from altritis, Anti-Inflammatory, Prevents diabetes, Prevents cancer'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 10/08/2019

Desc: Ajo King Circulacion

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/16/2019

Desc: Ajo King Brand Colesterol
Notes: The product appears to be an unapproved new drug; because its label includes claims such as; "Alto Colesterol"(high Cholesterol); "Hipertension"(hypertension); "Riesgos de Infarto" (risks of heart attack); "Taquicardias" (tachycardias) and "Enfemedad Cardiovascular" (cardiovascular disease). The product also appears to not be GRAS and effective for the referenced uses.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/01/2021

Desc: Ajo King Higado-Vesicula
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Hepatic cirrhosis, Biliary cirrhosis, Biliary colic, Inflammation of the liver, Liver poisoning, Inflammation and poisoning of the gallbladder'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/01/2021

Desc: Ajo King Artritis
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Arthritis, Rheumatism, Gout, Osteoarthritis, Arteriosclerosis, Sciatica, Uric Acid, Pain in joints'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/01/2021

Desc: Ajo King Nervios
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Headache, Depression, Anxiety, Insomnia'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/01/2021

Desc: Ajo King Rinon / Vejiga
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Waist pain, Inflammation of the Waist, Gallstones, Prostate problems, Urinary infections, Back pain'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/09/2019

Desc: Ajo King Brand Glucosamina
Notes: The product appears to be an unapproved new drug; because its LBL includes claims such as; "Osteoporosis"(osteoporosis); "Osteoartritis" (osteoarthritis); "Dolor de Huesos" (bone ache) "Dolor de Articulaciones"[articulations (joint) pain] and "Inflamacion de Articulaciones"(joint inflammation). The product also appears to not be GRAS and effective for the referenced uses.

60 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Nervios
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Headache, Depression, Anxiety, Insomnia'.

60 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Diabetes
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Frequent Urination, Sores on the body, Allergies, Kidney problems'.

60 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Artritis
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Arthritis, Rheumatism, Gout, Osteoarthritis, Arteriosclerosis, Sciatica, Uric Acid, Pain in joints'.

60 - - - -- Human and Animal Drugs
Date Published: 08/16/2019

Desc: Ajo King Brand Vision
Notes: The product appears to be an unapproved new drug; because its label includes claims such as; "Vision Borrosa" (blurred vision) and "Inflamacion de Parpados" (eyelid inflammation). The product also appears to not be GRAS and effective for the referenced uses.

60 - - - -- Human and Animal Drugs
Date Published: 08/09/2019

Desc: Ajo King Brand Glucosamina
Notes: The product appears to be an unapproved new drug; because its LBL includes claims such as; "Osteoporosis"(osteoporosis); "Osteoartritis" (osteoarthritis); "Dolor de Huesos" (bone ache) "Dolor de Articulaciones"[articulations (joint) pain] and "Inflamacion de Articulaciones"(joint inflammation). The product also appears to not be GRAS and effective for the referenced uses.

60 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Jengibre
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Anti-ulcer, It is used to prevent cardiovascular diseases, Fight migraines'.

60 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Presion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'High pressure, Anxiety, Headache, Ringing in the Ears, Migranas'.

60 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Gastritis Colitis
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Gastritis, Reflux, Ulcers, Inflammation, Burning in the pit of the stomach'.

60 - - - -- Human and Animal Drugs
Date Published: 08/16/2019

Desc: Ajo King Brand Colesterol
Notes: The product appears to be an unapproved new drug; because its label includes claims such as; "Alto Colesterol"(high Cholesterol); "Hipertension"(hypertension); "Riesgos de Infarto" (risks of heart attack); "Taquicardias" (tachycardias) and "Enfemedad Cardiovascular" (cardiovascular disease). The product also appears to not be GRAS and effective for the referenced uses.

60 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Curcuma
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Relieves pain from altritis, Anti-Inflammatory, Prevents diabetes, Prevents cancer'.

60 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Higado-Vesicula
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Hepatic cirrhosis, Biliary cirrhosis, Biliary colic, Inflammation of the liver, Liver poisoning, Inflammation and poisoning of the gallbladder'.

60 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Mejora Tu Vision
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Blurry vision, Inflammation of the eyelids'.

60 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Mujer (Frasco 1 & Frasco 2)
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Colic, Inflammation of the Belly, Abdominal pain, Anxiety, Insomnia'.

60 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Rinon / Vejiga
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Waist pain, Inflammation of the Waist, Gallstones, Prostate problems, Urinary infections, Back pain'.

61 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Higado-Vesicula
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Hepatic cirrhosis, Biliary cirrhosis, Biliary colic, Inflammation of the liver, Liver poisoning, Inflammation and poisoning of the gallbladder'.

61 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Jengibre
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Anti-ulcer, It is used to prevent cardiovascular diseases, Fight migraines'.

61 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Rinon / Vejiga
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Waist pain, Inflammation of the Waist, Gallstones, Prostate problems, Urinary infections, Back pain'.

61 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Mejora Tu Vision
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Blurry vision, Inflammation of the eyelids'.

61 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Mujer (Frasco 1 & Frasco 2)
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Colic, Inflammation of the Belly, Abdominal pain, Anxiety, Insomnia'.

61 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Gastritis Colitis
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Gastritis, Reflux, Ulcers, Inflammation, Burning in the pit of the stomach'.

61 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Diabetes
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Frequent Urination, Sores on the body, Allergies, Kidney problems'.

61 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Curcuma
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Relieves pain from altritis, Anti-Inflammatory, Prevents diabetes, Prevents cancer'.

61 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Presion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'High pressure, Anxiety, Headache, Ringing in the Ears, Migranas'.

61 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Artritis
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Arthritis, Rheumatism, Gout, Osteoarthritis, Arteriosclerosis, Sciatica, Uric Acid, Pain in joints'.

61 - - - -- Human and Animal Drugs
Date Published: 08/16/2019

Desc: Ajo King Brand Vision
Notes: The product appears to be an unapproved new drug; because its label includes claims such as; "Vision Borrosa" (blurred vision) and "Inflamacion de Parpados" (eyelid inflammation). The product also appears to not be GRAS and effective for the referenced uses.

61 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Nervios
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Headache, Depression, Anxiety, Insomnia'.

61 - - - -- Human and Animal Drugs
Date Published: 08/16/2019

Desc: Ajo King Brand Colesterol
Notes: The product appears to be an unapproved new drug; because its label includes claims such as; "Alto Colesterol"(high Cholesterol); "Hipertension"(hypertension); "Riesgos de Infarto" (risks of heart attack); "Taquicardias" (tachycardias) and "Enfemedad Cardiovascular" (cardiovascular disease). The product also appears to not be GRAS and effective for the referenced uses.

61 - - - -- Human and Animal Drugs
Date Published: 08/09/2019

Desc: Ajo King Brand Glucosamina
Notes: The product appears to be an unapproved new drug; because its LBL includes claims such as; "Osteoporosis"(osteoporosis); "Osteoartritis" (osteoarthritis); "Dolor de Huesos" (bone ache) "Dolor de Articulaciones"[articulations (joint) pain] and "Inflamacion de Articulaciones"(joint inflammation). The product also appears to not be GRAS and effective for the referenced uses.

62 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Presion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'High pressure, Anxiety, Headache, Ringing in the Ears, Migranas'.

62 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Diabetes
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Frequent Urination, Sores on the body, Allergies, Kidney problems'.

62 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Gastritis Colitis
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Gastritis, Reflux, Ulcers, Inflammation, Burning in the pit of the stomach'.

62 - - - -- Human and Animal Drugs
Date Published: 08/09/2019

Desc: Ajo King Brand Glucosamina
Notes: The product appears to be an unapproved new drug; because its LBL includes claims such as; "Osteoporosis"(osteoporosis); "Osteoartritis" (osteoarthritis); "Dolor de Huesos" (bone ache) "Dolor de Articulaciones"[articulations (joint) pain] and "Inflamacion de Articulaciones"(joint inflammation). The product also appears to not be GRAS and effective for the referenced uses.

62 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Jengibre
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Anti-ulcer, It is used to prevent cardiovascular diseases, Fight migraines'.

62 - - - -- Human and Animal Drugs
Date Published: 08/16/2019

Desc: Ajo King Brand Vision
Notes: The product appears to be an unapproved new drug; because its label includes claims such as; "Vision Borrosa" (blurred vision) and "Inflamacion de Parpados" (eyelid inflammation). The product also appears to not be GRAS and effective for the referenced uses.

62 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Artritis
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Arthritis, Rheumatism, Gout, Osteoarthritis, Arteriosclerosis, Sciatica, Uric Acid, Pain in joints'.

62 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Curcuma
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Relieves pain from altritis, Anti-Inflammatory, Prevents diabetes, Prevents cancer'.

62 - - - -- Human and Animal Drugs
Date Published: 08/16/2019

Desc: Ajo King Brand Colesterol
Notes: The product appears to be an unapproved new drug; because its label includes claims such as; "Alto Colesterol"(high Cholesterol); "Hipertension"(hypertension); "Riesgos de Infarto" (risks of heart attack); "Taquicardias" (tachycardias) and "Enfemedad Cardiovascular" (cardiovascular disease). The product also appears to not be GRAS and effective for the referenced uses.

62 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Mejora Tu Vision
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Blurry vision, Inflammation of the eyelids'.

62 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Nervios
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Headache, Depression, Anxiety, Insomnia'.

62 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Rinon / Vejiga
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Waist pain, Inflammation of the Waist, Gallstones, Prostate problems, Urinary infections, Back pain'.

62 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Higado-Vesicula
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Hepatic cirrhosis, Biliary cirrhosis, Biliary colic, Inflammation of the liver, Liver poisoning, Inflammation and poisoning of the gallbladder'.

63 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Artritis
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Arthritis, Rheumatism, Gout, Osteoarthritis, Arteriosclerosis, Sciatica, Uric Acid, Pain in joints'.

63 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Curcuma
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Relieves pain from altritis, Anti-Inflammatory, Prevents diabetes, Prevents cancer'.

63 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Mejora Tu Vision
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Blurry vision, Inflammation of the eyelids'.

63 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Gastritis Colitis
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Gastritis, Reflux, Ulcers, Inflammation, Burning in the pit of the stomach'.

63 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Jengibre
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Anti-ulcer, It is used to prevent cardiovascular diseases, Fight migraines'.

63 - - - -- Human and Animal Drugs
Date Published: 08/16/2019

Desc: Ajo King Brand Colesterol
Notes: The product appears to be an unapproved new drug; because its label includes claims such as; "Alto Colesterol"(high Cholesterol); "Hipertension"(hypertension); "Riesgos de Infarto" (risks of heart attack); "Taquicardias" (tachycardias) and "Enfemedad Cardiovascular" (cardiovascular disease). The product also appears to not be GRAS and effective for the referenced uses.

63 - - - -- Human and Animal Drugs
Date Published: 08/16/2019

Desc: Ajo King Brand Vision
Notes: The product appears to be an unapproved new drug; because its label includes claims such as; "Vision Borrosa" (blurred vision) and "Inflamacion de Parpados" (eyelid inflammation). The product also appears to not be GRAS and effective for the referenced uses.

63 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Presion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'High pressure, Anxiety, Headache, Ringing in the Ears, Migranas'.

63 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Higado-Vesicula
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Hepatic cirrhosis, Biliary cirrhosis, Biliary colic, Inflammation of the liver, Liver poisoning, Inflammation and poisoning of the gallbladder'.

63 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Mujer (Frasco 1 & Frasco 2)
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Colic, Inflammation of the Belly, Abdominal pain, Anxiety, Insomnia'.

63 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Nervios
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Headache, Depression, Anxiety, Insomnia'.

63 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Rinon / Vejiga
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Waist pain, Inflammation of the Waist, Gallstones, Prostate problems, Urinary infections, Back pain'.

63 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Diabetes
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Frequent Urination, Sores on the body, Allergies, Kidney problems'.

63 - - - -- Human and Animal Drugs
Date Published: 08/09/2019

Desc: Ajo King Brand Glucosamina
Notes: The product appears to be an unapproved new drug; because its LBL includes claims such as; "Osteoporosis"(osteoporosis); "Osteoartritis" (osteoarthritis); "Dolor de Huesos" (bone ache) "Dolor de Articulaciones"[articulations (joint) pain] and "Inflamacion de Articulaciones"(joint inflammation). The product also appears to not be GRAS and effective for the referenced uses.

64 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Mujer (Frasco 1 & Frasco 2)
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Colic, Inflammation of the Belly, Abdominal pain, Anxiety, Insomnia'.

64 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Nervios
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Headache, Depression, Anxiety, Insomnia'.

64 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Mejora Tu Vision
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Blurry vision, Inflammation of the eyelids'.

64 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Jengibre
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Anti-ulcer, It is used to prevent cardiovascular diseases, Fight migraines'.

64 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Curcuma
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Relieves pain from altritis, Anti-Inflammatory, Prevents diabetes, Prevents cancer'.

64 - - - -- Human and Animal Drugs
Date Published: 08/09/2019

Desc: Ajo King Brand Glucosamina
Notes: The product appears to be an unapproved new drug; because its LBL includes claims such as; "Osteoporosis"(osteoporosis); "Osteoartritis" (osteoarthritis); "Dolor de Huesos" (bone ache) "Dolor de Articulaciones"[articulations (joint) pain] and "Inflamacion de Articulaciones"(joint inflammation). The product also appears to not be GRAS and effective for the referenced uses.

64 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Gastritis Colitis
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Gastritis, Reflux, Ulcers, Inflammation, Burning in the pit of the stomach'.

64 - - - -- Human and Animal Drugs
Date Published: 08/16/2019

Desc: Ajo King Brand Colesterol
Notes: The product appears to be an unapproved new drug; because its label includes claims such as; "Alto Colesterol"(high Cholesterol); "Hipertension"(hypertension); "Riesgos de Infarto" (risks of heart attack); "Taquicardias" (tachycardias) and "Enfemedad Cardiovascular" (cardiovascular disease). The product also appears to not be GRAS and effective for the referenced uses.

64 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Rinon / Vejiga
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Waist pain, Inflammation of the Waist, Gallstones, Prostate problems, Urinary infections, Back pain'.

64 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Presion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'High pressure, Anxiety, Headache, Ringing in the Ears, Migranas'.

64 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Higado-Vesicula
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Hepatic cirrhosis, Biliary cirrhosis, Biliary colic, Inflammation of the liver, Liver poisoning, Inflammation and poisoning of the gallbladder'.

64 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Diabetes
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Frequent Urination, Sores on the body, Allergies, Kidney problems'.

64 - - - -- Human and Animal Drugs
Date Published: 08/16/2019

Desc: Ajo King Brand Vision
Notes: The product appears to be an unapproved new drug; because its label includes claims such as; "Vision Borrosa" (blurred vision) and "Inflamacion de Parpados" (eyelid inflammation). The product also appears to not be GRAS and effective for the referenced uses.

64 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Artritis
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Arthritis, Rheumatism, Gout, Osteoarthritis, Arteriosclerosis, Sciatica, Uric Acid, Pain in joints'.

65 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Mejora Tu Vision
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Blurry vision, Inflammation of the eyelids'.

65 - - - -- Human and Animal Drugs
Date Published: 08/09/2019

Desc: Ajo King Brand Glucosamina
Notes: The product appears to be an unapproved new drug; because its LBL includes claims such as; "Osteoporosis"(osteoporosis); "Osteoartritis" (osteoarthritis); "Dolor de Huesos" (bone ache) "Dolor de Articulaciones"[articulations (joint) pain] and "Inflamacion de Articulaciones"(joint inflammation). The product also appears to not be GRAS and effective for the referenced uses.

65 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Diabetes
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Frequent Urination, Sores on the body, Allergies, Kidney problems'.

65 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Presion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'High pressure, Anxiety, Headache, Ringing in the Ears, Migranas'.

65 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Curcuma
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Relieves pain from altritis, Anti-Inflammatory, Prevents diabetes, Prevents cancer'.

65 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Jengibre
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Anti-ulcer, It is used to prevent cardiovascular diseases, Fight migraines'.

65 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Gastritis Colitis
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Gastritis, Reflux, Ulcers, Inflammation, Burning in the pit of the stomach'.

65 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Higado-Vesicula
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Hepatic cirrhosis, Biliary cirrhosis, Biliary colic, Inflammation of the liver, Liver poisoning, Inflammation and poisoning of the gallbladder'.

65 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Rinon / Vejiga
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Waist pain, Inflammation of the Waist, Gallstones, Prostate problems, Urinary infections, Back pain'.

65 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Nervios
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Headache, Depression, Anxiety, Insomnia'.

65 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Artritis
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Arthritis, Rheumatism, Gout, Osteoarthritis, Arteriosclerosis, Sciatica, Uric Acid, Pain in joints'.

65 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Mujer (Frasco 1 & Frasco 2)
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Colic, Inflammation of the Belly, Abdominal pain, Anxiety, Insomnia'.

65 - - - -- Human and Animal Drugs
Date Published: 08/16/2019

Desc: Ajo King Brand Colesterol
Notes: The product appears to be an unapproved new drug; because its label includes claims such as; "Alto Colesterol"(high Cholesterol); "Hipertension"(hypertension); "Riesgos de Infarto" (risks of heart attack); "Taquicardias" (tachycardias) and "Enfemedad Cardiovascular" (cardiovascular disease). The product also appears to not be GRAS and effective for the referenced uses.

65 - - - -- Human and Animal Drugs
Date Published: 08/16/2019

Desc: Ajo King Brand Vision
Notes: The product appears to be an unapproved new drug; because its label includes claims such as; "Vision Borrosa" (blurred vision) and "Inflamacion de Parpados" (eyelid inflammation). The product also appears to not be GRAS and effective for the referenced uses.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/08/2019

Desc: Ajo King Circulacion

66 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Diabetes
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Frequent Urination, Sores on the body, Allergies, Kidney problems'.

66 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Jengibre
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Anti-ulcer, It is used to prevent cardiovascular diseases, Fight migraines'.

66 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Artritis
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Arthritis, Rheumatism, Gout, Osteoarthritis, Arteriosclerosis, Sciatica, Uric Acid, Pain in joints'.

66 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Curcuma
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Relieves pain from altritis, Anti-Inflammatory, Prevents diabetes, Prevents cancer'.

66 - - - -- Human and Animal Drugs
Date Published: 08/16/2019

Desc: Ajo King Brand Colesterol
Notes: The product appears to be an unapproved new drug; because its label includes claims such as; "Alto Colesterol"(high Cholesterol); "Hipertension"(hypertension); "Riesgos de Infarto" (risks of heart attack); "Taquicardias" (tachycardias) and "Enfemedad Cardiovascular" (cardiovascular disease). The product also appears to not be GRAS and effective for the referenced uses.

66 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Rinon / Vejiga
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Waist pain, Inflammation of the Waist, Gallstones, Prostate problems, Urinary infections, Back pain'.

66 - - - -- Human and Animal Drugs
Date Published: 08/09/2019

Desc: Ajo King Brand Glucosamina
Notes: The product appears to be an unapproved new drug; because its LBL includes claims such as; "Osteoporosis"(osteoporosis); "Osteoartritis" (osteoarthritis); "Dolor de Huesos" (bone ache) "Dolor de Articulaciones"[articulations (joint) pain] and "Inflamacion de Articulaciones"(joint inflammation). The product also appears to not be GRAS and effective for the referenced uses.

66 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Presion
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'High pressure, Anxiety, Headache, Ringing in the Ears, Migranas'.

66 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Mejora Tu Vision
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Blurry vision, Inflammation of the eyelids'.

66 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Higado-Vesicula
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Hepatic cirrhosis, Biliary cirrhosis, Biliary colic, Inflammation of the liver, Liver poisoning, Inflammation and poisoning of the gallbladder'.

66 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Gastritis Colitis
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Gastritis, Reflux, Ulcers, Inflammation, Burning in the pit of the stomach'.

66 - - - -- Human and Animal Drugs
Date Published: 08/16/2019

Desc: Ajo King Brand Vision
Notes: Ajo King Brand Vision Notes; The product appears to be an unapproved new drug; because its label includes claims such as; "Vision Borrosa" (blurred vision) and "Inflamacion de Parpados" (eyelid inflammation). The product also appears to not be GRAS and effective for the referenced uses.

66 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Nervios
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Headache, Depression, Anxiety, Insomnia'.

66 - - - -- Human and Animal Drugs
Date Published: 02/01/2021

Desc: Ajo King Mujer (Frasco 1 & Frasco 2)
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Colic, Inflammation of the Belly, Abdominal pain, Anxiety, Insomnia'.

PRODUCTOS NATURALES DE QUERETARO S.A. DE C.V.
Date Published : 02/23/2012
Cosecha 6 , Los Arquitos , Queretaro, QRO MEXICO
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 02/23/2012

Desc: Soi Soys Powder Beverage Mix Reduces the risk of Heart Disease
Notes: Mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/25/2012

Desc: Alpicen Instant Beverage of Canary Seed
Notes: Mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/23/2012

Desc: Soi Soys Powder Beverage Mix Reduces the risk of Heart Disease
Notes: Mexico

Paletas Mara, S.A. de C.V.
Date Published : 10/12/2012
Calle Manuel Doblado No. 353 , Centro , Tabasco, Zacatecas MEXICO
33 S - - 06 Lollipop (without Chocolate)
Date Published: 02/05/2013

Desc: Pinata Candy Mixes (Combo Pinata
Notes: NOTE; Product label claims to help prevent cancer

33 S - - 06 Lollipop (without Chocolate)
Date Published: 10/12/2012

Notes: Acidulated Hard Candy Lollipops with Chili and Watermelon flavor- with antioxidants (Mara sandia paletas de caramelo macizo con tiene antioxidants); NOTE; Label indicates product helps prevent cancer

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/12/2012

Notes: Acidulated Hard Candy Lollipops with Chili and Watermelon flavor- with antioxidants (Mara sandia paletas de caramelo macizo con tiene antioxidants); NOTE; Label indicates product helps prevent cancer ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/05/2013

Desc: Pinata Candy Mixes (Combo Pinata & Combo Pinata con Chile)
Notes: NOTE; Product label claims to help prevent cancer

Pennwalt Labs de Mexico
Date Published : 08/20/2019
Unknown Street , Unknown, MEXICO
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/20/2019

Notes: Redotex

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/20/2019

Notes: Redotex

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

61 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

62 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

63 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

64 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

65 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

66 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex

Pharmaceutical International
Date Published : 09/30/2009
unknown , Rosarito Beach, Baja Ca MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/03/2019

Notes: All drugs; 8/30/1989

56 - - - -- Antibiotics (Human/Animal)
Date Published: 12/03/2019

Notes: All drugs; 8/30/1989

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 12/03/2019

Notes: All drugs; 8/30/1989

61 - - - -- Human and Animal Drugs
Date Published: 12/03/2019

Notes: All drugs; 8/30/1989

62 - - - -- Human and Animal Drugs
Date Published: 12/03/2019

Notes: All drugs; 8/30/1989

63 - - - -- Human and Animal Drugs
Date Published: 12/03/2019

Notes: All drugs; 8/30/1989

64 - - - -- Human and Animal Drugs
Date Published: 12/03/2019

Notes: All drugs; 8/30/1989

65 - - - -- Human and Animal Drugs
Date Published: 12/03/2019

Notes: All drugs; 8/30/1989

66 - - - -- Human and Animal Drugs
Date Published: 12/03/2019

Notes: All drugs; 8/30/1989

Proactive Internacional, S.A de C.V
Date Published : 04/02/2010
Avenida Simon Bolivar 1561-C , Col. Mitras Centro, Monterrey , Monterrey, Nuevo Leon MEXICO
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 04/02/2010

Desc: Marajo (Liquid dietary supplements)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/02/2010

Desc: Marajo (Liquid dietary supplements)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/02/2010

Desc: Marajo (Liquid dietary supplements)

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 04/02/2010

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 04/02/2010

61 - - - -- Human and Animal Drugs
Date Published: 04/02/2010

62 - - - -- Human and Animal Drugs
Date Published: 04/02/2010

63 - - - -- Human and Animal Drugs
Date Published: 04/02/2010

64 - - - -- Human and Animal Drugs
Date Published: 04/02/2010

65 - - - -- Human and Animal Drugs
Date Published: 04/02/2010

66 - - - -- Human and Animal Drugs
Date Published: 04/02/2010

Productores de Tuna San Jose del Sitio S de P.R. de R.L
Date Published : 02/11/2020
Francisco Villa No. Exterior 8 , Zacatecas, Zacatecas MEXICO
41 B - - -- Foods W/Suppl Nutr
Date Published: 02/11/2020

Desc: Nopaliux (Nopal Dietary Supplement)
Notes: The product appears to be an unapproved new drug as the internet promotion of the product includes claims such as (not an all-inclusive list): '...Regular niveles de glucose (DIABETES)' - Regulate glucose levels (DIABETES); '...Previene ulceras gastricas' - Prevents gastric ulcers; '...Ayuda a regular cholesterol' - It helps regulate cholesterol; '...Antibiotico natural' - Natural antibiotic.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/11/2020

Desc: Nopaliux (Nopal Dietary Supplement)
Notes: The product appears to be an unapproved new drug as the internet promotion of the product includes claims such as (not an all-inclusive list): '...Regular niveles de glucose (DIABETES)' - Regulate glucose levels (DIABETES); '...Previene ulceras gastricas' - Prevents gastric ulcers; '...Ayuda a regular cholesterol' - It helps regulate cholesterol; '...Antibiotico natural' - Natural antibiotic.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/11/2020

Desc: Nopaliux (Nopal Dietary Supplement)
Notes: The product appears to be an unapproved new drug as the internet promotion of the product includes claims such as (not an all-inclusive list): '...Regular niveles de glucose (DIABETES)' - Regulate glucose levels (DIABETES); '...Previene ulceras gastricas' - Prevents gastric ulcers; '...Ayuda a regular cholesterol' - It helps regulate cholesterol; '...Antibiotico natural' - Natural antibiotic.

Productos Medix, S.A. de C.V.
Date Published : 08/20/2019
Calzada del Hueso No. 39 , Col. Ex Ejidos de Santa Ursula Coapa , Mexico Df, DF MEXICO
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/20/2019

Notes: Redotex (Generic Name is Dialicels)

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/20/2019

Notes: Redotex (Generic Name is Dialicels)

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex (Generic Name is Dialicels)

61 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex (Generic Name is Dialicels)

62 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex (Generic Name is Dialicels)

63 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex (Generic Name is Dialicels)

64 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex (Generic Name is Dialicels)

65 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex (Generic Name is Dialicels)

66 - - - -- Human and Animal Drugs
Date Published: 08/20/2019

Notes: Redotex (Generic Name is Dialicels)

RAFAEL BERRUETA SORIANO
Date Published : 02/02/2021
Calle Chicle Las Gloriasdel Colli 674 , Fracc. La Gloria Del Colli, Zapopan , Zapopan, Jalisco MEXICO
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 02/02/2021

Desc: Shampoo Del Indio Huichol Prevent Hair Loss

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 02/02/2021

Desc: Shampoo Del Indio Huichol Prevent Hair Loss

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/02/2021

Desc: Shampoo Del Indio Huichol Prevent Hair Loss

Riger Natural
Date Published : 03/12/2012
Calzada De Tialpan No 587 , Tialrneontia, MEXICO
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/12/2012

Desc: Reumofan Plus
Notes: Mexico

Roir, S.A. de C.V
Date Published : 09/26/2017
Puerto Escondido 23800-F , Parque Industrial PacificoIII , Tijuana, Baja California MEXICO
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 09/26/2017

Desc: Head & Shoulders Shampoo

53 I - - -- Oral Hygiene Prod
Date Published: 10/19/2017

Desc: Crest Complete 4 EN 1 Toothpaste
Notes:                                                                                                                                                                                                            

61 H - - 05 Zinc Pyrithione (Anti-Bacterial)
Date Published: 09/26/2017

Desc: Head & Shoulders Shampoo

63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic)
Date Published: 10/19/2017

Desc: Crest Complete 4 EN 1 Toothpaste
Notes:                                                                                                                                                                                                            

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/26/2017

Desc: Head & Shoulders Shampoo

SMEDICAL HEALTH AND BEAUTY S DE
Date Published : 06/14/2017
Prado Norte 470 Piso 4 , Col. MIGUEL HIDALGO , Hidalgo, Nuevo Leon MEXICO
66 - - - -- Human and Animal Drugs
Date Published: 06/14/2017

Desc: No Lice Essence Diffuser Rubber Bands
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; ' ... No Lice ...; ...Up to 2 months of treatment; prolonged release of natural active ingredients ...'

80 L - - JL Detectors And Removers, Lice, (Including Combs)
Date Published: 06/14/2017

Desc: No Lice Essence Diffuser Rubber Bands
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; ' ... No Lice ...; ...Up to 2 months of treatment; prolonged release of natural active ingredients ...' ;

80 P - - UN Lice removal kit containing a solution
Date Published: 06/14/2017

Desc: No Lice Essence Diffuser Rubber Bands
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; ' ... No Lice ...; ...Up to 2 months of treatment; prolonged release of natural active ingredients ...'

SOLUCIONES EN BIO SEGURIDAD AMBIENT
Date Published : 07/22/2020
Bahia Escondida 60 , Miramar, MEXICO
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 07/22/2020

Desc: Hand Sanitizer

62 H - - 05 Ethyl Alcohol (Anti-Microbial)
Date Published: 07/22/2020

Desc: Hand Sanitizer

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 07/22/2020

Desc: Hand Sanitizer

SOLUCIONES HGC S. DE R.L. DE C.V.
Date Published : 10/08/2013
Avenida Independencia No. 1016 , Fracc. La Rinconada, Aguascalientes , Aguascalientes, Aguascalientes MEXICO
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/08/2013

Desc: Esbelin siloutte (Herbal blend with L-Carnitine)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/08/2013

Desc: Esbelin siloutte (Herbal blend with L-Carnitine)

Sharpmeds.com
Date Published : 09/30/2009
Jose Carlos domain @ sharpmeds.com , Apartado Postal 10-65666 , Mexico City, null 425369, MEXICO
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                    

Silver Tech de Mexico S.A de C.V.
Date Published : 03/18/2021
Av. Autotransporte 422 Bodega 2 , Leon, Guanajuato MEXICO
62 H - - 99 Anti-Microbial N.E.C.
Date Published: 03/18/2021

Desc: REIN 47 Nanotech Cleaner Hand Sanitizer Gel

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 03/18/2021

Desc: REIN 47 Nanotech Cleaner Alcohol Free Hand Sanitizer Gel

TECNO BOTANICA DE MEXICO SA DE CV
Date Published : 11/22/2011
Soledad 92 2do Piso, Merced Balbuena , Deleg. V. Carranza , MEXICO, MX-DIF MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 11/22/2011

Desc: Micosanasol Tea Tree Oil Skin Drops
Notes: mexico

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 02/14/2012

Desc: Topical Garlic Oil Ajonol
Notes: Mexico

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 11/22/2011

Desc: 'Boldoa Oil' Ear Drops
Notes: mexico

54 F - - 10 Garlic (Herbal & Botanicals, not Teas)
Date Published: 02/14/2012

Desc: Topical Garlic Oil Ajonol
Notes: mexico

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/14/2012

Desc: Topical Garlic Oil Ajonol
Notes: mexico

62 F - - 99 Anti-Infective, Topical N.E.C.
Date Published: 11/22/2011

Desc: Micosanasol Tea Tree Oil Skin Drops
Notes: mexico

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 11/22/2011

Desc: 'Boldoa Oil' Ear Drops
Notes: mexico

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 02/14/2012

Desc: Topical Garlic Oil Ajonol
Notes: Mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/14/2012

Desc: Topical Garlic Oil Ajonol
Notes: Mexico

Tecno Botanica De Mexico S A D E C V
Date Published : 08/18/2011
Soledad 88 Altos 4 , Colonia Merced Centro , Cuauhtemoc, DF MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 02/14/2012

Desc: Topical Garlic Oil Ajonol
Notes: mexico

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 08/18/2011

Desc: Facial Mask of Clay Virgen
Notes: Meixco

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/18/2011

Desc: Facial Mask of Clay Virgen
Notes: Mexico

54 F - - 10 Garlic (Herbal & Botanicals, not Teas)
Date Published: 02/14/2012

Desc: Topical Garlic Oil Ajonol
Notes: mexico

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/14/2012

Desc: Topical Garlic Oil Ajonol
Notes: mexico

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 02/14/2012

Desc: Topical Garlic Oil Ajonol
Notes: mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/14/2012

Desc: Topical Garlic Oil Ajonol
Notes: mexico

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/18/2011

Desc: Facial Mask of Clay Virgen
Notes: Mexico

Tonic Life S de RL
Date Published : 12/14/2010
Calle Acambaro 1008 , Col. Fracc Plan De Guanajuato, Irapuato , Irapuato, Guanajuato MEXICO
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 12/14/2010

Notes: All Drug Products; All Dietary Supplement; Mexico

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/14/2010

Notes: All Drug Products; All Dietary Supplement; Mexico

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 12/14/2010

Notes: All Drug Products; All Dietary Supplement; Mexico

61 - - - -- Human and Animal Drugs
Date Published: 12/14/2010

Notes: All Drug Products; All Dietary Supplement; Mexico

62 - - - -- Human and Animal Drugs
Date Published: 12/14/2010

Notes: All Drug Products; All Dietary Supplement; Mexico

63 - - - -- Human and Animal Drugs
Date Published: 12/14/2010

Notes: All Drug Products; All Dietary Supplement; Mexico

64 - - - -- Human and Animal Drugs
Date Published: 12/14/2010

Notes: All Drug Products; All Dietary Supplement; Mexico

65 - - - -- Human and Animal Drugs
Date Published: 12/14/2010

Notes: All Drug Products; All Dietary Supplement; Mexico

66 - - - -- Human and Animal Drugs
Date Published: 12/14/2010

Notes: All Drug Products; All Dietary Supplement; Mexico

Trokar, S.A. de C.V.
Date Published : 06/22/2021
Francisco I. Madero No 42 Santa Cruz Meyehualco , Iztapalapa, MEXICO
62 H - - 99 Anti-Microbial N.E.C.
Date Published: 06/22/2021

Desc: SQ2 SKIN ANTISEPTIC HAND SANITIZER FOAM
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): “4 hours of protection, protection from microorganisms such as Staphylococcus aureus, Escherichia coli, Salmonella typhi, Candida albicans, and viruses.”

Unilever Mexico S de R.L. de C.V.
Date Published : 07/11/2013
Calle 21 Este No. 1 , Zona Industrial Civac , Jiutepec, Morelos MEXICO
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/11/2013

Desc: Ponds Clarent B
Notes: mexico

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 07/11/2013

Desc: Ponds Clarent B
Notes: mexico

Vida Herbal, S.A de C.V
Date Published : 09/27/2010
Mariano Matamoros No. 243 , Col. Analco , Guadalajara, Jalisco MEXICO
53 E - - 05 Rinses (Hair Preparations, Non-coloring)
Date Published: 11/27/2017

Desc: Herb of Grace Oil
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Aids in Rheumatic pain …'; '… Aids in arthritis …'.

53 E - - 05 Rinses (Hair Preparations, Non-coloring)
Date Published: 11/27/2017

Desc: Bergamota Capilar Care Bergamot Oil
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Helps fortify hair roots …'.

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 11/27/2017

Desc: Bergamota Capilar Care Bergamot Oil
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Helps fortify hair roots …'.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 11/27/2017

Desc: Bergamota Capilar Care Bergamot Oil
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Helps fortify hair roots …'.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/27/2017

Desc: Bergamota Capilar Care Bergamot Oil
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Helps fortify hair roots …'.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/27/2017

Desc: Herb of Grace Oil
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Aids in Rheumatic pain …'; '… Aids in arthritis …'.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/27/2017

Desc: La Vaquita Balsamo Blanco Ointment
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… [R]eapply the ointment … until the recovery of the injury …'; '… Ointment with anti-inflammatory and rubefacient action, useful in treatment for diseases such as: mastis and wounds caused by blows, muscle and joint inflammations, sprains and sprains, as well as rheumatism in general …'.

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/27/2010

Desc: Nograx Artichoke Patch Aka Hollywood Patch
Notes: Mexico

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/27/2010

Desc: Nograx Artichoke Patch Aka Hollywood Patch
Notes: Mexico

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 11/27/2017

Desc: La Vaquita Balsamo Blanco Ointment
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… [R]eapply the ointment … until the recovery of the injury …'; '… Ointment with anti-inflammatory and rubefacient action, useful in treatment for diseases such as: mastis and wounds caused by blows, muscle and joint inflammations, sprains and sprains, as well as rheumatism in general …'.

62 Q - - 99 Anti-Rheumatic N.E.C.
Date Published: 11/27/2017

Desc: Herb of Grace Oil
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Aids in Rheumatic pain …'; '… Aids in arthritis …'.

Zellen Cell Pharmaceuticals
Date Published : 09/30/2009
Apartado Postal No 1118 , Tijuana, MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/08/2022

Notes: Zellen Live Cell Therapy and all other products (GPI-DR) 10/22/1992

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 03/08/2022

Notes: Zellen Live Cell Therapy and all other products (GPI-DR) 10/22/1992

61 - - - -- Human and Animal Drugs
Date Published: 03/08/2022

Notes: Zellen Live Cell Therapy and all other products (GPI-DR) 10/22/1992

62 - - - -- Human and Animal Drugs
Date Published: 03/08/2022

Notes: Zellen Live Cell Therapy and all other products (GPI-DR) 10/22/1992

63 - - - -- Human and Animal Drugs
Date Published: 03/08/2022

Notes: Zellen Live Cell Therapy and all other products (GPI-DR) 10/22/1992

64 - - - -- Human and Animal Drugs
Date Published: 03/08/2022

Notes: Zellen Live Cell Therapy and all other products (GPI-DR) 10/22/1992

65 - - - -- Human and Animal Drugs
Date Published: 03/08/2022

Notes: Zellen Live Cell Therapy and all other products (GPI-DR) 10/22/1992

66 - - - -- Human and Animal Drugs
Date Published: 03/08/2022

Notes: Zellen Live Cell Therapy and all other products (GPI-DR) 10/22/1992

Zermat Internacional Sa De Cv
Date Published : 11/08/2018
Torre 3 , Circuito Interior (Calzada Melchor Ocampo); Col. Veronica Anzures, Miguel Hidalgo , Ciudad De Mexico, Ciudad de Mexico MEXICO
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 11/08/2018

Desc: Intimate Shampoo / Shampoo de Higiene Intima
Notes: Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA).

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 11/08/2018

Desc: Intimate Shampoo / Shampoo de Higiene Intima
Notes: Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA).

53 U - - 10 Personal Cleanliness, Cosmetic products containing animal by-products (other animal by-products)
Date Published: 11/08/2018

Desc: Intimate Shampoo / Shampoo de Higiene Intima
Notes: Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA).

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 11/08/2018

Desc: Intimate Shampoo / Shampoo de Higiene Intima
Notes: Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA).

sarodi bq sa de cv
Date Published : 06/16/2023
Avenida Naucalpan Toluca # 869 , Pueblo San Rafael Chamapa, Naucalpan De Juarez , Naucalpan De Juarez, Mexico MEXICO
54 B - - 99 Mineral N.E.C.
Date Published: 06/16/2023

Desc: BiOrganics Wonder Maka Capsules

54 K - - 20 Maca (Herbal & Botanicals, not Teas II)
Date Published: 06/16/2023

Desc: BiOrganics Wonder Maka Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/16/2023

Desc: BiOrganics Wonder Maka Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/16/2023

Desc: BiOrganics Wonder Maka Capsules


NEPAL


Asian Thai Foods (P)
Date Published : 08/14/2023
P.O,BOX 133 , Sonapur, NP-KO NEPAL
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 08/14/2023

Desc: OKHATI Papaya Whitening Soap

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 08/14/2023

Desc: OKHATI Papaya Whitening Soap

66 P - - -- Ultraviolet Screen/Sunscreen
Date Published: 08/14/2023

Desc: OKHATI Papaya Whitening Soap

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/14/2023

Desc: OKHATI Papaya Whitening Soap

BEST MAD HONEY, MITHO MASINO FOODS
Date Published : 04/25/2023
Pasikot, Budhanilkantha , Kathmandu, Kathmandu NEPAL
36 C - - -- Honey
Date Published: 04/26/2023

Desc: Best Mad Honey

66 H - - 99 Sweetener N.E.C.
Date Published: 04/25/2023

Desc: Best Mad Honey

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/25/2023

Desc: Best Mad Honey

SHREE JAYAKALI JADIBUTI UDHYOG P
Date Published : 08/14/2023
Balaju-16 , Kathmandu, Kathmandu NEPAL
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 01/22/2024

Desc: Ayurvedic Okhati Papaya Soap

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 01/22/2024

Desc: Okhati Ayurvedic Bath Soap

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 08/14/2023

Desc: OKHATI Papaya Whitening Soap

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 01/22/2024

Desc: Ayurvedic Okhati Neem Soap

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 08/14/2023

Desc: OKHATI Papaya Whitening Soap

66 P - - -- Ultraviolet Screen/Sunscreen
Date Published: 08/14/2023

Desc: OKHATI Papaya Whitening Soap

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/14/2023

Desc: OKHATI Papaya Whitening Soap

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/22/2024

Desc: Ayurvedic Okhati Neem Soap

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/22/2024

Desc: Okhati Ayurvedic Bath Soap

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/22/2024

Desc: Ayurvedic Okhati Papaya Soap


NETHERLANDS


Alcin Cosmetic Nederland BV
Date Published : 09/30/2009
unknown , unknown, NETHERLANDS
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Bgli
Date Published : 11/16/2011
Rijnkade 21a , Weesp, Noord-holland NETHERLANDS
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/16/2011

Desc: Glyco Health Protein (Vitamin D Preparation)
Notes: Netherlands

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/13/2019

Desc: Glyco Health Protein
Notes: 11/18/2011

Bgli
Date Published : 11/16/2011
Pobox 105 , Rijswijk, Zuid-holland NETHERLANDS
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/16/2011

Desc: Glyco Health Protein (Vitamin D Preparation)
Notes: Netherlands

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/16/2011

Desc: Glyco Health Protein (Vitamin D Preparation)
Notes: Netherlands

Chempropack Bv
Date Published : 09/13/2019
Donker Duyvisweg 45 , Dordrecht, NETHERLANDS
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/13/2019

Notes: "G-Spot", 3/30/2000

De Sjamaan
Date Published : 09/30/2009
Klarendalseweg 185 , 6822 GJ , Arnhem, NETHERLANDS
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/17/2022

Desc: All drug and dietary supplement products
Notes: GPI-DR/IND-54 10/7/2002

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All drug and dietary supplement products GPI-DR/IND-54 10/7/2002

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drug and dietary supplement products GPI-DR/IND-54 10/7/2002

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drug and dietary supplement products GPI-DR/IND-54 10/7/2002

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drug and dietary supplement products GPI-DR/IND-54 10/7/2002

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drug and dietary supplement products GPI-DR/IND-54 10/7/2002

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drug and dietary supplement products GPI-DR/IND-54 10/7/2002

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drug and dietary supplement products GPI-DR/IND-54 10/7/2002

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drug and dietary supplement products GPI-DR/IND-54 10/7/2002

Eu Supplements
Date Published : 09/29/2016
Regulierenring 12 , Bunnik, Utrecht NETHERLANDS
53 I - - 02 Mouthwashes and Breath Fresheners (Liquids and Sprays), without Fluoride (Oral Hygiene Products)
Date Published: 09/29/2016

Desc: Macact Mouthwash

54 A - - 14 Vit D
Date Published: 09/29/2016

Desc: Macact Mouthwash

54 A - - 14 Vit D
Date Published: 09/29/2016

Desc: GcOleic (or Goleic)

54 A - - 99 Vitamin, N.E.C.
Date Published: 09/29/2016

Desc: Macact Mouthwash

54 A - - 99 Vitamin, N.E.C.
Date Published: 09/29/2016

Desc: GcOleic (or Goleic)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/29/2016

Desc: GcOleic (or Goleic)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/29/2016

Desc: Macact Mouthwash

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/29/2016

Desc: Macact Mouthwash

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/29/2016

Desc: GcOleic (or Goleic)

55 P - - 72 Oleic Acid (Pharmaceutic Necessity - Emulsion Adjunct)
Date Published: 09/29/2016

Desc: GcOleic (or Goleic)

55 P - - 72 Oleic Acid (Pharmaceutic Necessity - Emulsion Adjunct)
Date Published: 09/29/2016

Desc: Macact Mouthwash

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2016

Desc: GcOleic (or Goleic)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2016

Desc: Macact Mouthwash

Green Growth
Date Published : 10/31/2012
Veebnweidestraat 86 , Purmerend, NETHERLANDS
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/31/2012

Desc: Marine Phytoplankton

H&A HOLLAND
Date Published : 01/05/2022
Stephensonstraat 10 R , Zoetermeer, Zuid-Holland NETHERLANDS
23 R - - 02 Sesame Seed (Edible Seed Paste)
Date Published: 01/05/2022

Desc: MAZI TAHIN (SESAME PASTE)
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘[the ingredient Tahin] reduces the chance of high blood pressure, anemia and cancer . . . and lowers bad cholesterol.’.

37 K - - 21 Sesame Paste
Date Published: 01/05/2022

Desc: MAZI TAHIN (SESAME PASTE)
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘[the ingredient Tahin] reduces the chance of high blood pressure, anemia and cancer . . . and lowers bad cholesterol.’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/05/2022

Desc: MAZI TAHIN (SESAME PASTE)
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘[the ingredient Tahin] reduces the chance of high blood pressure, anemia and cancer . . . and lowers bad cholesterol.’.

HEALTH SUPPLEMENTS
Date Published : 10/04/2016
Regulierenring 12 , Bunnik, Utrecht NETHERLANDS
53 I - - 02 Mouthwashes and Breath Fresheners (Liquids and Sprays), without Fluoride (Oral Hygiene Products)
Date Published: 10/04/2016

Desc: Macact Mouthwash

54 A - - 14 Vit D
Date Published: 10/04/2016

Desc: Macact Mouthwash

54 A - - 14 Vit D
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

54 A - - 15 Vitamin D2 (Calciferol)
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

54 A - - 99 Vitamin, N.E.C.
Date Published: 10/04/2016

Desc: Macact Mouthwash

54 A - - 99 Vitamin, N.E.C.
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/04/2016

Desc: Macact Mouthwash

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/04/2016

Desc: Macact Mouthwash

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

55 P - - 72 Oleic Acid (Pharmaceutic Necessity - Emulsion Adjunct)
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

55 P - - 72 Oleic Acid (Pharmaceutic Necessity - Emulsion Adjunct)
Date Published: 10/04/2016

Desc: Macact Mouthwash

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/04/2016

Desc: GcOleic (or Goleic)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/04/2016

Desc: Macact Mouthwash

IMPERIAL FEET B.V.
Date Published : 10/27/2022
Jacob Van Lennepstraat 120c , Amsterdam, Noord-Holland NETHERLANDS
53 - - - -- Cosmetics
Date Published: 10/27/2022

Desc: Imperial Feet
Notes: Product label contains statement, “The solution for ATHLETE’S FOOT”. Product shipping container contains statement, “Athlete’s Feet Solution”. Either statement can be used to identify product subject to DWPE under this Import Alert listing.

53 - - - -- Cosmetics
Date Published: 05/11/2023

Desc: Imperial Feet Nail Mycosis Solution

56 G - - -- Antifungal
Date Published: 05/11/2023

Desc: Imperial Feet Nail Mycosis Solution

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/11/2023

Desc: Imperial Feet Nail Mycosis Solution

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/27/2022

Desc: Imperial Feet
Notes: Product label contains statement, “The solution for ATHLETE’S FOOT”. Product shipping container contains statement, “Athlete’s Feet Solution”. Either statement can be used to identify product subject to DWPE under this Import Alert listing.

IMPERIAL FEET B.V.
Date Published : 05/11/2023
Galjoenstraat 22 , Dronten, Flevoland NETHERLANDS
53 - - - -- Cosmetics
Date Published: 05/11/2023

Desc: Imperial Feet Nail Mycosis Solution

56 G - - -- Antifungal
Date Published: 05/11/2023

Desc: Imperial Feet Nail Mycosis Solution

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/11/2023

Desc: Imperial Feet Nail Mycosis Solution

IMPERIAL FEET BV
Date Published : 10/27/2022
Weteringschans 165c , Amsterdam, Noord-Holland NETHERLANDS
53 - - - -- Cosmetics
Date Published: 10/27/2022

Desc: Imperial Feet
Notes: Product label contains statement, “The solution for ATHLETE’S FOOT”. Product shipping container contains statement, “Athlete’s Feet Solution”. Either statement can be used to identify product subject to DWPE under this Import Alert listing.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/27/2022

Desc: Imperial Feet
Notes: Product label contains statement, “The solution for ATHLETE’S FOOT”. Product shipping container contains statement, “Athlete’s Feet Solution”. Either statement can be used to identify product subject to DWPE under this Import Alert listing.

Lelylan Ltd.
Date Published : 08/16/2010
Nieuwe Hoogstraat 4 , Amsterdam, Noord-holland NETHERLANDS
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/16/2010

Desc: K2 incense products in all varieties including K2 Summit; K2 Standard; K2 Citron; K2 Blonde contains synthetic cannabinoids
Notes: Country; Netherland

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/16/2010

Notes: PRODUCT: K2 incense products in all varieties including K2 Summit; K2 Standard; K2 Citron; K2 Blonde contains synthetic cannabinoids COUNTRY: Netherland

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 08/16/2010

Notes: PRODUCT: K2 incense products in all varieties including K2 Summit; K2 Standard; K2 Citron; K2 Blonde contains synthetic cannabinoids COUNTRY: Netherland

61 - - - -- Human and Animal Drugs
Date Published: 08/16/2010

Notes: PRODUCT: K2 incense products in all varieties including K2 Summit; K2 Standard; K2 Citron; K2 Blonde contains synthetic cannabinoids COUNTRY: Netherland

62 - - - -- Human and Animal Drugs
Date Published: 08/16/2010

Notes: PRODUCT: K2 incense products in all varieties including K2 Summit; K2 Standard; K2 Citron; K2 Blonde contains synthetic cannabinoids COUNTRY: Netherland

63 - - - -- Human and Animal Drugs
Date Published: 08/16/2010

Notes: PRODUCT: K2 incense products in all varieties including K2 Summit; K2 Standard; K2 Citron; K2 Blonde contains synthetic cannabinoids COUNTRY: Netherland

64 - - - -- Human and Animal Drugs
Date Published: 08/16/2010

Notes: PRODUCT: K2 incense products in all varieties including K2 Summit; K2 Standard; K2 Citron; K2 Blonde contains synthetic cannabinoids COUNTRY: Netherland

65 - - - -- Human and Animal Drugs
Date Published: 08/16/2010

Notes: PRODUCT: K2 incense products in all varieties including K2 Summit; K2 Standard; K2 Citron; K2 Blonde contains synthetic cannabinoids COUNTRY: Netherland

66 - - - -- Human and Animal Drugs
Date Published: 08/16/2010

Notes: PRODUCT: K2 incense products in all varieties including K2 Summit; K2 Standard; K2 Citron; K2 Blonde contains synthetic cannabinoids COUNTRY: Netherland

Lelypharma BV
Date Published : 11/28/2023
Zuiveringweg 42 , Lelystad, Flevoland NETHERLANDS
61 X - - 21 Doxylamine Succinate (Anti-Histaminic)
Date Published: 11/28/2023

Desc:            Night Syrup

Mag Essentials
Date Published : 05/10/2018
Loes van Marlestraat 9 , Weesp, Noord-Holland NETHERLANDS
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/10/2018

Desc: Mag Essentials Ultra Pure Magnesium Oil Spray
Notes: Medical claims made on product labeling including websites.

65 R - - 10 Magnesium Chloride (Replenisher)
Date Published: 05/10/2018

Desc: Mag Essentials Ultra Pure Magnesium Oil Spray
Notes: Medical claims made on product labeling including websites.

N&M HANDELSONDERNEMING
Date Published : 09/14/2023
Keizersgracht 520h , Amsterdam, Noord-Holland NETHERLANDS
36 C - - -- Honey
Date Published: 09/14/2023

Desc: Real Mad Honey

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/14/2023

Desc: Real Mad Honey

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/14/2023

Desc: Real Mad Honey

Nutricia NV
Date Published : 06/28/2010
Eerste Stationsstraat 186 , Zoetermeer, Zuid-Holland NETHERLANDS
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 06/28/2010

Desc: Souvenaid Beverage
Notes: Netherlands

41 G - - 01 Nutritionally Complete Formulations
Date Published: 09/26/2023

Desc: Souvenaid Beverage

41 G - - 99 Medical Foods, N.E.C.
Date Published: 06/28/2010

Desc: Souvenaid Beverage
Notes: Netherlands

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/28/2010

Desc: Souvenaid Beverage
Notes: Netherlands

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/28/2010

Desc: Souvenaid Beverage
Notes: Netherlands

Oriveda
Date Published : 12/13/2019
Overtoom 520/3 , Amsterdam, Noord-Holland NETHERLANDS
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/15/2023

Desc: Blended Mushroom Extract Capsules
Notes: Website states that the product is intended for use in the cure, mitigation, treatment, or prevention of disease.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/15/2023

Desc: Turkey Tail Mushroom Extract Capsules
Notes: Website states that the product is intended for use in the cure, mitigation, treatment, or prevention of disease.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/13/2019

Desc: TURKEY TAIL MUSHROOM EXTRACT CAPSULES
Notes: Website states that the product is intended for use in the cure, mitigation, treatment, or prevention of disease.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/13/2019

Desc: BLENDED MUSHROOM EXTRACT CAPSULES
Notes: Website states that the product is intended for use in the cure, mitigation, treatment, or prevention of disease.

Otc Pharma Interna
Date Published : 09/30/2009
Edisonweg 22 , Gorinchem, NETHERLANDS
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2009

Notes: 10/9/2007. Diabe Cinn Capsules. This product is labeled for People with Type II diabetes treating the characteristic signs and symptoms (lowering blood sugar and increasing insulin activity) of this disease.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 10/9/2007. Diabe Cinn Capsules. This product is labeled for People with Type II diabetes treating the characteristic signs and symptoms (lowering blood sugar and increasing insulin activity) of this disease.

Ote Pharma Sol B.V.
Date Published : 10/02/2023
Vluchtoord 38 , Uden, Noord-Brabant NETHERLANDS
60 F B L 04 Zinc Stearate (Adsorbant), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 10/02/2023

Desc: Womens Tear Stimulation Dry Eye Drops

60 F B L 04 Zinc Stearate (Adsorbant), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 10/02/2023

Desc: Ortho-K Thick (Night) Eye Drops

60 F B L 04 Zinc Stearate (Adsorbant), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 10/02/2023

Desc: Tear Stimulation Forte Dry Eye Drops

60 F B L 04 Zinc Stearate (Adsorbant), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 10/02/2023

Desc: Cataract Eye Drops with Cineraria

60 F B L 04 Zinc Stearate (Adsorbant), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 10/02/2023

Desc: Ortho-K Thin (Daytime) Eye Drops

60 F B L 04 Zinc Stearate (Adsorbant), Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 10/02/2023

Desc: Allergy Desensitization Eye Drops

Phytogenix
Date Published : 09/29/2016
Regulierenring 12a , Bunnik, Utrecht NETHERLANDS
53 I - - 02 Mouthwashes and Breath Fresheners (Liquids and Sprays), without Fluoride (Oral Hygiene Products)
Date Published: 09/29/2016

Desc: Macact Mouthwash

54 A - - 14 Vit D
Date Published: 09/29/2016

Desc: GcOleic (or Goleic)

54 A - - 14 Vit D
Date Published: 09/29/2016

Desc: Macact Mouthwash

54 A - - 99 Vitamin, N.E.C.
Date Published: 09/29/2016

Desc: GcOleic (or Goleic)

54 A - - 99 Vitamin, N.E.C.
Date Published: 09/29/2016

Desc: Macact Mouthwash

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/29/2016

Desc: GcOleic (or Goleic)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/29/2016

Desc: Macact Mouthwash

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/29/2016

Desc: GcOleic (or Goleic)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/29/2016

Desc: Macact Mouthwash

55 P - - 72 Oleic Acid (Pharmaceutic Necessity - Emulsion Adjunct)
Date Published: 09/29/2016

Desc: Macact Mouthwash

55 P - - 72 Oleic Acid (Pharmaceutic Necessity - Emulsion Adjunct)
Date Published: 09/29/2016

Desc: GcOleic (or Goleic)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2016

Desc: Macact Mouthwash

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2016

Desc: GcOleic (or Goleic)

Rx-Pharmacy.cc
Date Published : 09/30/2009
Pharm Export , Hornweg 104518ar , Amsterdam, Noord-Holland NETHERLANDS
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                      The firm appears to be selling accutane online and include airmail shippine.

SPIRULINA INTERNATIONAL BV
Date Published : 09/30/2009
Edisonweg 22 , Gorinchem, Zuid-Holland NETHERLANDS
54 A - - 99 Vitamin, N.E.C.
Date Published: 09/30/2009

Notes: Spirulina Tablets; This products labelings structure; function or disease claims including speeding up recovery from illness. Also one of the directions for use involves topical application which takes it out of the dietary supplement classification for that use.; 10/9/2007

54 Y - - 01 Spirulina (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, n.e.c.)
Date Published: 09/30/2009

Notes: Spirulina Tablets; This products labelings structure; function or disease claims including speeding up recovery from illness. Also one of the directions for use involves topical application which takes it out of the dietary supplement classification for that use.; 10/9/2007

Vd3supplements
Date Published : 09/29/2016
Regulierenring 12 , Bunnik, Utrecht NETHERLANDS
53 I - - 02 Mouthwashes and Breath Fresheners (Liquids and Sprays), without Fluoride (Oral Hygiene Products)
Date Published: 09/29/2016

Desc: Macact Mouthwash

54 A - - 14 Vit D
Date Published: 09/29/2016

Desc: Macact Mouthwash

54 A - - 14 Vit D
Date Published: 09/29/2016

Desc: GcOleic (or Goleic)

54 A - - 99 Vitamin, N.E.C.
Date Published: 09/29/2016

Desc: GcOleic (or Goleic)

54 A - - 99 Vitamin, N.E.C.
Date Published: 09/29/2016

Desc: Macact Mouthwash

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/29/2016

Desc: GcOleic (or Goleic)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/29/2016

Desc: Macact Mouthwash

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/29/2016

Desc: Macact Mouthwash

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/29/2016

Desc: GcOleic (or Goleic)

55 P - - 72 Oleic Acid (Pharmaceutic Necessity - Emulsion Adjunct)
Date Published: 09/29/2016

Desc: Macact Mouthwash

55 P - - 72 Oleic Acid (Pharmaceutic Necessity - Emulsion Adjunct)
Date Published: 09/29/2016

Desc: GcOleic (or Goleic)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2016

Desc: GcOleic (or Goleic)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/29/2016

Desc: Macact Mouthwash


NEW ZEALAND


Antipodes Nature Ltd
Date Published : 12/05/2013
Po Box 888 , Wellington, NEW ZEALAND
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 12/05/2013

Desc: Grace Gentle Cream Cleanser

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 12/05/2013

Desc: Grapeseed Butter Cleanser

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/22/2014

Desc: Saviour Skin Balm
Notes: Problem; Unapproved New Drug

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/22/2014

Desc: Aua Manuka Honey Treatment Mask
Notes: Problem; Unapproved New Drug

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/22/2014

Desc: Aua Manuka Honey Treatment Mask
Notes: Problem; Unapproved New Drug

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/22/2014

Desc: Saviour Skin Balm
Notes: Problem; Unapproved New Drug

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/05/2013

Desc: Rejoice Light Facial Day Cream

53 L - - 07 Night (Skin Care Preparations)
Date Published: 12/05/2013

Desc: Kiwi Seed Oil Eye Cream

53 L - - 07 Night (Skin Care Preparations)
Date Published: 12/05/2013

Desc: Avocado Pear Nourishing Night Cream

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 07/22/2014

Desc: Aua Manuka Honey Treatment Mask
Notes: Problem; Unapproved New Drug

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 12/05/2013

Desc: Ananda Antioxidant-Rich Gentle Toner

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/05/2013

Desc: Juliet Skin Brightening Gel Cleanser

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/05/2013

Desc: Joyous Protein-Rich Night Replenish

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/22/2014

Desc: Saviour Skin Balm
Notes: Problem; Unapproved New Drug

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/05/2013

Desc: Divine Face Oil Organic Avocado Oil and Rosehip

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/05/2013

Desc: Hosanna H2O Intensive Skin-Plumping Serum

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/05/2013

Desc: Apostle Skin-Brightening

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/22/2014

Desc: Aua Manuka Honey Treatment Mask
Notes: Problem; Unapproved New Drug

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013

Desc: Rejoice Light Facial Day Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013

Desc: Joyous Protein-Rich Night Replenish

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013

Desc: Apostle Skin-Brightening

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013

Desc: Hosanna H2O Intensive Skin-Plumping Serum

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013

Desc: Divine Face Oil Organic Avocado Oil and Rosehip

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013

Desc: Grapeseed Butter Cleanser

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013

Desc: Ananda Antioxidant-Rich Gentle Toner

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013

Desc: Kiwi Seed Oil Eye Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013

Desc: Juliet Skin Brightening Gel Cleanser

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013

Desc: Avocado Pear Nourishing Night Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013

Desc: Grace Gentle Cream Cleanser

Apis Skin Care Cream
Date Published : 09/30/2009
219 Tuam St , Christchurch, NEW ZEALAND
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/30/2009

Notes: 9/12/07 The chlamydia treatment creams products is sold and promoted on the internet for the treatment of chlamydia. Based on it uses, this product is a drug. Further, CDER is not aware of any substantial scientific evidence that this producr is generally recognized as safe and effective for the conditions recommended or suggested in its labeling.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 9/12/07 The chlamydia treatment creams products is sold and promoted on the internet for the treatment of chlamydia. Based on it uses, this product is a drug. Further, CDER is not aware of any substantial scientific evidence that this producr is generally recognized as safe and effective for the conditions recommended or suggested in its labeling.

Apis Skin Care Cream Ltd
Date Published : 09/30/2009
68 Aylesford Street, St Albans , Christchurch, NEW ZEALAND
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/30/2009

Notes: 9/12/2007

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 9/12/2007

Atmor Sales & Marketing Ltd
Date Published : 05/25/2012
Po Box 44 , Beachlands, NEW ZEALAND
36 C - - 04 Honey
Date Published: 05/25/2012

Desc: East Cape Active Manuka Honey UMF 18
Notes: New Zealand (NZ)

Atmor Sales and Marketing
Date Published : 05/25/2012
Unit 7 , 41 Smales Rd; East Tamaki , Auckland, Auckland NEW ZEALAND
36 C - - 04 Honey
Date Published: 05/25/2012

Desc: East Cape Active Manuka Honey UMF 18
Notes: New Zealand (NZ)

Atmor Sales and Marketing
Date Published : 05/25/2012
Unit 7 , 41 Smales Rd; East Tamaki , Auckland, Auckland NEW ZEALAND
36 C - - 04 Honey
Date Published: 05/25/2012

Desc: East Cape Active Manuka Honey UMF 18
Notes: New Zealand (NZ)

Ebos Group
Date Published : 04/11/2011
249-243 Bush Road, Albany , Auckland, NEW ZEALAND
62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 04/11/2011

Desc: Anti Inflammatory Herbal Releiv
Notes: New Zealand

Evergreen Life Limited
Date Published : 01/16/2013
219 Bush Road , Albany , Auckland, Auckland NEW ZEALAND
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 01/16/2013

Desc: Propolis Toothpaste

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/16/2013

Desc: Propolis Toothpaste

GSFOODS Ltd
Date Published : 07/19/2011
6B Southern Reclamation , Havelock , Blenheim, NZ-MBH NEW ZEALAND
36 C - - 04 Honey
Date Published: 07/19/2011

Desc: Honeymark Manuka Honey Lozenges
Notes: Note; Multiple medical claims are associated with these products; New Zealand ;

62 U - - 99 Anti-Tussive/Cold N.E.C.
Date Published: 07/19/2011

Desc: Honeymark Manuka Honey Lozenges
Notes: Note; Multiple medical claims are associated with these products; New Zealand

Healtheries of New Zealand Limited
Date Published : 05/13/2015
PH # 26 - 117 Lansford Crescent , Avondale , Auckland, NEW ZEALAND
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/13/2015

Desc: Green Lipped Mussel (Seatone) Extract

Honey Collection Ltd
Date Published : 03/10/2014
69 Grove Road , Mayfield , Blenheim , Marlborough NEW ZEALAND
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/10/2014

Desc: New Life Placenta Cream

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 05/05/2014

Desc: Active Manuka Honey Cream

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/10/2014

Desc: New Life Placenta Cream

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 03/10/2014

Desc: New Life Placenta Cream

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 03/10/2014

Desc: New Life Placenta Cream

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/05/2014

Desc: Active Manuka Honey Cream

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 03/10/2014

Desc: New Life Placenta Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/05/2014

Desc: Active Manuka Honey Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/10/2014

Desc: New Life Placenta Cream

Honey Valley New Zealand Limited
Date Published : 07/19/2011
15 Treneglos Street , P.O. Box 2155 , Washdyke Timaru, NEW ZEALAND
36 C - - 04 Honey
Date Published: 07/19/2011

Desc: Manuka Honey
Notes: Note; Multiple medical claims are associated with these products; AKA 100% Pure New Zealand Honey Limited; New Zealand

NRG Group Limited
Date Published : 09/01/2020
Avondale , 438b Rosebank Road , Auckland, Auckland NEW ZEALAND
28 C - - 99 Natural Extract or Flavor, N.E.C.
Date Published: 09/01/2020

Desc: SeaCare Dietary Supplement
Notes: This product appears to be an unapproved new drug as the product labeling on the website includes claims such as: "Taylor has been on SeaCare for more than 8 years, and her mom says she never gets sick with colds, the flu, or other bugs while attending school 4 days a week!...Taylor...DIPG..."

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 09/01/2020

Desc: SeaCare Dietary Supplement
Notes: This product appears to be an unapproved new drug as the product labeling on the website includes claims such as: "Taylor has been on SeaCare for more than 8 years, and her mom says she never gets sick with colds, the flu, or other bugs while attending school 4 days a week!...Taylor...DIPG..."

54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 09/01/2020

Desc: SeaCare Dietary Supplement
Notes: This product appears to be an unapproved new drug as the product labeling on the website includes claims such as: "Taylor has been on SeaCare for more than 8 years, and her mom says she never gets sick with colds, the flu, or other bugs while attending school 4 days a week!...Taylor...DIPG..."

54 A - - 99 Vitamin, N.E.C.
Date Published: 09/01/2020

Desc: SeaCare Dietary Supplement
Notes: This product appears to be an unapproved new drug as the product labeling on the website includes claims such as: "Taylor has been on SeaCare for more than 8 years, and her mom says she never gets sick with colds, the flu, or other bugs while attending school 4 days a week!...Taylor...DIPG..."

54 G - - 99 Animal By-Products and Extracts, N.E.C.
Date Published: 09/01/2020

Desc: SeaCare Dietary Supplement
Notes: This product appears to be an unapproved new drug as the product labeling on the website includes claims such as: "Taylor has been on SeaCare for more than 8 years, and her mom says she never gets sick with colds, the flu, or other bugs while attending school 4 days a week!...Taylor...DIPG..."

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/01/2020

Desc: SeaCare Dietary Supplement
Notes: This product appears to be an unapproved new drug as the product labeling on the website includes claims such as: "Taylor has been on SeaCare for more than 8 years, and her mom says she never gets sick with colds, the flu, or other bugs while attending school 4 days a week!...Taylor...DIPG..."

Natural Solutions
Date Published : 05/25/2012
4464 Te Araroa Road , Te Araroa, Waikato NEW ZEALAND
36 C - - 04 Honey
Date Published: 05/25/2012

Desc: East Cape Active Manuka Honey UMF 18
Notes: New Zealand (NZ)

Nrg Group Ltd
Date Published : 09/01/2020
76 Bluegrey Avenue , Auckland, NEW ZEALAND
28 C - - 99 Natural Extract or Flavor, N.E.C.
Date Published: 09/01/2020

Desc: SeaCare Dietary Supplement
Notes: This product appears to be an unapproved new drug as the product labeling on the website includes claims such as: "Taylor has been on SeaCare for more than 8 years, and her mom says she never gets sick with colds, the flu, or other bugs while attending school 4 days a week!...Taylor...DIPG..."

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 09/01/2020

Desc: SeaCare Dietary Supplement
Notes: This product appears to be an unapproved new drug as the product labeling on the website includes claims such as: "Taylor has been on SeaCare for more than 8 years, and her mom says she never gets sick with colds, the flu, or other bugs while attending school 4 days a week!...Taylor...DIPG..."

54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 09/01/2020

Desc: SeaCare Dietary Supplement
Notes: This product appears to be an unapproved new drug as the product labeling on the website includes claims such as: "Taylor has been on SeaCare for more than 8 years, and her mom says she never gets sick with colds, the flu, or other bugs while attending school 4 days a week!...Taylor...DIPG..."

54 A - - 99 Vitamin, N.E.C.
Date Published: 09/01/2020

Desc: SeaCare Dietary Supplement
Notes: This product appears to be an unapproved new drug as the product labeling on the website includes claims such as: "Taylor has been on SeaCare for more than 8 years, and her mom says she never gets sick with colds, the flu, or other bugs while attending school 4 days a week!...Taylor...DIPG..."

54 G - - 99 Animal By-Products and Extracts, N.E.C.
Date Published: 09/01/2020

Desc: SeaCare Dietary Supplement
Notes: This product appears to be an unapproved new drug as the product labeling on the website includes claims such as: "Taylor has been on SeaCare for more than 8 years, and her mom says she never gets sick with colds, the flu, or other bugs while attending school 4 days a week!...Taylor...DIPG..."

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/01/2020

Desc: SeaCare Dietary Supplement
Notes: This product appears to be an unapproved new drug as the product labeling on the website includes claims such as: "Taylor has been on SeaCare for more than 8 years, and her mom says she never gets sick with colds, the flu, or other bugs while attending school 4 days a week!...Taylor...DIPG..."

Pearson & Craig Cosmetics
Date Published : 03/01/2012
Unit 7 / 41 Smales Road , The Orchard East Tamaki , Auckland, NEW ZEALAND
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/01/2012

Desc: Placenta Serum
Notes: New Zealand

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/01/2012

Desc: Placenta Creme
Notes: New Zealand

Planet Drugs Direct
Date Published : 09/30/2009
P.O. 105-290 , Auckland, NEW ZEALAND
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 04/08/2020

Desc: Abarelix
Notes:                            

64 R - - 21 Somatropin (Hormone)
Date Published: 04/08/2020

Notes:                            

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                            


NICARAGUA


Laboratorios Bio Nature
Date Published : 10/04/2016
Restauranta Cesar Cra S. Km 8 Tope 4c , Managua, NICARAGUA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/04/2016

Desc: Crema con Filtro Solar (Sunscreen Cream)
Notes: Medical claims on product labels


NIGERIA


ADEFOLORUNSHO TECH ENT
Date Published : 04/18/2016
PLOT 9, GBOYEGA IJAODOLA DRIVE , OFF ALL ISIBA ROAD , Igbala Sango Ota, Ogun NIGERIA
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 04/18/2016

Desc: Virgo Hair Fertilizer & Hair Conditioning Cream

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 04/18/2016

Desc: Virgo Hair Fertilizer & Hair Conditioning Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/18/2016

Desc: Virgo Hair Fertilizer & Hair Conditioning Cream

Associated Pharm/Food & Chemical LTDunkop
Date Published : 09/13/2019
Eziama iIndustrial Estate , Lagos, NIGERIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: Sulpher Ointment 11/8/2008

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Sulpher Ointment 11/8/2008

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Sulpher Ointment 11/8/2008

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Sulpher Ointment 11/8/2008

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Sulpher Ointment 11/8/2008

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Sulpher Ointment 11/8/2008

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Sulpher Ointment 11/8/2008

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Sulpher Ointment 11/8/2008

Authentic Natural Products
Date Published : 08/25/2016
Libra Plaza, Suite D1 , Baale Animashaun Rd., Alakuko , Lagos, NIGERIA
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 08/25/2016

Desc: First Class Lady Hair Booster Hair & Scalp Treatment
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Helps to Control Dandruff; Promotes Rapid Healthy Hair Growth; Relieves Scalp Itching; and Controls Broken Hair & Delays Ageing. ;

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 08/25/2016

Desc: First Class Lady Hair Booster Hair & Scalp Treatment
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Helps to Control Dandruff; Promotes Rapid Healthy Hair Growth; Relieves Scalp Itching; and Controls Broken Hair & Delays Ageing

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 08/25/2016

Desc: First Class Lady Hair Booster Hair & Scalp Treatment
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Helps to Control Dandruff; Promotes Rapid Healthy Hair Growth; Relieves Scalp Itching; and Controls Broken Hair & Delays Ageing

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/25/2016

Desc: First Class Lady Hair Booster Hair & Scalp Treatment
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Helps to Control Dandruff; Promotes Rapid Healthy Hair Growth; Relieves Scalp Itching; and Controls Broken Hair & Delays Ageing

BLEMIVIV KONCEPT
Date Published : 01/22/2020
Off Adeniyi Jones , 31 Oluwole Rd. , Lagos, Lagos State NIGERIA
53 L - - -- Skin Care Prep
Date Published: 01/22/2020

Desc: Blemiviv Whitening Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/22/2020

Desc: Blemiviv Whitening Cream

BULLION GO-NEAT GLOBAL LTD
Date Published : 03/06/2024
# 1 Amras Crescent, Torotoro Quarters , Km 36, Lagos Ibadan Expressway , Ibafo, Ogun State NIGERIA
54 A - - -- Vitamin
Date Published: 03/06/2024

Desc: Coco Samba
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

54 C - - -- Protein
Date Published: 03/06/2024

Desc: Coco Samba
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 03/06/2024

Desc: Coco Samba
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

61 - - - -- Human and Animal Drugs
Date Published: 03/06/2024

Desc: Coco Samba
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

66 V - - -- Patent Medicines, Etc
Date Published: 03/06/2024

Desc: Coco Samba
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

Beneks Pharmaceuticals Ltd
Date Published : 05/03/2018
n.4 B Dupe Otegbola St. , Satelite Town , Lagos, NIGERIA
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/03/2018

Desc: Hot Movate Gel

63 V - - 99 Depigmentor N.E.C.
Date Published: 05/03/2018

Desc: Hot Movate Gel

64 L - - 06 Betamethasone Dipropionate (Glucocorticoid)
Date Published: 05/03/2018

Desc: Hot Movate Gel

Bond Chemical
Date Published : 04/05/2021
Adesakin Laout Awe , Lagoxlagox, NIGERIA
56 D - - 21 Gentamicin Sulfate (Aminoglycosides)
Date Published: 04/05/2021

Desc: ABF-3 Cream

61 W - - 04 Clotrimazole (Anti-Fungal) (Not Antibiotic)
Date Published: 04/05/2021

Desc: ABF-3 Cream

64 L - - 02 Beclomethasone Dipropionate (Glucocorticoid)
Date Published: 04/05/2021

Desc: ABF-3 Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/05/2021

Desc: ABF-3 Cream

CHRIS ISAAC
Date Published : 09/29/2014
Oshodi Expressway , 250 Royal Exchange Plaza , Oshodi, Lagos NIGERIA
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/29/2014

Desc: Beneks Cleartone Fast Action Cream (Clobetasol Propionate)
Notes: The products are new drugs within the meaning of Section 201(p) without an effective NDA

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/29/2014

Desc: Beneks Fashion Fair Cream (Clobetasol Propionate)
Notes: The products are new drugs within the meaning of Section 201(p) without an effective NDA

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/29/2014

Desc: Beneks Cleartone Fast Action Gel (Betamethasone Dipropionate)
Notes: The products are new drugs within the meaning of Section 201(p) without an effective NDA

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/29/2014

Desc: Visible Difference Cream (Clobetasol Propionate)

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/29/2014

Desc: Tempovate Cream (Clobetasol Proprioate)

64 L - - 06 Betamethasone Dipropionate (Glucocorticoid)
Date Published: 09/29/2014

Desc: Beneks Cleartone Fast Action Gel (Betamethasone Dipropionate)
Notes: The products are new drugs within the meaning of Section 201(p) without an effective NDA

64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 09/29/2014

Desc: Beneks Cleartone Fast Action Cream (Clobetasol Propionate)
Notes: The products are new drugs within the meaning of Section 201(p) without an effective NDA

64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 09/29/2014

Desc: Beneks Fashion Fair Cream (Clobetasol Propionate)
Notes: The products are new drugs within the meaning of Section 201(p) without an effective NDA

64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 09/29/2014

Desc: Visible Difference Cream (Clobetasol Propionate)

64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 09/29/2014

Desc: Tempovate Cream (Clobetasol Proprioate)

Catherine Abbaa
Date Published : 09/30/2009
98 Badagry Exp Way , Lagos, NIGERIA
53 - - - -- Cosmetics
Date Published: 09/30/2009

Notes: 3/9/2004. All skin bleaching; lightening lotions; creams soaps and serums.

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: 3/9/2004

Chukwuma Ukwata
Date Published : 01/29/2010
1 Boji Boji Owa Roadgra Delta State , Benin City, Edo NIGERIA
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 03/21/2022

Desc: Virgin Hair Fertilizer
Notes: Country: Nigeria 1/28/2010

Copac Nigeria ltd
Date Published : 09/30/2009
Plot K6 Apapa-Oshodi Expressway , Lagos, Ng-La NIGERIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 7/7/2008. Albabukum Powerder (Aspirin and Caffeine). This product is labeled to contain 100 sachets; each sachet containing acetylsalicylic acid 760 mg and caffeine 60 mg. This product is indicated for fast relief of pain; cold; headache and feverishness. There is yet no final monograph for internal analgesics. However; this and all other internal analgesic OTC drug products are requires to bear certain labeling including drug facts format (21CFR 201.66); the Reyes Syndrome Warning (21CFR 201.314). This product also does not comply with the tamper evident packaging requirements for OTC drugs (21CFR 211.132)

Daily - Need Industries Ltd.
Date Published : 03/06/2024
Plots 9 & 10, Daily-Need Lane , Off Lapio Street, Matori , Lagos, Lagos State NIGERIA
54 A - - -- Vitamin
Date Published: 03/06/2024

Desc: De-Deons Syrup of Haemoglobin Vitamin B12
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

54 C - - -- Protein
Date Published: 03/06/2024

Desc: De-Deons Syrup of Haemoglobin Vitamin B12
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 03/06/2024

Desc: De-Deons Syrup of Haemoglobin Vitamin B12
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

61 - - - -- Human and Animal Drugs
Date Published: 03/06/2024

Desc: De-Deons Syrup of Haemoglobin Vitamin B12
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

66 V - - -- Patent Medicines, Etc
Date Published: 03/06/2024

Desc: De-Deons Syrup of Haemoglobin Vitamin B12
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

Drugfield Pharmaceuticals Ltd
Date Published : 07/30/2021
380 Lynson Chemical Ave , Lagoslagos, NIGERIA
55 P - - 97 Methyl Salicylate (Pharmaceutic Necessity - Flavor)
Date Published: 07/30/2021

Desc: NeuroGesic Greaseless Ointment
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): “INDICATIONS…Provides rapid relief from muscular aches, swelling and stiffness associated with rheumatism and musculo-skeletal disorders…For sportsmen and women, when used before physical efforts, it both stimulates and loosen the muscles, thus preparing them for stressful action”.

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 07/30/2021

Desc: NeuroGesic Greaseless Ointment
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): “INDICATIONS…Provides rapid relief from muscular aches, swelling and stiffness associated with rheumatism and musculo-skeletal disorders…For sportsmen and women, when used before physical efforts, it both stimulates and loosen the muscles, thus preparing them for stressful action”.

62 M - - 08 Menthol (Anti-Pruritic)
Date Published: 07/30/2021

Desc: NeuroGesic Greaseless Ointment
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): “INDICATIONS…Provides rapid relief from muscular aches, swelling and stiffness associated with rheumatism and musculo-skeletal disorders…For sportsmen and women, when used before physical efforts, it both stimulates and loosen the muscles, thus preparing them for stressful action”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/30/2021

Desc: NeuroGesic Greaseless Ointment
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): “INDICATIONS…Provides rapid relief from muscular aches, swelling and stiffness associated with rheumatism and musculo-skeletal disorders…For sportsmen and women, when used before physical efforts, it both stimulates and loosen the muscles, thus preparing them for stressful action”.

Duwin Pharmaceutical & Chemical Co. Ltd.
Date Published : 09/30/2009
38 Denton St. , Ebutte-metta , Lagos, NIGERIA
53 L C - -- Skin Care Prep, Cream
Date Published: 08/21/2019

Desc: Regge Lemon Gel .05% Betamethasone Dipropionate
Notes: 10/15/1999

53 L C - -- Skin Care Prep, Cream
Date Published: 08/21/2019

Desc: Toprate Cream .05% Clobetasol Propionate
Notes: 10/15/1999

53 L C - -- Skin Care Prep, Cream
Date Published: 08/21/2019

Desc: Omic Gel Edkeen .025% Fluocinonide
Notes: 10/15/1999

53 L C - -- Skin Care Prep, Cream
Date Published: 08/21/2019

Desc: Topsone Gel .05% Bethamethasone Dipropionate
Notes: 10/15/1999

64 L - - 06 Betamethasone Dipropionate (Glucocorticoid)
Date Published: 08/21/2019

Desc: Regge Lemon Gel .05% Betamethasone Dipropionate
Notes: 10/15/1999

64 L - - 06 Betamethasone Dipropionate (Glucocorticoid)
Date Published: 08/21/2019

Desc: Topsone Gel .05% Bethamethasone Dipropionate
Notes: 10/15/1999

64 L - - 28 Fluocinonide (Glucocorticoid)
Date Published: 08/21/2019

Desc: Omic Gel Edkeen .025% Fluocinonide
Notes: 10/15/1999

64 L - - 28 Fluocinonide (Glucocorticoid)
Date Published: 09/30/2009

Notes: Omic Gel Edkeen 11/15/1999

64 L - - 99 Glucocorticoid N.E.C.
Date Published: 08/21/2019

Desc: Toprate Cream .05% Clobetasol Propionate
Notes: 10/15/1999

64 L - - 99 Glucocorticoid N.E.C.
Date Published: 08/21/2019

Desc: Topsovate Cream Edkeen .05% Clobetasone butyrate
Notes: 10/15/1999

Glaxo Smith Kline Consumer
Date Published : 09/30/2009
Nig Plc Igbesa Road , Agbara, Ng-Og NIGERIA
66 V - - -- Patent Medicines, Etc
Date Published: 09/30/2009

Notes: 9/16/2008. Medicated Powder. Mentholated. This product is labeled to contain tincture of matricaria; is indicated for teething and slight stomach upsets during infancym and FDA is not aware that the product is generally recognized as safe and effective for its labeled uses.

Global Ind. Nigeria Ltd
Date Published : 09/16/2019
41 Egbon Street Ugowo , Benin City, NIGERIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/16/2019

Notes: Aboniki Balm, 11/21/2008

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Aboniki Balm, 11/21/2008

61 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Aboniki Balm, 11/21/2008

62 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Aboniki Balm, 11/21/2008

63 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Aboniki Balm, 11/21/2008

64 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Aboniki Balm, 11/21/2008

65 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Aboniki Balm, 11/21/2008

66 - - - -- Human and Animal Drugs
Date Published: 09/16/2019

Notes: Aboniki Balm, 11/21/2008

Guaranty Cargo Solution
Date Published : 08/16/2016
293 Iju Water Road Iju , Lagos, Cross River State NIGERIA
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 08/25/2016

Desc: First Class Lady Hair Booster Hair & Scalp Treatment
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Helps to Control Dandruff; Promotes Rapid Healthy Hair Growth; Relieves Scalp Itching; and Controls Broken Hair & Delays Ageing.

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 08/25/2016

Desc: First Class Lady Hair Booster Hair & Scalp Treatment
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Helps to Control Dandruff; Promotes Rapid Healthy Hair Growth; Relieves Scalp Itching; and Controls Broken Hair & Delays Ageing. ;

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 08/25/2016

Desc: First Class Lady Hair Booster Hair & Scalp Treatment
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Helps to Control Dandruff; Promotes Rapid Healthy Hair Growth; Relieves Scalp Itching; and Controls Broken Hair & Delays Ageing. ;

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 08/16/2016

Desc: Sunblock Face Cream (Carrot Extracts)
Notes: Medical claims on product labels

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 08/16/2016

Desc: Sunblock Face Cream (Carrot Extracts)
Notes: Medical claims on product labels

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/25/2016

Desc: First Class Lady Hair Booster Hair & Scalp Treatment
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Helps to Control Dandruff; Promotes Rapid Healthy Hair Growth; Relieves Scalp Itching; and Controls Broken Hair & Delays Ageing. ;

J. C. Udeozor & Sons Global Industries
Date Published : 04/07/2020
10-12 Izu-Osayogie St. Iguosa , Benin City, Edo NIGERIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/07/2020

Desc: Aboniki Balm
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'For quick relief of aches and pains, rheumatism, cold, catarrh, sprain and dislocation...'.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/07/2020

Desc: Aboniki Balm
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'For quick relief of aches and pains, rheumatism, cold, catarrh, sprain and dislocation...'.

60 L - - 99 Analgesic, N.E.C.
Date Published: 04/07/2020

Desc: Aboniki Balm
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'For quick relief of aches and pains, rheumatism, cold, catarrh, sprain and dislocation...'.

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 04/07/2020

Desc: Aboniki Balm
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'For quick relief of aches and pains, rheumatism, cold, catarrh, sprain and dislocation...'.

62 M - - 08 Menthol (Anti-Pruritic)
Date Published: 04/07/2020

Desc: Aboniki Balm
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'For quick relief of aches and pains, rheumatism, cold, catarrh, sprain and dislocation...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/07/2020

Desc: Aboniki Balm
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'For quick relief of aches and pains, rheumatism, cold, catarrh, sprain and dislocation...'.

Jagal Pharma Limited
Date Published : 09/30/2009
Jagal Road , Oregun , Lagos, NIGERIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 7/2/2008. Soap. The labeling on this product makes a disease claim. The label states, "use in a place of toilet soeap for both prevention and treatment of scabies." Thus, this product is a drug under 201(g)(1), which is defined as "articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals..."

Martana Nigeria Ltd
Date Published : 08/26/2010
16 Kehinede Adenirokun St. , Isolo, NG-LA NIGERIA
02 - - - -- Whole Grains/Milled Grain Products/Starches
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

04 - - - -- Macaroni/Noodle Products
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

05 - - - -- Cereal Preparations/Breakfast Foods
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

07 - - - -- Snack Food Items
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

09 - - - -- Milk/Butter/Dried Milk Products
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

12 - - - -- Cheese/Cheese Products
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

13 - - - -- Ice Cream and related Products
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

14 - - - -- Filled Milk/Imitation Milk Products
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

15 - - - -- Eggs/Egg Products
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

16 - - - -- Fishery/Seafood Products
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

17 - - - -- Meats, Meat Products and Poultry
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

18 - - - -- Vegetable Protein Products
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

20 - - - -- Fruit/Fruit Products
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

21 - - - -- Fruit/Fruit Products
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

22 - - - -- Fruit/Fruit Products
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

23 - - - -- Nuts/Edible Seeds
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

24 - - - -- Vegetables/Vegetable Products
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

25 - - - -- Vegetables/Vegetable Products
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

26 - - - -- Vegetable Oils
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

27 - - - -- Dressing/Condiments
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

28 - - - -- Spices, Flavors And Salts
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

29 - - - -- Soft Drinks/Water
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

31 - - - -- Coffee/Tea
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

32 - - - -- Alcoholic Beverages
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

38 - - - -- Soups
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

39 - - - -- Prepared Salad Products
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

40 A - - -- Baked Goods (Baby)
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

40 B - - -- Cereal (Baby)
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

40 D - - -- Veg (Baby)
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

40 J - - -- Egg Prod (Baby)
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

40 K - - -- Pudding/Custard (Baby)
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

40 L - - -- Soups/Soup Mix (Baby)
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

40 X - - -- Market Basket Sampling
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

40 Y - - -- Baby Food N.E.C.
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

52 B - - 06 Corn Husks (Food Related)
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

52 B - - 07 Snail Shells (Food Related)
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

52 D - - -- Live Animals
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

61 - - - -- Human and Animal Drugs
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

62 - - - -- Human and Animal Drugs
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

63 - - - -- Human and Animal Drugs
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

64 - - - -- Human and Animal Drugs
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

65 - - - -- Human and Animal Drugs
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

66 - - - -- Human and Animal Drugs
Date Published: 08/26/2010

Notes: Calabaa Chalk/Shere (salted & unsalted) Aka "Calabash Clay" and "NZU" Country: Nigeria

Neimeth International Pharm., PLC
Date Published : 07/30/2021
Plot 16, Akanni Doherty Layout , Oregun, Lagos NIGERIA
55 Q - - 45 Phenol (Pharmaceutic Necessity - Preservative)
Date Published: 07/30/2021

Desc: NCP Liquid Antiseptic
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "27 UNIQUE USES AND COUNTING … Sore Throat Septic/Ulcerated Throat(Tonsillitis) Gum Troubles Mouth Ulcers…”.

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 07/30/2021

Desc: NCP Liquid Antiseptic
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "27 UNIQUE USES AND COUNTING … Sore Throat Septic/Ulcerated Throat(Tonsillitis) Gum Troubles Mouth Ulcers…”.

62 M - - 09 Liquid Phenol (Anti-Pruritic)
Date Published: 07/30/2021

Desc: NCP Liquid Antiseptic
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "27 UNIQUE USES AND COUNTING … Sore Throat Septic/Ulcerated Throat(Tonsillitis) Gum Troubles Mouth Ulcers…”.

64 A - - 99 Disinfectant N.E.C.
Date Published: 07/30/2021

Desc: NCP Liquid Antiseptic
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "27 UNIQUE USES AND COUNTING … Sore Throat Septic/Ulcerated Throat(Tonsillitis) Gum Troubles Mouth Ulcers…”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/30/2021

Desc: NCP Liquid Antiseptic
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "27 UNIQUE USES AND COUNTING … Sore Throat Septic/Ulcerated Throat(Tonsillitis) Gum Troubles Mouth Ulcers…”.

OLOWOLOMAKURE ENT.
Date Published : 03/06/2024
145 Powerline Road , Iteagun Ifo, Ogun State NIGERIA
54 A - - -- Vitamin
Date Published: 03/06/2024

Desc: Senuebo
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

54 C - - -- Protein
Date Published: 03/06/2024

Desc: Senuebo
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 03/06/2024

Desc: Senuebo
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

61 - - - -- Human and Animal Drugs
Date Published: 03/06/2024

Desc: Senuebo
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

66 V - - -- Patent Medicines, Etc
Date Published: 03/06/2024

Desc: Senuebo
Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

Omoleye Oguntoyinbo
Date Published : 09/20/2011
67 Owodunni St Palmgrove , Lagos, Lagos NIGERIA
53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 09/20/2011

Desc: Virgin Hair Fertilizer (Hair Cream)
Notes: Nigeria

Orange Drugs Comapny
Date Published : 09/30/2009
Ilupeju , Town Planning St. , Lagos, Lagos NIGERIA
64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 09/30/2009

Notes: 11/12/2008 Neutrotone Cream.

PZ CUSSONS NIGERIA PLC
Date Published : 09/22/2021
487 Shegamu-Ikondu Road , Lagos, NIGERIA
60 F - - 03 Talc (Adsorbant)
Date Published: 09/22/2021

Desc: Medicated Mentholated Dusting Powder
Notes: A labeling statement documenting the intended use of the product include, but may not be limited to, the following: “has excellent antiseptic…properties…”.                                                                                              

PZ Nigeria Limited
Date Published : 09/30/2009
Ilupeju , 45/47 Town Planning Way , Lagos, Ng-La NIGERIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 7/7/2008. Medicated Powder. Metholated. The term "medicated" on the label represents and suggests that the product is intended for "drug" uses. The immediate container label also identifies the product for antiseptic use and to treat prickly heat. These are also drug claims under 201(g)(1), which defines a drug as articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals..."

66 V - - -- Patent Medicines, Etc
Date Published: 07/29/2019

Desc: Medicated Powder (mentholated) "Robb Ointment"
Notes: Labeling on the product does not differentiate between active and inactive ingredients and the listed ingredients are not recognized as approved active ingredients for nasal decongestion under the monograph.; 9/16/2008

Reckitt Benckiser Nigeria Ltd
Date Published : 11/19/2021
Plot C 2/3 , Agbara Industrial Estate, Ogun State NIGERIA
56 Y - - 99 Antibiotic N.E.C.
Date Published: 11/19/2021

Desc: Dettol Antiseptic-Disinfectant
Notes: Product labeling makes drug claims that include, but are not limited to the following: “ANTISEPTIC – DISINFECTANT”, “PROVEN EFFECTIVE AGAINST GERMS *** BACTERIA & FUNGI *** E.coli*, Salmonella, Listeria, Staph. aureus #, E.hirae, Vibrio cholera, Candida albicans” and “* *** Antibiotic resistant strain***# including antibiotic resistant strain MRSA *** Contraindicated in eczema, allergy to ingredients, children under 1 year, pregnant and breast-feeding women unless under doctor’s supervision.”.                                                                                      

61 F - - 21 Chloroxylenol (Anti-Bacterial) (Not Antibiotic)
Date Published: 11/19/2021

Desc: Dettol Antiseptic-Disinfectant
Notes: Product labeling makes drug claims that include, but are not limited to the following: “ANTISEPTIC – DISINFECTANT”, “PROVEN EFFECTIVE AGAINST GERMS *** BACTERIA & FUNGI *** E.coli*, Salmonella, Listeria, Staph. aureus #, E.hirae, Vibrio cholera, Candida albicans” and “* *** Antibiotic resistant strain***# including antibiotic resistant strain MRSA *** Contraindicated in eczema, allergy to ingredients, children under 1 year, pregnant and breast-feeding women unless under doctor’s supervision.”.                                                                                      

62 F - - 23 Isopropyl Alcohol (Anti-Infective, Topical)
Date Published: 11/19/2021

Desc: Dettol Antiseptic-Disinfectant
Notes: Product labeling makes drug claims that include, but are not limited to the following: “ANTISEPTIC – DISINFECTANT”, “PROVEN EFFECTIVE AGAINST GERMS *** BACTERIA & FUNGI *** E.coli*, Salmonella, Listeria, Staph. aureus #, E.hirae, Vibrio cholera, Candida albicans” and “* *** Antibiotic resistant strain***# including antibiotic resistant strain MRSA *** Contraindicated in eczema, allergy to ingredients, children under 1 year, pregnant and breast-feeding women unless under doctor’s supervision.”.                                                                                      

64 F - - 99 Enzyme Inhibitor N.E.C.
Date Published: 11/19/2021

Desc: Dettol Antiseptic-Disinfectant
Notes: Product labeling makes drug claims that include, but are not limited to the following: “ANTISEPTIC – DISINFECTANT”, “PROVEN EFFECTIVE AGAINST GERMS *** BACTERIA & FUNGI *** E.coli*, Salmonella, Listeria, Staph. aureus #, E.hirae, Vibrio cholera, Candida albicans” and “* *** Antibiotic resistant strain***# including antibiotic resistant strain MRSA *** Contraindicated in eczema, allergy to ingredients, children under 1 year, pregnant and breast-feeding women unless under doctor’s supervision.”.                                                                                      

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/19/2021

Desc: Dettol Antiseptic-Disinfectant
Notes: Product labeling makes drug claims that include, but are not limited to the following: “ANTISEPTIC – DISINFECTANT”, “PROVEN EFFECTIVE AGAINST GERMS *** BACTERIA & FUNGI *** E.coli*, Salmonella, Listeria, Staph. aureus #, E.hirae, Vibrio cholera, Candida albicans” and “* *** Antibiotic resistant strain***# including antibiotic resistant strain MRSA *** Contraindicated in eczema, allergy to ingredients, children under 1 year, pregnant and breast-feeding women unless under doctor’s supervision.”.                                                                                      

SC Johnson & Son Nigeria Ltd.,
Date Published : 02/20/2018
13/14 Abimbola Street , Isolo , Lagos, NIGERIA
55 P - - 25 Benzoic Acid (Pharmaceutic Necessity - Antifungal Agent)
Date Published: 02/20/2018

Desc: Nixoderm Cream

62 M - - 08 Menthol (Anti-Pruritic)
Date Published: 02/20/2018

Desc: Nixoderm Cream

64 X - - 06 Salicylic Acid (Keratolytic)
Date Published: 02/20/2018

Desc: Nixoderm Cream

65 L - - 11 Titanium Dioxide (Protectant)
Date Published: 02/20/2018

Desc: Nixoderm Cream

65 T - - 04 Sulfur (Scabicide)
Date Published: 02/20/2018

Desc: Nixoderm Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/20/2018

Desc: Nixoderm Cream

Salawu Enterprises Ltd
Date Published : 09/30/2009
10 Onikosi Street , Otta, NIGERIA
64 L - - -- Glucocorticoid
Date Published: 09/30/2009

Notes: Shipper 10/15/1999. Dermovate Cream

66 V - - -- Patent Medicines, Etc
Date Published: 09/30/2009

Notes: 9/16/2008. Medicated Powder. Mentholated. This product is labeled to contain tincture of matricaria; is indicated for teething and slight stomach upsets during infancym and FDA is not aware that the product is generally recognized as safe and effective for its labeled uses.

Sears Pharmaceuticals & Chemicals Ltd
Date Published : 09/30/2009
Unknown , Lagos, NIGERIA
53 L C - -- Skin Care Prep, Cream
Date Published: 09/30/2009

Notes: 10/15/1999 Dermacare Gel

64 L - - 28 Fluocinonide (Glucocorticoid)
Date Published: 09/30/2009

Notes: Dermacare Gel 11/15/1999

Smooford International Ltd.
Date Published : 09/30/2009
Box 41 , Iperu-Remo , Ogun State, NIGERIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/05/2024

Desc: To to Skin Soap
Notes: 7/2/2008 The labeling on this product makes several disease claims. On the “Indications/Claims” label, it states that the product should be used for ringworm, scabies and pediculosis capitis, which is a parasitic infection. Thus, this product is a drug under 201(g)(1), which is defined as “articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals…”

TETMOSOL HELLO PRODUCTS
Date Published : 04/08/2020
Ikeja General Hospital St. , Lagos, Lagos NIGERIA
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/08/2020

Desc: Tetmosol Medicated Soap
Notes: Based on the product labeling, the article, "Tetmosol Medicated Soap," is a "drug" as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article (other than food) intended to cure, mitigate, treat, or prevent disease and/or to affect the structure or function of the body. Specifically, this product is intended for the treatment of one more diseases, including rashes caused by scabies.; Therefore, this product appears to be a new drug within the meaning of section 201(p) of the Act, 21 U.S.C. 321(p) because this product is not generally recognized as safe and effective under the conditions prescribed, recommended or suggested in the labeling. According to section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use. "Adequate directions for use" are directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined by section 503(b)(1)(A), of the FD&C Act, 21 U.S.C. 353(b)(1)(A), can only be used safely at the direction, and under the supervision, of a licensed practitioner. "Tetmosol Medicated Soap" is intended for the treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Thus, it is impossible to write adequate directions for a layperson to use this product safely for its intended purposes. Accordingly, the labeling for "Tetmosol Medicated Soap" fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the FD&C Act.

Victoria Adeyinka
Date Published : 03/09/2022
Agaloke Estate , Apata , Ibadan, Oyo NIGERIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/09/2022

Desc: Jekonmo Herbal Mixture
Notes: The product appears to be an unapproved new drug as the product’s label includes statements such as (not an all-inclusive list): ‘INDICATIONS…PILE…WAIST PAINS…LOW SPERM COUNT’.

Virgin Beauty Industries Nig Ltd
Date Published : 09/12/2014
Plot 9, Gboyega Ijaodola Drive , Off Alli-Isiba Road , Igbala Sango Ota Ogun State, NIGERIA
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 04/15/2016

Desc: Virgin Hair Fertilizer & Hair Conditioning Cream

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 04/15/2016

Desc: Virgo Hair Fertilizer & Hair Conditioning Cream

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 04/15/2016

Desc: Virgo Hair Fertilizer & Hair Conditioning Cream

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 04/15/2016

Desc: Virgin Hair Fertilizer & Hair Conditioning Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/15/2016

Desc: Virgo Hair Fertilizer & Hair Conditioning Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/15/2016

Desc: Virgin Hair Fertilizer & Hair Conditioning Cream

Vixa Pharmaceutical
Date Published : 02/03/2021
13b Sunny Jigide St , Ogudu Lagosogudu Lagos, NIGERIA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 02/03/2021

Desc: SKINEAL Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory, Antipruritic'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 02/03/2021

Desc: SKINEAL Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory, Antipruritic'.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 02/03/2021

Desc: SKINEAL Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory, Antipruritic'.

56 D - - 41 Neomycin Sulfate (Aminoglycosides)
Date Published: 02/03/2021

Desc: SKINEAL Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory, Antipruritic'.

56 G - - 99 Antifungal N.E.C.
Date Published: 02/03/2021

Desc: SKINEAL Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory, Antipruritic'.

61 H - - 99 Anti-Bacterial, N.E.C.
Date Published: 02/03/2021

Desc: SKINEAL Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory, Antipruritic'.

61 W - - 47 Ketoconazole (Anti-Fungal) (Not Antibiotic)
Date Published: 02/03/2021

Desc: SKINEAL Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory, Antipruritic'.

61 W - - 99 A-Fungal N.E.C.
Date Published: 02/03/2021

Desc: SKINEAL Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory, Antipruritic'.

64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 02/03/2021

Desc: SKINEAL Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory, Antipruritic'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/03/2021

Desc: SKINEAL Creme
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory, Antipruritic'.

Yemtos Produce Multinational Company LTD
Date Published : 07/23/2020
24 Unity Close, Selewu, Igbogbo , Ikorodu, Lagos State NIGERIA
31 M - - -- Tea With Blends of (fruits,botanical,grains,etc)
Date Published: 07/23/2020

Desc: Mudet Herbal Mixture
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Its effect in curing the following ailments: 1. Diabetes 2. Low Sperm Count ... 4. Pile ... 6. Gonorrhea 7. Hypertension 8. Body Pains & Waist Pains 9. Toilet Infection 10. Stomach Pain'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/23/2020

Desc: Mudet Herbal Mixture
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Its effect in curing the following ailments: 1. Diabetes 2. Low Sperm Count ... 4. Pile ... 6. Gonorrhea 7. Hypertension 8. Body Pains & Waist Pains 9. Toilet Infection 10. Stomach Pain'.


NORWAY


Immunocorp Consumer Health AS
Date Published : 05/22/2015
Enebakkveien 117 , Oslo, OSLO NORWAY
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/22/2015

Desc: nbg 24;7 Facial Moisturizer (dry skin)

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/22/2015

Desc: nbg 24;7 Facial Moisturizer (normal/combination skin)

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/22/2015

Desc: nbg 24;7 Facial Serum

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/22/2015

Desc: nbg 24;7 Body Lotion

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/22/2015

Desc: nbg 24;7 Eye Gel

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 05/22/2015

Desc: nbg 24;7 Facial Moisturizer (normal/combination skin)

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 05/22/2015

Desc: nbg 24;7 Facial Moisturizer (dry skin)

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 05/22/2015

Desc: nbg 24;7 Body Lotion

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 05/22/2015

Desc: nbg 24;7 Facial Serum

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 05/22/2015

Desc: nbg 24;7 Facial Moisturizer (dry skin)

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 05/22/2015

Desc: nbg 24;7 Facial Moisturizer (normal/combination skin)

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 05/22/2015

Desc: nbg 24;7 Eye Gel

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/22/2015

Desc: nbg 24;7 Facial Moisturizer (dry skin)

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/22/2015

Desc: nbg 24;7 Facial Moisturizer (normal/combination skin)

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/22/2015

Desc: nbg 24;7 Eye Gel

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/22/2015

Desc: nbg 24;7 Facial Serum

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/22/2015

Desc: nbg 24;7 Body Lotion

53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 05/22/2015

Desc: nbg 24;7 Facial Moisturizer (dry skin)

53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 05/22/2015

Desc: nbg 24;7 Body Lotion

53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 05/22/2015

Desc: nbg 24;7 Facial Moisturizer (normal/combination skin)

53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 05/22/2015

Desc: nbg 24;7 Eye Gel

53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 05/22/2015

Desc: nbg 24;7 Facial Serum

Nutraq as
Date Published : 05/21/2015
Enebakkveien 117 , Oslo, NO-03 NORWAY
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/21/2015

Desc: nbg 24;7 Facial Serum

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/21/2015

Desc: nbg 24;7 Facial Moisturizer (normal/combination skin)

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/21/2015

Desc: nbg 24;7 Body Lotion

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/21/2015

Desc: nbg 24;7 Eye Gel

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/21/2015

Desc: nbg 24;7 Facial Moisturizer (dry skin)

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 05/21/2015

Desc: nbg 24;7 Facial Moisturizer (normal/combination skin)

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 05/21/2015

Desc: nbg 24;7 Facial Moisturizer (dry skin)

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 05/21/2015

Desc: nbg 24;7 Facial Serum

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 05/21/2015

Desc: nbg 24;7 Eye Gel

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 05/21/2015

Desc: nbg 24;7 Facial Moisturizer (normal/combination skin)

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 05/21/2015

Desc: nbg 24;7 Facial Moisturizer (dry skin)

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 05/21/2015

Desc: nbg 24;7 Body Lotion

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/21/2015

Desc: nbg 24;7 Facial Moisturizer (normal/combination skin)

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/21/2015

Desc: nbg 24;7 Body Lotion

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/21/2015

Desc: nbg 24;7 Facial Moisturizer (dry skin)

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/21/2015

Desc: nbg 24;7 Eye Gel

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/21/2015

Desc: nbg 24;7 Facial Serum

53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 05/21/2015

Desc: nbg 24;7 Facial Moisturizer (dry skin)

53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 05/21/2015

Desc: nbg 24;7 Facial Serum

53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 05/21/2015

Desc: nbg 24;7 Eye Gel

53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 05/21/2015

Desc: nbg 24;7 Body Lotion

53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 05/21/2015

Desc: nbg 24;7 Facial Moisturizer (normal/combination skin)


PAKISTAN


A.M Cosmetics
Date Published : 12/02/2015
319-A, Gulshan-E-Ravi , Lahorelahore, PAKISTAN
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/02/2015

Desc: Faiza Beauty Cream
Notes: Product labels make medical claims

53 - - - -- Cosmetics
Date Published: 08/14/2018

Desc: No. 1 Faiza Beauty Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/14/2018

Desc: No. 1 Faiza Beauty Cream

A.Q. & Company
Date Published : 01/03/2017
10-11 Eidgah M. A. Jinnah Roadg. P. O. , Karachi, PAKISTAN
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/03/2017

Desc: Hashmi Amla Plus Hair Oil
Notes: Product labels made medical claims

AL-QAYYUM & SONS INTERNATIONAL
Date Published : 10/14/2016
519-Abbas Block Mustafha Town , WAHDAT ROAD , Lahore, None of the above PAKISTAN
53 J - - -- Personal Cleanliness
Date Published: 10/14/2016

Desc: Rose Water Facial Cleanser

53 L - - -- Skin Care Prep
Date Published: 10/14/2016

Desc: Rose Water Facial Cleanser

53 Y - - -- Cosmetics and Cosmetic Products,n.e.c.
Date Published: 10/14/2016

Desc: Rose Water Facial Cleanser

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/14/2016

Desc: Rose Water Facial Cleanser

AMIR INTERNATIONAL
Date Published : 04/02/2010
6-A MARKAZ-E-ANWAR BUIL , JAMILA ST , KARACHI, PAKISTAN
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/02/2010

Desc: Amir's Kalonji Oil

Agro Hub International (Pvt) Ltd
Date Published : 02/24/2015
254-a 249 , Hub, Baluchistan PAKISTAN
55 R - - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent)
Date Published: 02/24/2015

Desc: Himalayan Salt Massage Stone
Notes: The aforementioned product appears to be an unapproved new drug as the claims found in the labeling, including the website www.saltability.com, that establish the intended uses for the product include, but are not limited to, the following: 'Himalayan Salt Detox Domes…absorbs and extracts toxins from your body, helps support blood circulation and reduces swelling', 'Salt lamps…provide complementary treatment for many illnesses, as well as respiratory problems such as sinusitis, and migraines with no ill side effects', 'Himalayan Salt Stone…provides amazing healing properties for both the human body and the environment that we inhabit', 'Directions for use: Freezing the stone, apply to areas of water retention, swelling or pain', and 'Himalayan Crystal Salt benefits the body by…stimulating circulation…lowering blood pressure…soothing sore muscles…removing toxins from the body…reducing signs of aging…reducing inflammation…'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/24/2015

Desc: Himalayan Salt Massage Stone
Notes: The aforementioned product appears to be an unapproved new drug as the claims found in the labeling, including the website www.saltability.com, that establish the intended uses for the product include, but are not limited to, the following: 'Himalayan Salt Detox Domes…absorbs and extracts toxins from your body, helps support blood circulation and reduces swelling', 'Salt lamps…provide complementary treatment for many illnesses, as well as respiratory problems such as sinusitis, and migraines with no ill side effects', 'Himalayan Salt Stone…provides amazing healing properties for both the human body and the environment that we inhabit', 'Directions for use: Freezing the stone, apply to areas of water retention, swelling or pain', and 'Himalayan Crystal Salt benefits the body by…stimulating circulation…lowering blood pressure…soothing sore muscles…removing toxins from the body…reducing signs of aging…reducing inflammation…'.

89 L - - YG Massager, Therapeutic, Manual
Date Published: 02/24/2015

Desc: Himalayan Salt Massage Stone
Notes: The aforementioned product appears to be an unapproved new drug as the claims found in the labeling, including the website www.saltability.com, that establish the intended uses for the product include, but are not limited to, the following: 'Himalayan Salt Detox Domes…absorbs and extracts toxins from your body, helps support blood circulation and reduces swelling', 'Salt lamps…provide complementary treatment for many illnesses, as well as respiratory problems such as sinusitis, and migraines with no ill side effects', 'Himalayan Salt Stone…provides amazing healing properties for both the human body and the environment that we inhabit', 'Directions for use: Freezing the stone, apply to areas of water retention, swelling or pain', and 'Himalayan Crystal Salt benefits the body by…stimulating circulation…lowering blood pressure…soothing sore muscles…removing toxins from the body…reducing signs of aging…reducing inflammation…'.

Al-madni Shahid Yaman
Date Published : 02/07/2011
Unknown , Karachi, Sindh PAKISTAN
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/07/2011

Desc: Miswak Toothstick (Al Madni Super Peelu Miswak)
Notes: Pakistan

Au Natural Stones
Date Published : 11/22/2010
111/3 Khayben-e-ittehand , Phase 6 DHA , kARACHI, PK-SD PAKISTAN
77 K - - CO Inhaler, Nasal
Date Published: 11/22/2010

Desc: Himalayan Salt Inhaler
Notes: Pakistan;** Note: OASIS Declared Manufacturer

C.P.H.L
Date Published : 08/14/2018
213027 Minrora , Swat, PAKISTAN
53 - - - -- Cosmetics
Date Published: 08/14/2018

Desc: Seven Herbal Ubtan Cream with Sunscreen

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/14/2018

Desc: Seven Herbal Ubtan Cream with Sunscreen

English Biscuit Manufacturers (Pvt.) Ltd.
Date Published : 01/27/2014
Plot 1-4, Sector 23, Korangi Industrial Area , Karachi, Sindh PAKISTAN
03 A - - 03 Biscuits
Date Published: 01/27/2014

Desc: Whole Wheat Slices - Pure Fibre

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 01/27/2014

Desc: Whole Wheat Slices - Pure Fibre

03 J - - 99 Filled/Iced Cookies,Biscuits and Wafers, N.E.C.
Date Published: 01/27/2014

Desc: Whole Wheat Slices - Pure Fibre

03 M - - 99 Cookie,Biscuit,Wafer Dough, N.E.C.
Date Published: 01/27/2014

Desc: Whole Wheat Slices - Pure Fibre

Evan & Mayer International
Date Published : 09/19/2012
Plot No. 10 Sector C-Iv, K.E.P.Z Korangi Landhi Town , Karachi, Sindh PAKISTAN
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/14/2016

Desc: Stillmans Freckle Cream
Notes: Product label shows manufacturer as Evan & Mayer Int'l K.E.P.Z., P.O. Box 13007, Karachi, Pakistan. There is no corresponding FEI #.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/14/2016

Desc: Stillmans Skin Bleach Cream
Notes: Product label shows manufacturer as Evan & Mayer Int'l K.E.P.Z., P.O. Box 13007, Karachi, Pakistan. There is no corresponding FEI #.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/14/2016

Desc: Stillmans Freckle Cream
Notes: Product label shows manufacturer as Evan & Mayer Int'l K.E.P.Z., P.O. Box 13007, Karachi, Pakistan. There is no corresponding FEI #.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/14/2016

Desc: Stillmans Skin Bleach Cream
Notes: Product label shows manufacturer as Evan & Mayer Int?l K.E.P.Z.; P.O. Box 13007; Karachi; Pakistan. There is no corresponding FEI #.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/14/2016

Desc: Stillmans Freckle Cream
Notes: Product label shows manufacturer as Evan & Mayer Int'l K.E.P.Z., P.O. Box 13007, Karachi, Pakistan. There is no corresponding FEI #.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2012

Desc: Fairness Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/14/2016

Desc: Stillmans Skin Bleach Cream
Notes: Product label shows manufacturer as Evan & Mayer Int'l K.E.P.Z., P.O. Box 13007, Karachi, Pakistan. There is no corresponding FEI #.

Farzan Herbal & Farzana Dawakhana
Date Published : 10/20/2009
Dastagir No. 9 , Karachi, PK-SD PAKISTAN
53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 01/22/2010

Desc: Amleen Hair Oil

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/10/2009

Desc: Dawa E Husn Powder (Lae Pholo Sa Nikhar)

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/10/2009

Desc: Mercureen Ointment

53 - - - -- Cosmetics
Date Published: 09/18/2019

Notes: Yaquteen Tooth Cleaning Powder; 1/22/2010

54 A G L 99 Vitamin, N.E.C., Hum Rx Comb Ingr, NonSterile Liquid
Date Published: 11/13/2009

Desc: Nearocard-Energy Syrup

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/30/2010

Desc: Mukhrij Tablets
Notes: Country; Pakitan

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/10/2009

Desc: Vasakeen Energy Syrup

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/10/2009

Desc: Ispaghol Husk

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/10/2009

Desc: Carafsin Digestive Tablets

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/20/2009

Desc: Mukhrij Powder

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/10/2009

Desc: Lemeen

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/10/2009

Desc: Joshanda

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/13/2009

Desc: Al-Imsakeen Tablets

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/20/2009

Desc: Almond Oil

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/22/2010

Desc: Bedar Sugar Free Energy Syrup

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/27/2009

Desc: Herbo Card Blood Pressure Relief Tablets

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/20/2009

Desc: Banafsha Shehtoot Cough Expectorant (Herbal)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/20/2009

Desc: Alozeen Ointment

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 10/20/2009

Notes: Yaquteen Tooth Cleaning Powder; 1/22/2010

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 01/22/2010

Desc: Qutour Eye Drops
Notes: Country; Pakistan

60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 12/10/2009

Desc: Carafsin Tablet

60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 12/10/2009

Desc: Shatra Syrup

60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 01/22/2010

Desc: Amleen Hair Oil

60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 03/30/2010

Desc: Mukhrij Tablets
Notes: Country; Pakitan

60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 01/22/2010

Desc: Pakistan
Notes: Roseen Eye Drops

60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 01/22/2010

Desc: Yaquteen Tooth Cleaning Powder
Notes: 1/22/2010

60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 12/10/2009

Desc: Abreshandard Tablets

60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 12/10/2009

Desc: LEKOREEN

60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 11/13/2009

Desc: Nearocard-Energy Syrup

60 - - - -- Human and Animal Drugs
Date Published: 10/20/2009

Notes: Yaquteen Tooth Cleaning Powder; 1/22/2010

61 - - - -- Human and Animal Drugs
Date Published: 10/20/2009

Notes: Yaquteen Tooth Cleaning Powder; 1/22/2010

62 - - - -- Human and Animal Drugs
Date Published: 10/20/2009

Notes: Yaquteen Tooth Cleaning Powder; 1/22/2010

63 - - - -- Human and Animal Drugs
Date Published: 10/20/2009

Notes: Yaquteen Tooth Cleaning Powder; 1/22/2010

64 - - - -- Human and Animal Drugs
Date Published: 10/20/2009

Notes: Yaquteen Tooth Cleaning Powder; 1/22/2010

65 - - - -- Human and Animal Drugs
Date Published: 10/20/2009

Notes: Yaquteen Tooth Cleaning Powder; 1/22/2010

66 - - - -- Human and Animal Drugs
Date Published: 10/27/2009

Desc: Herbo Card Blood Pressure Relief Tablets

66 - - - -- Human and Animal Drugs
Date Published: 10/20/2009

Notes: Yaquteen Tooth Cleaning Powder; 1/22/2010

66 - - - -- Human and Animal Drugs
Date Published: 11/13/2009

Desc: Al-Imsakeen Tablets

HAMDARD LABORATORIES ( WAQF ) PAKISTAN
Date Published : 01/14/2010
Al-Majeed , Nazimabad , Karachi, Sindh PAKISTAN
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/14/2010

Notes: Product: Endemali, Habb-ul-Misk-93, Hamdard Herbal Ointment, Hulbene Icterence, Ispaghol, Jawarish Jalinus, Jawarish Kamuni Jigarine, Joshanda, Joshina, Khamira Gaozaban Laooq Sapistan, Ma¿jun Filasfa, Ma¿jun Suranjan Masturin, Naunehal Herbal Gripe Water Neo-Carmina, Qulzum, Safi, Sualin, Sualin Inhaler Sharbat Faulad, Somina, Suduri, Tunsukh; Country: Pakistan

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/14/2010

Notes: Product: Endemali, Habb-ul-Misk-93, Hamdard Herbal Ointment, Hulbene Icterence, Ispaghol, Jawarish Jalinus, Jawarish Kamuni Jigarine, Joshanda, Joshina, Khamira Gaozaban Laooq Sapistan, Ma¿jun Filasfa, Ma¿jun Suranjan Masturin, Naunehal Herbal Gripe Water Neo-Carmina, Qulzum, Safi, Sualin, Sualin Inhaler Sharbat Faulad, Somina, Suduri, Tunsukh; Country: Pakistan

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Product: Endemali, Habb-ul-Misk-93, Hamdard Herbal Ointment, Hulbene Icterence, Ispaghol, Jawarish Jalinus, Jawarish Kamuni Jigarine, Joshanda, Joshina, Khamira Gaozaban Laooq Sapistan, Ma¿jun Filasfa, Ma¿jun Suranjan Masturin, Naunehal Herbal Gripe Water Neo-Carmina, Qulzum, Safi, Sualin, Sualin Inhaler Sharbat Faulad, Somina, Suduri, Tunsukh; Country: Pakistan

61 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Product: Endemali, Habb-ul-Misk-93, Hamdard Herbal Ointment, Hulbene Icterence, Ispaghol, Jawarish Jalinus, Jawarish Kamuni Jigarine, Joshanda, Joshina, Khamira Gaozaban Laooq Sapistan, Ma¿jun Filasfa, Ma¿jun Suranjan Masturin, Naunehal Herbal Gripe Water Neo-Carmina, Qulzum, Safi, Sualin, Sualin Inhaler Sharbat Faulad, Somina, Suduri, Tunsukh; Country: Pakistan

62 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Product: Endemali, Habb-ul-Misk-93, Hamdard Herbal Ointment, Hulbene Icterence, Ispaghol, Jawarish Jalinus, Jawarish Kamuni Jigarine, Joshanda, Joshina, Khamira Gaozaban Laooq Sapistan, Ma¿jun Filasfa, Ma¿jun Suranjan Masturin, Naunehal Herbal Gripe Water Neo-Carmina, Qulzum, Safi, Sualin, Sualin Inhaler Sharbat Faulad, Somina, Suduri, Tunsukh; Country: Pakistan

63 R - - 05 Sodium Monofluorophosphate (Dental Caries Prophylactic)
Date Published: 02/20/2015

Desc: Miswak Peelu Toothpaste

63 R - - 99 Dental Caries Prophylactic N.E.C.
Date Published: 12/09/2011

Desc: Miswak Peelu Toothpaste
Notes: Pakistan

63 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Product: Endemali, Habb-ul-Misk-93, Hamdard Herbal Ointment, Hulbene Icterence, Ispaghol, Jawarish Jalinus, Jawarish Kamuni Jigarine, Joshanda, Joshina, Khamira Gaozaban Laooq Sapistan, Ma¿jun Filasfa, Ma¿jun Suranjan Masturin, Naunehal Herbal Gripe Water Neo-Carmina, Qulzum, Safi, Sualin, Sualin Inhaler Sharbat Faulad, Somina, Suduri, Tunsukh; Country: Pakistan

64 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Product: Endemali, Habb-ul-Misk-93, Hamdard Herbal Ointment, Hulbene Icterence, Ispaghol, Jawarish Jalinus, Jawarish Kamuni Jigarine, Joshanda, Joshina, Khamira Gaozaban Laooq Sapistan, Ma¿jun Filasfa, Ma¿jun Suranjan Masturin, Naunehal Herbal Gripe Water Neo-Carmina, Qulzum, Safi, Sualin, Sualin Inhaler Sharbat Faulad, Somina, Suduri, Tunsukh; Country: Pakistan

65 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Product: Endemali, Habb-ul-Misk-93, Hamdard Herbal Ointment, Hulbene Icterence, Ispaghol, Jawarish Jalinus, Jawarish Kamuni Jigarine, Joshanda, Joshina, Khamira Gaozaban Laooq Sapistan, Ma¿jun Filasfa, Ma¿jun Suranjan Masturin, Naunehal Herbal Gripe Water Neo-Carmina, Qulzum, Safi, Sualin, Sualin Inhaler Sharbat Faulad, Somina, Suduri, Tunsukh; Country: Pakistan

66 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: Product: Endemali, Habb-ul-Misk-93, Hamdard Herbal Ointment, Hulbene Icterence, Ispaghol, Jawarish Jalinus, Jawarish Kamuni Jigarine, Joshanda, Joshina, Khamira Gaozaban Laooq Sapistan, Ma¿jun Filasfa, Ma¿jun Suranjan Masturin, Naunehal Herbal Gripe Water Neo-Carmina, Qulzum, Safi, Sualin, Sualin Inhaler Sharbat Faulad, Somina, Suduri, Tunsukh; Country: Pakistan

Hemani International
Date Published : 06/24/2016
Plot No. 11, Sector A-IV Karachi 75150 , Karachi, Sindh PAKISTAN
31 K - - 01 Tea, Black
Date Published: 06/24/2016

Desc: Mixture of Herbs Tea Cholesterol
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Supplement assists in controlling Cholesterol; Herbal Tea.

31 K - - 01 Tea, Black
Date Published: 06/24/2016

Desc: Mixture of Herbs Tea Cough & Cold
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: Supplement helps against Cold & Cough, Herbal Tea.

31 K - - 01 Tea, Black
Date Published: 06/24/2016

Desc: Mixture of Herbs Tea Blood Pressure
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: Supplement assists in controlling Blood Pressure, Herbal Tea.

31 K - - 01 Tea, Black
Date Published: 06/24/2016

Desc: Thyme Tea
Notes: DWPE; 3/15/2013

31 K - - 01 Tea, Black
Date Published: 06/24/2016

Desc: Mixture of Herbs Tea - Diabetes
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?Supplement assists in controlling Diabetes; Herbal Tea?.

31 K - - 02 Tea, Green
Date Published: 06/24/2016

Desc: Mixture of Herbs Tea Cough & Cold
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: Supplement helps against Cold & Cough, Herbal Tea.

31 K - - 02 Tea, Green
Date Published: 06/24/2016

Desc: Mixture of Herbs Tea Cholesterol
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Supplement assists in controlling Cholesterol; Herbal Tea

31 K - - 02 Tea, Green
Date Published: 06/24/2016

Desc: Mixture of Herbs Tea - Diabetes
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?Supplement assists in controlling Diabetes; Herbal Tea?.

31 K - - 02 Tea, Green
Date Published: 06/24/2016

Desc: Mixture of Herbs Tea Blood Pressure
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: Supplement assists in controlling Blood Pressure, Herbal Tea.

31 K - - 99 Tea, N.E.C.
Date Published: 06/24/2016

Desc: Mixture of Herbs Tea Cholesterol
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Supplement assists in controlling Cholesterol; Herbal Tea

31 K - - 99 Tea, N.E.C.
Date Published: 06/24/2016

Desc: Mixture of Herbs Tea Blood Pressure
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: Supplement assists in controlling Blood Pressure, Herbal Tea.

31 K - - 99 Tea, N.E.C.
Date Published: 06/24/2016

Desc: Mixture of Herbs Tea Cough & Cold
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Supplement helps against Cold & Cough; Herbal Tea.

31 K - - 99 Tea, N.E.C.
Date Published: 06/24/2016

Desc: Mixture of Herbs Tea - Diabetes
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?Supplement assists in controlling Diabetes; Herbal Tea?.

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 06/24/2016

Desc: Zait Maujiza Anti Dandruff
Notes: Pakistan; DWPE; 7/16/2013

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 11/27/2019

Desc: Fleurs by Hemani Stretch Marks Soap
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'Prevent & Eliminate Stretch Marks & Scars' and 'This soap acts to remove skin scars ...'

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 08/16/2016

Desc: Jive Papaya (Herbal) Soap
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: '... helps get rid of Acne ... and make it clear from acne'.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 08/16/2016

Desc: Fleur's by Hemani Papaya Herbal Soap
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'Helps fade away Acne & Acne Spots ... It helps to get rid of Acne & Acne Scars...'.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 06/24/2016

Desc: Hemani Black Seeds Oil
Notes: 5/27/16

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 06/24/2016

Desc: Mixture of Herbs Tea - Diabetes
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?Supplement assists in controlling Diabetes; Herbal Tea?.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 06/24/2016

Desc: Mixture of Herbs Tea Blood Pressure
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: Supplement assists in controlling Blood Pressure, Herbal Tea.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 06/24/2016

Desc: Mixture of Herbs Tea Cholesterol
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Supplement assists in controlling Cholesterol; Herbal Tea

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 06/24/2016

Desc: Mixture of Herbs Tea Cough & Cold
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: Supplement helps against Cold & Cough, Herbal Tea.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/24/2016

Desc: Hemani Black Seeds Oil
Notes: The aforementioned product appears to be an unapproved new drug as the website; http;//shop.hemaniherbal.us/Black-Seeds-Oil-250ml_p_211.html; affiliated with the product indicates that black seed oil is suitable for treating headache; nasal congestion; and colds and flus. In addition; the product labeling (insert) indicates; 'This herb has been used for ... allergies; inflammation ...'; 'Effective against diseases such as bronchitis; Asthma; Neuropathies ...'; '[C]ontrols blood pressure and cholesterol ...'; 'Used for relieve (sic) in congestion ...'.;02/24/2015

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/24/2016

Desc: Mixture of Herbs Tea Cholesterol
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; Supplement assists in controlling Cholesterol; Herbal Tea

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/24/2016

Desc: Hemani Black Seeds Oil
Notes: The aforementioned product appears to be an unapproved new drug as the website; http;//shop.hemaniherbal.us/Black-Seeds-Oil-250ml_p_211.html; affiliated with the product indicates that black seed oil is suitable for treating headache; nasal congestion; and colds and flus. In addition; the product labeling (insert) indicates; 'This herb has been used for ... allergies; inflammation ...'; 'Effective against diseases such as bronchitis; Asthma; Neuropathies ...'; '[C]ontrols blood pressure and cholesterol ...'; 'Used for relieve (sic) in congestion ...'. ;02/24/15

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/16/2016

Desc: Fleur's by Hemani Stretch Marks Soap
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; 'Prevent & Eliminate Stretch Marks & Scars' and 'This soap acts to remove skin scars...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/16/2016

Desc: Fleur's by Hemani Papaya Herbal Soap
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; 'Helps fade away Acne & Acne Spots ... It helps to get rid of Acne & Acne Scars...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/24/2016

Desc: Mixture of Herbs Tea Cough & Cold
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: Supplement helps against Cold & Cough, Herbal Tea.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/24/2016

Desc: Mixture of Herbs Tea Blood Pressure

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/16/2016

Desc: Jive Papaya (Herbal) Soap
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; '... helps get rid of Acne ... and make it clear from acne'.

76 E - - FW Toothbrush, Manual
Date Published: 06/24/2016

Desc: Miswak Toothbrush
Notes: Pakistan; DWPE; 7/16/2013

Herbion Pakistan (Pvt.) Ltd.
Date Published : 03/01/2021
Plot 30, Sector 28 Korangi Industrial Area , Karachi, Sindh PAKISTAN
62 G - - 41 Ibuprofen (Anti-Inflammatory)
Date Published: 03/01/2021

Desc: Children's Novex Ibuprofen Oral Suspension 100mg/5m

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/01/2021

Desc: Children's Novex Ibuprofen Oral Suspension 100mg/5m

Ilmi Kitab Ghar
Date Published : 01/03/2017
Asan Mal Oja Road Urdu Bazar , Karachi, Pakistan, PAKISTAN
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/03/2017

Desc: Dettol Soap Bar
Notes: Product labels made medical claims

M.K. ENTERPRISES
Date Published : 03/30/2010
Floor 2nd , 67 Wazir Mansion; Nicol Road , Karachi, Sindh PAKISTAN
28 A - - 18 Fennel, Whole (Spice)
Date Published: 03/30/2010

Desc: Arq Badian (Qarshi Fennel Arq)

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 03/30/2010

Desc: Johar Joshanda

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 10/21/2011

Desc: Amir's Kalonji Oil (Dietary Supplement)
Notes: Karachi

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/21/2011

Desc: Amir's Kalonji Oil (Dietary Supplement)
Notes: Karachi

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/30/2010

Desc: Johar Joshanda

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/30/2010

Desc: Arq Badian (Qarshi Fennel Arq)

M.Manzoor & Co. Pakistan (Pvt) Ltd.
Date Published : 08/07/2014
13-Sindh Market M.A. Jinnah Road , Karachi, PAKISTAN
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 08/07/2014

Desc: Dettol Soap

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 08/07/2014

Desc: Neem Soap
Notes: The product makes the following claims; For Prickly Heat & Smooth Skin. Prickly Heat is a skin rash or disease known as miliaria. Additionally; the product lacks declaration of an ingredient statement and it appears product lacks drug listing and manufacturer lacks firm registration as a drug manufacturer with the FDA.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/07/2014

Desc: Dettol Soap

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/07/2014

Desc: Neem Soap
Notes: The product makes the following claims; For Prickly Heat & Smooth Skin. Prickly Heat is a skin rash or disease known as miliaria. Additionally; the product lacks declaration of an ingredient statement and it appears product lacks drug listing and manufacturer lacks firm registration as a drug manufacturer with the FDA.

MOHAMMAD HASHIM TAJIR SURMA
Date Published : 01/03/2017
22-L-A4, C-2, Block , Karachi, Sindh PAKISTAN
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/03/2017

Desc: Hashmi Sweet Almond Oil
Notes: Product labels made medical claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/03/2017

Desc: Hashmi Castor Seed Oil
Notes: Product labels made medical claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/03/2017

Desc: Hashmi Black Seed Oil
Notes: Product labels made medical claims

Mustafa Enterprises
Date Published : 09/10/2012
MR 5/88, Thanai Lane, Jodia Bazar , Karachi, PK-SD PAKISTAN
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/10/2012

Desc: Black Seeds Oil Kalonji Oil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/10/2012

Desc: Black Seeds Oil Kalonji Oil

Poonia Brothers (PAK)
Date Published : 03/15/2018
10 KM Alam Chowk , Hafiz Abad Road , Gujranwala, PAKISTAN
53 - - - -- Cosmetics
Date Published: 03/15/2018

Desc: Faiza Beauty Cream
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; '... Removes the pimples ... freckles; spots and acne problems ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/15/2018

Desc: Faiza Beauty Cream
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; '... Removes the pimples ... freckles; spots and acne problems ...'. ;

QARSHI INDUSTRIES
Date Published : 08/30/2021
No. 58/1-6 Phase I , Khyber Pakhtunkhwa, PAKISTAN
31 K - - -- Tea
Date Published: 08/30/2021

Desc: Qarshi JOHAR JOSHANDA Instant Herbal Tea
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "For Flu, Cough, Cold, Catarrh, Throat Irritation and Fever.”.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 08/30/2021

Desc: Qarshi JOHAR JOSHANDA Instant Herbal Tea
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "For Flu, Cough, Cold, Catarrh, Throat Irritation and Fever.”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/30/2021

Desc: Qarshi JOHAR JOSHANDA Instant Herbal Tea
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "For Flu, Cough, Cold, Catarrh, Throat Irritation and Fever.”.

Qarshi Industries (PVT) Ltd.
Date Published : 03/30/2010
56/2-3 Insustrial Estate , Hattar, PK-NW PAKISTAN
28 A - - 18 Fennel, Whole (Spice)
Date Published: 03/30/2010

Desc: Arq Badian (Qarshi Fennel Arq)

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 03/30/2010

Desc: Johar Joshanda

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/30/2010

Desc: Johar Joshanda

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/30/2010

Desc: Arq Badian (Qarshi Fennel Arq)

Qarshi Industries (Pvt) Ltd
Date Published : 08/30/2021
Plot No. 56/1-4, Industrial Estate , Hattar, Distt: Haripur, Khyber Pakhtunkhwa , Haripur, Khyber Pakhtunkhwa PAKISTAN
31 K - - -- Tea
Date Published: 08/30/2021

Desc: Qarshi JOHAR JOSHANDA Instant Herbal Tea
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "For Flu, Cough, Cold, Catarrh, Throat Irritation and Fever.”.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 08/30/2021

Desc: Qarshi JOHAR JOSHANDA Instant Herbal Tea
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "For Flu, Cough, Cold, Catarrh, Throat Irritation and Fever.”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/30/2021

Desc: Qarshi JOHAR JOSHANDA Instant Herbal Tea
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "For Flu, Cough, Cold, Catarrh, Throat Irritation and Fever.”.

S.J. ENTERPRISES
Date Published : 08/14/2018
# 21-22-22nd Flr. Barry , Karachi, Sindh PAKISTAN
53 - - - -- Cosmetics
Date Published: 08/14/2018

Desc: Chandni Whitening Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/14/2018

Desc: Chandni Whitening Cream

Saeed Ghani
Date Published : 11/13/2009
No 11, Shop 3, Tariq Road , Falcon Plaza , Karachi, PAKISTAN
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 12/10/2009

Desc: Rose Vital Skin Tonic and Rose Vital Face Wash

55 Q - - 38 Stronger Rose Water (Pharmaceutic Necessity - Perfume)
Date Published: 12/10/2009

Desc: Rose Vital Skin Tonic and Rose Vital Face Wash

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/10/2009

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

61 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

62 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

63 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

64 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

65 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/13/2009

Desc: Herbal Hair Hina Powder

66 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

Shaheen Enterprises
Date Published : 08/14/2018
Plot 2604 and 2606/3 Rangiwara , Hazara Colony , Karachi, Sindh PAKISTAN
53 - - - -- Cosmetics
Date Published: 08/14/2018

Desc: Fresh Face Beauty Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/14/2018

Desc: Fresh Face Beauty Cream

Tabaneez Enterprises
Date Published : 06/27/2018
58, Falak Corporate City, Bboultan market, , Karachi, PAKISTAN
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 06/27/2018

Desc: Barirah Whitening Face Wash

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/27/2018

Desc: Barirah Whitening Face Wash

The Stillman Company
Date Published : 08/14/2018
18th East Street No 143 Industrial Phase , Karachi, PAKISTAN
53 - - - -- Cosmetics
Date Published: 08/16/2018

Desc: Stillman's Freckle Cream

53 - - - -- Cosmetics
Date Published: 08/16/2018

Desc: Stillman's Skin Bleach Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/16/2018

Desc: Stillman's Skin Bleach Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/16/2018

Desc: Stillman's Freckle Cream

Traders World Corporation
Date Published : 10/02/2014
Plot No. F362 , Site Metroville , Karachi, Sindh PAKISTAN
28 S - - 02 Plain Salt (Table Salt)
Date Published: 10/02/2014

Desc: Himalayan Salt with Salt Pipe Inhaler
Notes: Unapproved New Drug; Misbranded

28 S - - 99 Salt (Table Salt) N.E.C.
Date Published: 10/02/2014

Desc: Himalayan Salt with Salt Pipe Inhaler
Notes: Unapproved New Drug; Misbranded

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/02/2014

Desc: Himalayan Salt with Salt Pipe Inhaler
Notes: Unapproved New Drug; Misbranded

Trend International
Date Published : 06/27/2018
30-B Small Industiral Area , Sahiwal, PAKISTAN
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 06/27/2018

Desc: Nisa Carmel Milk Beauty Whitening Soap

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/27/2018

Desc: Nisa Carmel Milk Beauty Whitening Soap

UNILEVER PAKISTAN FOODS LIMITED
Date Published : 10/27/2009
Avari Plaza , Fatima Jinnah Road , Karachi, None of the above PAKISTAN
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/27/2009

Desc: Fairness Cream

Zain Enterprises
Date Published : 01/03/2017
181-Deh Gujro , University Road , Karachi, Sindh PAKISTAN
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/03/2017

Desc: Herbal Shine Hair Oil
Notes: Product labels made medical claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/03/2017

Desc: Al Khair Rose Water
Notes: Product labels made medical claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/03/2017

Desc: Hashmi Isaghol Psyllium Husk
Notes: Product labels made medical claims


PANAMA


4cnrs-skincare
Date Published : 09/30/2009
Santovittorio Holdings Ltd. , PO Box 87-1008 , Panama 7, PANAMA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                         

Inhousedrugstore dba Inhousepharmacy
Date Published : 09/30/2009
Santovittorio Holdings Ltd. , Apartado 6-6305 , El Dorado,, PANAMA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                                                     <

Laboratorio Urena
Date Published : 09/30/2009
Via Argentina Edif Balmoral , Bugaba, PANAMA
31 K - - 99 Tea, N.E.C.
Date Published: 09/30/2009

Notes: 1/5/2006 Te Diossana.                         This website makes direct reference to treatmenst for cancer cures as well as treatments for AIDS and diabetes. Additionally, a letter that accompanies the imported product states in Spanish that this product has been used to treat patients with cancer, leukemia, and HIV positive obtaining good results even on those patients with terminal conditions. We are not aware of any substantial scientific evidence that establishes that this product is generally recognized as safe and effective for its intended use. This product is not the subject of an approved new or abbreviated new drug application.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 09/30/2009

Notes: 1/5/2006 Te Diossana.                         This website makes direct reference to treatmenst for cancer cures as well as treatments for AIDS and diabetes. Additionally, a letter that accompanies the imported product states in Spanish that this product has been used to treat patients with cancer, leukemia, and HIV positive obtaining good results even on those patients with terminal conditions. We are not aware of any substantial scientific evidence that establishes that this product is generally recognized as safe and effective for its intended use. This product is not the subject of an approved new or abbreviated new drug application.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2009

Notes: 1/5/2006 Te Diossana.                         This website makes direct reference to treatmenst for cancer cures as well as treatments for AIDS and diabetes. Additionally, a letter that accompanies the imported product states in Spanish that this product has been used to treat patients with cancer, leukemia, and HIV positive obtaining good results even on those patients with terminal conditions. We are not aware of any substantial scientific evidence that establishes that this product is generally recognized as safe and effective for its intended use. This product is not the subject of an approved new or abbreviated new drug application.

Tangny Enterprises, Inc.
Date Published : 09/30/2009
Edificio Banco Aliado, Apt 6443 , Calle Ricardo Arias, Piso No. 15 , Panama 5, R. de Panama, PANAMA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                          

bestonlineforeignpharmacies.com
Date Published : 09/30/2009
ExpertInfo, Inc. , Jose Luis Soto, PO Box 2411-0834 , Panama City, PANAMA
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Desc:
Notes: Web Site: www.bestonlineforeignpharmacies.com/ 2/8/2007. The above appears to be a buyers group.


PARAGUAY


Laboratorio y Herboristeria Santa Margarita S/A
Date Published : 01/19/2012
Ruta 1 Mcal Francisco Solano Lopes , Km 197 5 , San Juan Bautista, Misiones PARAGUAY
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 01/19/2012

Desc: Herbal & Botanicals (teas) Plan 30 Dias Adelgaza Te Relax Te

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/19/2012

Desc: Herbal & Botanicals (teas) Plan 30 Dias Adelgaza Te Relax Te


PERU


Access Trading Sac
Date Published : 02/08/2012
Cal. Santo Toribio , Oyague No. 508 , Lima, Lima PERU
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/08/2012

Notes: Phoenix Balm Ashan Inka UdG Pain Relief Cat's Claw Face Ointment; Peru

ECORLAT E.I.R.L.
Date Published : 09/30/2009
Alfredo Salazar , # 228 , Lima/Mrafores, PE-LIM PERU
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: 11/20/2007. Ercorlat. This product is sold as a dietary supplement containing papaya extract; garlic and other ingrediants. FDA analysis found furosemide in this product. Furosemide is the active ingrediant in the FDA approved drug Lasix and twenty nine other drug products.

Fito Peru Export Import S.A.C.
Date Published : 05/19/2023
Av. Separadora Industrial N 864 , Ate , Cercado DE Lima, Lima PERU
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 05/19/2023

Desc: Antiparasitos Antiparasite Blend Herbal Tea

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/19/2023

Desc: Antiparasitos Antiparasite Blend Herbal Tea

INKA FOREST EXPORT S.A.C
Date Published : 08/16/2017
Mza. B Lote. 15 Asociacion Residencial San Francisco- San Martin De Porres-Lima-Peru , Lima, PE-LIM PERU
53 - - - -- Cosmetics
Date Published: 08/16/2017

Notes: Dragon's Blood Extract- Dietary Supplement

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/16/2017

Notes: Dragon's Blood Extract- Dietary Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/16/2017

Desc: Dragon's Blood Extract- Dietary Supplement

LABORATORIOS ALPHA NATURA SAC
Date Published : 10/16/2015
Av. Las Camelias # 725 Piso 8vo. , San Isidro, Lima PERU
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/19/2015

Desc: Natura Brain Support Capsules

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/16/2015

Desc: Natura Herbal Slim Dietary Supplement

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/16/2015

Desc: Natura Prosta - OK
Notes: Lacks adequate directions for use; Unapproved New Drug

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/22/2015

Desc: Natura Liver Support Capsules

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/16/2015

Desc: Natura Anti-Stress Supplement

54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 10/16/2015

Desc: Natura Herbal Slim Dietary Supplement

54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 10/16/2015

Desc: Natura Anti-Stress Supplement

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/19/2015

Desc: Natura Brain Support Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/22/2015

Desc: Natura Liver Support Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/16/2015

Desc: Natura Herbal Slim Dietary Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/16/2015

Desc: Natura Anti-Stress Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/19/2015

Desc: Natura Brain Support Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/22/2015

Desc: Natura Liver Support Capsules

MARTIN CCORISAPRA ROMAN
Date Published : 03/10/2017
Avenida Las Aguilas , Avenida Las Aguilas; 1248 Urb. , San Juan De Lurigancho, Lima PERU
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/29/2020

Desc: Phyllanthus Leaves Powder
Notes: Product appears to be misbranded according to the FD&CA Section 502(f)(1) when used as an ingredient in the following products: Royal Break-Stone Kidney-Bladder Support, Royal Chanca Piedra Kidney-Bladder Support, Royal Break-Stone Liver-Gall Bladder Support, Royal Chanca Piedra Liver-Gall Bladder Support, and Royal Chanca Piedra Supports Kidney, Liver, and Gall Bladder Health.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/29/2020

Desc: Phyllanthus Leaves Powder
Notes: Product appears to be misbranded according to the FD&CA Section 502(f)(1) when used as an ingredient in the following products: Royal Break-Stone Kidney-Bladder Support, Royal Chanca Piedra Kidney-Bladder Support, Royal Break-Stone Liver-Gall Bladder Support, Royal Chanca Piedra Liver-Gall Bladder Support, and Royal Chanca Piedra Supports Kidney, Liver, and Gall Bladder Health.


PHILIPPINES


Akita Herbal Products
Date Published : 09/30/2009
Volga St., Corner Zambensi , Friendship , Pampanga, Central Luzon PHILIPPINES
54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 09/30/2009

Notes: Cancers Protocol 11/17/2003

66 V - - -- Patent Medicines, Etc
Date Published: 09/30/2009

Notes: 11/17/2003 Cancers Protocol

B.P. Larsen, Inc.
Date Published : 09/10/2012
596 Gloria St.,Ortigas Extensionmarick , Cainta Rizal, PHILIPPINES
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/10/2012

Desc: Dermcare Hydroquinone 4% Bleaching Cream Regular

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/10/2012

Desc: Dermcare Hydroquinone 4% Bleaching Cream Regular

Bcp Dermatological Corp
Date Published : 01/26/2012
1570 Dapitan Stde La Paz Bldg , Sampaloc Manilasampaloc Manila, PHILIPPINES
53 - - - -- Cosmetics
Date Published: 01/26/2012

Notes: Kojic Acid Soap Bar, Bleaching Black Soap, Licorice Pink Soap, Derm Option 4-1 Lotion, Dermablend Papaya Orange Skin Whitening Soap, Dermablend Sunblock Lotion SPF 24, Derm Option Alumchlor 3, Derm Option 4-1 Cream; Country: Philippines

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/26/2012

Notes: Kojic Acid Soap Bar, Bleaching Black Soap, Licorice Pink Soap, Derm Option 4-1 Lotion, Dermablend Papaya Orange Skin Whitening Soap, Dermablend Sunblock Lotion SPF 24, Derm Option Alumchlor 3, Derm Option 4-1 Cream; Country: Philippines

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 01/26/2012

Notes: Kojic Acid Soap Bar, Bleaching Black Soap, Licorice Pink Soap, Derm Option 4-1 Lotion, Dermablend Papaya Orange Skin Whitening Soap, Dermablend Sunblock Lotion SPF 24, Derm Option Alumchlor 3, Derm Option 4-1 Cream; Country: Philippines

61 - - - -- Human and Animal Drugs
Date Published: 01/26/2012

Notes: Kojic Acid Soap Bar, Bleaching Black Soap, Licorice Pink Soap, Derm Option 4-1 Lotion, Dermablend Papaya Orange Skin Whitening Soap, Dermablend Sunblock Lotion SPF 24, Derm Option Alumchlor 3, Derm Option 4-1 Cream; Country: Philippines

62 - - - -- Human and Animal Drugs
Date Published: 01/26/2012

Notes: Kojic Acid Soap Bar, Bleaching Black Soap, Licorice Pink Soap, Derm Option 4-1 Lotion, Dermablend Papaya Orange Skin Whitening Soap, Dermablend Sunblock Lotion SPF 24, Derm Option Alumchlor 3, Derm Option 4-1 Cream; Country: Philippines

63 - - - -- Human and Animal Drugs
Date Published: 01/26/2012

Notes: Kojic Acid Soap Bar, Bleaching Black Soap, Licorice Pink Soap, Derm Option 4-1 Lotion, Dermablend Papaya Orange Skin Whitening Soap, Dermablend Sunblock Lotion SPF 24, Derm Option Alumchlor 3, Derm Option 4-1 Cream; Country: Philippines

64 - - - -- Human and Animal Drugs
Date Published: 01/26/2012

Notes: Kojic Acid Soap Bar, Bleaching Black Soap, Licorice Pink Soap, Derm Option 4-1 Lotion, Dermablend Papaya Orange Skin Whitening Soap, Dermablend Sunblock Lotion SPF 24, Derm Option Alumchlor 3, Derm Option 4-1 Cream; Country: Philippines

65 - - - -- Human and Animal Drugs
Date Published: 01/26/2012

Notes: Kojic Acid Soap Bar, Bleaching Black Soap, Licorice Pink Soap, Derm Option 4-1 Lotion, Dermablend Papaya Orange Skin Whitening Soap, Dermablend Sunblock Lotion SPF 24, Derm Option Alumchlor 3, Derm Option 4-1 Cream; Country: Philippines

66 - - - -- Human and Animal Drugs
Date Published: 01/26/2012

Notes: Kojic Acid Soap Bar, Bleaching Black Soap, Licorice Pink Soap, Derm Option 4-1 Lotion, Dermablend Papaya Orange Skin Whitening Soap, Dermablend Sunblock Lotion SPF 24, Derm Option Alumchlor 3, Derm Option 4-1 Cream; Country: Philippines

Beauche International
Date Published : 12/05/2013
Blk 2, Lot 24 Aguinaldo Hi-Way, Sampaloc , Cavite, PHILIPPINES
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/05/2013

Desc: Beauty Bar

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 12/05/2013

Desc: Cosmetic kit containing Skin Toner

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 12/05/2013

Desc: Beauty Bar

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/05/2013

Desc: Clarifying Solution

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/05/2013

Desc: Rejuvenating Cream

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/05/2013

Desc: Exfoliating Cream

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/05/2013

Desc: Age Eraser Cream w/ SPF

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 12/05/2013

Desc: Clarifying Solution

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 12/05/2013

Desc: Rejuvenating Cream

64 X - - 06 Salicylic Acid (Keratolytic)
Date Published: 12/05/2013

Desc: Exfoliating Cream

65 L - - 99 Protectant N.E.C.
Date Published: 12/05/2013

Desc: Age Eraser Cream w/ SPF

Bethany Sales
Date Published : 10/24/2013
903 Paragon Plaza , Mandaluyong, PHILIPPINES
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/24/2013

Desc: Eskinol Papaya Smooth White Facial Deep Cleanser

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/24/2013

Desc: Eskinol Spot-less White Facial Deep Cleaner

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/24/2013

Desc: Eskinol Oil Control Facial Deep Cleanser

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/24/2013

Desc: Eskinol Classic White Facial Deep Cleanser

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 10/24/2013

Desc: Eskinol Classic White Facial Deep Cleanser

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 10/24/2013

Desc: Eskinol Oil Control Facial Deep Cleanser

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 10/24/2013

Desc: Eskinol Spot-less White Facial Deep Cleaner

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 10/24/2013

Desc: Eskinol Papaya Smooth White Facial Deep Cleanser

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/24/2013

Desc: Eskinol Spot-less White Facial Deep Cleaner

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/24/2013

Desc: Eskinol Oil Control Facial Deep Cleanser

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/24/2013

Desc: Eskinol Papaya Smooth White Facial Deep Cleanser

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/24/2013

Desc: Eskinol Classic White Facial Deep Cleanser

Colgate-Palmolive Phillipines Inc.
Date Published : 05/03/2018
1049 J. Rizal Ave. , Metro Manila, PHILIPPINES
61 H - - 99 Anti-Bacterial, N.E.C.
Date Published: 05/03/2018

Desc: Palmolive Naturals Anti-Dandruff Shampoo & Conditioner

62 S - - 99 Anti-Seborrheic N.E.C.
Date Published: 05/03/2018

Desc: Palmolive Naturals Anti-Dandruff Shampoo & Conditioner

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/03/2018

Desc: Palmolive Naturals Anti-Dandruff Shampoo & Conditioner

Euro-Med Laboratories Phil
Date Published : 10/08/2013
Km 36 Gen. Emilio Aguinaldo Hwy , Cavite, PHILIPPINES
65 F - - 04 Water (Pharm Aid) For Inj, Sterile, U.S.P.
Date Published: 10/08/2013

Desc: Strerile Water for Injection
Notes: Phillipines

FIRST VITA PLUS MARKETING CORPORATION
Date Published : 05/31/2013
2/F SUNTREE TOWER, 13 MERALCO AVENUE, , ORTIGAS CENTER, PASIG CITY , Metro Manila, National Capital Region PHILIPPINES
20 S - - 99 Core Fruit Juices or Concentrates, N.E.C.
Date Published: 05/31/2013

Desc: First Vita Plus Natural Health Drink; Guyabano (Soursop Fruit)
Notes: Philippines

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 05/31/2013

Desc: First Vita Plus Natural Health Drink; Guyabano (Soursop Fruit)
Notes: Philippines

50 L - - 16 Fruit Juice
Date Published: 10/23/2014

Desc: First Vita Plus Powder Drink Guyabano (Soursop Fruit)
Notes: Medical claims

50 L - - 16 Fruit Juice
Date Published: 10/23/2014

Desc: First Vita Plus Natural Health Drink (various flavors)
Notes: Medical claims

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 07/24/2018

Desc: Safeguard Bar Soap
Notes: Mfg. declared in OASIS is FIRST VITA PLUS MARKETING CORPORATION Mfg. appeared on product label is proctor & gamble distributing Philippines

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/23/2014

Desc: First Vita Plus Powder Drink Guyabano (Soursop Fruit)
Notes: Medical claims

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/23/2014

Desc: First Vita Plus Natural Health Drink (various flavors)
Notes: Medical claims

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/31/2013

Desc: First Vita Plus Natural Health Drink; Guyabano (Soursop Fruit)
Notes: Philippines

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/31/2013

Desc: First Vita Plus Natural Health Drink; Guyabano (Soursop Fruit)
Notes: Philippines

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/23/2014

Desc: First Vita Plus Natural Health Drink (various flavors)
Notes: Medical claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/24/2018

Desc: Safeguard Bar Soap
Notes: Mfg. declared in OASIS is FIRST VITA PLUS MARKETING CORPORATION Mfg. appeared on product label is proctor & gamble distributing Philippines

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/31/2013

Desc: First Vita Plus Natural Health Drink; Guyabano (Soursop Fruit)
Notes: Philippines

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/23/2014

Desc: First Vita Plus Powder Drink Guyabano (Soursop Fruit)
Notes: Medical claims

Greenplus
Date Published : 08/27/2014
No. 1 Rizal Street , Calamba, Calabarzon PHILIPPINES
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 08/27/2014

Desc: Moringa Oil Extract
Notes: The referenced Moringa products appear to be unapproved new drugs as http;//greenplus.com.ph (manufacturer's website) makes the following claims such as; prevent arthritis; prevent anemia; fight blindness; reduce the cholesterol;fight alzheimer's disease. In addition; the product label for the Moringa Oil Extract states; Preventing hair loss. Promotes cellular growth and the product label for the Moringa Tea states; Helps stabilize blood pressure; modulates anemia and diabetes; helps prevent prostate and skin cancer.

54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued)
Date Published: 08/27/2014

Desc: Moringa Tea
Notes: The referenced Moringa products appear to be unapproved new drugs as http;//greenplus.com.ph (manufacturer's website) makes the following claims such as; prevent arthritis; prevent anemia; fight blindness; reduce the cholesterol;fight alzheimer's disease. In addition; the product label for the Moringa Oil Extract states; Preventing hair loss. Promotes cellular growth and the product label for the Moringa Tea states; Helps stabilize blood pressure; modulates anemia and diabetes; helps prevent prostate and skin cancer.

54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd
Date Published: 08/27/2014

Desc: MORINGA ph Moringa Leaf 500mg Capsules
Notes: The referenced Moringa products appear to be unapproved new drugs as http;//greenplus.com.ph (manufacturer's website) makes the following claims such as; prevent arthritis; prevent anemia; fight blindness; reduce the cholesterol;fight alzheimer's disease. In addition; the product label for the Moringa Oil Extract states; Preventing hair loss. Promotes cellular growth and the product label for the Moringa Tea states; Helps stabilize blood pressure; modulates anemia and diabetes; helps prevent prostate and skin cancer.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/27/2014

Desc: Moringa Oil Extract
Notes: The referenced Moringa products appear to be unapproved new drugs as http;//greenplus.com.ph (manufacturer's website) makes the following claims such as; prevent arthritis; prevent anemia; fight blindness; reduce the cholesterol;fight alzheimer's disease. In addition; the product label for the Moringa Oil Extract states; Preventing hair loss. Promotes cellular growth and the product label for the Moringa Tea states; Helps stabilize blood pressure; modulates anemia and diabetes; helps prevent prostate and skin cancer.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/27/2014

Desc: MORINGA ph Moringa Leaf 500mg Capsules
Notes: The referenced Moringa products appear to be unapproved new drugs as http;//greenplus.com.ph (manufacturer's website) makes the following claims such as; prevent arthritis; prevent anemia; fight blindness; reduce the cholesterol;fight alzheimer's disease. In addition; the product label for the Moringa Oil Extract states; Preventing hair loss. Promotes cellular growth and the product label for the Moringa Tea states; Helps stabilize blood pressure; modulates anemia and diabetes; helps prevent prostate and skin cancer.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/27/2014

Desc: Moringa Tea
Notes: The referenced Moringa products appear to be unapproved new drugs as http;//greenplus.com.ph (manufacturer's website) makes the following claims such as; prevent arthritis; prevent anemia; fight blindness; reduce the cholesterol;fight alzheimer's disease. In addition; the product label for the Moringa Oil Extract states; Preventing hair loss. Promotes cellular growth and the product label for the Moringa Tea states; Helps stabilize blood pressure; modulates anemia and diabetes; helps prevent prostate and skin cancer

Herbcare Corporation
Date Published : 09/30/2009
Herbcare Center, Pdc Compound , Las Pinas City, PHILIPPINES
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 09/30/2009

Notes: Tea Form

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: Capsule Form

Herbcare Corporation
Date Published : 09/30/2009
Box 163 , Las Pinas, PHILIPPINES
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 09/30/2009

Notes: Tea form

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: Capsule Form

Intelligent Skin Care Inc.
Date Published : 09/18/2013
605 Ecoplaza Bldg.2305 Don Chino Roces , Makati Citymakati City, PHILIPPINES
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 09/07/2017

Desc: Placenta Herbal Beauty Soap
Notes: Problem(s); Drug claims on product label

53 J - - 02 Deodorants (underarm)(Not Antiperspirant) (Personal Cleanliness)
Date Published: 09/18/2013

Desc: Whitening Anti-Perspirant Deodorant

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/18/2013

Desc: Essential Whitening Lotion with SPF 30

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/18/2013

Desc: Essential Whitening Lotion with SPF 30

62 W - - 99 Astringent/Anti-Perspirant N.E.C.
Date Published: 09/18/2013

Desc: Whitening Anti-Perspirant Deodorant

65 L - - 99 Protectant N.E.C.
Date Published: 09/18/2013

Desc: Essential Whitening Lotion with SPF 30

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 09/18/2013

Desc: Essential Whitening Lotion with SPF 30

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/07/2017

Desc: Placenta Herbal Beauty Soap
Notes: Problem(s); Drug claims on product label

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/18/2013

Desc: Essential Whitening Lotion with SPF 30

International Pharmaceutical Inc
Date Published : 10/18/2017
San Jose De la Montana , St. Mabola; CITY , Cebu, Central Visayas PHILIPPINES
53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations)
Date Published: 10/18/2017

Desc: Efficascent Oil (Liniment)

60 L - - 07 Camphorated Oil
Date Published: 10/18/2017

Desc: Efficascent Oil (Liniment)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/18/2017

Desc: Efficascent Oil (Liniment)

JOY TABLE SAUCE
Date Published : 03/29/2013
13 4th Street , Butuan City, Caraga PHILIPPINES
53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 03/29/2013

Desc: Joy Tangland Distilled Lemongrass Hydrosol

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/29/2013

Desc: Joy Tangland Distilled Lemongrass Hydrosol

Ken'S Beauty And Wellness Shop
Date Published : 09/30/2013
9a Sto. Tomas , St , Quezon City, National Capital Region PHILIPPINES
65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 09/30/2013

Desc: Glutathione Soap
Notes: Philippines

65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 09/30/2013

Desc: Maximum Strength Glutathione Soap
Notes: Philippines

65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 09/30/2013

Desc: Gluta Powerpeel Whitening and Peeling Soap
Notes: Philippines

65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 09/30/2013

Desc: Glutathione with Rosehip Oil and Sunblock Cream
Notes: Philippines

65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 09/30/2013

Desc: Glutathione Whitening With Sunblock Lotion
Notes: Philippines

Kyler & Kaitlyn Trading
Date Published : 09/30/2013
912 Julio Nakpil St. , Malate Manila, PHILIPPINES
65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 09/30/2013

Desc: Gluta Powerpeel Whitening and Peeling Soap
Notes: Philippines

65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 09/30/2013

Desc: Glutathione Whitening With Sunblock Lotion
Notes: Philippines

65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 09/30/2013

Desc: Glutathione with Rosehip Oil and Sunblock Cream
Notes: Philippines

65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 09/30/2013

Desc: Maximum Strength Glutathione Soap
Notes: Philippines

65 G - - 99 Pigmentation Agent N.E.C.
Date Published: 09/30/2013

Desc: Glutathione Soap
Notes: Philippines

LEJAL LAB INC.
Date Published : 07/26/2019
MacArthur Highway , Meycauayan, Bulacan PHILIPPINES
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/26/2019

Notes: LiverGuard Silymarin Lecithin Capsules;The product appears to be an unapproved new drug as the product's websites include disease claims such as (not an all-inclusive list): '...Fights Liver Cancer...; ...Helps fight Hepatitis, Fatty Liver, Cirrhosis...; ...Lowers bad cholesterol and triglycerides...; ...Liver disease...'.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/26/2019

Notes: LiverGuard Silymarin Lecithin Capsules; The product appears to be an unapproved new drug as the product's websites include disease claims such as (not an all-inclusive list): '...Fights Liver Cancer...; ...Helps fight Hepatitis, Fatty Liver, Cirrhosis...; ...Lowers bad cholesterol and triglycerides...; ...Liver disease...'.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 07/26/2019

Notes: LiverGuard Silymarin Lecithin Capsules; The product appears to be an unapproved new drug as the product's websites include disease claims such as (not an all-inclusive list): '...Fights Liver Cancer...; ...Helps fight Hepatitis, Fatty Liver, Cirrhosis...; ...Lowers bad cholesterol and triglycerides...; ...Liver disease...'.

61 - - - -- Human and Animal Drugs
Date Published: 07/26/2019

Notes: LiverGuard Silymarin Lecithin Capsules; The product appears to be an unapproved new drug as the product's websites include disease claims such as (not an all-inclusive list): '...Fights Liver Cancer...; ...Helps fight Hepatitis, Fatty Liver, Cirrhosis...; ...Lowers bad cholesterol and triglycerides...; ...Liver disease...'.

62 - - - -- Human and Animal Drugs
Date Published: 07/26/2019

Notes: LiverGuard Silymarin Lecithin Capsules; The product appears to be an unapproved new drug as the product's websites include disease claims such as (not an all-inclusive list): '...Fights Liver Cancer...; ...Helps fight Hepatitis, Fatty Liver, Cirrhosis...; ...Lowers bad cholesterol and triglycerides...; ...Liver disease...'.

63 - - - -- Human and Animal Drugs
Date Published: 07/26/2019

Notes: LiverGuard Silymarin Lecithin Capsules; The product appears to be an unapproved new drug as the product's websites include disease claims such as (not an all-inclusive list): '...Fights Liver Cancer...; ...Helps fight Hepatitis, Fatty Liver, Cirrhosis...; ...Lowers bad cholesterol and triglycerides...; ...Liver disease...'.

64 - - - -- Human and Animal Drugs
Date Published: 07/26/2019

Notes: LiverGuard Silymarin Lecithin Capsules; The product appears to be an unapproved new drug as the product's websites include disease claims such as (not an all-inclusive list): '...Fights Liver Cancer...; ...Helps fight Hepatitis, Fatty Liver, Cirrhosis...; ...Lowers bad cholesterol and triglycerides...; ...Liver disease...'.

65 - - - -- Human and Animal Drugs
Date Published: 07/26/2019

Notes: LiverGuard Silymarin Lecithin Capsules; The product appears to be an unapproved new drug as the product's websites include disease claims such as (not an all-inclusive list): '...Fights Liver Cancer...; ...Helps fight Hepatitis, Fatty Liver, Cirrhosis...; ...Lowers bad cholesterol and triglycerides...; ...Liver disease...'.

66 - - - -- Human and Animal Drugs
Date Published: 07/26/2019

Notes: LiverGuard Silymarin Lecithin Capsules; The product appears to be an unapproved new drug as the product's websites include disease claims such as (not an all-inclusive list): '...Fights Liver Cancer...; ...Helps fight Hepatitis, Fatty Liver, Cirrhosis...; ...Lowers bad cholesterol and triglycerides...; ...Liver disease...'.

Lloyd Laboratories Inc.
Date Published : 09/07/2010
10 Lloyd Avenue, First Bulacam , Bulacan, Central Luzon PHILIPPINES
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/30/2012

Desc: Malungai Life Oil Capsule
Notes: Philippines ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/30/2012

Desc: Malungai Life Oil Capsule
Notes: Philippines ;

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 09/07/2010

Desc: Malungai Life Oil Capsule
Notes: Philippines

Lorenzana Food International
Date Published : 09/28/2012
Unit 28 , 300 Legaspi, Barangay 658; Towers , Manila, National Capital Region PHILIPPINES
21 V - - 15 Mangosteen, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 09/28/2012

Desc: Mangosteen Juice Apple Flavor

21 V - - 15 Mangosteen, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 09/28/2012

Desc: Mangosteen Malunggay Juice Moringa Oleifera

31 A - - 03 Coffee, Instant
Date Published: 09/28/2012

Desc: Mangosteen Coffee with Coconut Sugar

31 A - - 03 Coffee, Instant
Date Published: 09/28/2012

Desc: Mangosteen Black Arabica Coffee

31 A - - 03 Coffee, Instant
Date Published: 09/28/2012

Desc: Mangosteen Guyabano Soursop Coffee

31 A - - 03 Coffee, Instant
Date Published: 09/28/2012

Desc: Mangosteen Malunggay Moringa Oleifera Coffee

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 09/28/2012

Desc: Gluta Mangosteen Whitening & Moisturizing Soap

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/28/2012

Desc: Gluta Mangosteen Lotion SPF 15

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/28/2012

Desc: Optima Malunggay Capsules

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/28/2012

Desc: Mangosteen Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2012

Desc: Mangosteen Malunggay Juice Moringa Oleifera

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2012

Desc: Mangosteen Coffee with Coconut Sugar

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2012

Desc: Mangosteen Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2012

Desc: Mangosteen Black Arabica Coffee

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2012

Desc: Mangosteen Juice Apple Flavor

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2012

Desc: Optima Malunggay Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2012

Desc: Mangosteen Malunggay Moringa Oleifera Coffee

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2012

Desc: Gluta Mangosteen Lotion SPF 15

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2012

Desc: Gluta Mangosteen Whitening

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/28/2012

Desc: Mangosteen Guyabano Soursop Coffee

Northfield Laboratories, Inc.
Date Published : 01/30/2012
#8 Philstar Ave. , 1st Bulacan Industrial City , Malolos, PH-BUL PHILIPPINES
54 A - - 13 Vitamin C (Ascorbic Acid)
Date Published: 01/30/2012

Desc: Fern C
Notes: Phillippines

Northfield Laboratories, Inc.
Date Published : 01/30/2012
#8 Philstar Ave. , 1st Bulacan Industrial City , Malolos, PH-BUL PHILIPPINES
54 A - - 13 Vitamin C (Ascorbic Acid)
Date Published: 01/30/2012

Desc: Fern C
Notes: Phillippines

Northfield Laboratories, Inc.
Date Published : 01/30/2012
#8 Philstar Ave. , 1st Bulacan Industrial City , Malolos, PH-BUL PHILIPPINES
54 A - - 13 Vitamin C (Ascorbic Acid)
Date Published: 01/30/2012

Desc: Fern C
Notes: Phillippines

Origins Pharaceutical And Trading
Date Published : 11/20/2018
Unit 202 1807 J.Villanueva Leon Guinto , Malatemalate, PHILIPPINES
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 11/20/2018

Desc: Kojie San Skin Lightening Soap

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 11/20/2018

Desc: Kojie San Skin Lightening Soap

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 11/20/2018

Desc: Kojie San Body Lightening Lotion

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/20/2018

Desc: Kojie San Body Lightening Lotion

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/20/2018

Desc: Kojie San Body Lightening Lotion

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/20/2018

Desc: Kojie San Skin Lightening Soap

Panacea-Pharmacy.com
Date Published : 09/30/2009
Gamma Commercial Complex , #47 Rizal Highway cor. Manila Avenue , Subic Bay Freeport, Olongapo City, PHILIPPINES
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                           

Pasciolco International Inc.
Date Published : 03/21/2020
1358 Capistrano St. , Tiaong, QUEZON PHILIPPINES
21 V - - 48 Coconut, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 03/21/2020

Desc: Munkijo Virgin Coconut Oil Mentholatum
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dab under nose to alleviate colds...'; 'Rub on chest and throat to improve cough...'; 'Relieves itch from insect bites...'.

26 A - - 01 Coconut Oil, Crude
Date Published: 03/21/2020

Desc: Munkijo Virgin Coconut Oil Mentholatum
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dab under nose to alleviate colds...'; 'Rub on chest and throat to improve cough...'; 'Relieves itch from insect bites...'.

27 V - - 08 Coconut Vinegar
Date Published: 03/21/2020

Desc: Munkijo Virgin Coconut Oil Mentholatum
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dab under nose to alleviate colds...'; 'Rub on chest and throat to improve cough...'; 'Relieves itch from insect bites...'.

37 J - - 99 Sauces, n.e.c.
Date Published: 03/21/2020

Desc: Munkijo Virgin Coconut Oil Mentholatum
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dab under nose to alleviate colds...'; 'Rub on chest and throat to improve cough...'; 'Relieves itch from insect bites...'.

53 - - - -- Cosmetics
Date Published: 03/21/2020

Desc: Munkijo Virgin Coconut Oil Mentholatum
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dab under nose to alleviate colds...'; 'Rub on chest and throat to improve cough...'; 'Relieves itch from insect bites...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/21/2020

Desc: Munkijo Virgin Coconut Oil Mentholatum
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dab under nose to alleviate colds...'; 'Rub on chest and throat to improve cough...'; 'Relieves itch from insect bites...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/21/2020

Desc: Munkijo Virgin Coconut Oil Mentholatum
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dab under nose to alleviate colds...'; 'Rub on chest and throat to improve cough...'; 'Relieves itch from insect bites...'.

Philippine Oahu Manufacturing Inc.
Date Published : 02/10/2014
730 Ragasa Compound , Parian , Calamba, PH-LAG PHILIPPINES
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 02/10/2014

Desc: Placenta Skin Whitening and Anti-Aging In 1 Day Cream (Placenta Day Cream and Night Cream)
Notes: Philippines

Psalmstre Enterprises
Date Published : 02/10/2014
Unit 503, 5th fl. Jmj Bldg. , P, Sanchezcor. Pat. , Metro Manila, PHILIPPINES
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 02/10/2014

Desc: Placenta Herbal Beauty Soap Skin Whitening and Anti-Aging In 1 (Placenta Soap)
Notes: Philippines

Rdl Pharmaceutical Laboratory Inc
Date Published : 01/19/2018
Catitipan Diversion Road, Buhangin , Davao City, PHILIPPINES
63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 01/19/2018

Desc: Hydroquinone Tretinoin Babyface Solution Anti-Acne Keratolytic Depigmenting Agent

64 X - - 07 Tretinoin (Keratolytic)
Date Published: 01/19/2018

Desc: Hydroquinone Tretinoin Babyface Solution Anti-Acne Keratolytic Depigmenting Agent

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/19/2018

Desc: Hydroquinone Tretinoin Babyface Solution Anti-Acne Keratolytic Depigmenting Agent

SILVER STAR RESOURCES CO., INC.
Date Published : 08/04/2013
230 Don Pedro St., Kapalaran Subd. , Metro Manila, National Capital Region PHILIPPINES
21 V - - 15 Mangosteen, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 08/04/2013

Desc: Lorenzana Mangosteen Malunggay Juice
Notes: Note; Structure/function claims found on package labeling and website

21 V - - 15 Mangosteen, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 08/25/2013

Desc: Lorenzana's Mangosteen Guyabano Juice

31 A - - 02 Coffee, Ground
Date Published: 08/04/2013

Desc: Lorenzana Mangosteen Guybano Coffee
Notes: Note; Structure/function claims found on package labeling and website

31 A - - 02 Coffee, Ground
Date Published: 08/04/2013

Desc: Lorenzana Mangosteen Malunggay Coffee
Notes: Note; Structure/function claims found on package labeling and website

31 A - - 03 Coffee, Instant
Date Published: 08/04/2013

Desc: Lorenzana Mangosteen Malunggay Coffee
Notes: Note; Structure/function claims found on package labeling and website

31 A - - 03 Coffee, Instant
Date Published: 08/04/2013

Desc: Lorenzana Mangosteen Guybano Coffee
Notes: Note; Structure/function claims found on package labeling and website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/04/2013

Desc: Lorenzana Mangosteen Guybano Coffee
Notes: Note; Structure/function claims found on package labeling and website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/04/2013

Desc: Lorenzana Mangosteen Malunggay Juice
Notes: Note; Structure/function claims found on package labeling and website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/04/2013

Desc: Lorenzana Mangosteen Malunggay Coffee
Notes: Note; Structure/function claims found on package labeling and website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/25/2013

Desc: Lorenzana's Mangosteen Guyabano Juice

Sara Lee Philippines, Inc.
Date Published : 09/30/2009
24/F, Tower1,Insular Life Corp. Center , Filinves Corp. City Alabang Muntinlupa C , Manila, PHILIPPINES
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 07/20/2010

Desc: Lemon Facial Cleanser
Notes: Philippines

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 07/20/2010

Desc: Lemon Facial Cleanser
Notes: Philippines

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/20/2010

Desc: Lemon Facial Cleanser
Notes: Philippines

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/30/2009

Notes: 1/3/2008 Block and White Papaya Lotion, Radiance Lotion SPF 10 and Ultima Skin Perfecting Whitener. The block and white skin creams are unapproved new drugs based on their skin bleaching claims and are also misbranded for failure to bear an ingrediant statement.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 1/3/2008 Block and White Papaya Lotion, Radiance Lotion SPF 10 and Ultima Skin Perfecting Whitener. The block and white skin creams are unapproved new drugs based on their skin bleaching claims and are also misbranded for failure to bear an ingrediant statement.

66 - - - -- Human and Animal Drugs
Date Published: 07/20/2010

Desc: Lemon Facial Cleanser
Notes: Phililppines

Splash Corporation
Date Published : 09/30/2009
No. 17 F. Lazaro Street Canumay West , Metro Manila, National Capital Region PHILIPPINES
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/30/2009

Notes: 11/18/2008 Maxi-Peel Exfoliant.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 11/18/2008 Maxi-Peel Exfoliant.

Stalder Laboratiories
Date Published : 01/26/2012
4 Region , San Pablo Laguna , San Isidro, Davao Region PHILIPPINES
53 - - - -- Cosmetics
Date Published: 01/26/2012

Notes: Kojic Acid Soap Bar, Bleaching Black Soap, Licorice Pink Soap, Derm Option 4-1 Lotion, Dermablend Papaya Orange Skin Whitening Soap, Dermablend Sunblock Lotion SPF 24, Derm Option Alumchlor 3, Derm Option 4-1 Cream; Country: Philippines

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/26/2012

Notes: Kojic Acid Soap Bar, Bleaching Black Soap, Licorice Pink Soap, Derm Option 4-1 Lotion, Dermablend Papaya Orange Skin Whitening Soap, Dermablend Sunblock Lotion SPF 24, Derm Option Alumchlor 3, Derm Option 4-1 Cream; Country: Philippines

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 01/26/2012

Notes: Kojic Acid Soap Bar, Bleaching Black Soap, Licorice Pink Soap, Derm Option 4-1 Lotion, Dermablend Papaya Orange Skin Whitening Soap, Dermablend Sunblock Lotion SPF 24, Derm Option Alumchlor 3, Derm Option 4-1 Cream; Country: Philippines

61 - - - -- Human and Animal Drugs
Date Published: 01/26/2012

Notes: Kojic Acid Soap Bar, Bleaching Black Soap, Licorice Pink Soap, Derm Option 4-1 Lotion, Dermablend Papaya Orange Skin Whitening Soap, Dermablend Sunblock Lotion SPF 24, Derm Option Alumchlor 3, Derm Option 4-1 Cream; Country: Philippines

62 - - - -- Human and Animal Drugs
Date Published: 01/26/2012

Notes: Kojic Acid Soap Bar, Bleaching Black Soap, Licorice Pink Soap, Derm Option 4-1 Lotion, Dermablend Papaya Orange Skin Whitening Soap, Dermablend Sunblock Lotion SPF 24, Derm Option Alumchlor 3, Derm Option 4-1 Cream; Country: Philippines

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 04/25/2012

Desc: Hydroquinone Tretinoin 2%.0.01% Topical Solution Anti-Acne/Depigmenting
Notes: Philippines

63 V - - 99 Depigmentor N.E.C.
Date Published: 04/25/2012

Desc: Hydroquinone Tretinoin 2%.0.01% Topical Solution Anti-Acne/Depigmenting
Notes: Philippines

63 - - - -- Human and Animal Drugs
Date Published: 01/26/2012

Notes: Kojic Acid Soap Bar, Bleaching Black Soap, Licorice Pink Soap, Derm Option 4-1 Lotion, Dermablend Papaya Orange Skin Whitening Soap, Dermablend Sunblock Lotion SPF 24, Derm Option Alumchlor 3, Derm Option 4-1 Cream; Country: Philippines

64 - - - -- Human and Animal Drugs
Date Published: 01/26/2012

Notes: Kojic Acid Soap Bar, Bleaching Black Soap, Licorice Pink Soap, Derm Option 4-1 Lotion, Dermablend Papaya Orange Skin Whitening Soap, Dermablend Sunblock Lotion SPF 24, Derm Option Alumchlor 3, Derm Option 4-1 Cream; Country: Philippines

65 - - - -- Human and Animal Drugs
Date Published: 01/26/2012

Notes: Kojic Acid Soap Bar, Bleaching Black Soap, Licorice Pink Soap, Derm Option 4-1 Lotion, Dermablend Papaya Orange Skin Whitening Soap, Dermablend Sunblock Lotion SPF 24, Derm Option Alumchlor 3, Derm Option 4-1 Cream; Country: Philippines

66 - - - -- Human and Animal Drugs
Date Published: 01/26/2012

Notes: Kojic Acid Soap Bar, Bleaching Black Soap, Licorice Pink Soap, Derm Option 4-1 Lotion, Dermablend Papaya Orange Skin Whitening Soap, Dermablend Sunblock Lotion SPF 24, Derm Option Alumchlor 3, Derm Option 4-1 Cream; Country: Philippines

Synergreens International Trading Inc.,
Date Published : 08/05/2019
L2-201A 2F, Pavilion Building, Unit L2 201A , Greenfield District , Mandaluyong, Metro Manila PHILIPPINES
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/05/2019

Notes: Synergreens Vegetable And Fruit Dietary Supplement Powder; Note: The product appears to be an unapproved new drug as the product's labeling (brochure) includes disease claims such as (not an all-inclusive list): '...[A]nti-aging...; ...[E]ffective prevention of cardiovascular diseases...; [P]revent Cancer...; [P]revent ulcerative colitis...'.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/05/2019

Notes: Synergreens Vegetable And Fruit Dietary Supplement Powder; Note: The product appears to be an unapproved new drug as the product's labeling (brochure) includes disease claims such as (not an all-inclusive list): '...[A]nti-aging...; ...[E]ffective prevention of cardiovascular diseases...; [P]revent Cancer...; [P]revent ulcerative colitis...'. ;

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 08/05/2019

Notes: Synergreens Vegetable And Fruit Dietary Supplement Powder; Note: The product appears to be an unapproved new drug as the product's labeling (brochure) includes disease claims such as (not an all-inclusive list): '...[A]nti-aging...; ...[E]ffective prevention of cardiovascular diseases...; [P]revent Cancer...; [P]revent ulcerative colitis...'. ;

61 - - - -- Human and Animal Drugs
Date Published: 08/05/2019

Notes: Synergreens Vegetable And Fruit Dietary Supplement Powder; Note: The product appears to be an unapproved new drug as the product's labeling (brochure) includes disease claims such as (not an all-inclusive list): '...[A]nti-aging...; ...[E]ffective prevention of cardiovascular diseases...; [P]revent Cancer...; [P]revent ulcerative colitis...'. ;

62 - - - -- Human and Animal Drugs
Date Published: 08/05/2019

Notes: Synergreens Vegetable And Fruit Dietary Supplement Powder; Note: The product appears to be an unapproved new drug as the product's labeling (brochure) includes disease claims such as (not an all-inclusive list): '...[A]nti-aging...; ...[E]ffective prevention of cardiovascular diseases...; [P]revent Cancer...; [P]revent ulcerative colitis...'. ;

63 - - - -- Human and Animal Drugs
Date Published: 08/05/2019

Notes: Synergreens Vegetable And Fruit Dietary Supplement Powder; Note: The product appears to be an unapproved new drug as the product's labeling (brochure) includes disease claims such as (not an all-inclusive list): '...[A]nti-aging...; ...[E]ffective prevention of cardiovascular diseases...; [P]revent Cancer...; [P]revent ulcerative colitis...'. ;

64 - - - -- Human and Animal Drugs
Date Published: 08/05/2019

Notes: Synergreens Vegetable And Fruit Dietary Supplement Powder; Note: The product appears to be an unapproved new drug as the product's labeling (brochure) includes disease claims such as (not an all-inclusive list): '...[A]nti-aging...; ...[E]ffective prevention of cardiovascular diseases...; [P]revent Cancer...; [P]revent ulcerative colitis...'. ;

65 - - - -- Human and Animal Drugs
Date Published: 08/05/2019

Notes: Synergreens Vegetable And Fruit Dietary Supplement Powder; Note: The product appears to be an unapproved new drug as the product's labeling (brochure) includes disease claims such as (not an all-inclusive list): '...[A]nti-aging...; ...[E]ffective prevention of cardiovascular diseases...; [P]revent Cancer...; [P]revent ulcerative colitis...'. ;

66 - - - -- Human and Animal Drugs
Date Published: 08/05/2019

Notes: Synergreens Vegetable And Fruit Dietary Supplement Powder; Note: The product appears to be an unapproved new drug as the product's labeling (brochure) includes disease claims such as (not an all-inclusive list): '...[A]nti-aging...; ...[E]ffective prevention of cardiovascular diseases...; [P]revent Cancer...; [P]revent ulcerative colitis...'. ;

Therma Cosmetica Inc.
Date Published : 04/28/2010
1724 A. Mabini St. , Metro Manila, PH-00 PHILIPPINES
31 A - - -- Coffee
Date Published: 04/28/2010

Desc: Barako Coffee with Memory Enhancer
Notes: Philippines

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/28/2010

Desc: Barako Coffee with Memory Enhancer
Notes: Philippines

Total Nature's Great Value, Inc.
Date Published : 09/30/2009
Balite I , Silang, Cavite PHILIPPINES
21 D - - 13 Berries and Subtropica/Tropical Fruits, Mixed, Juices or Concentrates
Date Published: 09/30/2009

Desc: Bio Enzyme Plus; Natural Fruit Juice
Notes: This product is promoted as a dietary supplement to aid in combating numerous diseases. The product labeling lists a number of known diseases and states that the product contains enzymes and free radical scavengers which fight disease. The firm's website also contains numerous testimonials regarding the use of Bio Enzyme Plus in aiding recovery from various diseases; e.g. leukemia; glaucoma; epilepsy and breast cancer.5/11/09

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/30/2009

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Desc: Bio Enzyme Plus; Natural Fruit Juice
Notes: This product is promoted as a dietary supplement to aid in combating numerous diseases. The product labeling lists a number of known diseases and states that the product contains enzymes and free radical scavengers which fight disease. The firm's website also contains numerous testimonials regarding the use of Bio Enzyme Plus in aiding recovery from various diseases; e.g. leukemia; glaucoma; epilepsy and breast cancer. 5/11/09

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Unilever Philippines, Inc. - Cavite Factory
Date Published : 12/19/2017
Gateway Business Park Barangay Javalera , Linares , Gen. Trias, Calabarzon PHILIPPINES
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 03/02/2018

Desc: Cream Silk Dandruff Free Conditioner

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 12/19/2017

Desc: New Vaseline Itch & Dandruff-Free (VASELINE - PURPLE)

61 H - - 05 Zinc Pyrithione (Anti-Bacterial)
Date Published: 03/02/2018

Desc: Cream Silk Dandruff Free Conditioner

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/19/2017

Desc: New Vaseline Itch & Dandruff-Free (VASELINE - PURPLE)

Unilever Philippines, Inc. - Cavite Factory
Date Published : 10/10/2013
Gateway Business Park Barangay Javalera , Linares , Gen. Trias, Calabarzon PHILIPPINES
53 D - - 02 Perfumes (Fragrance Preparations)
Date Published: 10/10/2013

Desc: Roll on Deodorant Rexona Antiperspirant

53 D - - 99 Other Fragrance Preparations, N.E.C.
Date Published: 10/10/2013

Desc: Roll on Deodorant Rexona Antiperspirant

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 03/02/2018

Desc: Cream Silk Dandruff Free Conditioner

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 12/19/2017

Desc: New Vaseline Itch & Dandruff-Free (VASELINE ? PURPLE)

53 J - - 02 Deodorants (underarm)(Not Antiperspirant) (Personal Cleanliness)
Date Published: 10/10/2013

Desc: Roll on Deodorant Rexona Antiperspirant

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 12/10/2019

Desc: Eskinol Refreshing Facial Deep Cleanser with Pure Cucumber Extract
Notes: These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 12/10/2019

Desc: Eskinol Oil Control Facial Deep Cleanser with Pure Lemon Extract
Notes: These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 04/17/2015

Desc: Eskinol Spot-less White Facial Deep Cleanser
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following; anti-bacterial formula; Whitens; Lightens dark spots in as early as 1 week; Micro-cleanse Anti-bacterial Formula; With pure Calamansi Extract known to whiten skin; With Vitamin C derivative to help lighten dark spots in as early as 1 week

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 04/17/2015

Desc: Eskinol Papaya Smooth White Facial Deep Cleanser
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Micro-cleanse Anti-bacterial Formula; With pure Papaya Extract and Vitamin B3 to whiten skin in as early as 1 week.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/17/2015

Desc: Eskinol Spot-less White Facial Deep Cleanser
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Lightens dark spots in as early as 1 week; Micro-cleanse Anti-bacterial Formula; With pure Calamansi Extract known to whiten skin; With Vitamin C derivative to help lighten dark spots in as early as 1 week.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/17/2015

Desc: Eskinol Papaya Smooth White Facial Deep Cleanser
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Micro-cleanse Anti-bacterial Formula; With pure Papaya Extract and Vitamin B3 to whiten skin in as early as 1 week.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/10/2019

Desc: Eskinol Refreshing Facial Deep Cleanser with Pure Cucumber Extract
Notes: These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/10/2019

Desc: Eskinol Oil Control Facial Deep Cleanser with Pure Lemon Extract
Notes: These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/17/2015

Desc: Eskinol Papaya Smooth White Facial Deep Cleanser
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Micro-cleanse Anti-bacterial Formula; With pure Papaya Extract and Vitamin B3 to whiten skin in as early as 1 week.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/17/2015

Desc: Eskinol Spot-less White Facial Deep Cleanser
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Lightens dark spots in as early as 1 week; Micro-cleanse Anti-bacterial Formula; With pure Calamansi Extract known to whiten skin; ?With Vitamin C derivative to help lighten dark spots in as early as 1 week.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/10/2019

Desc: Eskinol Oil Control Facial Deep Cleanser with Pure Lemon Extract
Notes: These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/10/2019

Desc: Eskinol Refreshing Facial Deep Cleanser with Pure Cucumber Extract
Notes: These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products.

61 H - - 05 Zinc Pyrithione (Anti-Bacterial)
Date Published: 03/02/2018

Desc: Cream Silk Dandruff Free Conditioner

62 W - - -- Astring/A-Perspirant
Date Published: 10/10/2013

Desc: Roll on Deodorant Rexona Antiperspirant

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/10/2019

Desc: Eskinol Refreshing Facial Deep Cleanser with Pure Cucumber Extract
Notes: These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/17/2015

Desc: Eskinol Spot-less White Facial Deep Cleanser
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Lightens dark spots in as early as 1 week; Micro-cleanse Anti-bacterial Formula; With pure Calamansi Extract known to whiten skin; With Vitamin C derivative to help lighten dark spots in as early as 1 week.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/19/2017

Desc: New Vaseline Itch & Dandruff-Free (VASELINE ? PURPLE)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/10/2019

Desc: Eskinol Oil Control Facial Deep Cleanser with Pure Lemon Extract
Notes: These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/17/2015

Desc: Eskinol Papaya Smooth White Facial Deep Cleanser
Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Micro-cleanse Anti-bacterial Formula; With pure Papaya Extract and Vitamin B3 to whiten skin in as early as 1 week.

proctor & gamble distributing philippines
Date Published : 07/24/2018
6750 ayala office tower , ayala ave., makati city , Makati, PH-00 PHILIPPINES
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 07/24/2018

Desc: Safeguard Bar Soap
Notes: Mfg. declared in OASIS is FIRST VITA PLUS MARKETING CORPORATION Mfg. appeared on product label is proctor & gamble distributing Philippines

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/24/2018

Desc: Safeguard Bar Soap
Notes: Mfg. declared in OASIS is FIRST VITA PLUS MARKETING CORPORATION Mfg. appeared on product label is proctor & gamble distributing Philippines


POLAND


Beauty International Group
Date Published : 07/06/2016
Pl. Wolnica 13/10 , Cracow, Malopolskie POLAND
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso GEN'X Cream #2

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: GEN'X Eye Care

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso CAPIL

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso HYDRA Cream

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso LIFT

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso GEN'X

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso CALM

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso HAIR

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso White Brightening Serum

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso HYDRA

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso White Booster

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso HYDRA Eye Care

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso ECM

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso LIFT

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: GEN'X Eye Care

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso HYDRA

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso GEN'X Cream #2

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso CAPIL

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso HAIR

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso White Booster

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso White Brightening Serum

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso GEN'X

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso CALM

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso ECM

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso HYDRA Eye Care

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso HYDRA Cream

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso HYDRA Cream

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso HYDRA Eye Care

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso GEN'X Eye Care

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso GEN'X Cream #2

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso ECM

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso HYDRA

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso HAIR

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso CAPIL

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso White Booster

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso GEN'X

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso White Brightening Serum

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso LIFT

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso CALM

Beauty International Sylwia Michno
Date Published : 07/06/2016
Mlynka 58 , Rudawa, Malopolskie POLAND
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso HYDRA Cream

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso White Brightening Serum

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso LIFT

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso HYDRA

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso GEN'X

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso HAIR

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso GEN'X Eye Care

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso CALM

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso White Booster

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso GEN'X Cream #2

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso HYDRA Eye Care

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso ECM

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/06/2016

Desc: Meso CAPIL

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso HYDRA Eye Care

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso HYDRA

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso CALM

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso White Brightening Serum

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso White Booster

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso HYDRA Cream

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso CAPIL

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso LIFT

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso HAIR

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso GEN'X Cream #2

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso ECM

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso GEN'X Eye Care

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 07/06/2016

Desc: Meso GEN'X

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso GEN'X Cream #2

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso CALM

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso White Booster

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso GEN'X

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso HYDRA Eye Care

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso GEN'X Eye Care

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso CAPIL

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso LIFT

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso HYDRA

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso White Brightening Serum

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso HYDRA Cream

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso GEN'X

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso HAIR

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/06/2016

Desc: Meso ECM

Floslek Furmanek
Date Published : 04/27/2016
Ul. Geodetow 154 , Piaseczno, Mazowieckie POLAND
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 04/27/2016

Desc: NATURAL SKIN CREAM ARNICA ACTIVE WARMING GEL
Notes: Medical claims on product labels & website

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 04/27/2016

Desc: NATURAL SKIN CREAM ARNICA ACTIVE COOLING GEL
Notes: Medical claims on product labels & website

Laboratorium Kosmetyczne
Date Published : 04/27/2016
Ul. Geodetow 154 , Piaseczno, Mazowieckie POLAND
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 04/27/2016

Desc: NATURAL SKIN CREAM ARNICA ACTIVE COOLING GEL
Notes: Medical claims on product labels & website

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 04/27/2016

Desc: NATURAL SKIN CREAM ARNICA ACTIVE WARMING GEL
Notes: Medical claims on product labels & website

Panacea Pharmacy.com &/or Medica Center or Deca-Sustanon.com
Date Published : 09/30/2009
Karznik, David, Pretrova , Wroclaw 5548, POLAND
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 06/15/2020

Desc: Abarelix
Notes:                                                                                                                                   

64 R - - 21 Somatropin (Hormone)
Date Published: 06/15/2020

Notes:                                                                                                                                   

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007;                                                                                                                                   

Takeda Pharma Sp. z o.o.
Date Published : 08/04/2015
Ul. Prosta 68 , Warsaw, Mazowieckie POLAND
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/04/2015

Desc: AMOL Body Rubbing Alcohol with Liquid Herbal Extract
Notes: Lacks adequate directions for use; Unapproved New Drug

65 S - - 01 Rubbing Alcohol (Rubefacient)
Date Published: 08/04/2015

Desc: AMOL Body Rubbing Alcohol with Liquid Herbal Extract
Notes: Lacks adequate directions for use; Unapproved New Drug

Web Trading Group
Date Published : 09/12/2016
Ul. Mietowa 3/04 , Gdynia, Pomorskie POLAND
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/12/2016

Desc: OSTARINE(MK-2866)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/12/2016

Desc: OSTARINE(MK-2866)

Wroclawskie Zaklady Zielarskie Herbapol S.A.
Date Published : 07/10/2015
Ul. Swietego Mikolaja 65/68 , Wroclaw, Dolnoslaskie POLAND
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/10/2015

Desc: Radirex (Rhubarb root extract)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/10/2015

Desc: Radirex (Rhubarb root extract)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/10/2015

Desc: Radirex (Rhubarb root extract)


PORTUGAL


Lusomedicamenta Sociedade Tecnica Farmaceutica S.A
Date Published : 01/02/2019
Estrada Consiglieri Pedroso 69-B , Queluz De Baixo , Barcarena, Lisbon PORTUGAL
60 W - - 16 Mebendazole (Anthelmintic)
Date Published: 01/02/2019

Desc: Vermox (Mebendazole)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/02/2019

Desc: Vermox (Mebendazole)


ROMANIA


Nanotech Health Ltd.
Date Published : 04/15/2016
Aeroportul Int'L Henri Coanda Zona , Otopeni, Ilfov ROMANIA
54 A - - 99 Vitamin, N.E.C.
Date Published: 04/15/2016

Desc: Nanoxyn Alpha Modified Release Tablets "Nutritional Supplement"
Notes: Claims on product label

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/15/2016

Desc: Nanoxyn Alpha Modified Release Tablets "Nutritional Supplement"
Notes: Claims on product label

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/15/2016

Desc: Nanoxyn Alpha Modified Release Tablets "Nutritional Supplement"
Notes: Claims on product label

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/15/2016

Desc: Nanoxyn Alpha Modified Release Tablets "Nutritional Supplement"
Notes: Claims on product label

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 04/15/2016

Desc: Nanoxyn Alpha Modified Release Tablets "Nutritional Supplement"
Notes: Claims on product label

SC PlantExtrakt
Date Published : 03/22/2017
Zalaului f.n. , Radaia, Cluj ROMANIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/22/2017

Desc: UTI Relief
Notes: Medical/Disease claims made on product labels and websites

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/22/2017

Desc: Allergy Relief
Notes: Medical/Disease claims made on product labels and websites

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/22/2017

Desc: Flu Relief
Notes: Medical/Disease claims made on product labels and websites

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/22/2017

Desc: Black Currant
Notes: Medical/Disease claims made on product labels and websites

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/22/2017

Desc: Digestive Relief
Notes: Medical/Disease claims made on product labels and websites

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/22/2017

Desc: Earache Relief
Notes: Medical/Disease claims made on product labels and websites

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/22/2017

Desc: Digestive Relief
Notes: Medical/Disease claims made on product labels and websites

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/22/2017

Desc: Allergy Relief
Notes: Medical/Disease claims made on product labels and websites

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/22/2017

Desc: Earache Relief
Notes: Medical/Disease claims made on product labels and websites

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/22/2017

Desc: Flu Relief
Notes: Medical/Disease claims made on product labels and websites

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/22/2017

Desc: UTI Relief
Notes: Medical/Disease claims made on product labels and websites

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/22/2017

Desc: Black Currant
Notes: Medical/Disease claims made on product labels and websites


RUSSIA


AGROPACK
Date Published : 10/14/2010
SHKOLNAYA STR. 2A , CHESNOKOVKA, RU-BA RUSSIA
36 C - - -- Honey
Date Published: 10/14/2010

Desc: Honey (Linden) and Honey (Flower)
Notes: Russia

Amk Export Ltd
Date Published : 01/24/2012
121170 Square Of Pobedy 2/1 , Moscow, RUSSIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/24/2012

Desc: Candy Tablet Nicotrim
Notes: Russia

Anabolics-Online
Date Published : 09/30/2009
Jarda Pokorny, Libusina 37 , Praha, , Czech Republic, RUSSIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                                

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

73 - - - -- Anesthesiology
Date Published: 09/30/2009

74 - - - -- Cardiovascular
Date Published: 09/30/2009

76 - - - -- Dental
Date Published: 09/30/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/30/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/30/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/30/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/30/2009

84 - - - -- Neurological
Date Published: 09/30/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/30/2009

86 - - - -- Ophthalmic
Date Published: 09/30/2009

87 - - - -- Orthopedic
Date Published: 09/30/2009

89 - - - -- Physical Medicine
Date Published: 09/30/2009

90 - - - -- Radiology
Date Published: 09/30/2009

INAT-FARMA
Date Published : 01/24/2012
Aprelevka, Naro-Fominsk District , ul. Aprelevskaya 16 , Aprelevka, Moskovskaya obl RUSSIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/24/2012

Desc: Candy Tablet Nicotrim
Notes: Russia

LLC PHARMACOR PRODUCTION
Date Published : 03/04/2024
K. 5 Ofis 247 , Ul. Repischeva D. 14 , Sankt-Peterburg, Sankt-Peterburg g RUSSIA
41 Y - - -- Dietary Conv Nec
Date Published: 03/04/2024

Desc: Vladonix Capsules

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 03/04/2024

Desc: Vladonix Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/04/2024

Desc: Vladonix Capsules

MERCATUS NOVA COMPANY
Date Published : 07/29/2010
Elektrostalskoe Sh 1 A , Noginsk, Moskovskaya obl RUSSIA
02 - - - -- Whole Grains/Milled Grain Products/Starches
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

04 - - - -- Macaroni/Noodle Products
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

05 - - - -- Cereal Preparations/Breakfast Foods
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

07 - - - -- Snack Food Items
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

09 - - - -- Milk/Butter/Dried Milk Products
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

12 - - - -- Cheese/Cheese Products
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

13 - - - -- Ice Cream and related Products
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

14 - - - -- Filled Milk/Imitation Milk Products
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

15 - - - -- Eggs/Egg Products
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

16 - - - -- Fishery/Seafood Products
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

17 - - - -- Meats, Meat Products and Poultry
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

18 - - - -- Vegetable Protein Products
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

20 - - - -- Fruit/Fruit Products
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

21 - - - -- Fruit/Fruit Products
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

22 - - - -- Fruit/Fruit Products
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

23 - - - -- Nuts/Edible Seeds
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

24 - - - -- Vegetables/Vegetable Products
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

25 - - - -- Vegetables/Vegetable Products
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

26 - - - -- Vegetable Oils
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

27 - - - -- Dressing/Condiments
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

28 - - - -- Spices, Flavors And Salts
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

29 - - - -- Soft Drinks/Water
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

31 - - - -- Coffee/Tea
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

32 - - - -- Alcoholic Beverages
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

38 - - - -- Soups
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

39 - - - -- Prepared Salad Products
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

40 A - - -- Baked Goods (Baby)
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

40 B - - -- Cereal (Baby)
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

40 D - - -- Veg (Baby)
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

40 J - - -- Egg Prod (Baby)
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

40 K - - -- Pudding/Custard (Baby)
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

40 L - - -- Soups/Soup Mix (Baby)
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

40 Q - - -- Pasta and Noodle Combination Dinners Without Meat
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

40 X - - -- Market Basket Sampling
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

40 Y - - -- Baby Food N.E.C.
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

42 A - - -- Whole Edible Insects (adults and immature stages)
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

42 B - - -- Milled Edible Insect Products
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

42 C - - -- Edible Insect Bars
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

42 D - - -- Edible Insect Bakery Products
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

42 E - - -- Edible Insect Candy With Chocolate
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

42 F - - -- Edible Insect Candy Without Chocolate
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

42 G - - -- Edible Insect Capsules
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

42 H - - -- Edible Insect Granola or Trail Mix
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

42 I - - -- Edible Insect Jerky
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

42 J - - -- Edible Insect Ice Cream and Related Products
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

42 K - - -- Edible Insect Oils
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

42 L - - -- Edible Insect Smoothies
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

42 M - - -- Edible Insect Soups
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

42 N - - -- Edible Insect Spreads And Pastes
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

42 O - - -- Edible Insect Beverages
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

42 P - - -- Edible Insect Protein: Simulated Meats and Tofu
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

42 Q - - -- Edible Insect Salts and Spices
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

42 R - - -- Edible Insect Products N.E.C.
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

52 B - - 06 Corn Husks (Food Related)
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

52 B - - 07 Snail Shells (Food Related)
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

52 B - - 12 Bird's Nest
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

52 D - - -- Live Animals
Date Published: 09/13/2019

Notes: 7/29/2010; Sea Buckthorn Oil; Russia

54 F - - 40 Buckthorn (Herbal & Botanicals, not Teas)
Date Published: 07/29/2010

Desc: Sea Buckthorn Oil
Notes: Russia

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/29/2010

Notes: Sea Buckthorn Oil; Russia

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 07/29/2010

Notes: Sea Buckthorn Oil; Russia

61 - - - -- Human and Animal Drugs
Date Published: 07/29/2010

Notes: Sea Buckthorn Oil; Russia

62 - - - -- Human and Animal Drugs
Date Published: 07/29/2010

Notes: Sea Buckthorn Oil; Russia

63 - - - -- Human and Animal Drugs
Date Published: 07/29/2010

Notes: Sea Buckthorn Oil; Russia

64 - - - -- Human and Animal Drugs
Date Published: 07/29/2010

Notes: Sea Buckthorn Oil; Russia

65 - - - -- Human and Animal Drugs
Date Published: 07/29/2010

Notes: Sea Buckthorn Oil; Russia

66 - - - -- Human and Animal Drugs
Date Published: 07/29/2010

Notes: Sea Buckthorn Oil; Russia

OOO "MEDPAL-ONKO"
Date Published : 04/12/2012
ul. Fridrikha Engelsa 75/21 , Moscow, Moscow g RUSSIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/12/2012

Desc: Viprosal B Cream
Notes: Russia

OOO AGROPACK
Date Published : 10/14/2010
ul. Shkolnaya 2A , Chesnokovka, Bashkortostan Resp RUSSIA
36 C - - -- Honey
Date Published: 10/14/2010

Desc: Honey (Linden) and Honey (Flower)
Notes: Russia

Your-Online-Pharmacy.com
Date Published : 09/30/2009
Mikalai Markau , Polevaya 3A , Grodno, Belarus, RUSSIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                              

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                              

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                              

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                              

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                              

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                              

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                              

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. GPI = DR.                              


SAINT LUCIA


Furtil Seamoss
Date Published : 03/23/2021
Praslin , Mon Repos, Castries SAINT LUCIA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/23/2021

Desc: FURTIL Sea Moss
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'A Powerful Anti-Inflammatory'; 'Can Help with Colds and Cough'; 'High in iodine which helps prevent radiation poisoning'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/23/2021

Desc: FURTIL Sea Moss
Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'A Powerful Anti-Inflammatory'; 'Can Help with Colds and Cough'; 'High in iodine which helps prevent radiation poisoning'.

Scylla Premium Seamoss
Date Published : 06/08/2021
La - Pointe, Mon-Repos , Micoud, Vieux Fort SAINT LUCIA
24 T - - 29 Seaweed (Leaf & Stem Vegetable)
Date Published: 06/08/2021

Desc: Dried Sea Moss
Notes: The product appears to be an unapproved new drug as the product label includes drug/disease claims under ‘BENEFITS’: “Anti-Inflammatory” and “Relieves Respiratory Conditions”

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2021

Desc: Dried Sea Moss
Notes: The product appears to be an unapproved new drug as the product label includes drug/disease claims under ‘BENEFITS’: “Anti-Inflammatory” and “Relieves Respiratory Conditions”

THE GREAT PHYSICIAN INTERNATIONAL
Date Published : 08/07/2019
Jeremie Street , Castries, SAINT LUCIA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/07/2019

Desc: Fey Duvan
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "Blood regulator". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/07/2019

Desc: Womb Cleanser
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as;"The Womb Cleanser helps to clean the womb by increasing contractions of the uterine walls and also helps to balance the female hormones";"Helps to induce menstruation and decrease the pain during the menstrual cycle by the reduction of clot formation and iron building".The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/07/2019

Desc: Pure Green
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as; "It is utilized to increase the haemoglobin [sic] content of the blood thus improves its oxygen carrying capacity" and "helps to effectively relieve headaches caused by iron deficiency". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/07/2019

Desc: Blood Detox
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "BLOOD DETOX" and "Blood and organ cleansing". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/07/2019

Desc: Pure Gold
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "The Pure Gold helps to clear mucous from the system and aids the elimination of poor circulation and respiratory tract infection." The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL."

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/07/2019

Desc: Free Up Laxative
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as; "LAXATIVE"; "Colon Cleanser"; "Free up Laxative which aggressively cleanses the colon of all waste material and plaque that has been compiled on the colonic walls over the years". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

60 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Fey Duvan
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "Blood regulator". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

60 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Blood Detox
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "BLOOD DETOX" and "Blood and organ cleansing". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

60 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Womb Cleanser
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as;"The Womb Cleanser helps to clean the womb by increasing contractions of the uterine walls and also helps to balance the female hormones";"Helps to induce menstruation and decrease the pain during the menstrual cycle by the reduction of clot formation and iron building".The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

60 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Pure Green
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as; "It is utilized to increase the haemoglobin [sic] content of the blood thus improves its oxygen carrying capacity" and "helps to effectively relieve headaches caused by iron deficiency". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

60 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Free Up Laxative
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as; "LAXATIVE"; "Colon Cleanser"; "Free up Laxative which aggressively cleanses the colon of all waste material and plaque that has been compiled on the colonic walls over the years". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

60 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Pure Gold
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "The Pure Gold helps to clear mucous from the system and aids the elimination of poor circulation and respiratory tract infection." The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

61 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Pure Gold
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "The Pure Gold helps to clear mucous from the system and aids the elimination of poor circulation and respiratory tract infection." The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

61 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Free Up Laxative
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as; "LAXATIVE"; "Colon Cleanser"; "Free up Laxative which aggressively cleanses the colon of all waste material and plaque that has been compiled on the colonic walls over the years". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

61 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Pure Green
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as; "It is utilized to increase the haemoglobin [sic] content of the blood thus improves its oxygen carrying capacity" and "helps to effectively relieve headaches caused by iron deficiency". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

61 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Blood Detox
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "BLOOD DETOX" and "Blood and organ cleansing". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

61 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Womb Cleanser
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as;"The Womb Cleanser helps to clean the womb by increasing contractions of the uterine walls and also helps to balance the female hormones";"Helps to induce menstruation and decrease the pain during the menstrual cycle by the reduction of clot formation and iron building".The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

61 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Fey Duvan
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "Blood regulator". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

62 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Pure Green
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as; "It is utilized to increase the haemoglobin [sic] content of the blood thus improves its oxygen carrying capacity" and "helps to effectively relieve headaches caused by iron deficiency". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

62 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Blood Detox
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "BLOOD DETOX" and "Blood and organ cleansing". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

62 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Womb Cleanser
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as;"The Womb Cleanser helps to clean the womb by increasing contractions of the uterine walls and also helps to balance the female hormones";"Helps to induce menstruation and decrease the pain during the menstrual cycle by the reduction of clot formation and iron building".The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

62 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Pure Gold
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "The Pure Gold helps to clear mucous from the system and aids the elimination of poor circulation and respiratory tract infection." The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

62 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Fey Duvan
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "Blood regulator". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

62 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Free Up Laxative
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as; "LAXATIVE"; "Colon Cleanser"; "Free up Laxative which aggressively cleanses the colon of all waste material and plaque that has been compiled on the colonic walls over the years". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

63 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Pure Green
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as; "It is utilized to increase the haemoglobin [sic] content of the blood thus improves its oxygen carrying capacity" and "helps to effectively relieve headaches caused by iron deficiency". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

63 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Fey Duvan
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "Blood regulator". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

63 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Free Up Laxative
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as; "LAXATIVE"; "Colon Cleanser"; "Free up Laxative which aggressively cleanses the colon of all waste material and plaque that has been compiled on the colonic walls over the years". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

63 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Pure Gold
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "The Pure Gold helps to clear mucous from the system and aids the elimination of poor circulation and respiratory tract infection." The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

63 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Womb Cleanser
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as;"The Womb Cleanser helps to clean the womb by increasing contractions of the uterine walls and also helps to balance the female hormones";"Helps to induce menstruation and decrease the pain during the menstrual cycle by the reduction of clot formation and iron building".The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

63 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Blood Detox
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "BLOOD DETOX" and "Blood and organ cleansing". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

64 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Free Up Laxative
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as; "LAXATIVE"; "Colon Cleanser"; "Free up Laxative which aggressively cleanses the colon of all waste material and plaque that has been compiled on the colonic walls over the years". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

64 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Blood Detox
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "BLOOD DETOX" and "Blood and organ cleansing". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

64 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Pure Green
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as; "It is utilized to increase the haemoglobin [sic] content of the blood thus improves its oxygen carrying capacity" and "helps to effectively relieve headaches caused by iron deficiency". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

64 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Womb Cleanser
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as;"The Womb Cleanser helps to clean the womb by increasing contractions of the uterine walls and also helps to balance the female hormones";"Helps to induce menstruation and decrease the pain during the menstrual cycle by the reduction of clot formation and iron building".The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

64 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Pure Gold
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "The Pure Gold helps to clear mucous from the system and aids the elimination of poor circulation and respiratory tract infection." The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

64 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Fey Duvan
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "Blood regulator". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

65 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Free Up Laxative
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as; "LAXATIVE"; "Colon Cleanser"; "Free up Laxative which aggressively cleanses the colon of all waste material and plaque that has been compiled on the colonic walls over the years". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

65 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Pure Gold
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "The Pure Gold helps to clear mucous from the system and aids the elimination of poor circulation and respiratory tract infection." The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

65 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Fey Duvan
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "Blood regulator". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

65 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Womb Cleanser
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as;"The Womb Cleanser helps to clean the womb by increasing contractions of the uterine walls and also helps to balance the female hormones";"Helps to induce menstruation and decrease the pain during the menstrual cycle by the reduction of clot formation and iron building".The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

65 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Pure Green
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as; "It is utilized to increase the haemoglobin [sic] content of the blood thus improves its oxygen carrying capacity" and "helps to effectively relieve headaches caused by iron deficiency". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

65 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Blood Detox
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "BLOOD DETOX" and "Blood and organ cleansing". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

66 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Fey Duvan
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "Blood regulator". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

66 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Pure Green
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as; "It is utilized to increase the haemoglobin [sic] content of the blood thus improves its oxygen carrying capacity" and "helps to effectively relieve headaches caused by iron deficiency". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

66 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Pure Gold
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "The Pure Gold helps to clear mucous from the system and aids the elimination of poor circulation and respiratory tract infection." The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

66 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Blood Detox
Notes: The product appears to be an unapproved new drug; because its LBL and website include claims such as; "BLOOD DETOX" and "Blood and organ cleansing". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

66 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Free Up Laxative
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as; "LAXATIVE"; "Colon Cleanser"; "Free up Laxative which aggressively cleanses the colon of all waste material and plaque that has been compiled on the colonic walls over the years". The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.

66 - - - -- Human and Animal Drugs
Date Published: 08/07/2019

Desc: Womb Cleanser
Notes: The product appears to be an unapproved new drug; because its LBL/website include claims such as;"The Womb Cleanser helps to clean the womb by increasing contractions of the uterine walls and also helps to balance the female hormones";"Helps to induce menstruation and decrease the pain during the menstrual cycle by the reduction of clot formation and iron building".The product also appears to not be GRAS and effective for use under the conditions prescribed; recommended or suggested on its LBL.


SAUDI ARABIA


Al Amri Ast
Date Published : 10/25/2012
60th Street, Babab Sharif , Jeddah, SAUDI ARABIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/25/2012

Desc: Black Seed Vapor Rub

Binzagr Unilever Ltd.
Date Published : 04/14/2014
Industrial Area Phase 111 , Jeddah, SAUDI ARABIA
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/14/2014

Desc: Lifebuoy total 10 Soap with active5

Eastern Light Trading Est.
Date Published : 12/02/2015
Jeddah , Jeddah, Makkah SAUDI ARABIA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/02/2015

Desc: Faiza Beauty Cream
Notes: Product labels make medical claims

Glaxo Saudi Arabia Ltd.
Date Published : 05/24/2011
Unknown , Unknown, SAUDI ARABIA
64 L - - 08 Betamethasone Valerate (Glucocorticoid)
Date Published: 07/19/2012

Desc: Betnoxate Betamethasone Valerate Glucocorticoid
Notes: Saudi Arabia

64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 05/24/2011

Desc: Dermovate Cream
Notes: Saudi Arabia

GlaxoSmithKline
Date Published : 05/24/2011
Unknown , Unknown, SAUDI ARABIA
64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 05/24/2011

Desc: Dermovate Cream
Notes: Saudi Arabia

Hamil Al Musk
Date Published : 10/20/2009
Phase 4, Industrial Area , Jeddah, SAUDI ARABIA
53 F - - 01 Hair Dyes and Colors (all Types Require Caution Statements and Patch Tests) (Hair Coloring Preparati
Date Published: 06/02/2010

Desc: All Hair Oils
Notes: Saudi Arabia

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/20/2009

Notes: Watercress Oil; The immediate container label states it is for Protecting hair from falling; Makes it smooth; Feeding hair and remove scalehead. Garlic Oil; The immediate container label states it Treats Dandruff; Prevents Hair Falling; Revitalizes the hair and makes it long; General strengthens the hair. REASON FOR ALERT; The labeling represents and suggests that the product is intended for

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/02/2010

Desc: All Hair Oils
Notes: Saudi Arabia


SEYCHELLES


Bionational Pharmaceuticals
Date Published : 09/30/2009
POB 998, 1st Floor, Office 14 , Trinity House , Victoria, Mahe, SEYCHELLES
54 - - Y -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), NEC
Date Published: 09/30/2009

Notes: 9/12/2007. Nu Eyes and Can-C Eyedrops.

55 Q P - 58 Glycerin (Pharmaceutic Necessity - Solvent), Pharma Necess
Date Published: 09/17/2019

Notes: 9/12/2007. Nu Eyes and Can-C Eyedrops.

55 R P - 12 Carboxymethylcellulose Sodium (Pharmaceutic Necessity - Suspending Agent), Pharma Necess
Date Published: 09/17/2019

Notes: 9/12/2007. Nu Eyes and Can-C Eyedrops.

66 - - V -- Human and Animal Drugs, Compressed Medical Gas
Date Published: 09/30/2009

Notes: 9/12/2007. Nu Eyes and Can-C Eyedrops.


SIERRA LEONE


Morvigor Ltd.
Date Published : 06/22/2018
27 Peeler Street , Wellington, SIERRA LEONE
31 K - - -- Tea
Date Published: 06/22/2018

Desc: Morvigor Moringa Herbal Tea

31 N - - -- Novelty Tea
Date Published: 06/22/2018

Desc: Morvigor Moringa Herbal Tea

54 E - - -- Herbal and Botanical
Date Published: 06/22/2018

Desc: Morvigor Moringa Herbal Tea

54 J - - -- Herbal and Botanical II
Date Published: 06/22/2018

Desc: Morvigor Moringa Herbal Tea

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/22/2018

Desc: Morvigor Moringa Herbal Tea


SINGAPORE


1 Drugstore On Line
Date Published : 09/30/2009
429 Rochor Road , Startech Holding Limited , Unknown, SINGAPORE
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 08/06/2020

Desc: Abarelix
Notes:                            

64 R - - 21 Somatropin (Hormone)
Date Published: 08/06/2020

Notes:                                

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                                

111 Drug Store.Com
Date Published : 09/30/2009
Unknown , Unknown, SINGAPORE
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 08/20/2020

Desc: Abarelix
Notes:                       

64 R - - 21 Somatropin (Hormone)
Date Published: 08/20/2020

Notes:                       

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                       

Apex Cosmeceutical Industry Pte
Date Published : 12/22/2014
27 Mandai Estate 60 01 02 03 , Sin, SINGAPORE
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/22/2014

Desc: CF Comedone Formula
Notes: The aforementioned product appears to be an unapproved new drug as the product label and website (www.derma-rx.com) indicate the product is used to treat comedone

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 12/22/2014

Desc: CF Comedone Formula
Notes: The aforementioned product appears to be an unapproved new drug as the product label and website (www.derma-rx.com) indicate the product is used to treat comedone.

61 H - - 99 Anti-Bacterial, N.E.C.
Date Published: 12/22/2014

Desc: CF Comedone Formula
Notes: The aforementioned product appears to be an unapproved new drug as the product label and website (www.derma-rx.com) indicate the product is used to treat comedone.

Beacons Pharmaceuticals Pte Ltd
Date Published : 11/08/2017
21 Chin Bee Avenue , Singapore, SG-05 SINGAPORE
54 F - - 33 Astragalus (Milk Vetch Root), (Herbal & Botanicals, not Teas)
Date Published: 11/08/2017

Desc: NeuroAid
Notes: Medical claims made on company?s website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2017

Desc: NeuroAid
Notes: Medical claims made on company?s website

DB Group (BH Pharmacy)
Date Published : 09/30/2009
Blk 820 Yishun Street 81 , #06-656 , Unknown, SINGAPORE
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 08/06/2020

Desc: Abarelix
Notes:                     

64 R - - 21 Somatropin (Hormone)
Date Published: 08/06/2020

Notes:                     

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                     

Derma-Rx Int'L Aesthetics Pte
Date Published : 12/22/2014
213 Henderson Road 01-08 , Sin, SINGAPORE
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/22/2014

Desc: CF Comedone Formula
Notes:                                                                                                                                                                                                        

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 12/22/2014

Desc: CF Comedone Formula
Notes:                                                                                                                                                                                                        

61 H - - 99 Anti-Bacterial, N.E.C.
Date Published: 12/22/2014

Desc: CF Comedone Formula
Notes:                                                                                                                                                                                                        

Goldendays
Date Published : 12/05/2014
26a Purvis Street , Singapore, SINGAPORE
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)-; V. TAPAD Meno
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)- V. TAPADradiance
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)- V. GOPAD
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)- V. TAPAD
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)-V. TAPADmenstrua
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/08/2014

Desc: Detox Pads (transdermal)-V. TAPADmed
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

60 J - - 99 Ammonia Detoxicant, N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)-V. TAPADmenstrua
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

60 J - - 99 Ammonia Detoxicant, N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)-V. TAPADmed
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374 ;

60 J - - 99 Ammonia Detoxicant, N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)- V. GOPAD
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

60 J - - 99 Ammonia Detoxicant, N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)-; V. TAPAD Meno
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

60 J - - 99 Ammonia Detoxicant, N.E.C.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)- V. TAPAD
Notes: ;Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)-; V. TAPAD Meno
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)-V. TAPADmed
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)- V. TAPAD
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)- V. TAPADradiance
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)-V. TAPADmenstrua
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2014

Desc: Detox Pads (transdermal)- V. GOPAD
Notes: Mfg. per OASIS & Packing List is Goldendays Eco Naturalcare Pte.; Ltd.; FEI # 3011081030 Mfg/distributor per product label is Goldendays International Holdings; FEI # 3010889374

Netzah Pharmacy Co
Date Published : 04/18/2016
115 Airport Cargo Road , #02-20 Cargo Agents Building C , Singapore, SINGAPORE
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/18/2016

Desc: Naltrexone 4.5mg Capsules
Notes:                                                                                                                                                                                                                                                                                                      

60 M - - 28 Naltrexone Hydrochloride (Analgesic, Narcotic)
Date Published: 04/18/2016

Desc: Naltrexone 4.5mg Capsules
Notes:                                                                                                                                                                                                                                                                                                      

60 T - - 15 Naltrexone (Antagonist)
Date Published: 04/18/2016

Desc: Naltrexone 4.5mg Capsules
Notes:                                                                                                                                                                                                                                                                                                      

ONECARE WELLNESS
Date Published : 03/07/2017
10 Ubi Crescent , #04-99 Ubi Techpark , Singapore, SINGAPORE
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/07/2017

Desc: Praventac Capsules
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; 'The breakthrough solution for acne-prone skin; [I]t inhibits the growth of the propionibacterium; which is ...responsible for acne; Praventac's anti-inflammatory properties mean that the size of spots is reduced and blemishes heal quicker; Clear acne and repair damage skin cells with Praventac - a leading acne-fighting formula'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/07/2017

Desc: Ag-Factor Capsules
Notes: The product appears to be an unapproved new drug as the product website includes claims such as; ?[P]rotecting us against cancer via cytokines production (natural cancer killer cells); Reduce Redness Associated With Inflammation; Whey Protein Hydrolysate (an ingredient in Ag-Factor) ? milk protein can reduce risk of cancer?.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/07/2017

Desc: Praventac Capsules
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; 'The breakthrough solution for acne-prone skin; [I]t inhibits the growth of the propionibacterium; which is ...responsible for acne; Praventac's anti-inflammatory properties mean that the size of spots is reduced and blemishes heal quicker; Clear acne and repair damage skin cells with Praventac - a leading acne-fighting formula'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/07/2017

Desc: Ag-Factor Capsules
Notes: The product appears to be an unapproved new drug as the product website includes claims such as; ?[P]rotecting us against cancer via cytokines production (natural cancer killer cells); Reduce Redness Associated With Inflammation; Whey Protein Hydrolysate (an ingredient in Ag-Factor) ? milk protein can reduce risk of cancer?.

Opto-Pharm Pte Ltd.
Date Published : 09/30/2009
13 Tuas Avenue 12 , Singapore, SINGAPORE
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2009

Notes: Orto eyes is labeled as a dietary supplement and as a protectant against eye irritation or to relieve dryness of the eye. Based on its route of administration (opthamalic); this product does not qualify as a dietary supplement because it is not ingested. In addition; the website www.aor.ca that describes Ortho Eyes product; promotes one of its ingrediants N-acetyl-carnosine to improve eyesite; treat corneal dtsrophy; corneal trophic keratitus and bullous keratopathy. Based on its intended uses this product is a drug. Further; we are not aware of anyth substantial scientific evidence that this product is generally recognized as safe and effective for the conditions recommended or suggested on its labeling.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: Ortho eyes is labeled as a dietary supplement and as a protectant against eye irritation or to relieve dryness of the eye. Based on its route of administration (opthamalic); this product does not qualify as a dietary supplement because it is not ingested. In addition; the website www.aor.ca that describes Ortho Eyes product; promotes one of its ingrediants N-acetyl-carnosine to improve eyesite; treat corneal dtsrophy; corneal trophic keratitus and bullous keratopathy. Based on its intended uses this product is a drug. Further; we are not aware of anyth substantial scientific evidence that this product is generally recognized as safe and effective for the conditions recommended or suggested on its labeling.

Smith Meyers Laboratories
Date Published : 12/15/2011
8 Temasek Boulevard , Floor 42 Suntec Tower Three , Singapore, SINGAPORE
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/07/2012

Desc: Invitar Body Gel
Notes: Sinapore

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/07/2012

Desc: Invitar Body Gel
Notes: Singapore

TR Networks Limited
Date Published : 09/30/2009
50 Macpherson Road , Amazana , Singapore, SINGAPORE
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 4/6/2007 Kinohimitsu detox Patches                       


SLOVAKIA


Megagear Ltd.
Date Published : 03/08/2013
Namestie 1 Maja 15 , Bratislava, Bratislavsk¿ SLOVAKIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/08/2013

Desc: Tren Enant 150 Winny 50 and Testobol 250
Notes: Country; Slovakia

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/10/2013

Desc: Deca 200 Dietary Supplement

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/10/2013

Desc: Susta Max 200 Dietary Supplement

55 R - - 99 Pharmaceutic Necessities, N.E.C.
Date Published: 06/10/2013

Desc: Deca 200 Dietary Supplement

55 R - - 99 Pharmaceutic Necessities, N.E.C.
Date Published: 06/10/2013

Desc: Susta Max 200 Dietary Supplement


SLOVENIA


Heiltropfen
Date Published : 06/07/2016
Anastazija Sabina Stanovnik , Ptujptuj, SLOVENIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/07/2016

Desc: Zeolite Clinoptilolite
Notes: Medical claims on product labels and website

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/07/2016

Desc: DMSO (Dimethyl Sulfoxid)
Notes: Medical claims on product labels and website


SOUTH AFRICA


Access Meds
Date Published : 09/30/2009
46 Parnlet , Newcastle, SOUTH AFRICA
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 05/26/2020

Desc: Abarelix
Notes:                      

64 R - - 21 Somatropin (Hormone)
Date Published: 05/26/2020

Notes:                      

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                      

Afriplex (Pty) Ltd.
Date Published : 01/25/2017
10 De Vreugde Crescent , Paarl, Western Cape SOUTH AFRICA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/25/2017

Desc: HERBEX DETOX TABLETS
Notes: Medical claims made on product label

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/25/2017

Desc: HERBEX FAT BURN COMPLETE PACK
Notes: Medical claims made on product label

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/25/2017

Desc: HERBEX APPETITE CONTROL FORMULA
Notes: Medical claims made on product label

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/25/2017

Desc: HERBEX FAT BURN KICK START PACK FOR MEN
Notes: Medical claims made on product label

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2017

Desc: HERBEX DETOX TABLETS
Notes: Medical claims made on product label

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2017

Desc: HERBEX FAT BURN KICK START PACK FOR MEN
Notes: Medical claims made on product label

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2017

Desc: HERBEX APPETITE CONTROL FORMULA
Notes: Medical claims made on product label

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2017

Desc: HERBEX FAT BURN COMPLETE PACK
Notes: Medical claims made on product label

Annique Skincare Products
Date Published : 01/14/2010
29 Regency Ave, Route 21, Corporate Park , Irene, SOUTH AFRICA
53 A - - 02 Lotions, Oils, Powders and Creams (Baby Products)
Date Published: 01/22/2010

Desc: Baby Resque Cream

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 01/22/2010

Desc: Revitalizing Cream

53 L - - 07 Night (Skin Care Preparations)
Date Published: 01/14/2010

Desc: Pamperlang Resque Cream
Notes: Country; South Africa

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 01/14/2010

Desc: PH Balancing Freshener
Notes: Country; South Africa

53 L - - -- Skin Care Prep
Date Published: 02/01/2010

Desc: Vitamin E Tissue Oil
Notes: Note: Product claims to ¿protect against sunburn, dehydration, and ageing¿ and will restructure damaged cell walls.

54 E - - 16 Licorice (Herbal & Botanical Teas)
Date Published: 02/02/2010

Desc: Vitamin E Tissue Oil
Notes: Note; Product claims to ?protect against sunburn; dehydration; and ageing? and will restructure damaged cell walls.

60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 01/14/2010

Desc: Pamperlang Resque Cream
Notes: Country; South Africa

60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 01/14/2010

Desc: Ph Balancing Freshener
Notes: Country; South Africa

60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 01/22/2010

Desc: Revitalizing Cream

60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 01/22/2010

Desc: Baby Resque Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/14/2010

Desc: Pamperlang Resque Cream
Notes: Country; South Africa

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/14/2010

Desc: Ph Balancing Freshener
Notes: Country; South Africa

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/22/2010

Desc: Baby Resque Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/01/2010

Desc: Vitamin E Tissue Oil
Notes: Note: Product claims to ¿protect against sunburn, dehydration, and ageing¿ and will restructure damaged cell walls.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/22/2010

Desc: Revitalizing Cream

Biogenesis Laboratories Order Form
Date Published : 09/30/2009
P.O. Box 48119 , Kommetjie 7976, SOUTH AFRICA
62 I - - -- A-Neoplastic
Date Published: 09/30/2009

Notes: Curaderm-BEC5 Cream                        8/30/2007

64 X - - 06 Salicylic Acid (Keratolytic)
Date Published: 09/30/2009

Notes: Curaderm-BEC5 Cream                        8/30/2007

64 X - - -- Keratolytic
Date Published: 09/30/2009

Notes:                        8/30/2007 Curaderm-BEC5 Cream

Cauldron Chemicals (Pty) Ltd
Date Published : 10/08/2013
23 Mayfield Ave , Cape Town, SOUTH AFRICA
53 D - - 01 Colognes and Toilet Waters (Fragrance Preparations)
Date Published: 10/08/2013

Desc: Edge Trust-Perfume

53 D - - 02 Perfumes (Fragrance Preparations)
Date Published: 10/08/2013

Desc: Edge Trust-Perfume

53 D - - 99 Other Fragrance Preparations, N.E.C.
Date Published: 10/08/2013

Desc: Edge Trust-Perfume

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/08/2013

Desc: Edge Trust-Perfume

Damaansa Holdings Pty Ltd
Date Published : 06/08/2011
24 Warrington Road , Cape Town, Western Cape SOUTH AFRICA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/08/2011

Desc: Faith Herbal Drops Extract Dietary Supplements
Notes: South Africa

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2011

Desc: Faith Herbal Drops Extract Dietary Supplements
Notes: South Africa

Edelweiss Pharmaceuticals
Date Published : 05/22/2012
Mocke Road, Diep River , B12-13 Prime Park , Cape Town, Western Cape SOUTH AFRICA
54 B - - 99 Mineral N.E.C.
Date Published: 05/22/2012

Desc: Sceletium Tablets & Capsules

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/22/2012

Desc: Sceletium Tablets

Genesis 11 Church
Date Published : 08/11/2014
7 Clivia Close Heather Park , Georgegeorge, SOUTH AFRICA
54 B - - 99 Mineral N.E.C.
Date Published: 08/11/2014

Desc: MMS
Notes:                                                                                                                                                                                                     

54 B - - 99 Mineral N.E.C.
Date Published: 08/11/2014

Desc: MMS2
Notes:                                                                                                                                                                                                     

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/11/2014

Desc: MMS2
Notes:                                                                                                                                                                                                         

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/11/2014

Desc: MMS
Notes:                                                                                                                                                                                                     

Go2Pharma
Date Published : 11/28/2011
12 Pickwick Road , Cape Town, Western Cape SOUTH AFRICA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 11/28/2011

Desc: Thyro-Pet and Eye Heal
Notes: South Africa

60 - - - -- Human and Animal Drugs
Date Published: 11/28/2011

Desc: Thyro-Pet and Eye Heal
Notes: South Africa

61 - - - -- Human and Animal Drugs
Date Published: 12/01/2011

Desc: Thyro-Pet and Eye Heal
Notes: South Africa

62 - - - -- Human and Animal Drugs
Date Published: 11/28/2011

Desc: Thyro-Pet and Eye Heal
Notes: South Africa

63 - - - -- Human and Animal Drugs
Date Published: 11/28/2011

Desc: Thyro-Pet and Eye Heal
Notes: South Africa

64 - - - -- Human and Animal Drugs
Date Published: 11/28/2011

Desc: Thyro-Pet and Eye Heal
Notes: South Africa

65 - - - -- Human and Animal Drugs
Date Published: 11/28/2011

Desc: Thyro-Pet and Eye Heal
Notes: South Africa

66 - - - -- Human and Animal Drugs
Date Published: 11/28/2011

Desc: Thyro-Pet and Eye Heal
Notes: South Africa

HEALTHYLIFE CAPETOWN
Date Published : 03/15/2024
Rondebosch Cape Town 77 , Cape Town, Western Cape SOUTH AFRICA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/15/2024

Desc: COLOPERM Powder

HERBEX PTY LIMITED
Date Published : 01/25/2017
Unit 2 , Nexus Place , Cape Town, Western Cape SOUTH AFRICA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/25/2017

Desc: HERBEX APPETITE CONTROL FORMULA
Notes: Medical claims made on product label

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/25/2017

Desc: HERBEX FAT BURN KICK START PACK FOR MEN
Notes: Medical claims made on product label

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/25/2017

Desc: HERBEX FAT BURN COMPLETE PACK
Notes: Medical claims made on product label

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/25/2017

Desc: HERBEX DETOX TABLETS
Notes: Medical claims made on product label

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2017

Desc: HERBEX FAT BURN COMPLETE PACK
Notes: Medical claims made on product label

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2017

Desc: HERBEX APPETITE CONTROL FORMULA
Notes: Medical claims made on product label

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2017

Desc: HERBEX DETOX TABLETS
Notes: Medical claims made on product label

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2017

Desc: HERBEX FAT BURN KICK START PACK FOR MEN
Notes: Medical claims made on product label

Hands Down Distribution
Date Published : 06/08/2011
24B Warrington Road , Kenilworth , Cape Town, SOUTH AFRICA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/08/2011

Desc: Faith Herbal Drops Extract Dietary Supplements
Notes: South Africa

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2011

Desc: Faith Herbal Drops Extract Dietary Supplements
Notes: South Africa

In Conidence Health Cc
Date Published : 07/11/2013
12 Hely Road Maitland , Cape Town, SOUTH AFRICA
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/11/2013

Desc: XXXL Penis Enlarging Ointment
Notes: South Africa

66 S - - 99 Vasodilator N.E.C.
Date Published: 07/11/2013

Desc: XXXL Penis Enlarging Ointment
Notes: South Africa

Kyron Laboratories Pty Limited
Date Published : 08/09/2016
29 Barney Road , Johannesburg, Gauteng SOUTH AFRICA
60 L - - 99 Analgesic, N.E.C.
Date Published: 08/09/2016

Desc: Arnica Ice Cooling Gel
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?A cooling gel as an aid in the relief of stiffness and soreness; painful muscles; tendons and joints?; and ?Effective as a pre- and post- workout rub for all muscular aches and pains?.

62 M - - 08 Menthol (Anti-Pruritic)
Date Published: 08/09/2016

Desc: Arnica Ice Cooling Gel
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?A cooling gel as an aid in the relief of stiffness and soreness; painful muscles; tendons and joints?; and ?Effective as a pre- and post- workout rub for all muscular aches and pains?.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/09/2016

Desc: Arnica Ice Cooling Gel
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?A cooling gel as an aid in the relief of stiffness and soreness; painful muscles; tendons and joints?; and ?Effective as a pre- and post- workout rub for all muscular aches and pains?.

MILLER METHODS
Date Published : 03/21/2017
77 10th Road , Johannesburg, Gauteng SOUTH AFRICA
53 J - - -- Personal Cleanliness
Date Published: 03/21/2017

Desc: ACTIV O2 Skin Breakout Clearing Lotion
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; "Discover the healing properties and accelerated skin clearing action of ACTIV O2; Provides effective relief from pimples and blemishes to leave skin smooth and flawless".

53 J - - -- Personal Cleanliness
Date Published: 03/21/2017

Desc: ACTIV O2 Skin Breakout Cleansing Bar
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; "Discover the healing properties and accelerated skin clearing action of ACTIV O2; ... specially formulated for problem skin; with Salicylic Acid to help slow down shedding of cells inside the follicles".

53 J - - -- Personal Cleanliness
Date Published: 03/21/2017

Desc: ACTIV O2 Skin Breakout Clearing Cream
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; "...Skin Breakout Clearing Cream ... ; High performance skin clearing action..".

53 L - - -- Skin Care Prep
Date Published: 03/21/2017

Desc: ACTIV O2 Skin Breakout Cleansing Bar
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; "Discover the healing properties and accelerated skin clearing action of ACTIV O2; ? specially formulated for problem skin; with Salicylic Acid to help slow down shedding of cells inside the follicles".

53 L - - -- Skin Care Prep
Date Published: 03/21/2017

Desc: ACTIV O2 Skin Breakout Clearing Cream
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; "...Skin Breakout Clearing Cream ... ; High performance skin clearing action..".

53 L - - -- Skin Care Prep
Date Published: 03/21/2017

Desc: ACTIV O2 Skin Breakout Clearing Lotion
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; "Discover the healing properties and accelerated skin clearing action of ACTIV O2; Provides effective relief from pimples and blemishes to leave skin smooth and flawless".

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 03/21/2017

Desc: ACTIV O2 Skin Breakout Clearing Cream
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; "...Skin Breakout Clearing Cream ... ; High performance skin clearing action..".

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 03/21/2017

Desc: ACTIV O2 Skin Breakout Clearing Lotion
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; "Discover the healing properties and accelerated skin clearing action of ACTIV O2; Provides effective relief from pimples and blemishes to leave skin smooth and flawless".

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 03/21/2017

Desc: ACTIV O2 Skin Breakout Cleansing Bar
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; "Discover the healing properties and accelerated skin clearing action of ACTIV O2; ... specially formulated for problem skin; with Salicylic Acid to help slow down shedding of cells inside the follicles".

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/21/2017

Desc: ACTIV O2 Skin Breakout Clearing Cream
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; "...Skin Breakout Clearing Cream ... ; High performance skin clearing action..".

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/21/2017

Desc: ACTIV O2 Skin Breakout Clearing Lotion
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; "Discover the healing properties and accelerated skin clearing action of ACTIV O2; Provides effective relief from pimples and blemishes to leave skin smooth and flawless".

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/21/2017

Desc: ACTIV O2 Skin Breakout Cleansing Bar
Notes: The product appears to be an unapproved new drug as the product label includes claims such as; "Discover the healing properties and accelerated skin clearing action of ACTIV O2; ... specially formulated for problem skin; with Salicylic Acid to help slow down shedding of cells inside the follicles".

MULTI MINERAL SUPPLEMENT
Date Published : 07/08/2020
1 Quark Crescent , Sandton, Gauteng SOUTH AFRICA
53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Disinfection Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Spray your ready solution on all surfaces that you suspect infection . . . Hands . . . can also be sprayed safely'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Nasal/Throat Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Comfortably find best position within nostril and spray solution three times. Best practice is to feel the solution towards the back of throat...'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 1 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Bath Tablets
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as (not an all-inclusive list): [Website]:'MMS BATH 12 TABLETS - BEST SKIN INFECTION CONTROL'; [Label]:'Lay in the bath and soak the skin for 20-30 mins...'

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Magnesium Bicarb Body Decalcifier Dry Mix
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): '[H]ydrozone Magnesium BiCarb demonstrated that optimal hydration with Hydrozone Magnesium BiCarb over three months may significantly increase blood magnesium levels, may significantly stabilise [sic] blood parathyroid hormone levels and may significantly increase blood albumin protein levels. These factors have been identified in independent international studies as factors that are significantly correlated to either decreased risk or increased survival of a range of serious diseases including ischaemic [sic] heart disease, stroke, osteoporosis, osteoarthritis, atherosclerosis ('hardening of the arteries'), breast cancer, other cancers and many of the debilitating diseases associated with ageing [sic]...'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Curagel
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'CuraGel destroys 99.9% of all known pathogens causing chronic skin infections ...'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Body Cream
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'HOW DOES IT WORK . . .effectively fighting off infection. The Multi Mineral Supplement II special formula is a natural antibacterial wound or infection healing agent. This day and night cream contains the skin's own active Multi Mineral Supplement II formula and moisturized to effectively ward off infection and heal wounds...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Bath Tablets
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as (not an all-inclusive list): [Website]:'MMS BATH 12 TABLETS - BEST SKIN INFECTION CONTROL'; [Label]:'Lay in the bath and soak the skin for 20-30 mins...'

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Nasal/Throat Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Comfortably find best position within nostril and spray solution three times. Best practice is to feel the solution towards the back of throat...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Disinfection Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Spray your ready solution on all surfaces that you suspect infection . . . Hands . . . can also be sprayed safely'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Curagel
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'CuraGel destroys 99.9% of all known pathogens causing chronic skin infections ...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 1 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Magnesium Bicarb Body Decalcifier Dry Mix
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): '[H]ydrozone Magnesium BiCarb demonstrated that optimal hydration with Hydrozone Magnesium BiCarb over three months may significantly increase blood magnesium levels, may significantly stabilise [sic] blood parathyroid hormone levels and may significantly increase blood albumin protein levels. These factors have been identified in independent international studies as factors that are significantly correlated to either decreased risk or increased survival of a range of serious diseases including ischaemic [sic] heart disease, stroke, osteoporosis, osteoarthritis, atherosclerosis ('hardening of the arteries'), breast cancer, other cancers and many of the debilitating diseases associated with ageing [sic]...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Curagel
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'CuraGel destroys 99.9% of all known pathogens causing chronic skin infections ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Bath Tablets
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as (not an all-inclusive list): [Website]:'MMS BATH 12 TABLETS - BEST SKIN INFECTION CONTROL'; [Label]:'Lay in the bath and soak the skin for 20-30 mins...'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Body Cream
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'HOW DOES IT WORK . . .effectively fighting off infection. The Multi Mineral Supplement II special formula is a natural antibacterial wound or infection healing agent. This day and night cream contains the skin's own active Multi Mineral Supplement II formula and moisturized to effectively ward off infection and heal wounds...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 1 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Magnesium Bicarb Body Decalcifier Dry Mix
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): '[H]ydrozone Magnesium BiCarb demonstrated that optimal hydration with Hydrozone Magnesium BiCarb over three months may significantly increase blood magnesium levels, may significantly stabilise [sic] blood parathyroid hormone levels and may significantly increase blood albumin protein levels. These factors have been identified in independent international studies as factors that are significantly correlated to either decreased risk or increased survival of a range of serious diseases including ischaemic [sic] heart disease, stroke, osteoporosis, osteoarthritis, atherosclerosis ('hardening of the arteries'), breast cancer, other cancers and many of the debilitating diseases associated with ageing [sic]...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Disinfection Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Spray your ready solution on all surfaces that you suspect infection . . . Hands . . . can also be sprayed safely'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Nasal/Throat Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Comfortably find best position within nostril and spray solution three times. Best practice is to feel the solution towards the back of throat...'.

MULTI MINERAL SUPPLEMENT
Date Published : 07/08/2020
13 First Road , George, Western Cape SOUTH AFRICA
53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Disinfection Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Spray your ready solution on all surfaces that you suspect infection . . . Hands . . . can also be sprayed safely'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Nasal/Throat Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Comfortably find best position within nostril and spray solution three times. Best practice is to feel the solution towards the back of throat...'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Curagel
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'CuraGel destroys 99.9% of all known pathogens causing chronic skin infections ...'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Magnesium Bicarb Body Decalcifier Dry Mix
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): '[H]ydrozone Magnesium BiCarb demonstrated that optimal hydration with Hydrozone Magnesium BiCarb over three months may significantly increase blood magnesium levels, may significantly stabilise [sic] blood parathyroid hormone levels and may significantly increase blood albumin protein levels. These factors have been identified in independent international studies as factors that are significantly correlated to either decreased risk or increased survival of a range of serious diseases including ischaemic [sic] heart disease, stroke, osteoporosis, osteoarthritis, atherosclerosis ('hardening of the arteries'), breast cancer, other cancers and many of the debilitating diseases associated with ageing [sic]...'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 1 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Bath Tablets
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as (not an all-inclusive list): [Website]:'MMS BATH 12 TABLETS - BEST SKIN INFECTION CONTROL'; [Label]:'Lay in the bath and soak the skin for 20-30 mins...'

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Body Cream
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'HOW DOES IT WORK . . .effectively fighting off infection. The Multi Mineral Supplement II special formula is a natural antibacterial wound or infection healing agent. This day and night cream contains the skin's own active Multi Mineral Supplement II formula and moisturized to effectively ward off infection and heal wounds...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Body Cream
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'HOW DOES IT WORK . . .effectively fighting off infection. The Multi Mineral Supplement II special formula is a natural antibacterial wound or infection healing agent. This day and night cream contains the skin's own active Multi Mineral Supplement II formula and moisturized to effectively ward off infection and heal wounds...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Disinfection Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Spray your ready solution on all surfaces that you suspect infection . . . Hands . . . can also be sprayed safely'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Magnesium Bicarb Body Decalcifier Dry Mix
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): '[H]ydrozone Magnesium BiCarb demonstrated that optimal hydration with Hydrozone Magnesium BiCarb over three months may significantly increase blood magnesium levels, may significantly stabilise [sic] blood parathyroid hormone levels and may significantly increase blood albumin protein levels. These factors have been identified in independent international studies as factors that are significantly correlated to either decreased risk or increased survival of a range of serious diseases including ischaemic [sic] heart disease, stroke, osteoporosis, osteoarthritis, atherosclerosis ('hardening of the arteries'), breast cancer, other cancers and many of the debilitating diseases associated with ageing [sic]...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Curagel
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'CuraGel destroys 99.9% of all known pathogens causing chronic skin infections ...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 1 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Nasal/Throat Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Comfortably find best position within nostril and spray solution three times. Best practice is to feel the solution towards the back of throat...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Bath Tablets
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as (not an all-inclusive list): [Website]:'MMS BATH 12 TABLETS - BEST SKIN INFECTION CONTROL'; [Label]:'Lay in the bath and soak the skin for 20-30 mins...'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Curagel
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'CuraGel destroys 99.9% of all known pathogens causing chronic skin infections ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Bath Tablets
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as (not an all-inclusive list): [Website]:'MMS BATH 12 TABLETS - BEST SKIN INFECTION CONTROL'; [Label]:'Lay in the bath and soak the skin for 20-30 mins...'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Magnesium Bicarb Body Decalcifier Dry Mix
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): '[H]ydrozone Magnesium BiCarb demonstrated that optimal hydration with Hydrozone Magnesium BiCarb over three months may significantly increase blood magnesium levels, may significantly stabilise [sic] blood parathyroid hormone levels and may significantly increase blood albumin protein levels. These factors have been identified in independent international studies as factors that are significantly correlated to either decreased risk or increased survival of a range of serious diseases including ischaemic [sic] heart disease, stroke, osteoporosis, osteoarthritis, atherosclerosis ('hardening of the arteries'), breast cancer, other cancers and many of the debilitating diseases associated with ageing [sic]...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 1 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Body Cream
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'HOW DOES IT WORK . . .effectively fighting off infection. The Multi Mineral Supplement II special formula is a natural antibacterial wound or infection healing agent. This day and night cream contains the skin's own active Multi Mineral Supplement II formula and moisturized to effectively ward off infection and heal wounds...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Nasal/Throat Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Comfortably find best position within nostril and spray solution three times. Best practice is to feel the solution towards the back of throat...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Disinfection Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Spray your ready solution on all surfaces that you suspect infection . . . Hands . . . can also be sprayed safely'.

MULTI MINERAL SUPPLEMENT
Date Published : 07/08/2020
Po Box 4672 , George, Western Cape SOUTH AFRICA
53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Magnesium Bicarb Body Decalcifier Dry Mix
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): '[H]ydrozone Magnesium BiCarb demonstrated that optimal hydration with Hydrozone Magnesium BiCarb over three months may significantly increase blood magnesium levels, may significantly stabilise [sic] blood parathyroid hormone levels and may significantly increase blood albumin protein levels. These factors have been identified in independent international studies as factors that are significantly correlated to either decreased risk or increased survival of a range of serious diseases including ischaemic [sic] heart disease, stroke, osteoporosis, osteoarthritis, atherosclerosis ('hardening of the arteries'), breast cancer, other cancers and many of the debilitating diseases associated with ageing [sic]...'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Body Cream
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'HOW DOES IT WORK . . .effectively fighting off infection. The Multi Mineral Supplement II special formula is a natural antibacterial wound or infection healing agent. This day and night cream contains the skin's own active Multi Mineral Supplement II formula and moisturized to effectively ward off infection and heal wounds...'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 1 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Disinfection Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Spray your ready solution on all surfaces that you suspect infection . . . Hands . . . can also be sprayed safely'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Curagel
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'CuraGel destroys 99.9% of all known pathogens causing chronic skin infections ...'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Bath Tablets
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as (not an all-inclusive list): [Website]:'MMS BATH 12 TABLETS - BEST SKIN INFECTION CONTROL'; [Label]:'Lay in the bath and soak the skin for 20-30 mins...'

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Nasal/Throat Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Comfortably find best position within nostril and spray solution three times. Best practice is to feel the solution towards the back of throat...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Magnesium Bicarb Body Decalcifier Dry Mix
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): '[H]ydrozone Magnesium BiCarb demonstrated that optimal hydration with Hydrozone Magnesium BiCarb over three months may significantly increase blood magnesium levels, may significantly stabilise [sic] blood parathyroid hormone levels and may significantly increase blood albumin protein levels. These factors have been identified in independent international studies as factors that are significantly correlated to either decreased risk or increased survival of a range of serious diseases including ischaemic [sic] heart disease, stroke, osteoporosis, osteoarthritis, atherosclerosis ('hardening of the arteries'), breast cancer, other cancers and many of the debilitating diseases associated with ageing [sic]...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 1 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Disinfection Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Spray your ready solution on all surfaces that you suspect infection . . . Hands . . . can also be sprayed safely'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Nasal/Throat Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Comfortably find best position within nostril and spray solution three times. Best practice is to feel the solution towards the back of throat...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Body Cream
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'HOW DOES IT WORK . . .effectively fighting off infection. The Multi Mineral Supplement II special formula is a natural antibacterial wound or infection healing agent. This day and night cream contains the skin's own active Multi Mineral Supplement II formula and moisturized to effectively ward off infection and heal wounds...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Bath Tablets
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as (not an all-inclusive list): [Website]:'MMS BATH 12 TABLETS - BEST SKIN INFECTION CONTROL'; [Label]:'Lay in the bath and soak the skin for 20-30 mins...'

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Curagel
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'CuraGel destroys 99.9% of all known pathogens causing chronic skin infections ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Curagel
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'CuraGel destroys 99.9% of all known pathogens causing chronic skin infections ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Magnesium Bicarb Body Decalcifier Dry Mix
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): '[H]ydrozone Magnesium BiCarb demonstrated that optimal hydration with Hydrozone Magnesium BiCarb over three months may significantly increase blood magnesium levels, may significantly stabilise [sic] blood parathyroid hormone levels and may significantly increase blood albumin protein levels. These factors have been identified in independent international studies as factors that are significantly correlated to either decreased risk or increased survival of a range of serious diseases including ischaemic [sic] heart disease, stroke, osteoporosis, osteoarthritis, atherosclerosis ('hardening of the arteries'), breast cancer, other cancers and many of the debilitating diseases associated with ageing [sic]...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Body Cream
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'HOW DOES IT WORK . . .effectively fighting off infection. The Multi Mineral Supplement II special formula is a natural antibacterial wound or infection healing agent. This day and night cream contains the skin's own active Multi Mineral Supplement II formula and moisturized to effectively ward off infection and heal wounds...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 1 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Bath Tablets
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as (not an all-inclusive list): [Website]:'MMS BATH 12 TABLETS - BEST SKIN INFECTION CONTROL'; [Label]:'Lay in the bath and soak the skin for 20-30 mins...'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Disinfection Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Spray your ready solution on all surfaces that you suspect infection . . . Hands . . . can also be sprayed safely'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Nasal/Throat Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Comfortably find best position within nostril and spray solution three times. Best practice is to feel the solution towards the back of throat...'.

Multi Mineral Supplement
Date Published : 07/08/2020
First Street 31 Fairview , Johannesburg, SOUTH AFRICA
53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 1 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Bath Tablets
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as (not an all-inclusive list): [Website]:'MMS BATH 12 TABLETS - BEST SKIN INFECTION CONTROL'; [Label]:'Lay in the bath and soak the skin for 20-30 mins...'

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Disinfection Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Spray your ready solution on all surfaces that you suspect infection . . . Hands . . . can also be sprayed safely'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Body Cream
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'HOW DOES IT WORK . . .effectively fighting off infection. The Multi Mineral Supplement II special formula is a natural antibacterial wound or infection healing agent. This day and night cream contains the skin's own active Multi Mineral Supplement II formula and moisturized to effectively ward off infection and heal wounds...'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Nasal/Throat Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Comfortably find best position within nostril and spray solution three times. Best practice is to feel the solution towards the back of throat...'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Curagel
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'CuraGel destroys 99.9% of all known pathogens causing chronic skin infections ...'.

53 B - - -- Bath Prep
Date Published: 07/08/2020

Desc: Magnesium Bicarb Body Decalcifier Dry Mix
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): '[H]ydrozone Magnesium BiCarb demonstrated that optimal hydration with Hydrozone Magnesium BiCarb over three months may significantly increase blood magnesium levels, may significantly stabilise [sic] blood parathyroid hormone levels and may significantly increase blood albumin protein levels. These factors have been identified in independent international studies as factors that are significantly correlated to either decreased risk or increased survival of a range of serious diseases including ischaemic [sic] heart disease, stroke, osteoporosis, osteoarthritis, atherosclerosis ('hardening of the arteries'), breast cancer, other cancers and many of the debilitating diseases associated with ageing [sic]...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Curagel
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'CuraGel destroys 99.9% of all known pathogens causing chronic skin infections ...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 1 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Nasal/Throat Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Comfortably find best position within nostril and spray solution three times. Best practice is to feel the solution towards the back of throat...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Magnesium Bicarb Body Decalcifier Dry Mix
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): '[H]ydrozone Magnesium BiCarb demonstrated that optimal hydration with Hydrozone Magnesium BiCarb over three months may significantly increase blood magnesium levels, may significantly stabilise [sic] blood parathyroid hormone levels and may significantly increase blood albumin protein levels. These factors have been identified in independent international studies as factors that are significantly correlated to either decreased risk or increased survival of a range of serious diseases including ischaemic [sic] heart disease, stroke, osteoporosis, osteoarthritis, atherosclerosis ('hardening of the arteries'), breast cancer, other cancers and many of the debilitating diseases associated with ageing [sic]...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Disinfection Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Spray your ready solution on all surfaces that you suspect infection . . . Hands . . . can also be sprayed safely'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Body Cream
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'HOW DOES IT WORK . . .effectively fighting off infection. The Multi Mineral Supplement II special formula is a natural antibacterial wound or infection healing agent. This day and night cream contains the skin's own active Multi Mineral Supplement II formula and moisturized to effectively ward off infection and heal wounds...'.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Bath Tablets
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as (not an all-inclusive list): [Website]:'MMS BATH 12 TABLETS - BEST SKIN INFECTION CONTROL'; [Label]:'Lay in the bath and soak the skin for 20-30 mins...'

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Body Cream
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'HOW DOES IT WORK . . .effectively fighting off infection. The Multi Mineral Supplement II special formula is a natural antibacterial wound or infection healing agent. This day and night cream contains the skin's own active Multi Mineral Supplement II formula and moisturized to effectively ward off infection and heal wounds...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Nasal/Throat Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Comfortably find best position within nostril and spray solution three times. Best practice is to feel the solution towards the back of throat...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Magnesium Bicarb Body Decalcifier Dry Mix
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): '[H]ydrozone Magnesium BiCarb demonstrated that optimal hydration with Hydrozone Magnesium BiCarb over three months may significantly increase blood magnesium levels, may significantly stabilise [sic] blood parathyroid hormone levels and may significantly increase blood albumin protein levels. These factors have been identified in independent international studies as factors that are significantly correlated to either decreased risk or increased survival of a range of serious diseases including ischaemic [sic] heart disease, stroke, osteoporosis, osteoarthritis, atherosclerosis ('hardening of the arteries'), breast cancer, other cancers and many of the debilitating diseases associated with ageing [sic]...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Disinfection Spray Multi Mineral Water Supplement
Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Dissolve one tablet of [Multi Mineral Water Supplement]. Spray your ready solution on all surfaces that you suspect infection . . . Hands . . . can also be sprayed safely'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 1 Tablets
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'The BEST SELLING cancer-fighting protocol. 12 EASYMMS tablets and one tub MMS2 tablets ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Curagel
Notes: The product appears to be an unapproved new drug as the product website includes claims such as (not an all-inclusive list): 'CuraGel destroys 99.9% of all known pathogens causing chronic skin infections ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/08/2020

Desc: Multi Mineral Water Supplement 2 Bath Tablets
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as (not an all-inclusive list): [Website]:'MMS BATH 12 TABLETS - BEST SKIN INFECTION CONTROL'; [Label]:'Lay in the bath and soak the skin for 20-30 mins...'

OPHTHALMICA (PTY) LTD
Date Published : 08/02/2022
1 Albert Road, Park , Irene, SOUTH AFRICA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

60 - - - -- Human and Animal Drugs
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

61 - - - -- Human and Animal Drugs
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

62 - - - -- Human and Animal Drugs
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

63 - - - -- Human and Animal Drugs
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

64 - - - -- Human and Animal Drugs
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

65 - - - -- Human and Animal Drugs
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

66 - - - -- Human and Animal Drugs
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

68 - - - -- Animal Devices and Diagnostic Products
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

73 - - - -- Anesthesiology
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

74 - - - -- Cardiovascular
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

76 - - - -- Dental
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

77 - - - -- Ear,Nose And Throat
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

78 - - - -- Gastroenterological & Urological
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

79 - - - -- General & Plastic Surgery
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

80 - - - -- General Hospital/Personal Use
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

84 - - - -- Neurological
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

85 - - - -- Obstetrical & Gynecological
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

86 - - - -- Ophthalmic
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

87 - - - -- Orthopedic
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

89 - - - -- Physical Medicine
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

90 - - - -- Radiology
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

OPHTHALMICA PTY LTD
Date Published : 08/02/2022
Park Bldg , 101 Albert Road , Centurion, Gauteng SOUTH AFRICA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

60 - - - -- Human and Animal Drugs
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

61 - - - -- Human and Animal Drugs
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

62 - - - -- Human and Animal Drugs
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

63 - - - -- Human and Animal Drugs
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

64 - - - -- Human and Animal Drugs
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

65 - - - -- Human and Animal Drugs
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

66 - - - -- Human and Animal Drugs
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

68 - - - -- Animal Devices and Diagnostic Products
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

73 - - - -- Anesthesiology
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

74 - - - -- Cardiovascular
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

76 - - - -- Dental
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

77 - - - -- Ear,Nose And Throat
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

78 - - - -- Gastroenterological & Urological
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

79 - - - -- General & Plastic Surgery
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

80 - - - -- General Hospital/Personal Use
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

84 - - - -- Neurological
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

85 - - - -- Obstetrical & Gynecological
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

86 - - - -- Ophthalmic
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

87 - - - -- Orthopedic
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

89 - - - -- Physical Medicine
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

90 - - - -- Radiology
Date Published: 08/02/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

Organic Aloe
Date Published : 03/11/2011
39 Industrial Avenue , Albertinia, Western Cape SOUTH AFRICA
63 H - - 99 Cathartic N.E.C.
Date Published: 03/14/2011

Desc: Aloe Bitter Arthro-Detox Tablets
Notes: South Africa

Sa Post Office - Xps
Date Published : 08/11/2014
14 Jones Road , Jetparkjetpark, SOUTH AFRICA
54 B - - 99 Mineral N.E.C.
Date Published: 08/11/2014

Desc: MMS
Notes:                                                                                                                                                                                                     

54 B - - 99 Mineral N.E.C.
Date Published: 08/11/2014

Desc: MMS2
Notes:                                                                                                                                                                                                     

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/11/2014

Desc: MMS2
Notes:                                                                                                                                                                                                         

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/11/2014

Desc: MMS
Notes:                                                                                                                                                                                                     

Sa Post Office - Xps
Date Published : 08/11/2014
19 Jones Road , Jetparkjetpark, SOUTH AFRICA
53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations)
Date Published: 08/19/2014

Desc: MMS Bath Tablets
Notes:                                                                                                                                                                                                  

54 B - - 99 Mineral N.E.C.
Date Published: 08/11/2014

Desc: MMS
Notes:                                                                                                                                                                                                     

54 B - - 99 Mineral N.E.C.
Date Published: 08/11/2014

Desc: MMS2
Notes:                                                                                                                                                                                                     

60 L - - 99 Analgesic, N.E.C.
Date Published: 08/19/2014

Desc: Magnesium Oil Spray
Notes:                                                                                                                                                                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/11/2014

Desc: MMS2
Notes:                                                                                                                                                                                                         

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/19/2014

Desc: MMS Bath Tablets
Notes:                                                                                                                                                                                                  

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/11/2014

Desc: MMS
Notes:                                                                                                                                                                                                     

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/19/2014

Desc: Magnesium Oil Spray
Notes:                                                                                                                                                                                                      

Soulever Wellness Salon Cc
Date Published : 03/29/2018
5 Woodside Close , Cape Town, Western Cape SOUTH AFRICA
53 I - - 02 Mouthwashes and Breath Fresheners (Liquids and Sprays), without Fluoride (Oral Hygiene Products)
Date Published: 03/29/2018

Desc: Cocobaci Black with Activated Charcoal-organic mint flavor- teeth whitening

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 03/29/2018

Desc: Cocobaci Black with Activated Charcoal-organic mint flavor- teeth whitening

55 P - - 12 Activated Charcoal (Pharmaceutic Necessity - Absorbant)
Date Published: 03/29/2018

Desc: Cocobaci Black with Activated Charcoal-organic mint flavor- teeth whitening

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/29/2018

Desc: Cocobaci Black with Activated Charcoal-organic mint flavor- teeth whitening

Southern Implants, (Pty.) Ltd.
Date Published : 11/07/2018
One Albert Road , Irene, Gauteng, SOUTH AFRICA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 11/07/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 11/07/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 11/07/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

61 - - - -- Human and Animal Drugs
Date Published: 11/07/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

62 - - - -- Human and Animal Drugs
Date Published: 11/07/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

63 - - - -- Human and Animal Drugs
Date Published: 11/07/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

64 - - - -- Human and Animal Drugs
Date Published: 11/07/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

65 - - - -- Human and Animal Drugs
Date Published: 11/07/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

66 - - - -- Human and Animal Drugs
Date Published: 11/07/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

68 - - - -- Animal Devices and Diagnostic Products
Date Published: 11/07/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

73 - - - -- Anesthesiology
Date Published: 08/16/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

74 - - - -- Cardiovascular
Date Published: 08/16/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

76 - - - -- Dental
Date Published: 08/16/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

77 - - - -- Ear,Nose And Throat
Date Published: 08/16/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

78 - - - -- Gastroenterological & Urological
Date Published: 08/16/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

79 - - - -- General & Plastic Surgery
Date Published: 08/16/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

80 - - - -- General Hospital/Personal Use
Date Published: 08/16/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

84 - - - -- Neurological
Date Published: 08/16/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

85 - - - -- Obstetrical & Gynecological
Date Published: 08/16/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

86 - - - -- Ophthalmic
Date Published: 08/16/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

87 - - - -- Orthopedic
Date Published: 08/16/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

89 - - - -- Physical Medicine
Date Published: 08/16/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

90 - - - -- Radiology
Date Published: 08/16/2022

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

TRITOF ENTERPRISES SA t/a PHEND PHARMACEUTICALS
Date Published : 01/04/2011
17 Westminster Avenue , Sandton, Gauteng SOUTH AFRICA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/04/2011

Desc: Electro Response Immune Booster
Notes: South Africa

62 M - - 09 Liquid Phenol (Anti-Pruritic)
Date Published: 09/01/2021

Desc: 3cp Antiseptic Liquid
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "3cp Antiseptic Liquid; Fights Infection Eases Pain For sore throats, mouth ulcers, cuts, grazes, bites, stings and spots. . . 3CP antiseptic action on germs prevents danger around the home disinfecting surface area and personal equipment as well as for first aid and personal hygiene”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/01/2021

Desc: 3cp Antiseptic Liquid
Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): "3cp Antiseptic Liquid; Fights Infection Eases Pain For sore throats, mouth ulcers, cuts, grazes, bites, stings and spots. . . 3CP antiseptic action on germs prevents danger around the home disinfecting surface area and personal equipment as well as for first aid and personal hygiene”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/04/2011

Desc: Electro Response Immune Booster
Notes: South Africa

Vaya Smooth Cosmetics Pty Ltd
Date Published : 09/20/2016
13 Access Park, 2 Albizia Place , Pinetown, SOUTH AFRICA
53 K - - -- Shaving Prep
Date Published: 09/20/2016

Desc: VAYA Smooth (all dosage formulations)

60 L - - 05 Aspirin (Analgesic)
Date Published: 09/20/2016

Desc: VAYA Smooth (all dosage formulations)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/20/2016

Desc: VAYA Smooth (all dosage formulations)


SPAIN


Aerosoles Preval S.A.
Date Published : 06/27/2018
Calle Del Estano 26 Y 28 , Apartado De Correos Num. 104 , Arganda Del Rey, Madrid SPAIN
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream;Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream;Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

61 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream;Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

62 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream;Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

63 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream;Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

64 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream;Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

65 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream;Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

66 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream;Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

Amdermik Sl
Date Published : 03/09/2017
Avinguda Cabrera 36 , Mataro, Barcelona SPAIN
53 L - - -- Skin Care Prep
Date Published: 03/09/2017

Desc: Hyaluronidase
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: 'The active hyaluronidase for virtual mesotherapy is essential for the elimination of liquids and to reduce the volume of adipocytes; Hyaluronidase is an enzyme that hydrolyzes hyaluronic acid (HA), promoting the diffusion of fluids in the tissues and facilitating their absorption; It also increases the action of the local anesthetic, prevents the risk of necrosis in sclerotherapy, and has fibrinolytic action.'

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/09/2017

Desc: Hyaluronidase
Notes: The product appears to be an unapproved new drug as the product website includes claims such as: 'The active hyaluronidase for virtual mesotherapy is essential for the elimination of liquids and to reduce the volume of adipocytes; Hyaluronidase is an enzyme that hydrolyzes hyaluronic acid (HA), promoting the diffusion of fluids in the tissues and facilitating their absorption; It also increases the action of the local anesthetic, prevents the risk of necrosis in sclerotherapy, and has fibrinolytic action.'

CATALYSIS, S.L.
Date Published : 09/30/2009
Poligono Ind. La Jerecita , Avenida Madera, 5 , Villaluenga De La Sagra, Toledo SPAIN
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 09/30/2009

Notes: 6/29/2000

53 J - - 02 Deodorants (underarm)(Not Antiperspirant) (Personal Cleanliness)
Date Published: 09/30/2009

Notes: 6/29/2000

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/30/2009

Notes: 6/29/2000

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/30/2009

Notes: 6/29/2000

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/17/2019

Notes: All products, 12/15/2006

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 H - - 05 Zinc Pyrithione (Anti-Bacterial)
Date Published: 09/30/2009

Notes: 6/29/2000

61 S - - 01 Coal Tar (Anti-Eczematic)
Date Published: 09/30/2009

Notes: 6/29/2000

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 S - - 01 Resorcinol Monoacetate (Anti-Seborrheic)
Date Published: 09/30/2009

Notes: 6/29/2000

62 S - - 99 Anti-Seborrheic N.E.C.
Date Published: 09/30/2009

Notes: 6/29/2000

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 S - - 01 Zinc-Eugenol (Cement) (Dental Protectant)
Date Published: 09/30/2009

Notes: 6/29/2000

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Casmara Cosmetics, S.A.
Date Published : 01/17/2018
Ciutat de Lliria n 29 y 31 , Pol¿¿gono Industrial Fuente del Jarro , Paterna, Valencia SPAIN
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 01/17/2018

Desc: Gold 2080 Facial Mask Hydrating

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 01/17/2018

Desc: Body Sculptor Cream Firming

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 01/17/2018

Desc: Facial Mask Ocean Miracle Treatment

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 01/17/2018

Desc: Elixir Cell Rejuvenating Facial Treatment

53 L - - -- Skin Care Prep
Date Published: 04/01/2021

Desc: Cleanser- Dermopurifying Oily Skin

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/17/2018

Desc: Facial Mask Ocean Miracle Treatment

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/17/2018

Desc: Body Sculptor Cream Firming

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/17/2018

Desc: Elixir Cell Rejuvenating Facial Treatment

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/17/2018

Desc: Gold 2080 Facial Mask Hydrating

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/01/2021

Desc: Cleanser- Dermopurifying Oily Skin

Cheminova International Sa
Date Published : 06/27/2018
Calle Macarena 14 , Madrid, Madrid SPAIN
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

61 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

62 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

63 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

64 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

65 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

66 - - - -- Human and Animal Drugs
Date Published: 06/27/2018

Notes: Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate).

Jabones Pardo S.A.
Date Published : 11/22/2010
Calle De La Sierra Nevada 1 , Fuenlabrada, Madrid SPAIN
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 08/01/2013

Desc: Le'dermis Jabon Anti-Acne Soap

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 11/22/2010

Desc: Movate Lemon Dermal Lightening Skin Creams
Notes: Spain

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/31/2013

Desc: Le'dermis Crema Anti-Acne

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/31/2013

Desc: Le'dermis Advanced Scar Cream

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/01/2013

Desc: Le'dermis Jabon Anti-Acne Soap

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/22/2010

Desc: Movate Lemon Dermal Lightening Skin Creams
Notes: Spain

53 L - - -- Skin Care Prep
Date Published: 04/07/2020

Desc: Idole or Cream Medical No. 2

54 A - - 99 Vitamin, N.E.C.
Date Published: 04/07/2020

Desc: Idole or Cream Medical No. 2

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 11/22/2010

Desc: Movate Lemon Dermal Lightening Skin Creams
Notes: Spain

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 11/22/2010

Desc: Topiclear Number One
Notes: Spain

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 11/22/2010

Desc: Topiclear Cocoa Butter
Notes: Spain

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 11/22/2010

Desc: Top White Whitening
Notes: Spain

63 V - - 99 Depigmentor N.E.C.
Date Published: 11/22/2010

Desc: Top White Whitening
Notes: Spain

63 V - - 99 Depigmentor N.E.C.
Date Published: 11/22/2010

Desc: Movate Lemon Dermal Lightening Skin Creams
Notes: Spain

63 V - - 99 Depigmentor N.E.C.
Date Published: 11/22/2010

Desc: Topiclear Cocoa Butter
Notes: Spain

63 V - - 99 Depigmentor N.E.C.
Date Published: 11/22/2010

Desc: Topiclear Number One
Notes: Spain

64 X - - 06 Salicylic Acid (Keratolytic)
Date Published: 07/31/2013

Desc: Le'dermis Crema Anti-Acne

64 X - - 06 Salicylic Acid (Keratolytic)
Date Published: 08/01/2013

Desc: Le'dermis Jabon Anti-Acne Soap

65 L - - 99 Protectant N.E.C.
Date Published: 07/31/2013

Desc: Le'dermis Advanced Scar Cream

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 07/31/2013

Desc: Le'dermis Advanced Scar Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/22/2010

Desc: Topiclear Cocoa Butter
Notes: Spain

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/01/2013

Desc: Le'dermis Jabon Anti-Acne Soap

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/31/2013

Desc: Le'dermis Advanced Scar Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/07/2020

Desc: Idole or Cream Medical No. 2

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/22/2010

Desc: Movate Lemon Dermal Lightening Skin Creams
Notes: Spain

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/31/2013

Desc: Le'dermis Crema Anti-Acne

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/22/2010

Desc: Top White Whitening
Notes: Spain

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/22/2010

Desc: Topiclear Number One
Notes: Spain

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 11/22/2010

Desc: Movate Lemon Dermal Lightening Skin Creams
Notes: Spain

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 11/22/2010

Desc: Topiclear Number One
Notes: Spain

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 11/22/2010

Desc: Top White Whitening
Notes: Spain

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 11/22/2010

Desc: Topiclear Cocoa Butter
Notes: Spain

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/31/2013

Desc: Le'dermis Advanced Scar Cream

Jublan S.L.
Date Published : 08/01/2012
Calle Illescas 55 , Madrid, SPAIN
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 08/01/2012

Desc: Aminexil
Notes: Spain;NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil).

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 08/01/2012

Desc: Aminexil
Notes: Spain;NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil).

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 08/01/2012

Desc: Aminexil
Notes: Spain;NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil).

62 C - - 41 Minoxidil (Anti-Hypertensive)
Date Published: 08/01/2012

Desc: Aminexil
Notes: Spain;NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil).

62 C - - 99 Anti-Hypertensive N.E.C.
Date Published: 08/01/2012

Desc: Aminexil
Notes: Spain;NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/01/2012

Desc: Aminexil
Notes: Spain;NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil).

Kerastase
Date Published : 08/01/2012
Pajaritos 43 , Madrid, SPAIN
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);Spain

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil).

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);Spain

62 C - - 41 Minoxidil (Anti-Hypertensive)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);Spain

62 C - - 99 Anti-Hypertensive N.E.C.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);Spain

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);Spain

L'Oreal Professionnel
Date Published : 08/01/2012
Tsa 1007 F 92667 Asnieres , Cedex, Madrid SPAIN
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);Spain

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);Spain

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);Spain

62 C - - 41 Minoxidil (Anti-Hypertensive)
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);Spain

62 C - - 99 Anti-Hypertensive N.E.C.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);Spain

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/01/2012

Desc: Aminexil
Notes: NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);Spain

NATURA BISSE INTERNATIONAL SA
Date Published : 01/06/2011
Calle Creu Casas I Sicart, 96 - Parc L'Alba , Cerdanyola Del Valles, Barcelona SPAIN
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 01/06/2011

Desc: Sun Defense Cream
Notes: Spain

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/06/2011

Desc: Sun Defense Cream
Notes: Spain

Nirvel Cosmetics S.L.
Date Published : 03/10/2014
Pol. Ind. Cotes C/F/No 9 , Alcoi, SPAIN
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 03/10/2014

Desc: Nirvel Capillary Energizing Lotion
Notes: Country; Spain

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 03/10/2014

Notes: Nirvel Capillary Energizing Treatment/ Tec Pack (Capillary Energizing Shampoo Biotin and Capillary Energizing Lotion Biotin) Country; Spain

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/10/2014

Desc: Homme Stomach Reducer
Notes: Country; Spain

Niuma Belleza
Date Published : 03/15/2018
C Tres Cruges 4 , Madrid, SPAIN
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 03/15/2018

Desc: Niuma Medicated Antiseptic Soap
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; '...For the prevention and treatment of skin and hair infections and disorders ...'.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 03/15/2018

Desc: Niuma Lemon Medicated Germicidal Soap
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; '... Gives a softer and smoother complexion adding fragrance and freshness to your skin ...'.

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 03/15/2018

Desc: Niuma Lemon Medicated Germicidal Soap
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; '... Gives a softer and smoother complexion adding fragrance and freshness to your skin ...'.

53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 03/15/2018

Desc: Niuma Medicated Antiseptic Soap
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; '...For the prevention and treatment of skin and hair infections and disorders ...'.

61 H - - 99 Anti-Bacterial, N.E.C.
Date Published: 03/15/2018

Desc: Niuma Lemon Medicated Germicidal Soap
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; '...Gives a softer and smoother complexion adding fragrance and freshness to your skin ...'.

61 H - - 99 Anti-Bacterial, N.E.C.
Date Published: 03/15/2018

Desc: Niuma Medicated Antiseptic Soap
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; '...For the prevention and treatment of skin and hair infections and disorders ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/15/2018

Desc: Niuma Medicated Antiseptic Soap
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; '...For the prevention and treatment of skin and hair infections and disorders ...'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/15/2018

Desc: Niuma Lemon Medicated Germicidal Soap
Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?? Gives a softer and smoother complexion adding fragrance and freshness to your skin ??

ORGONO PRODUCTS SL
Date Published : 08/28/2020
Nave 10 , C/Vilafortuny 4 , Vila-Seca, Tarragona SPAIN
54 B - - 99 Mineral N.E.C.
Date Published: 08/28/2020

Desc: ORGONO Living Silica
Notes: The product appears to be an unapproved new drug as the product's promotional website includes claims such as (not an all-inclusive list): '...perfect for those who experience inflamed joints ... and other health concerns'.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/28/2020

Desc: ORGONO Living Silica
Notes: The product appears to be an unapproved new drug as the product's promotional website includes claims such as (not an all-inclusive list): '...perfect for those who experience inflamed joints ... and other health concerns'.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/28/2020

Desc: ORGONO Living Silica
Notes: The product appears to be an unapproved new drug as the product's promotional website includes claims such as (not an all-inclusive list): '...perfect for those who experience inflamed joints ... and other health concerns'.

SILICIUM ESPANA LABORATORIOS SL
Date Published : 10/14/2011
Nave 10 , Parc Tecnologic i de Serveis l'Alba , Vila-Seca, Tarragona SPAIN
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/14/2011

Desc: Hemosil
Notes: spain

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/14/2011

Desc: Hemosil
Notes: spain

65 L - - 99 Protectant N.E.C.
Date Published: 10/14/2011

Desc: Hemosil
Notes: spain

Sesderma, SL
Date Published : 07/16/2013
Calle Massamagrell 3-5 , Poligono Industrial Rafelbunol , Rafelbunol, Valencia SPAIN
53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 07/16/2013

Desc: BTSES Anti-wrinkle Moisturizing Gel Cream

53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 07/16/2013

Desc: Hidraloe Eye Contour Cream

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/23/2018

Desc: Oxyses Mist

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/23/2018

Desc: Silkses Monodose Sterile Skin Moist

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/23/2018

Desc: Factor G Renew Facial Chin

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/16/2013

Desc: BTSES Anti-wrinkle Moisturizing Gel Cream

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/23/2018

Desc: Silkses Monodose Sterile Skin Moist

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/23/2018

Desc: Oxyses Mist

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/16/2013

Desc: Hidraloe Eye Contour Cream

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/23/2018

Desc: Factor G Renew Facial Chin

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/23/2018

Desc: Oxyses Mist

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/23/2018

Desc: Factor G Renew Facial Chin & Neck

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/16/2013

Desc: BTSES Anti-wrinkle Moisturizing Gel Cream

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/23/2018

Desc: Silkses Monodose Sterile Skin Moist

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/16/2013

Desc: Hidraloe Eye Contour Cream

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/16/2013

Desc: BTSES Anti-wrinkle Moisturizing Gel Cream

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/16/2013

Desc: Hidraloe Eye Contour Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/16/2013

Desc: BTSES Anti-wrinkle Moisturizing Gel Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/23/2018

Desc: Oxyses Mist

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/16/2013

Desc: Hidraloe Eye Contour Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/23/2018

Desc: Factor G Renew Facial Chin

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/23/2018

Desc: Silkses Monodose Sterile Skin Moist


SRI LANKA


Dru Era (Pvt) Ltd
Date Published : 04/18/2016
Nedimala , 54/11 Papilyana Road , Dehiwala, Colombo SRI LANKA
28 B - - 13 Cinnamon, Cassia, Ground, Cracked (Spice)
Date Published: 04/18/2016

Desc: Ceylon Cinnamon Dietary Supplements

28 C - - 13 Cinnamon, Cassia, Natural Extract or Flavor (Spice)
Date Published: 04/18/2016

Desc: Ceylon Cinnamon Dietary Supplements

54 A - - 99 Vitamin, N.E.C.
Date Published: 04/18/2016

Desc: Ceylon Cinnamon Dietary Supplements

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/18/2016

Desc: Ceylon Cinnamon Dietary Supplements

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/18/2016

Desc: Ceylon Cinnamon Dietary Supplements

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/18/2016

Desc: Ceylon Cinnamon Dietary Supplements

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 04/18/2016

Desc: Ceylon Cinnamon Dietary Supplements


SWEDEN


AnabolicShop
Date Published : 09/30/2009
DG (Damian Garel) , damiangarel@gmx.de, Lofgister 34 , Bjorntal, SWEDEN
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                        The firm appears to market various anabolic steroids as well.

Legosan AB
Date Published : 03/18/2024
Viagatan 16 , Kumla, Orebro Lan SWEDEN
54 F - - 84 Milk Thistle (Herbal & Botanical other than teas)
Date Published: 03/18/2024

Desc:            Active Liver Tablets

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/18/2024

Desc:            Active Liver Tablets

Orkla Care AB
Date Published : 11/25/2013
Svetsarvagen 15 , Solna, Stockholms Lan SWEDEN
65 F - - 06 Water, Purified (Eyewash)
Date Published: 11/25/2013

Desc: Cederroth Eye Wash

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/25/2013

Desc: Cederroth Eye Wash

86 K - - YG Device, Irrigation, Ocular Surgery
Date Published: 11/25/2013

Desc: Cederroth Eye Wash

Paragon Nordic
Date Published : 08/16/2010
Fabriksvagen 2 , Vallentuna, Stockholms Lan SWEDEN
64 X - - 06 Salicylic Acid (Keratolytic)
Date Published: 08/16/2010

Desc: Salvax (Salicylic Acid)
Notes: COUNTRY; Sweden

Pharmacure Health Care
Date Published : 03/06/2015
32 Teatergatan , Goteborg, SWEDEN
62 M - - 08 Menthol (Anti-Pruritic)
Date Published: 03/06/2015

Desc: Nozoil with Menthol

62 M - - 99 Anti-Pruritic N.E.C.
Date Published: 03/06/2015

Desc: Nozoil with Menthol

62 U - - 99 Anti-Tussive/Cold N.E.C.
Date Published: 03/06/2015

Desc: Nozoil with Menthol

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/06/2015

Desc: Nozoil with Menthol


SWITZERLAND


AAA Webmanagement AG
Date Published : 09/30/2009
Aegeristrasse 4 , Zug, Kantone Zug 6301, SWITZERLAND
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                       

Alchemie Forever Sarl
Date Published : 07/02/2012
4 Place Du Molard , Geneve, SWITZERLAND
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/02/2012

Desc: Antioxidant Relief for Feet

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/02/2012

Desc: Antioxidant Relief for Feet

Conseils De Sante S.A.
Date Published : 09/30/2009
P.O. Box 331 , 1211 , Geneva, SWITZERLAND
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: Anti-Aging Pill Multi-Tabs. This products contains deprenyl; vinpocetin; ergoloid mesylates (hydergine); procaine HCl; and hematoporphyrin. 1/27/1998

ESAPHARMA SWISS SA
Date Published : 04/07/2020
Via Campagna 30 , Bioggio, Ticino SWITZERLAND
64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 04/07/2020

Notes: Symba Cream- Skin Lite "N" Smooth Cream-Clobetasol Propionate 0.05% and Cymba Lemon Magic Cream (Clobetasol Propionate 0.05%)

Esapharma SA
Date Published : 10/25/2021
Via Niscioo 2 , S. Vittore, Graubunden SWITZERLAND
64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 10/25/2021

Desc: Civic Cream
Notes: The product appears to be an unapproved new drug as the product’s package insert notes the product contains the active ingredient Clobetasol Propionate 0.05% and includes statements such as (not an all-inclusive list): ‘… is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses …’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/25/2021

Desc: Civic Cream
Notes: The product appears to be an unapproved new drug as the product’s package insert notes the product contains the active ingredient Clobetasol Propionate 0.05% and includes statements such as (not an all-inclusive list): ‘… is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses …’.

Ethos Schweiz Llc
Date Published : 02/06/2017
Rue Du Rhone 14 , Genevageneva, SWITZERLAND
54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 02/06/2017

Desc: Ethos Mega Focus Liposomal Oral Dietary Supplement
Notes: The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Ethos Mega Focus … the ultimate super-nutrition for clearer sharper vision' and '… Healthy Eyes … Healthy Brain … Healthy Body'.

54 A - - 99 Vitamin, N.E.C.
Date Published: 02/06/2017

Desc: Ethos Mega Focus Liposomal Oral Dietary Supplement
Notes: The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Ethos Mega Focus … the ultimate super-nutrition for clearer sharper vision' and '… Healthy Eyes … Healthy Brain … Healthy Body'.

54 B - - 99 Mineral N.E.C.
Date Published: 02/06/2017

Desc: Ethos Mega Focus Liposomal Oral Dietary Supplement
Notes: The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Ethos Mega Focus … the ultimate super-nutrition for clearer sharper vision' and '… Healthy Eyes … Healthy Brain … Healthy Body'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/06/2017

Desc: Ethos Mega Focus Liposomal Oral Dietary Supplement
Notes: The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Ethos Mega Focus … the ultimate super-nutrition for clearer sharper vision' and '… Healthy Eyes … Healthy Brain … Healthy Body'.

FCC - Fragrances, Cosmetics & Consulting SA
Date Published : 09/30/2009
Chemin Des Iles , Aigle, SWITZERLAND
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/30/2015

Desc: Vitacreme B12 Regenerative Cream
Notes: There are drug claims on product associated website as well as in product brochures

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/30/2015

Desc: Vitacreme B12 Regenerative Cream
Notes: There are drug claims on product associated website as well as in product brochures

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 10/30/2015

Desc: Vitacreme B12 Regenerative Cream
Notes: There are drug claims on product associated website as well as in product brochures

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/30/2015

Desc: Vitacreme B12 Regenerative Cream
Notes: There are drug claims on product associated website as well as in product brochures.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: labeling states;

Farmacia Centrale
Date Published : 09/30/2009
Farmamondo, Via Volta 2 , Chiasso, SWITZERLAND
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                                                 According to the website, the isotretinoin is manufactured by Mepha Pharma.

Gnosis Bioresearch SA
Date Published : 10/06/2014
via Lischedi 4 , S. Antonino, Ticino SWITZERLAND
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/06/2014

Desc: LIPO 8
Notes: Product contains Sibutramine.

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 10/06/2014

Desc: LIPO 8
Notes: Product contains Sibutramine.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/06/2014

Desc: LIPO 8
Notes: Product contains Sibutramine.

Interlab
Date Published : 09/30/2009
Luzerner Str. 28 , CH-6330 , Cham-2G, SWITZERLAND
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All drugs. CH-6330-CHAM-2g; 6/22/1998

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. CH-6330-CHAM-2g; 6/22/1998

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. CH-6330-CHAM-2g; 6/22/1998

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. CH-6330-CHAM-2g; 6/22/1998

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. CH-6330-CHAM-2g; 6/22/1998

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. CH-6330-CHAM-2g; 6/22/1998

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. CH-6330-CHAM-2g; 6/22/1998

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs. CH-6330-CHAM-2g; 6/22/1998

Interlab-Sercoex S C
Date Published : 09/13/2019
Via Contonale 42 , Porza-Lugano, SWITZERLAND
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: All drugs; 6/22/1998

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 6/22/1998

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 6/22/1998

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 6/22/1998

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 6/22/1998

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 6/22/1998

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 6/22/1998

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All drugs; 6/22/1998

Lab. Start Up
Date Published : 09/03/2010
10 Cours De Rive , 1211 Geneve 3 , Geneve, Geneve SWITZERLAND
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/03/2010

Desc: Start up for Him Supplement (3 pills)
Notes: Switzerland

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/03/2010

Desc: Start up for him Supplement (12 pills)
Notes: Switzerland

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/03/2010

Desc: Start up for him Supplement (25 pills)
Notes: Switzerland

M. Opitz & Co. AG
Date Published : 02/24/2020
Haggenstrasse 40 , Saint Gall, Saint Gall SWITZERLAND
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 02/24/2020

Desc: Mila D'Opiz Professional Line Whitening Kit
Notes: The product appears to be an unapproved new drug as the label of the product and promotional website include claims such as (not an all-inclusive list): Product Label - 'Mila D'Opiz Professional Line Whitening Kit'; White Shade Vision Serum Label - 'Vision Serum with UV Protection'; White Shade Vision Serum Website - 'This serum protects against the harmful effects of UV radiation'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/24/2020

Desc: Mila D'Opiz Professional Line Whitening Kit
Notes: The product appears to be an unapproved new drug as the label of the product and promotional website include claims such as (not an all-inclusive list): Product Label - 'Mila D'Opiz Professional Line Whitening Kit'; White Shade Vision Serum Label - 'Vision Serum with UV Protection'; White Shade Vision Serum Website - 'This serum protects against the harmful effects of UV radiation'.

Mila D'Opiz Ag
Date Published : 02/24/2020
Haggenstrasse 40 , St Gallen, SWITZERLAND
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 02/24/2020

Desc: Mila D'Opiz Professional Line Whitening Kit
Notes: The product appears to be an unapproved new drug as the label of the product and promotional website include claims such as (not an all-inclusive list): Product Label - 'Mila D'Opiz Professional Line Whitening Kit'; White Shade Vision Serum Label - 'Vision Serum with UV Protection'; White Shade Vision Serum Website - 'This serum protects against the harmful effects of UV radiation'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/24/2020

Desc: Mila D'Opiz Professional Line Whitening Kit
Notes: The product appears to be an unapproved new drug as the label of the product and promotional website include claims such as (not an all-inclusive list): Product Label - 'Mila D'Opiz Professional Line Whitening Kit'; White Shade Vision Serum Label - 'Vision Serum with UV Protection'; White Shade Vision Serum Website - 'This serum protects against the harmful effects of UV radiation'.

Mitchell Cosmetics Sarl
Date Published : 09/30/2009
Chemin Byron 6 Bis , Case Postale 59 , Geneva, SWITZERLAND
53 L C - -- Skin Care Prep, Cream
Date Published: 09/30/2009

Notes: Regge Lemon Gel and Omic Gel Plus 10/15/1999

64 L - - 06 Betamethasone Dipropionate (Glucocorticoid)
Date Published: 09/30/2009

Notes: Regge Lemon Gel 10/15/1999

64 L - - 28 Fluocinonide (Glucocorticoid)
Date Published: 09/30/2009

Notes: Omic Gel Plus

Omnimedica Ag
Date Published : 09/30/2009
Laettenstrasse 27 , Schlieren, SWITZERLAND
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 7/3/2008. Cell Pro Line Nasal Spray and Oral Tablets. The labeling as well as internet includes drug claims that this product

PESCHKE TRADE GMBH
Date Published : 11/06/2018
Bosch 67 , Hunenberg, Zug SWITZERLAND
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

61 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

62 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

63 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

64 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

65 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

66 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

68 - - - -- Animal Devices and Diagnostic Products
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

73 - - - -- Anesthesiology
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

74 - - - -- Cardiovascular
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

76 - - - -- Dental
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

77 - - - -- Ear,Nose And Throat
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

78 - - - -- Gastroenterological & Urological
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

79 - - - -- General & Plastic Surgery
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

80 - - - -- General Hospital/Personal Use
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

84 - - - -- Neurological
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

85 - - - -- Obstetrical & Gynecological
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

86 - - - -- Ophthalmic
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

87 - - - -- Orthopedic
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

89 - - - -- Physical Medicine
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

90 - - - -- Radiology
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

Peschke Meditrade
Date Published : 11/06/2018
Chasigass 6a , Hunenberg, Zug SWITZERLAND
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

61 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

62 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

63 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

64 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

65 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

66 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

68 - - - -- Animal Devices and Diagnostic Products
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

73 - - - -- Anesthesiology
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

74 - - - -- Cardiovascular
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

76 - - - -- Dental
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

77 - - - -- Ear,Nose And Throat
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

78 - - - -- Gastroenterological & Urological
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

79 - - - -- General & Plastic Surgery
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

80 - - - -- General Hospital/Personal Use
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

84 - - - -- Neurological
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

85 - - - -- Obstetrical & Gynecological
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

86 - - - -- Ophthalmic
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

87 - - - -- Orthopedic
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

89 - - - -- Physical Medicine
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

90 - - - -- Radiology
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

Peschke Meritrade Gmbh
Date Published : 09/18/2015
Boesch 6331 , Huenenberg, Zg SWITZERLAND
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/18/2015

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/18/2015

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/18/2015

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

61 - - - -- Human and Animal Drugs
Date Published: 09/18/2015

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

62 - - - -- Human and Animal Drugs
Date Published: 09/18/2015

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

63 - - - -- Human and Animal Drugs
Date Published: 09/18/2015

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

64 - - - -- Human and Animal Drugs
Date Published: 09/18/2015

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

65 - - - -- Human and Animal Drugs
Date Published: 09/18/2015

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

66 - - - -- Human and Animal Drugs
Date Published: 09/18/2015

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

68 - - - -- Animal Devices and Diagnostic Products
Date Published: 11/14/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

73 - - - -- Anesthesiology
Date Published: 11/14/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

74 - - - -- Cardiovascular
Date Published: 11/14/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

76 - - - -- Dental
Date Published: 11/14/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

77 - - - -- Ear,Nose And Throat
Date Published: 11/14/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

78 - - - -- Gastroenterological & Urological
Date Published: 11/14/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

79 - - - -- General & Plastic Surgery
Date Published: 11/14/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

80 - - - -- General Hospital/Personal Use
Date Published: 11/14/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

84 - - - -- Neurological
Date Published: 11/14/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

85 - - - -- Obstetrical & Gynecological
Date Published: 11/14/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

86 - - - -- Ophthalmic
Date Published: 11/14/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

87 - - - -- Orthopedic
Date Published: 11/14/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

89 - - - -- Physical Medicine
Date Published: 11/14/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

90 - - - -- Radiology
Date Published: 11/14/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.sting.

Peschke Trade Gmbh
Date Published : 11/06/2018
Bosch 73 , Hunenberg, Zug SWITZERLAND
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

61 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

62 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

63 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

64 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

65 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

66 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

68 - - - -- Animal Devices and Diagnostic Products
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

73 - - - -- Anesthesiology
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

74 - - - -- Cardiovascular
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

76 - - - -- Dental
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

77 - - - -- Ear,Nose And Throat
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

78 - - - -- Gastroenterological & Urological
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

79 - - - -- General & Plastic Surgery
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

80 - - - -- General Hospital/Personal Use
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

84 - - - -- Neurological
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

85 - - - -- Obstetrical & Gynecological
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

86 - - - -- Ophthalmic
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

87 - - - -- Orthopedic
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

89 - - - -- Physical Medicine
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

90 - - - -- Radiology
Date Published: 11/06/2018

Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.

Similasan AG
Date Published : 09/12/2023
Chriesiweg 6 , Jonen, Zurich SWITZERLAND
53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Irritated Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Kids Allergy Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Red Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Dry Eye Nighttime Gel

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Pink Eye Nighttime Gel

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Aging Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Dry Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 11/21/2023

Desc:           Stye Eye Drops

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Stye Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 11/21/2023

Desc:           Pink Eye Drops

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Complete Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 11/21/2023

Desc:           Allergy Eye Drops

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Computer Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Allergy Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Kids Pink Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Children%u2019s Allergy Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 11/21/2023

Desc:     Pink Eye Drops

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Pink Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 11/21/2023

Desc:           Pink Eye Drops

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Computer Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Pink Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Red Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Dry Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Kids Pink Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Dry Eye Nighttime Gel

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Aging Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Complete Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 11/21/2023

Desc:     Pink Eye Drops

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Allergy Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Children%u2019s Allergy Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Irritated Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 11/21/2023

Desc:           Stye Eye Drops

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 11/21/2023

Desc:           Allergy Eye Drops

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Pink Eye Nighttime Gel

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Stye Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Kids Allergy Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Kids Allergy Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 11/21/2023

Desc:     Pink Eye Drops

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Pink Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 11/21/2023

Desc:           Allergy Eye Drops

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 11/21/2023

Desc:           Stye Eye Drops

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Allergy Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Computer Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Complete Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Children%u2019s Allergy Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Red Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Kids Pink Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Pink Eye Nighttime Gel

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Stye Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Dry Eye Nighttime Gel

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Dry Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Aging Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 11/21/2023

Desc:           Pink Eye Drops

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Irritated Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Complete Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Stye Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Kids Pink Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Children%u2019s Allergy Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Dry Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Computer Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Red Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:           Allergy Eye Drops

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Pink Eye Nighttime Gel

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Kids Allergy Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Aging Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:           Stye Eye Drops

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:     Pink Eye Drops

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Allergy Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:           Pink Eye Drops

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Irritated Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Dry Eye Nighttime Gel

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Pink Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Kids Pink Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Children%u2019s Allergy Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Pink Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Kids Allergy Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Complete Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Irritated Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Stye Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 11/21/2023

Desc:     Pink Eye Drops

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Computer Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Allergy Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Dry Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Aging Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 11/21/2023

Desc:           Allergy Eye Drops

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Red Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 11/21/2023

Desc:           Stye Eye Drops

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Dry Eye Nighttime Gel

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Pink Eye Nighttime Gel

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 11/21/2023

Desc:           Pink Eye Drops

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Allergy Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Stye Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Computer Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Kids Pink Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Dry Eye Nighttime Gel

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:     Pink Eye Drops

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Kids Allergy Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:           Allergy Eye Drops

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Pink Eye Nighttime Gel

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Children%u2019s Allergy Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Red Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Complete Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:           Stye Eye Drops

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Irritated Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:           Pink Eye Drops

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Aging Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Pink Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Dry Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Dry Eye Nighttime Gel

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Complete Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:           Pink Eye Drops

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Pink Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Stye Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Irritated Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Kids Pink Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Red Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Dry Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Aging Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Computer Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Children%u2019s Allergy Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:           Allergy Eye Drops

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Kids Allergy Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:           Stye Eye Drops

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Allergy Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:     Pink Eye Drops

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Pink Eye Nighttime Gel

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 11/21/2023

Desc:           Allergy Eye Drops

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Children%u2019s Allergy Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Pink Eye Nighttime Gel

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Kids Pink Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Computer Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 11/21/2023

Desc:           Stye Eye Drops

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Complete Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Stye Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Dry Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Kids Allergy Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 11/21/2023

Desc:           Pink Eye Drops

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Allergy Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Pink Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Irritated Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Dry Eye Nighttime Gel

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Red Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Aging Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 11/21/2023

Desc:     Pink Eye Drops

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Pink Eye Nighttime Gel

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Computer Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 11/21/2023

Desc:           Pink Eye Drops

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Kids Pink Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Aging Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 11/21/2023

Desc:           Allergy Eye Drops

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Kids Allergy Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Red Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Dry Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Allergy Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Complete Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Irritated Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Dry Eye Nighttime Gel

80 K - - YX Dispenser, Liquid Medication
Date Published: 11/21/2023

Desc:           Stye Eye Drops

80 K - - YX Dispenser, Liquid Medication
Date Published: 11/21/2023

Desc:     Pink Eye Drops

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Pink Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Children%u2019s Allergy Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Stye Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Irritated Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Stye Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Dry Eye Nighttime Gel

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Children%u2019s Allergy Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Kids Pink Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 11/21/2023

Desc:           Stye Eye Drops

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Red Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Pink Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Computer Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Aging Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Allergy Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Dry Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Kids Allergy Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 11/21/2023

Desc:     Pink Eye Drops

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 11/21/2023

Desc:           Pink Eye Drops

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Complete Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 11/21/2023

Desc:           Allergy Eye Drops

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Pink Eye Nighttime Gel

Similasan T&M Ag
Date Published : 09/12/2023
Industriestrasse 27 , Sarnen, SWITZERLAND
53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Computer Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 11/21/2023

Desc:     Pink Eye Drops

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Complete Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 11/21/2023

Desc:           Allergy Eye Drops

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Irritated Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Dry Eye Nighttime Gel

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Kids Allergy Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Aging Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Pink Eye Nighttime Gel

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 11/21/2023

Desc:           Stye Eye Drops

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Allergy Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Pink Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Kids Pink Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Stye Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 11/21/2023

Desc:           Pink Eye Drops

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Red Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Children%u2019s Allergy Eye Relief

53 C F - 05 Eye Makeup Remover (Eye Makeup Preparations), Pads
Date Published: 09/12/2023

Desc: Similasan Dry Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Aging Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Dry Eye Nighttime Gel

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Kids Allergy Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 11/21/2023

Desc:           Stye Eye Drops

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 11/21/2023

Desc:           Allergy Eye Drops

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 11/21/2023

Desc:           Pink Eye Drops

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Stye Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Kids Pink Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 11/21/2023

Desc:     Pink Eye Drops

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Irritated Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Pink Eye Nighttime Gel

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Dry Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Complete Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Red Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Allergy Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Children%u2019s Allergy Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Pink Eye Relief

53 J Y - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C., Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Computer Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 01/12/2024

Desc:     Pink Eye Drops

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Complete Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Red Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Aging Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Dry Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Dry Eye Nighttime Gel

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 11/21/2023

Desc:           Allergy Eye Drops

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Computer Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Pink Eye Nighttime Gel

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 01/12/2024

Desc: Similasan Stye Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Children%u2019s Allergy Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Irritated Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 11/21/2023

Desc:           Stye Eye Drops

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Kids Allergy Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 11/21/2023

Desc:           Pink Eye Drops

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Allergy Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Pink Eye Relief

53 L Y - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC)
Date Published: 09/12/2023

Desc: Similasan Kids Pink Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Red Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Allergy Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Complete Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Dry Eye Nighttime Gel

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:     Pink Eye Drops

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Kids Pink Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Aging Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Kids Allergy Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Children%u2019s Allergy Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:           Pink Eye Drops

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Dry Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Pink Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Pink Eye Nighttime Gel

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:           Stye Eye Drops

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Irritated Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Computer Eye Relief

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:           Allergy Eye Drops

61 K B K 06 Belladonna (Ext) (Anti-Cholinergic), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Stye Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Pink Eye Nighttime Gel

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Pink Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Kids Pink Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Stye Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Kids Allergy Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 11/21/2023

Desc:           Allergy Eye Drops

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Computer Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Aging Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Irritated Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Dry Eye Nighttime Gel

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 11/21/2023

Desc:     Pink Eye Drops

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 11/21/2023

Desc:           Stye Eye Drops

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Complete Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 11/21/2023

Desc:           Pink Eye Drops

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Children%u2019s Allergy Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Red Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Allergy Eye Relief

64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Dry Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:           Pink Eye Drops

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Complete Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Stye Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:           Allergy Eye Drops

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Irritated Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Children%u2019s Allergy Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:           Stye Eye Drops

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:     Pink Eye Drops

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Computer Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Pink Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Dry Eye Nighttime Gel

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Red Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Aging Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Dry Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Pink Eye Nighttime Gel

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Kids Allergy Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Allergy Eye Relief

65 T B K 04 Sulfur (Scabicide), Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Kids Pink Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:           Stye Eye Drops

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:           Pink Eye Drops

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Pink Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Allergy Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Red Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Computer Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Pink Eye Nighttime Gel

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:           Allergy Eye Drops

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Stye Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Dry Eye Nighttime Gel

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Irritated Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Dry Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 11/21/2023

Desc:     Pink Eye Drops

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Children%u2019s Allergy Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Kids Allergy Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Kids Pink Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Complete Eye Relief

66 Y B K 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, Sterile Liquid
Date Published: 09/12/2023

Desc: Similasan Aging Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Stye Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Children%u2019s Allergy Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 11/21/2023

Desc:     Pink Eye Drops

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Red Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Dry Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Pink Eye Nighttime Gel

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Allergy Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Irritated Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Complete Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 11/21/2023

Desc:           Pink Eye Drops

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 11/21/2023

Desc:           Stye Eye Drops

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Computer Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Pink Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Aging Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Kids Pink Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 11/21/2023

Desc:           Allergy Eye Drops

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Kids Allergy Eye Relief

66 Y B L 99 Exhibits - Other Drug Related Items N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Similasan Dry Eye Nighttime Gel

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Red Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Dry Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Pink Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 11/21/2023

Desc:           Pink Eye Drops

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Irritated Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Stye Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Aging Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Children%u2019s Allergy Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Complete Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Kids Allergy Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Allergy Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 11/21/2023

Desc:     Pink Eye Drops

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Dry Eye Nighttime Gel

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Kids Pink Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 11/21/2023

Desc:           Stye Eye Drops

80 K - - YX Dispenser, Liquid Medication
Date Published: 11/21/2023

Desc:           Allergy Eye Drops

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Computer Eye Relief

80 K - - YX Dispenser, Liquid Medication
Date Published: 09/12/2023

Desc: Similasan Pink Eye Nighttime Gel

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Red Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Kids Allergy Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Kids Pink Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Stye Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Pink Eye Nighttime Gel

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Pink Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Dry Eye Nighttime Gel

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Computer Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Complete Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Children%u2019s Allergy Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Dry Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Allergy Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Aging Eye Relief

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 11/21/2023

Desc:     Pink Eye Drops

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 11/21/2023

Desc:           Allergy Eye Drops

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 11/21/2023

Desc:           Pink Eye Drops

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 11/21/2023

Desc:           Stye Eye Drops

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Similasan Irritated Eye Relief

Swiss Caps AG
Date Published : 04/23/2014
Husenstrasse 35 , Kirchberg SG, St. Gallen SWITZERLAND
54 C - - 99 Protein N.E.C.
Date Published: 04/23/2014

Desc: Celergen Food Supplement
Notes: Problem; Unapproved New Drug

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/23/2014

Desc: Celergen Food Supplement
Notes: Problem; Unapproved New Drug

Vasperis
Date Published : 06/28/2013
2 Carrefour De Rive , Gen¿ve, SWITZERLAND
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 06/28/2013

Desc: O'Tentika Skin Tone Formula
Notes: France

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/28/2013

Desc: O'Tentika Skin Tone Formula
Notes: France


SYRIAN ARAB REPUBLIC


Alpha - Aleppo Pharmaceutical Industries
Date Published : 09/30/2009
not available , Aleppo, SYRIAN ARAB REPUBLIC
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/13/2019

Notes: All products, 11/21/2002

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All products. GPI=DR GPI=VI 11/21/2002

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009


TAIWAN


1 Meds
Date Published : 09/30/2009
Steven King, 21 Marion Street , Shorewood 7276, TAIWAN
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 09/30/2009

Notes: Abarelix;                

64 R - - 21 Somatropin (Hormone)
Date Published: 09/09/2020

Notes:                

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                

AN LIANG TAI TECHNOLOGY CO.,LTD
Date Published : 11/28/2017
No.8, Aly. 2, Ln. 407 , Mazu Rd. , Xinyuan Township, TAIWAN
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/28/2017

Desc: Taiwan Hot Spring Water Whitening Mask
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: "making skin…white" and "soothes skin discomfort".

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/28/2017

Desc: Taiwan Hot Spring Water Essence Mask
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: "making skin…white".

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/28/2017

Desc: Taiwan Hot Spring Water Whitening Mask (snail)
Notes: The product appears to be an unapproved new drug as the product labels and website include claims such as: "soothes skin discomfort", "delay skin aging", and "can make skin white".

BEAUTY RIVER INTERNATIONAL CO LTD
Date Published : 12/08/2021
4 F; No. 1, Wugong 5th Rd. , Xinzhuang Dist. , New Taipei City, TAIWAN
53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations)
Date Published: 12/08/2021

Desc: Low S Oil
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 C - - 04 Eye Lotion (Eye Makeup Preparations)
Date Published: 12/08/2021

Desc: Co Q-10 Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 C - - 04 Eye Lotion (Eye Makeup Preparations)
Date Published: 12/08/2021

Desc: Arbutin C & E Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 C - - 04 Eye Lotion (Eye Makeup Preparations)
Date Published: 12/08/2021

Desc: Fifth Element Peptide Cream
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations)
Date Published: 12/08/2021

Desc: Co Q-10 Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations)
Date Published: 12/08/2021

Desc: Fifth Element Peptide Cream
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations)
Date Published: 12/08/2021

Desc: Arbutin C & E Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Arbutin C & E Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Fifth Element Peptide Cream
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Co Q-10 Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Low S Oil
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Low S Oil
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Arbutin C & E Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Fifth Element Peptide Cream
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Co Q-10 Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Co Q-10 Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Fifth Element Peptide Cream
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Arbutin C & E Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Arbutin C & E Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Co Q-10 Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Fifth Element Peptide Cream
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/08/2021

Desc: Low S Oil
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/08/2021

Desc: Co Q-10 Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/08/2021

Desc: Fifth Element Peptide Cream
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/08/2021

Desc: Arbutin C & E Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

Biotanico, Inc.
Date Published : 03/16/2015
No. 1 Nanke 1st Rd. , Xinshi Dist. , Tainan City, TAIWAN
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2015

Desc: Stir Field of Elixir
Notes: Biotanico Inc. is the manufacturer. Balance Healthcare Limited is the shipper whose website refers to a link that makes drug claims of the aforementioned dietary supplement products

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2015

Desc: Female Treasure
Notes: Biotanico Inc. is the manufacturer. Balance Healthcare Limited is the shipper whose website refers to a link that makes drug claims of the aforementioned dietary supplement products

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2015

Desc: Warm the Mansion
Notes: Biotanico Inc. is the manufacturer. Balance Healthcare Limited is the shipper whose website refers to a link that makes drug claims of the aforementioned dietary supplement products

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2015

Desc: Freeing the Sun
Notes: Biotanico Inc. is the manufacturer. Balance Healthcare Limited is the shipper whose website refers to a link that makes drug claims of the aforementioned dietary supplement products

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2015

Desc: Arouse Power
Notes: Biotanico Inc. is the manufacturer. Balance Healthcare Limited is the shipper whose website refers to a link that makes drug claims of the aforementioned dietary supplement products.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2015

Desc: Brocade Sinews
Notes: Biotanico Inc. is the manufacturer.Balance Healthcare Limited is the shipper whose website refers to a link that makes drug claims of the aforementioned dietary supplement products.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2015

Desc: Clear QI
Notes: Biotanico Inc. is the manufacturer.Balance Healthcare Limited is the shipper whose website refers to a link that makes drug claims of the aforementioned dietary supplement products

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2015

Desc: Freeing the Moon
Notes: Biotanico Inc. is the manufacturer.Balance Healthcare Limited is the shipper whose website refers to a link that makes drug claims of the aforementioned dietary supplement products

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2015

Desc: Ease the Journey-Yin
Notes: Biotanico Inc. is the manufacturer. Balance Healthcare Limited is the shipper whose website refers to a link that makes drug claims of the aforementioned dietary supplement products.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2015

Desc: Bend Bamboo
Notes: Biotanico Inc. is the manufacturer. Balance Healthcare Limited is the shipper whose website refers to a link that makes drug claims of the aforementioned dietary supplement products.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2015

Desc: Children?s Herbal Sentinel
Notes: Biotanico Inc. is the manufacturer.Balance Healthcare Limited is the shipper whose website refers to a link that makes drug claims of the aforementioned dietary supplement products.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2015

Desc: Heavenly Empress
Notes: Biotanico Inc. is the manufacturer. Balance Healthcare Limited is the shipper whose website refers to a link that makes drug claims of the aforementioned dietary supplement products

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2015

Desc: Clear the Root
Notes: Biotanico Inc. is the manufacturer.Balance Healthcare Limited is the shipper whose website refers to a link that makes drug claims of the aforementioned dietary supplement products.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2015

Desc: Drain the Jade Valley
Notes: Biotanico Inc. is the manufacturer.Balance Healthcare Limited is the shipper whose website refers to a link that makes drug claims of the aforementioned dietary supplement products.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2015

Desc: Harmonizing the Moon
Notes: Biotanico Inc. is the manufacturer. Balance Healthcare Limited is the shipper whose website refers to a link that makes drug claims of the aforementioned dietary supplement products

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2015

Desc: Clear Yang
Notes: Biotanico Inc. is the manufacturer.Balance Healthcare Limited is the shipper whose website refers to a link that makes drug claims of the aforementioned dietary supplement products.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/10/2024

Desc:                Clear Skin Formula Tablets

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2015

Desc: Restrain the Flow
Notes: Biotanico Inc. is the manufacturer. Balance Healthcare Limited is the shipper whose website refers to a link that makes drug claims of the aforementioned dietary supplement products

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2015

Desc: Benefit the sinews
Notes: Biotanico Inc. is the manufacturer. Balance Healthcare Limited is the shipper whose website refers to a link that makes drug claims of the aforementioned dietary supplement products.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2015

Desc: Unicorn Pearl
Notes: Biotanico Inc. is the manufacturer. Balance Healthcare Limited is the shipper whose website refers to a link that makes drug claims of the aforementioned dietary supplement products

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/16/2015

Desc: Root the Spirit
Notes: Biotanico Inc. is the manufacturer. Balance Healthcare Limited is the shipper whose website refers to a link that makes drug claims of the aforementioned dietary supplement products

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/10/2024

Desc:                Clear Skin Formula Tablets

Charming Girl Trading Co.,Ltd
Date Published : 07/31/2012
24, 3 F , Beiping E. Rd.; Zhongzheng Dist. , Taipei City, TW-TPQ TAIWAN
53 L - - -- Skin Care Prep
Date Published: 08/14/2012

Desc: Whitening Eye Mask
Notes: Taiwan

53 L - - -- Skin Care Prep
Date Published: 07/31/2012

Desc: Whitening Jelly Mask
Notes: Taiwan

53 L - - -- Skin Care Prep
Date Published: 07/31/2012

Desc: Whitening Mask Concentrated
Notes: Taiwan

53 L - - -- Skin Care Prep
Date Published: 07/31/2012

Desc: Moisturizing Facial Jelly Mask
Notes: Taiwan

53 L - - -- Skin Care Prep
Date Published: 07/31/2012

Desc: Whitening Essence Mask
Notes: Taiwan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/31/2012

Desc: Moisturizing Facial Jelly Mask
Notes: Taiwan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/31/2012

Desc: Whitening Jelly Mask
Notes: Taiwan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/31/2012

Desc: Whitening Mask Concentrated
Notes: Taiwan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/31/2012

Desc: Whitening Essence Mask
Notes: Taiwan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/14/2012

Desc: Whitening Eye Mask
Notes: Taiwan

DrSignal Biotechnology Co Ltd.
Date Published : 06/04/2015
2 F , No. 2-1 Lane; 181 Jiuzong Rd., Sec.2 , Neihu District , Taipei, Taipei - Special Municipality TAIWAN
53 B - - 99 Other Bath Preparations, N.E.C.
Date Published: 06/04/2015

Desc: Stem Cell Skin Bioliquid
Notes: The aforementioned product appears to be an unapproved new drug as the product label and associated website; www.drsignal.com.tw; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/04/2015

Desc: Stem Cell Skin Bioliquid
Notes: The aforementioned product appears to be an unapproved new drug as the product label and associated website; www.drsignal.com.tw; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease.

Drsignal Biotechnology Co Ltd
Date Published : 06/05/2015
4f No 207-2 Sec 3 Pei Hsin Rd Hsin Tien , Shindian, TAIWAN
53 B - - 99 Other Bath Preparations, N.E.C.
Date Published: 06/05/2015

Desc: Stem Cell Skin Bioliquid
Notes: The aforementioned product appears to be an unapproved new drug as the product label and associated website; www.drsignal.com.tw; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/05/2015

Desc: Stem Cell Skin Bioliquid
Notes: The aforementioned product appears to be an unapproved new drug as the product label and associated website; www.drsignal.com.tw; imply the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease

Fengjia Biotechnology Ltd
Date Published : 02/01/2024
No 160 Lunnei , Tuku Township , Yunlin County, Yunlin TAIWAN
54 A - - 99 Vitamin, N.E.C.
Date Published: 02/01/2024

Desc:               Ginseng Turmeric Superjuice Dietary Supplement

54 A - - 99 Vitamin, N.E.C.
Date Published: 02/01/2024

Desc:               Collagen Glow Berries Dietary Supplement

54 E - - 12 Ginseng (Herbal & Botanical Teas)
Date Published: 02/01/2024

Desc:               Ginseng Turmeric Superjuice Dietary Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/01/2024

Desc:               Ginseng Turmeric Superjuice Dietary Supplement

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/01/2024

Desc:               Collagen Glow Berries Dietary Supplement

HIEMON ENTERPRISES CO LTD
Date Published : 08/28/2010
2fl No 7 Lane 41 Sec 2 Nanking E Rd , TAIPEI, TW-TPE TAIWAN
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/28/2010

Desc: Wonder Grass (also declared as Extract of Allii Tuberosi Semea)
Notes: Taiwan

Jsut International Co Ltd
Date Published : 04/23/2014
Situn District , NO. 123, 14f-3 , Taichung City, TAIWAN
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/23/2014

Desc: L-Ascorbic Acid Brightening Mask

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/23/2014

Desc: L-Ascorbic Acid Whitening Mask

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 04/23/2014

Desc: L-Ascorbic Acid Brightening Mask

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 04/23/2014

Desc: L-Ascorbic Acid Whitening Mask

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 04/23/2014

Desc: L-Ascorbic Acid Whitening Mask

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 04/23/2014

Desc: L-Ascorbic Acid Brightening Mask

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/23/2014

Desc: L-Ascorbic Acid Whitening Mask

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/23/2014

Desc: L-Ascorbic Acid Brightening Mask

Kaiser Pharmaceutical Co.
Date Published : 05/17/2011
No. 9 Huangong Rd. , Yongkang Dist. , Tainan City, TAIWAN
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/17/2011

Desc: She Chuang Zi (Cnidum Fruit)
Notes: Taiwan

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/17/2011

Desc: She Chuang Zi (Cnidum Fruit)
Notes: Taiwan

55 R - - 99 Pharmaceutic Necessities, N.E.C.
Date Published: 05/17/2011

Desc: She Chuang Zi (Cnidum Fruit)
Notes: Taiwan

66 - - - -- Human and Animal Drugs
Date Published: 08/30/2021

Desc: Human and Animal Drugs
Notes:                                                                                                                              

Maxigen Biotech, Inc.
Date Published : 04/23/2021
Guishan District , No. 88 Keji 1st Rd.; Guishan Dist. , Taoyuan City, TAIWAN
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/23/2021

Desc: Dp DERMACEUTICALS BRITE LITE 3D SCULPTURED MASK
Notes: The product appears to be an unapproved new drug as the product's label and associated website include claims such as (not an all-inclusive list): "Brightens, lightens the appearance of uneven skin tone discoloured skin..." (label); "[D]esigned to reduce the appearance of uneven skin tone, dark spots and blemishes, whilst helping the skin resist future darkening..." (label); "Brightens and lightens the appearance of uneven skin tone and discoloured skin..." (website); "[M]ay sedate pigment formation..." (both label and webpage); "Reduces the appearance of dark spots, age spots, freckles and sun damage..." (both label and website).

53 L - - -- Skin Care Prep
Date Published: 04/23/2021

Desc: Dp DERMACEUTICALS BRITE LITE 3D SCULPTURED MASK
Notes: The product appears to be an unapproved new drug as the product's label and associated website include claims such as (not an all-inclusive list): "Brightens, lightens the appearance of uneven skin tone discoloured skin..." (label); "[D]esigned to reduce the appearance of uneven skin tone, dark spots and blemishes, whilst helping the skin resist future darkening..." (label); "Brightens and lightens the appearance of uneven skin tone and discoloured skin..." (website); "[M]ay sedate pigment formation..." (both label and webpage); "Reduces the appearance of dark spots, age spots, freckles and sun damage..." (both label and website).

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 04/23/2021

Desc: Dp DERMACEUTICALS BRITE LITE 3D SCULPTURED MASK
Notes: The product appears to be an unapproved new drug as the product's label and associated website include claims such as (not an all-inclusive list): "Brightens, lightens the appearance of uneven skin tone discoloured skin..." (label); "[D]esigned to reduce the appearance of uneven skin tone, dark spots and blemishes, whilst helping the skin resist future darkening..." (label); "Brightens and lightens the appearance of uneven skin tone and discoloured skin..." (website); "[M]ay sedate pigment formation..." (both label and webpage); "Reduces the appearance of dark spots, age spots, freckles and sun damage..." (both label and website).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/23/2021

Desc: Dp DERMACEUTICALS BRITE LITE 3D SCULPTURED MASK
Notes: The product appears to be an unapproved new drug as the product's label and associated website include claims such as (not an all-inclusive list): "Brightens, lightens the appearance of uneven skin tone discoloured skin..." (label); "[D]esigned to reduce the appearance of uneven skin tone, dark spots and blemishes, whilst helping the skin resist future darkening..." (label); "Brightens and lightens the appearance of uneven skin tone and discoloured skin..." (website); "[M]ay sedate pigment formation..." (both label and webpage); "Reduces the appearance of dark spots, age spots, freckles and sun damage..." (both label and website).

Meditalent Enterprises Ltd.
Date Published : 09/30/2009
No. 51, Sec. 1 , 166, 5f-1; Minsheng E. Rd. Sec. 2 , Taipei City, TAIWAN
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/13/2019

Notes: All products. GPI = DR. GPI = VI 8/4/1999. 11/17/1999.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All products. GPI = DR. GPI = VI 8/4/1999. 11/17/1999.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products. GPI = DR. GPI = VI 8/4/1999. 11/17/1999.

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products. GPI = DR. GPI = VI 8/4/1999. 11/17/1999.

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products. GPI = DR. GPI = VI 8/4/1999. 11/17/1999.

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products. GPI = DR. GPI = VI 8/4/1999. 11/17/1999.

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products. GPI = DR. GPI = VI 8/4/1999. 11/17/1999.

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products. GPI = DR. GPI = VI 8/4/1999. 11/17/1999.

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All products. GPI = DR. GPI = VI 8/4/1999. 11/17/1999.

Meditech Enterprise Co Ltd
Date Published : 09/30/2009
Po Box 58388 , Taipei, TAIWAN
53 L C - -- Skin Care Prep, Cream
Date Published: 09/30/2009

Notes: 8/4/1999 Updated 11/17/1999. Products may be entering as skin care cosmetics; therefore we are including the product code 53LC (Skin care Preparations; along with the appropriate drug codes).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/13/2019

Notes: All Products; 8/4/1999

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: All Products; 8/4/1999

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All Products; 8/4/1999

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All Products; 8/4/1999

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All Products; 8/4/1999

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All Products; 8/4/1999

64 L - - 06 Betamethasone Dipropionate (Glucocorticoid)
Date Published: 09/30/2009

Notes: 8/4/1999 Updated 11/17/1999. Products may be entering as skin care cosmetics; therefore we are including the product code 53LC (Skin care Preparations; along with the appropriate drug codes).

64 L - - 28 Fluocinonide (Glucocorticoid)
Date Published: 09/30/2009

Notes: 8/4/1999 Updated 11/17/1999. Products may be entering as skin care cosmetics; therefore we are including the product code 53LC (Skin care Preparations; along with the appropriate drug codes).

64 L - - 99 Glucocorticoid N.E.C.
Date Published: 09/30/2009

Notes: 8/4/1999 Updated 11/17/1999. Products may be entering as skin care cosmetics; therefore we are including the product code 53LC (Skin care Preparations; along with the appropriate drug codes).

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All Products; 8/4/1999

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All Products; 8/4/1999

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: All Products; 8/4/1999

Mei Kwang Chemical Factory
Date Published : 08/22/2011
48 Lane 341 Chunghwa 2 Rd , Kaohsiung, TAIWAN
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 08/22/2011

Desc: Sun Block Lotion SPF 100 and Antirich Whitening Cream (Day Cream)SPF-32
Notes: Taiwan

65 L - - 11 Titanium Dioxide (Protectant)
Date Published: 08/22/2011

Desc: Sun Block Lotion SPF 100 and Antirich Whitening Cream (Day Cream)SPF-32
Notes: Taiwan

65 L - - 99 Protectant N.E.C.
Date Published: 08/22/2011

Desc: Sun Block Lotion SPF 100 and Antirich Whitening Cream (Day Cream)SPF-32
Notes: Taiwan

Pro Sero Co., Ltd
Date Published : 09/30/2009
No. 122, Section 1 , 7 F.; Ho-Ping West Road , Taipei, TAIWAN
60 L - - -- Analgesic
Date Published: 09/30/2009

Notes: Pro Sero Plaster pain relieving patch; 10/27/2006

79 K - - GX Tape And Bandage, Adhesive
Date Published: 09/30/2009

Notes: Pro Sero Plaster pain relieving patch; 10/27/2006

SHEN YUNG CO LTD
Date Published : 06/07/2011
No. 545 Dingtai Rd. , Wufeng Township , Wufeng, Taichung - District TAIWAN
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/07/2011

Notes: Vita-Ease External Pain Relieving Patch and Vita-Ease Aqua External Pain Relieving Patch; Taiwan

Sage Pharmaceuticals Inc.
Date Published : 12/08/2021
4 F , No. 1 Wugong 5th Rd.; Xinzhuang Dist. , New Taipei City, TAIWAN
53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations)
Date Published: 12/08/2021

Desc: Low S Oil
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 C - - 04 Eye Lotion (Eye Makeup Preparations)
Date Published: 12/08/2021

Desc: Arbutin C & E Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 C - - 04 Eye Lotion (Eye Makeup Preparations)
Date Published: 12/08/2021

Desc: Co Q-10 Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 C - - 04 Eye Lotion (Eye Makeup Preparations)
Date Published: 12/08/2021

Desc: Fifth Element Peptide Cream
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations)
Date Published: 12/08/2021

Desc: Arbutin C & E Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations)
Date Published: 12/08/2021

Desc: Fifth Element Peptide Cream
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations)
Date Published: 12/08/2021

Desc: Co Q-10 Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Arbutin C & E Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Low S Oil
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Fifth Element Peptide Cream
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Co Q-10 Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Low S Oil
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Fifth Element Peptide Cream
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Arbutin C & E Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Co Q-10 Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Co Q-10 Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Fifth Element Peptide Cream
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Arbutin C & E Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Co Q-10 Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Fifth Element Peptide Cream
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 12/08/2021

Desc: Arbutin C & E Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/08/2021

Desc: Low S Oil
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/08/2021

Desc: Co Q-10 Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/08/2021

Desc: Arbutin C & E Topical Serum
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/08/2021

Desc: Fifth Element Peptide Cream
Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

Shirley Chemical Corp.
Date Published : 07/26/2012
P.O. Box 1004 , Taipei , TAIWAN
53 L - - -- Skin Care Prep
Date Published: 07/26/2012

Desc: Shirley Beauty Cream
Notes: Taiwan

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/26/2012

Desc: Shirley Beauty Cream
Notes: Taiwan

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 07/26/2012

Desc: Shirley Beauty Cream
Notes: Taiwan

Soapberry Biotech Progress Co., Ltd.
Date Published : 04/14/2020
No. 62-18 Anding , Youche, Nan-an Village , Tainan City, TAIWAN
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 04/14/2020

Desc: Soapberry Hair Lather Awakening Peppermint
Notes: The product appears to be an unapproved new drug, as its promotional website includes claims such as: "antibacterial and anti-inflammatory", "stimulate hair growth and follicle circulation", "prevent DHT [Dihydrotestosterone]" and "protect scalp from dandruff, bacteria, and inflammation".

53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 04/14/2020

Desc: Soapberry Hair Lather Awakening Peppermint
Notes: The product appears to be an unapproved new drug, as its promotional website includes claims such as: "antibacterial and anti-inflammatory", "stimulate hair growth and follicle circulation", "prevent DHT [Dihydrotestosterone]" and "protect scalp from dandruff, bacteria, and inflammation".

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 04/14/2020

Desc: Soapberry Hair Lather Awakening Peppermint
Notes: The product appears to be an unapproved new drug, as its promotional website includes claims such as: "antibacterial and anti-inflammatory", "stimulate hair growth and follicle circulation", "prevent DHT [Dihydrotestosterone]" and "protect scalp from dandruff, bacteria, and inflammation".

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/14/2020

Desc: Soapberry Facial Wash Peppermint
Notes: The product appears to be an unapproved new drug, as its promotional website includes claims such as: "antibacterial and anti-inflammatory".

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 04/14/2020

Desc: Soapberry Body Lather Awakening Peppermint
Notes: The product appears to be an unapproved new drug, as its promotional website includes claims such as: "antibacterial and anti-inflammatory".

56 Y - - 99 Antibiotic N.E.C.
Date Published: 04/14/2020

Desc: Soapberry Hair Lather Awakening Peppermint
Notes: The product appears to be an unapproved new drug, as its promotional website includes claims such as: "antibacterial and anti-inflammatory", "stimulate hair growth and follicle circulation", "prevent DHT [Dihydrotestosterone]" and "protect scalp from dandruff, bacteria, and inflammation".

56 Y - - 99 Antibiotic N.E.C.
Date Published: 04/14/2020

Desc: Soapberry Body Lather Awakening Peppermint
Notes: The product appears to be an unapproved new drug, as its promotional website includes claims such as: "antibacterial and anti-inflammatory".

56 Y - - 99 Antibiotic N.E.C.
Date Published: 04/14/2020

Desc: Soapberry Facial Wash Peppermint
Notes: The product appears to be an unapproved new drug, as its promotional website includes claims such as: "antibacterial and anti-inflammatory".

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 04/14/2020

Desc: Soapberry Hair Lather Awakening Peppermint
Notes: The product appears to be an unapproved new drug, as its promotional website includes claims such as: "antibacterial and anti-inflammatory", "stimulate hair growth and follicle circulation", "prevent DHT [Dihydrotestosterone]" and "protect scalp from dandruff, bacteria, and inflammation".

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 04/14/2020

Desc: Soapberry Body Lather Awakening Peppermint
Notes: The product appears to be an unapproved new drug, as its promotional website includes claims such as: "antibacterial and anti-inflammatory".

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 04/14/2020

Desc: Soapberry Facial Wash Peppermint
Notes: The product appears to be an unapproved new drug, as its promotional website includes claims such as: "antibacterial and anti-inflammatory".

Taiyen Biotech Co., Ltd.
Date Published : 10/16/2012
No. 297 Chen-Kang Road, Sec. 1 , Tainan, TAIWAN
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 10/16/2012

Desc: Whitening Essence II Skin Care

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/16/2012

Desc: Whitening Essence II Skin Care

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/16/2012

Desc: Whitening Essence II Skin Care

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 10/16/2012

Desc: Whitening Essence II Skin Care

65 L - - 11 Titanium Dioxide (Protectant)
Date Published: 10/16/2012

Desc: Sun Block SPF50

65 L - - 99 Protectant N.E.C.
Date Published: 10/16/2012

Desc: Sun Block SPF50

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 10/16/2012

Desc: Sun Block SPF50

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/16/2012

Desc: Sun Block SPF50

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/16/2012

Desc: Whitening Essence II Skin Care


THAILAND


ASP International hrbal soap co, ltd.
Date Published : 12/18/2015
29 , 112 345 Road Lumpo District Bang , Bang Bua Thong, Nonthaburi THAILAND
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/18/2015

Desc: Asantee Tamarind and Ginger Soap
Notes: Labeling on product makes drug claims

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/18/2015

Desc: Asantee Rice Milk Soap with collagen
Notes: Labeling on product makes drug claims.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/18/2015

Desc: Asantee Papaya Soap
Notes: Labeling on product makes drug claims

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/18/2015

Desc: Asantee Soap Cucumber
Notes: Labeling on product makes drug claims

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/18/2015

Desc: Asantee Tamarind and Goat Milk Soap
Notes: Labeling on product makes drug claims

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/18/2015

Desc: Asantee Tamarind Soap
Notes: Labeling on product makes drug claims

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/18/2015

Desc: Asantee Tumeric and Ginger Soap
Notes: Labeling on product makes drug claims.

Beiersdorf (Thailand Co Ltd
Date Published : 07/28/2014
12th And 17th Fl Sathorn Thani , Bangkok, THAILAND
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/28/2014

Desc: Nivea UV Whitening Extra Cell Repair

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 07/28/2014

Desc: Nivea UV Whitening Extra Cell Repair & Protect Body Lotion

Bio Woman Co Ltd
Date Published : 11/06/2012
256 258 260 Ladprao 132 , Bangkok, THAILAND
53 C - - 01 Eyebrow Pencil (Eye Makeup Preparations)
Date Published: 11/06/2012

Desc: Kuu Spa Firm Cream Anti-Cellulite

53 C - - 01 Eyebrow Pencil (Eye Makeup Preparations)
Date Published: 11/06/2012

Desc: Bio Bust Breatrogenic Cream

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/06/2012

Desc: Bio Bust Breatrogenic Cream

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/06/2012

Desc: Kuu Spa Firm Cream Anti-Cellulite

Bond Innoventure Co.,Ltd
Date Published : 12/22/2015
95 Moo 8 Omnoi Katumban , Samutsakorn, THAILAND
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 12/22/2015

Desc: Bond Wipes - Men's Intimate Wipes
Notes: Product labeling has disease/drug claims.

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 12/22/2015

Desc: Bond Men's Intimate Wipes
Notes: Product labeling has disease/drug claims.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/22/2015

Desc: Bond Men's Intimate Wipes
Notes: Product labeling has disease/drug claims.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/22/2015

Desc: Bond Wipes - Men's Intimate Wipes
Notes: Product labeling has disease/drug claims.

Brywood Pharmaceutical Co., Ltd.
Date Published : 04/27/2017
58 Suksawat 7 , Suksawat Rd. , Bangkok, THAILAND
60 S - - 04 Aluminum Hydroxide (Antacid)
Date Published: 04/27/2017

Desc: Brygel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/27/2017

Desc: Brygel

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 04/27/2017

Desc: Brygel

Charisma Co., Ltd.
Date Published : 09/30/2009
248/1 Sukhumvit 16 , Khlong Toei, Bangkok THAILAND
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/13/2019

Notes: Ancom Tablets 2/12/2003

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: Ancom Tablets 2/12/2003

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets 2/12/2003

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets 2/12/2003

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets 2/12/2003

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets 2/12/2003

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets 2/12/2003

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets 2/12/2003

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets 2/12/2003

Colgate Palmolive Thailand Ltd
Date Published : 05/03/2018
19 Off Na Ranong Rd , Bangkok, FN THAILAND
61 H - - 99 Anti-Bacterial, N.E.C.
Date Published: 05/03/2018

Desc: Palmolive Naturals Anti-Dandruff Shampoo & Conditioner

62 S - - 99 Anti-Seborrheic N.E.C.
Date Published: 05/03/2018

Desc: Palmolive Naturals Anti-Dandruff Shampoo & Conditioner

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/03/2018

Desc: Palmolive Naturals Anti-Dandruff Shampoo & Conditioner

Cosmaprof Co Ltd
Date Published : 07/12/2017
42, 44, 46, Soi Ramkhamhaeng 60/3 , Huamark , Bang Kapi, Bangkok THAILAND
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/12/2017

Desc: CookieSkin Dermal Repair Brightening Body Lotion Sunscreen
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Brightening SPF20 Erase past damage to create brighter?Vitamin B3 brightens; firms; treats and prevents body acne. Vitamins C a powerful antioxidant that stimulates collagen; brightens and helps prevent sun damage

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/12/2017

Desc: CookieSkin Revitalizing Luminous Tonic
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; 4 in 1; Oil/Acne control; brighten; tighten; rejuvenate? Erase past damage to create brighter Vitamin B3 brightens; firms; treats and prevents body acne?Vitamins C a powerful antioxidant that stimulates collagen; brightens and helps prevent sun damage.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/12/2017

Desc: CookieSkin Complexion Shield Lotion Sunscreen
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; SPF 30 Maintain long lasting whitening results using this lotion to prevent skin darkening Titanium dioxide; a natural sunblock that slows aging due to sun damage Prevents skin darkening Prevents acne.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/12/2017

Desc: CookieSkin Dermal Repair Nourishing Whitening Cream
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Whitening. A very effective concentration of 4 clinically proven whitening ingredients; kojic dipalmitate; licorice; alpha arbutin and vitamin B3 to lighten and fade skin discolorations Kojic dipalmitate Licorice Alpha arbutin to accelerate the brightening of skin Whitens; brightens and lightens skin for lasting results?Helps clears blemishes and age spots; controls oil?Vitamin B3 brightens; firms; treats and prevents acne

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/12/2017

Desc: CookieSkin Miracle Revitalizing Luminous Cream
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; 4 in 1; Rejuvenate; brighten; firm treat [O]ne of the most effective hydroquinone free lightening products around. Diminishes the appearance of discoloration; dark spots; dark eye circles; marks. Treat and prevent hyperpigmentation. Treat and prevent sunburns.

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/12/2017

Desc: CookieSkin Dermal Repair Whitening Acne Serum
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Whitening Acne Serum?Combination oily/acne prone/aging skin. A rescue formula that detoxifies; prevents and reverses skin damage while creating a whiter; brighter more even skin tone.This hydroquinone free serum does more than whitens the skin; it is ideal for treating and preventing acne; dark spots; rough dull skin; and large pores.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/12/2017

Desc: CookieSkin Dermal Repair Brightening Body Lotion Sunscreen
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Brightening SPF20 Erase past damage to create brighter Vitamin B3 brightens; firms; treats and prevents body acne. Vitamins C a powerful antioxidant that stimulates collagen; brightens and helps prevent sun damage

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/12/2017

Desc: CookieSkin Miracle Revitalizing Luminous Cream
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; 4 in 1; Rejuvenate; brighten; firm treat [O]ne of the most effective hydroquinone free lightening products around. Diminishes the appearance of discoloration; dark spots; dark eye circles; marks. Treat and prevent hyperpigmentation. Treat and prevent sunburns.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/12/2017

Desc: CookieSkin Revitalizing Luminous Tonic
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; 4 in 1; Oil/Acne control; brighten; tighten; rejuvenate. Erase past damage to create brighter?Vitamin B3 brightens; firms; treats and prevents body acne?Vitamins C a powerful antioxidant that stimulates collagen; brightens and helps prevent sun damage.

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/12/2017

Desc: CookieSkin Dermal Repair Whitening Acne Serum
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Whitening Acne Serum?Combination oily/acne prone/aging skin. A rescue formula that detoxifies; prevents and reverses skin damage while creating a whiter; brighter more even skin tone.This hydroquinone free serum does more than whitens the skin; it is ideal for treating and preventing acne; dark spots; rough dull skin; and large pores. ;

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/12/2017

Desc: CookieSkin Dermal Repair Nourishing Whitening Cream
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Whitening. A very effective concentration of 4 clinically proven whitening ingredients; kojic dipalmitate; licorice; alpha arbutin and vitamin B3 to lighten and fade skin discolorations Kojic dipalmitate Licorice Alpha arbutin to accelerate the brightening of skin Whitens; brightens and lightens skin for lasting results Helps clears blemishes and age spots; controls oil Vitamin B3 brightens; firms; treats and prevents acne

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/12/2017

Desc: CookieSkin Complexion Shield Lotion Sunscreen
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; SPF 30 Maintain long lasting whitening results using this lotion to prevent skin darkening Titanium dioxide; a natural sunblock that slows aging due to sun damage Prevents skin darkening Prevents acne

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/12/2017

Desc: CookieSkin Complexion Shield Lotion Sunscreen
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; SPF 30 Maintain long lasting whitening results using this lotion to prevent skin darkening Titanium dioxide; a natural sunblock that slows aging due to sun damage Prevents skin darkening Prevents acne

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/12/2017

Desc: CookieSkin Dermal Repair Nourishing Whitening Cream
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Whitening. A very effective concentration of 4 clinically proven whitening ingredients; kojic dipalmitate; licorice; alpha arbutin and vitamin B3 to lighten and fade skin discolorations Kojic dipalmitate Licorice Alpha arbutin to accelerate the brightening of skin Whitens; brightens and lightens skin for lasting results Helps clears blemishes and age spots; controls oil Vitamin B3 brightens; firms; treats and prevents acne

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/12/2017

Desc: CookieSkin Miracle Revitalizing Luminous Cream
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; 4 in 1; Rejuvenate; brighten; firm treat [O]ne of the most effective hydroquinone free lightening products around. Diminishes the appearance of discoloration; dark spots; dark eye circles; marks. Treat and prevent hyperpigmentation. Treat and prevent sunburns

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/12/2017

Desc: CookieSkin Dermal Repair Whitening Acne Serum
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Whitening Acne Serum?Combination oily/acne prone/aging skin. A rescue formula that detoxifies; prevents and reverses skin damage while creating a whiter; brighter more even skin tone.This hydroquinone free serum does more than whitens the skin; it is ideal for treating and preventing acne; dark spots; rough dull skin; and large pores. ;

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/12/2017

Desc: CookieSkin Revitalizing Luminous Tonic
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; 4 in 1; Oil/Acne control; brighten; tighten; rejuvenate? Erase past damage to create brighter Vitamin B3 brightens; firms; treats and prevents body acne?Vitamins C a powerful antioxidant that stimulates collagen; brightens and helps prevent sun damage.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/12/2017

Desc: CookieSkin Dermal Repair Brightening Body Lotion Sunscreen
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Brightening SPF20 Erase past damage to create brighter Vitamin B3 brightens; firms; treats and prevents body acne. Vitamins C a powerful antioxidant that stimulates collagen; brightens and helps prevent sun damage

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 07/12/2017

Desc: CookieSkin Complexion Shield Lotion Sunscreen
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; SPF 30 Maintain long lasting whitening results using this lotion to prevent skin darkening Titanium dioxide; a natural sunblock that slows aging due to sun damage Prevents skin darkening Prevents acne

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 07/12/2017

Desc: CookieSkin Dermal Repair Brightening Body Lotion Sunscreen
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Brightening SPF20 Erase past damage to create brighter Vitamin B3 brightens; firms; treats and prevents body acne. Vitamins C a powerful antioxidant that stimulates collagen; brightens and helps prevent sun damage

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/12/2017

Desc: CookieSkin Miracle Revitalizing Luminous Cream
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; 4 in 1; Rejuvenate; brighten; firm treat [O]ne of the most effective hydroquinone free lightening products around?Diminishes the appearance of discoloration; dark spots; dark eye circles; marks. Treat and prevent hyperpigmentation. Treat and prevent sunburns

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/12/2017

Desc: CookieSkin Dermal Repair Brightening Body Lotion Sunscreen
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Brightening SPF20 Erase past damage to create brighter Vitamin B3 brightens; firms; treats and prevents body acne. Vitamins C a powerful antioxidant that stimulates collagen; brightens and helps prevent sun damage

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/12/2017

Desc: CookieSkin Complexion Shield Lotion Sunscreen
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; SPF 30 Maintain long lasting whitening results using this lotion to prevent skin darkening Titanium dioxide; a natural sunblock that slows aging due to sun damage Prevents skin darkening Prevents acne

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/12/2017

Desc: CookieSkin Revitalizing Luminous Tonic
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; 4 in 1; Oil/Acne control; brighten; tighten; rejuvenate. Erase past damage to create brighter?Vitamin B3 brightens; firms; treats and prevents body acne?Vitamins C a powerful antioxidant that stimulates collagen; brightens and helps prevent sun damage.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/12/2017

Desc: CookieSkin Dermal Repair Nourishing Whitening Cream
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Whitening. A very effective concentration of 4 clinically proven whitening ingredients; kojic dipalmitate; licorice; alpha arbutin and vitamin B3 to lighten and fade skin discolorations Kojic dipalmitate Licorice Alpha arbutin to accelerate the brightening of skin Whitens; brightens and lightens skin for lasting results Helps clears blemishes and age spots; controls oil Vitamin B3 brightens; firms; treats and prevents acne

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/12/2017

Desc: CookieSkin Dermal Repair Whitening Acne Serum
Notes: The product appears to be an unapproved new drug as the product label and website include claims such as; Whitening Acne Serum?Combination oily/acne prone/aging skin. A rescue formula that detoxifies; prevents and reverses skin damage while creating a whiter; brighter more even skin tone.This hydroquinone free serum does more than whitens the skin; it is ideal for treating and preventing acne; dark spots; rough dull skin; and large pores.

Devakam Apothecary Hall Co Ltd
Date Published : 10/20/2009
12/571 M 15 Bangna Thad , Samutprakarn, THAILAND
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/18/2011

Desc: Boxing Liniment (Namman Muay Liniment)
Notes: Thailand

60 L - - 99 Analgesic, N.E.C.
Date Published: 10/20/2009

Desc: Boxing Cream (Namman Muay Cream)

60 L - - 99 Analgesic, N.E.C.
Date Published: 08/18/2011

Desc: Boxing Liniment (Namman Muay Liniment)
Notes: Thailand

Devakarn Apothecary Hall Co.,Ltd.
Date Published : 08/18/2011
71 Moo 4 T.Pimpa A.Bangpakong , Chachoengsao, THAILAND
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/18/2011

Desc: Boxing Liniment (Namman Muay Liniment)
Notes: Thailand

60 K - - 99 Anabolic, N.E.C.
Date Published: 08/18/2011

Desc: Boxing Liniment (Namman Muay Liniment)
Notes: Thailand

Dorlene Ltd Co
Date Published : 12/08/2015
199/12 Soi Sen Plu 1 , Bangkok, THAILAND
53 A - - 02 Lotions, Oils, Powders and Creams (Baby Products)
Date Published: 12/08/2015

Desc: Dorlene Herbal Bust Cream with Ginseng and Pueraria (Spa Cream)

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/08/2015

Desc: Dorlene Herbal Bust Cream with Ginseng and Pueraria (Spa Cream)

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/08/2015

Desc: Dorlene Herbal Bust Cream with Ginseng and Pueraria (Spa Cream)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/08/2015

Desc: Dorlene Herbal Bust Cream with Ginseng and Pueraria (Spa Cream)

FIVE PAGODAS PHARMACY CO., LTD.
Date Published : 04/27/2017
238 , Thon Buri, Bangkok THAILAND
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/27/2017

Desc: Ya Hom Powder

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 04/27/2017

Desc: Ya Hom Powder

Gems Food and Drink Co., Ltd
Date Published : 11/10/2014
30/308 Moo 6 Soi Chinnakhet 2/1 , Ngamwongwan Rd , Thungsonghong Laksi, Bangkok THAILAND
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/10/2014

Desc: Lx1 Dietary Supplement
Notes: Problem(s); Unapproved New Drug Misbranded Adulterated; Product label and website bear medical claims and therefore the product is considered as a new drug within the meaning of Section 201(p) without an effective NDA. Product also contains unsafe additive (e.g. DMAA). ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/10/2014

Desc: Lx1 Dietary Supplement
Notes: Problem(s); Unapproved New Drug Misbranded Adulterated; Product label and website bear medical claims and therefore the product is considered as a new drug within the meaning of Section 201(p) without an effective NDA. Product also contains unsafe additive (e.g. DMAA).

Greater Poly Manufacturing
Date Published : 12/22/2015
66/1, 66/3 Phutthamonthon Sai5rd , Nakornpathom, THAILAND
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 12/22/2015

Desc: Bond Men's Intimate Wipes
Notes: Product labeling has disease/drug claims.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/22/2015

Desc: Bond Men's Intimate Wipes
Notes: Product labeling has disease/drug claims.

Greensville Co.,Ltd
Date Published : 05/23/2013
65/3 Ladkrabang Industrial Estate , Bangkok, THAILAND
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 05/23/2013

Desc: Harnn Oriental Herbs Hair Care Conditioner

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 05/23/2013

Desc: Oriental herbs anti-dandruff and hair revitalizing conditioner

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 05/23/2013

Desc: Harnn Oriental Herbs Hair Care Conditioner

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 05/23/2013

Desc: Oriental herbs anti-dandruff and hair revitalizing conditioner

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 05/23/2013

Desc: Water Lily Day Protection Cream

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/23/2013

Desc: Water Lily Day Protection Cream

Immunitor Manufacturer Co., Ltd.
Date Published : 09/30/2009
71 Moo 5 Sukumvit , Bangpakong Industrial Park , Chachoengsao, THAILAND
54 B - - 08 Magnesium (Mineral)
Date Published: 09/04/2019

Desc: V-1 V-4 Magnesium Dietary Supplements
Notes: 4/15/2004

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/04/2019

Desc: V-1 V-4 Magnesium Dietary Supplements
Notes: 4/15/2004

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/04/2019

Notes: V-1, V-4 Magnesium Dietary Supplements; 4/15/2004

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: V-1, V-4 Magnesium Dietary Supplements; 4/15/2004

61 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: V-1, V-4 Magnesium Dietary Supplements; 4/15/2004

62 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: V-1, V-4 Magnesium Dietary Supplements; 4/15/2004

63 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: V-1, V-4 Magnesium Dietary Supplements; 4/15/2004

64 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: V-1, V-4 Magnesium Dietary Supplements; 4/15/2004

65 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: V-1, V-4 Magnesium Dietary Supplements; 4/15/2004

66 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: V-1, V-4 Magnesium Dietary Supplements; 4/15/2004

Inter Medical Lab AKA Inter Medical Clinic
Date Published : 09/30/2009
24-16 Phahonyothin Rd , Lardyao, Jatujak , Bangkok, THAILAND
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/05/2019

Desc: I Inter Bangkok Clinic Weight Loss
Notes: 9/16/2005

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/05/2019

Desc: Bangkok Slim Weight Loss Program
Notes: 9/16/2005

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/05/2019

Notes: Bangkok Slim Weight Loss Program; I Inter Bangkok Clinic Weight Loss; 9/16/2005

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/05/2019

Notes: Bangkok Slim Weight Loss Program; I Inter Bangkok Clinic Weight Loss; 9/16/2005

61 - - - -- Human and Animal Drugs
Date Published: 09/05/2019

Notes: Bangkok Slim Weight Loss Program; I Inter Bangkok Clinic Weight Loss; 9/16/2005

62 - - - -- Human and Animal Drugs
Date Published: 09/05/2019

Notes: Bangkok Slim Weight Loss Program; I Inter Bangkok Clinic Weight Loss; 9/16/2005

63 - - - -- Human and Animal Drugs
Date Published: 09/05/2019

Notes: Bangkok Slim Weight Loss Program; I Inter Bangkok Clinic Weight Loss; 9/16/2005

64 - - - -- Human and Animal Drugs
Date Published: 09/05/2019

Notes: Bangkok Slim Weight Loss Program; I Inter Bangkok Clinic Weight Loss; 9/16/2005

65 - - - -- Human and Animal Drugs
Date Published: 09/05/2019

Notes: Bangkok Slim Weight Loss Program; I Inter Bangkok Clinic Weight Loss; 9/16/2005

66 - - - -- Human and Animal Drugs
Date Published: 09/05/2019

Notes: Bangkok Slim Weight Loss Program; I Inter Bangkok Clinic Weight Loss; 9/16/2005

Ionic Logistics Co.,LTD
Date Published : 03/21/2017
69 71 Soi Ramkhamhaeng 8 Yake 6 , Rama 9 Road, None of the above THAILAND
53 G - - 02 Face Powders (Makeup Preparations, not for Eyes)
Date Published: 03/21/2017

Desc: Shwe Pyi Nan Natural Whitening Thanakha (Lime Scented Hand Cream)

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 03/21/2017

Desc: Shwe Pyi Nan Natural Whitening Thanakha (Lime Scented Hand Cream)

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 03/21/2017

Desc: Shwe Pyi Nan Natural Whitening Thanakha (Lime Scented Hand Cream)

Jirashataporn Co Ltd
Date Published : 09/30/2009
72/2-3 Moo 10 Sukumvit Rd , Chachoengsao, THAILAND
54 B - - 08 Magnesium (Mineral)
Date Published: 09/30/2009

Notes: V-1; V-4 Magnesium Dietary Supplements GPI=DR.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/30/2009

Notes: V-1; V-4 Magnesium Dietary Supplements GPI=DR

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/04/2019

Notes: V-1; V-4 Magnesium Dietary Supplements; 4/15/2004

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: V-1; V-4 Magnesium Dietary Supplements; 4/15/2004

61 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: V-1; V-4 Magnesium Dietary Supplements; 4/15/2004

62 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: V-1; V-4 Magnesium Dietary Supplements; 4/15/2004

63 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: V-1; V-4 Magnesium Dietary Supplements; 4/15/2004

64 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: V-1; V-4 Magnesium Dietary Supplements; 4/15/2004

65 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: V-1; V-4 Magnesium Dietary Supplements; 4/15/2004

66 - - - -- Human and Animal Drugs
Date Published: 09/04/2019

Notes: V-1; V-4 Magnesium Dietary Supplements; 4/15/2004

Jisprapat Limited Parthership
Date Published : 09/07/2018
430/30-31 Issarapharb Road , Bangokyai , Bangkok, THAILAND
63 B - - 99 Bronchodilator N.E.C.
Date Published: 09/07/2018

Desc: Neti-Stik Aromatherapy Inhaler

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/07/2018

Desc: Neti-Stik Aromatherapy Inhaler

77 K - - CJ Applicator, Ent
Date Published: 09/07/2018

Desc: Neti-Stik Aromatherapy Inhaler

L'Oreal Thailand Limited
Date Published : 07/28/2014
179 South Sathom Rd , Bangkok, THAILAND
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 07/28/2014

Desc: L?Oreal White Perfect Fairness Control Moisturizing Day Cream SPF17

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 07/28/2014

Desc: L?Oreal White Perfect Fairness Control Moisturizing Day Cream SPF17

M.S. Beautyline Co Ltd
Date Published : 06/09/2016
594/142-143 Soi North , Bangkok, THAILAND
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 06/09/2016

Desc: Ginger Shampoo
Notes: Medical claims on product labels

Milott Laboratories Company Ltd.
Date Published : 12/05/2013
84/55 Moo 11 , Soi Tanasit Teparak Road , Bangplee Samutprakarn, THAILAND
53 G - - 05 Lipstick (Makeup Preparations, not for Eyes)
Date Published: 12/05/2013

Desc: BB Brightening Liquid Foundation

53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 12/05/2013

Desc: BB Brightening Liquid Foundation

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/05/2013

Desc: BB Brightening Liquid Foundation

Mr. Vikan
Date Published : 09/30/2009
Carrefour Rama 4 Road , MBE Suite 019 , Bangkok, THAILAND
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/13/2019

Notes: All drugs; 5/23/2003;                                                               

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All drugs; 5/23/2003;                                                               

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs; 5/23/2003;                                                               

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs; 5/23/2003;                                                               

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs; 5/23/2003;                                                               

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs; 5/23/2003;                                                               

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs; 5/23/2003;                                                               

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs; 5/23/2003;                                                               

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Notes: All drugs; 5/23/2003;                                                               

Nine & Nine Plus Limited Partnership
Date Published : 12/08/2015
185 , 4-5 Soi Watboromnivas , Pathum Wan, Bangkok THAILAND
53 A - - 02 Lotions, Oils, Powders and Creams (Baby Products)
Date Published: 12/18/2015

Desc: Whitening Ginseng and Pearl(Spa Cream)
Notes: Product labeling makes structure/function claims

53 A - - 02 Lotions, Oils, Powders and Creams (Baby Products)
Date Published: 12/22/2015

Desc: Aveer 2 Care Soap Whitening and Anti- Acne Blemish
Notes: Product labeling makes structure/function claims

53 A - - 02 Lotions, Oils, Powders and Creams (Baby Products)
Date Published: 12/08/2015

Desc: Dorlene Herbal Bust Cream with Ginseng and Pueraria (Spa Cream)
Notes: Note;                                                                                                                                                               

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/08/2015

Desc: Dorlene Herbal Bust Cream with Ginseng and Pueraria (Spa Cream)
Notes: Note;                                                                                                                                                               

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/18/2015

Desc: Asantee Papaya Soap
Notes: Labeling on product makes drug claims

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/24/2015

Desc: Yogurt Spa Milk Soap
Notes: Product labeling makes structure/function claims

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/24/2015

Desc: Sasaki Whitening Groin Cream
Notes: Product labeling makes structure/function claims

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/18/2015

Desc: Asantee Tumeric and Ginger Soap
Notes: Labeling on product makes drug claims

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/22/2015

Desc: Aveer 2 Care Soap Whitening and Anti- Acne Blemish
Notes: Product labeling makes structure/function claims

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/18/2015

Desc: Asantee Soap Cucumber
Notes: Labeling on product makes drug claims

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/18/2015

Desc: Asantee Rice Milk Soap with collagen
Notes: Labeling on product makes drug claims.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/18/2015

Desc: Whitening Ginseng and Pearl(Spa Cream)
Notes: Product labeling makes structure/function claims

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/18/2015

Desc: Asantee Tamarind and Goat Milk Soap
Notes: Labeling on product makes drug claims

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/18/2015

Desc: Asantee Tamarind Soap
Notes: Labeling on product makes drug claims

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/18/2015

Desc: Asantee Tamarind and Ginger Soap
Notes: Labeling on product makes drug claims

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/24/2015

Desc: Sasaki Whitening Groin Cream
Notes: Product labeling makes structure/function claims

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/22/2015

Desc: Aveer 2 Care Soap Whitening and Anti- Acne Blemish
Notes: Product labeling makes structure/function claims

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/08/2015

Desc: Dorlene Herbal Bust Cream with Ginseng and Pueraria (Spa Cream)
Notes: Note;                                                                                                                                                               

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/18/2015

Desc: Whitening Ginseng and Pearl(Spa Cream)
Notes: Product labeling makes structure/function claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/08/2015

Desc: Dorlene Herbal Bust Cream with Ginseng and Pueraria (Spa Cream)
Notes: Note;                                                                                                                                                               

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/18/2015

Desc: Whitening Ginseng and Pearl(Spa Cream)
Notes: Product labeling makes structure/function claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/22/2015

Desc: Aveer 2 Care Soap Whitening and Anti- Acne Blemish
Notes: Product labeling makes structure/function claims

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/24/2015

Desc: Sasaki Whitening Groin Cream
Notes: Product labeling makes structure/function claims

Panya Pisuchpen
Date Published : 03/02/2017
582-4 Yaowarad Rd. Sampanthawaong , Bangkok, THAILAND
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 03/02/2017

Desc: Clear Anti-Dandruff Shampoo

53 - - - -- Cosmetics
Date Published: 07/07/2017

Notes: All Drug and Drug Products;Only drug and drug products are subject to DWPE under Industry Codes 53 & 54.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/07/2017

Notes: All Drug and Drug Products;Only drug and drug products are subject to DWPE under Industry Codes 53 & 54.

55 P - - 97 Methyl Salicylate (Pharmaceutic Necessity - Flavor)
Date Published: 03/02/2017

Desc: Counterpain (Methyl Salicylate)

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/07/2017

Notes: All Drug and Drug Products

56 A - - 99 Penicillin Natural, N.E.C.
Date Published: 03/02/2017

Desc: Pencillin Tablets

56 G - - 99 Antifungal N.E.C.
Date Published: 03/02/2017

Desc: Antifungal and anti-inflammatory Ointment

56 - - - -- Antibiotics (Human/Animal)
Date Published: 07/07/2017

Notes: All Drug and Drug Products

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 07/07/2017

Notes: All Drug and Drug Products

61 - - - -- Human and Animal Drugs
Date Published: 07/07/2017

Notes: All Drug and Drug Products

62 G - - 59 Piroxicam (Anti-Inflammatory)
Date Published: 03/02/2017

Desc: Butazodin (Piroxicam) tablets

62 G - - 59 Piroxicam (Anti-Inflammatory)
Date Published: 03/02/2017

Desc: Piroxicam 20mg tablets

62 - - - -- Human and Animal Drugs
Date Published: 07/07/2017

Notes: All Drug and Drug Products

63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic)
Date Published: 03/02/2017

Desc: Prim Perfect Herbal Toothpaste

63 - - - -- Human and Animal Drugs
Date Published: 07/07/2017

Notes: All Drug and Drug Products

64 - - - -- Human and Animal Drugs
Date Published: 07/07/2017

Notes: All Drug and Drug Products

65 - - - -- Human and Animal Drugs
Date Published: 07/07/2017

Notes: All Drug and Drug Products

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/02/2017

Desc: Clear Anti-Dandruff Shampoo

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/02/2017

Desc: Prim Perfect Herbal Toothpaste

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 03/02/2017

Desc: Lee Buan Soa Pill (Fishing Brand)

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 03/02/2017

Desc: Mahahing V.S.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 03/02/2017

Desc: Yellow Liniment Oil (Peangjai Brand)

66 - - - -- Human and Animal Drugs
Date Published: 07/07/2017

Notes: All Drug and Drug Products

Pond's Chemical Thailand R.O.P.
Date Published : 10/01/2013
79 Ram Indra Road , Bangkok, THAILAND
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/01/2013

Desc: Trankal Supplement

Pop Inc
Date Published : 09/30/2009
Unknown , Bangkok, THAILAND
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/30/2009

Notes: 11/12/08 Pop Face Polish (AHA)

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: Pop Face Polish (AHA) ; 11/12/2008

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Pop Face Polish (AHA) ; 11/12/2008

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Pop Face Polish (AHA) ; 11/12/2008

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Pop Face Polish (AHA) ; 11/12/2008

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Pop Face Polish (AHA) ; 11/12/2008

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Pop Face Polish (AHA) ; 11/12/2008

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Pop Face Polish (AHA) ; 11/12/2008

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Pop Face Polish (AHA) ; 11/12/2008

Prolac (Thailand)
Date Published : 07/11/2013
279 M9, Tambon Umong , Muang Lamphun, Lamphun THAILAND
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/11/2013

Desc: Dokudami Houttuynia Liquid Dietary Supplement
Notes: NOTE; medical claims found on package labeling and website.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/11/2013

Desc: Yu Xing Cao Dietary Supplement
Notes: NOTE; medical claims found on package labeling and website

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/11/2013

Desc: Dokudami Houttuynia Liquid Dietary Supplement
Notes: NOTE; medical claims found on package labeling and website.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/11/2013

Desc: Yu Xing Cao Dietary Supplement
Notes: NOTE; medical claims found on package labeling and website.

62 V - - 99 Anti-Viral N.E.C.
Date Published: 07/11/2013

Desc: Dokudami Houttuynia Liquid Dietary Supplement
Notes: NOTE; medical claims found on package labeling and website.

62 V - - 99 Anti-Viral N.E.C.
Date Published: 07/11/2013

Desc: Yu Xing Cao Dietary Supplement
Notes: NOTE; medical claims found on package labeling and website.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/11/2013

Desc: Dokudami Houttuynia Liquid Dietary Supplement
Notes: NOTE; medical claims found on package labeling and website.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/11/2013

Desc: Yu Xing Cao Dietary Supplement
Notes: NOTE; medical claims found on package labeling and website

S.M. PHARMACEUTICAL CO LTD
Date Published : 04/27/2017
19 SUKUMVIT , SAMUTPRAKARN, THAILAND
56 Y - - 99 Antibiotic N.E.C.
Date Published: 04/27/2017

Desc: Mycosamthong Syrup; combination of Sulphamethoxazole and Trimethoprim

61 H - - 03 Trimethoprim (Anti-Bacterial)
Date Published: 04/27/2017

Desc: Mycosamthong Syrup; combination of Sulphamethoxazole and Trimethoprim

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/27/2017

Desc: Mycosamthong Syrup; combination of Sulphamethoxazole and Trimethoprim

Siam Industries International Co. Ltd.
Date Published : 12/13/2017
23 , 555 Muban Thang Rot Fai Fang Tawan Tok Lane , Hua Hin, Prachuap Khiri Khan THAILAND
54 A - - 99 Vitamin, N.E.C.
Date Published: 12/13/2017

Desc: Kwao Krua Kao (Pueraria Mirifica)
Notes: Problem(s): "Kwao Krua Kao (Pueraria Mirifica)" appears to be a drug as defined by section 201(g)(1) of the FD&C Act because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of man. "Kwao Krua Kao (Pueraria Mirifica)" also appears to be a new drug as defined by section 201(p) of the FD&C Act because we are not aware of evidence demonstrating that it is generally recognized as safe and effective for its labeled uses. A new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an FDA approved new drug application. "Kwao Krua Kao (Pueraria Mirifica)" is not the subject of such an application; therefore, it appears to be in violation of section 505(a) of the FD&C Act. Additionally, the product labeling for "Kwao Krua Kao (Pueraria Mirifica)" fails to bear adequate directions for its intended uses, causing "Kwao Krua Kao (Pueraria Mirifica)" to appear to be misbranded under section 502(f)(1) of the FD&C Act.

54 A - - 99 Vitamin, N.E.C.
Date Published: 12/13/2017

Desc: Kwao Krua Dang (Butea superba)
Notes: Problem(s): "Kwao Krua Dang (Butea superba)" appears to be a drug as defined by section 201(g)(1) of the FD&C Act because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of man. "Kwao Krua Dang (Butea superba)" also appears to be a new drug as defined by section 201(p) of the FD&C Act because we are not aware of evidence demonstrating that it is generally recognized as safe and effective for its labeled uses. A new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an FDA approved new drug application. "Kwao Krua Dang (Butea superba)" is not the subject of such an application; therefore, it appears to be in violation of section 505(a) of the FD&C Act. Additionally, the product labeling for "Kwao Krua Dang (Butea superba)" fails to bear adequate directions for its intended uses, causing "Kwao Krua Dang (Butea superba)" to appear to be misbranded under section 502(f)(1) of the FD&C Act.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/13/2017

Desc: Kwao Krua Kao (Pueraria Mirifica)
Notes: Problem(s): "Kwao Krua Kao (Pueraria Mirifica)" appears to be a drug as defined by section 201(g)(1) of the FD&C Act because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of man. "Kwao Krua Kao (Pueraria Mirifica)" also appears to be a new drug as defined by section 201(p) of the FD&C Act because we are not aware of evidence demonstrating that it is generally recognized as safe and effective for its labeled uses. A new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an FDA approved new drug application. "Kwao Krua Kao (Pueraria Mirifica)" is not the subject of such an application; therefore, it appears to be in violation of section 505(a) of the FD&C Act. Additionally, the product labeling for "Kwao Krua Kao (Pueraria Mirifica)" fails to bear adequate directions for its intended uses, causing "Kwao Krua Kao (Pueraria Mirifica)" to appear to be misbranded under section 502(f)(1) of the FD&C Act.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/13/2017

Desc: Kwao Krua Dang (Butea superba)
Notes: Problem(s): "Kwao Krua Dang (Butea superba)" appears to be a drug as defined by section 201(g)(1) of the FD&C Act because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of man. "Kwao Krua Dang (Butea superba)" also appears to be a new drug as defined by section 201(p) of the FD&C Act because we are not aware of evidence demonstrating that it is generally recognized as safe and effective for its labeled uses. A new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an FDA approved new drug application. "Kwao Krua Dang (Butea superba)" is not the subject of such an application; therefore, it appears to be in violation of section 505(a) of the FD&C Act. Additionally, the product labeling for "Kwao Krua Dang (Butea superba)" fails to bear adequate directions for its intended uses, causing "Kwao Krua Dang (Butea superba)" to appear to be misbranded under section 502(f)(1) of the FD&C Act.

Siam Yoko Co.,Ltd
Date Published : 12/29/2015
340 Thepharak Rd., Thepharak, Moung , Samutprakarn, Samut Prakan THAILAND
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/29/2015

Desc: Yoko Yogurt Milk Cream (Spa Cream)
Notes: Product labeling makes claims.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 12/29/2015

Desc: Yoko Yogurt Milk Cream (Spa Cream)
Notes: Product labeling makes claims.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/29/2015

Desc: Yoko Yogurt Milk Cream (Spa Cream)
Notes: Product labeling makes claims.

Soap-N-Scent Co., Ltd.
Date Published : 02/01/2010
327/ 9 Soi Srijundorn 2 Jareonprated Rd. , Changklan, THAILAND
63 W - - 02 Green Soap (Detergent)
Date Published: 02/01/2010

Desc: Fungal Cleanse Soap

63 W - - 02 Green Soap (Detergent)
Date Published: 02/01/2010

Desc: Warts No More Soap

Sukrit 55 Co., Ltd.
Date Published : 10/02/2014
78/6 moo 1 Mueang District , Samut Sakhon , THAILAND
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2014

Desc: MEZO Dietary Supplement Product
Notes: Sibutramine in product

60 R - - 19 Sibutramine HCL Monohydrate (Anorexic)
Date Published: 10/02/2014

Desc: MEZO Dietary Supplement Product
Notes: Sibutramine in product.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/02/2014

Desc: MEZO Dietary Supplement Product
Notes: Sibutramine in product

Surathin International Co Ltd
Date Published : 05/23/2013
723 Moo 3 Soi Praksa 3 , Buddharaksa Road , Amphur Mung, Samut Prakan THAILAND
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 05/23/2013

Desc: Harnn Shaal Skin Enlightenment Moisturizer

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/23/2013

Desc: Harnn Shaal Skin Enlightenment Moisturizer

T.P. Drug Laboratories (1969) Co., LTD
Date Published : 10/08/2013
98 Soi Sukhumvit 62 Yak 1 , Bangkok, THAILAND
54 A - - 13 Vitamin C (Ascorbic Acid)
Date Published: 10/08/2013

Desc: Vitamin C for injection
Notes: Thailand

56 E - - 80 Tetracycline (Tetracyclines)
Date Published: 07/07/2017

Desc: Urosed

56 E - - 81 Tetracycline Hydrochloride (Tetracyclines)
Date Published: 07/07/2017

Desc: Urosed

56 E - - 99 Tetracycline N.E.C.
Date Published: 07/07/2017

Desc: Urosed

60 K - - 99 Anabolic, N.E.C.
Date Published: 12/13/2017

Desc: Cypionax (Testosterone Cypionate)
Notes: Mecial claims made in mfg. website (www.tpdrug.com)

60 L - - 82 Phenazopyridine HCl (Analgesic)
Date Published: 07/07/2017

Desc: Urosed

61 G - - 56 Sulfamethizole (Anti-Bacterial) (Not Antibiotic)
Date Published: 07/07/2017

Desc: Urosed

Thai Developoment Pharmaceutical Comycin Ltd.
Date Published : 08/30/2021
100 Seonouannoi Ekmai Street , Crounthep Metropolitan, THAILAND
66 - - - -- Human and Animal Drugs
Date Published: 08/30/2021

Desc: Comycin Powder or syrup for children
Notes:                                                                                                                                                                  

Thai Nakorn Patana Co., Ltd,
Date Published : 04/27/2017
14 Thanon Ngamwongwan Soi 8 , Mueang Nonthaburi, Nonthaburi THAILAND
60 L - - 01 Acetaminophen (Analgesic)
Date Published: 04/27/2017

Desc: Paracetamol (acetaminophen)

The Jawarad Co Ltd
Date Published : 11/21/2016
1055 , 4 Soi Jawarad Sukhumvit , Bangkok, Bangkok THAILAND
60 L - - 01 Acetaminophen (Analgesic)
Date Published: 11/21/2016

Desc: Paracetamol Tablets

Top of Mind
Date Published : 05/09/2014
48/22 Ratchadaphisek Rd , Huai Khwang, Bangkok THAILAND
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 05/09/2014

Desc: 24 Shape Capsules

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 05/09/2014

Desc: Lady Top Brand S-Berry Capsules

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/09/2014

Desc: Lady Top Brand S-Berry Capsules

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/09/2014

Desc: 24 Shape Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/09/2014

Desc: Lady Top Brand S-Berry Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/09/2014

Desc: 24 Shape Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/09/2014

Desc: Lady Top Brand S-Berry Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/09/2014

Desc: 24 Shape Capsules

Tourasia Co., Ltd.
Date Published : 09/30/2009
246 Sukhumvit Soi 16 , Klongtoey , Bangkok, THAILAND
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/13/2019

Notes: Ancom Tablets ; 2/12/2003

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: Ancom Tablets ; 2/12/2003

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets ; 2/12/2003

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets ; 2/12/2003

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets ; 2/12/2003

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets ; 2/12/2003

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets ; 2/12/2003

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets ; 2/12/2003

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Ancom Tablets ; 2/12/2003

Vitality Health Products C/o Nimit Pharmacy
Date Published : 09/30/2009
944 Roma 4 Road , Bangkok, THAILAND
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: Dexfenfluramine 944 Medroxyprogesterone Premarin

VrDrug.com
Date Published : 09/30/2009
451 Ladprow Rd , Wangtonglang, Wangtonglang , Bangkok, Bangkok, THAILAND
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                  The firm appears to market clozaril (clozapine) as well.

65 V - - 13 Clozapine (Sedative)
Date Published: 09/30/2009

Notes: 2/8/2007                 


TOGO


Afoudji Kossi Ezi
Date Published : 09/19/2014
Qtier Tokoin Gbadago , Lome, TOGO
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 09/19/2014

Desc: Chambers Chapter 2000 Super Hairgrow Scalp Treatment
Notes: Unapproved New Drug

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 09/19/2014

Desc: Chambers Chapter 2000 Super Hairgrow Scalp Treatment
Notes: Unapproved New Drug

53 S - - 05 Hair Preparations, Cosmetic products containing animal by-products (ovine)
Date Published: 09/19/2014

Desc: Chambers Chapter 2000 Super Hairgrow Scalp Treatment
Notes: Unapproved New Drug

53 U - - 05 Hair Preparations (Non-coloring), Cosmetic products containing animal by-products (other)
Date Published: 09/19/2014

Desc: Chambers Chapter 2000 Super Hairgrow Scalp Treatment
Notes: Unapproved New Drug

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2014

Desc: Chambers Chapter 2000 Super Hairgrow Scalp Treatment
Notes: Unapproved New Drug

FABRIQUE RODIS VOB
Date Published : 07/02/2021
03, Bp 31118 , Lome, TOGO
53 L - - -- Skin Care Prep
Date Published: 08/30/2021

Desc: White Secret Lightening Body Cream/Lotion
Notes: The product appears to be an unapproved new drug as the product’s label includes claims such as (not an all-inclusive list): ““Lightening body cream . . . Bright result from the very first 5 days . . . White Secret contains ingredients proven to enlighter (sic) your skin and remove blackheads and spots. Also contains vitamin E that treats pigmented skin and tashes (sic). Prevents reappearance of dark tashes (sic).” FDA analysis found product to contain undeclared Hydroquinone.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 08/30/2021

Desc: White Secret Lightening Body Cream/Lotion
Notes: The product appears to be an unapproved new drug as the product’s label includes claims such as (not an all-inclusive list): ““Lightening body cream . . . Bright result from the very first 5 days . . . White Secret contains ingredients proven to enlighter (sic) your skin and remove blackheads and spots. Also contains vitamin E that treats pigmented skin and tashes (sic). Prevents reappearance of dark tashes (sic).” FDA analysis found product to contain undeclared Hydroquinone.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/30/2021

Desc: White Secret Lightening Body Cream/Lotion
Notes: The product appears to be an unapproved new drug as the product’s label includes claims such as (not an all-inclusive list): ““Lightening body cream . . . Bright result from the very first 5 days . . . White Secret contains ingredients proven to enlighter (sic) your skin and remove blackheads and spots. Also contains vitamin E that treats pigmented skin and tashes (sic). Prevents reappearance of dark tashes (sic).” FDA analysis found product to contain undeclared Hydroquinone.

RODIS
Date Published : 07/02/2021
03, Bp 31118 , Lome, TOGO
53 L - - -- Skin Care Prep
Date Published: 08/30/2021

Desc: White Secret Lightening Body Cream/Lotion
Notes: The product appears to be an unapproved new drug as the product’s label includes claims such as (not an all-inclusive list): ““Lightening body cream . . . Bright result from the very first 5 days . . . White Secret contains ingredients proven to enlighter (sic) your skin and remove blackheads and spots. Also contains vitamin E that treats pigmented skin and tashes (sic). Prevents reappearance of dark tashes (sic).” FDA analysis found product to contain undeclared Hydroquinone.

63 V - - 02 Hydroquinone (Depigmentor)
Date Published: 08/30/2021

Desc: White Secret Lightening Body Cream/Lotion
Notes: The product appears to be an unapproved new drug as the product’s label includes claims such as (not an all-inclusive list): ““Lightening body cream . . . Bright result from the very first 5 days . . . White Secret contains ingredients proven to enlighter (sic) your skin and remove blackheads and spots. Also contains vitamin E that treats pigmented skin and tashes (sic). Prevents reappearance of dark tashes (sic).” FDA analysis found product to contain undeclared Hydroquinone.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/30/2021

Desc: White Secret Lightening Body Cream/Lotion
Notes: The product appears to be an unapproved new drug as the product’s label includes claims such as (not an all-inclusive list): ““Lightening body cream . . . Bright result from the very first 5 days . . . White Secret contains ingredients proven to enlighter (sic) your skin and remove blackheads and spots. Also contains vitamin E that treats pigmented skin and tashes (sic). Prevents reappearance of dark tashes (sic).” FDA analysis found product to contain undeclared Hydroquinone.

Victago
Date Published : 09/26/2014
Sc Bp , Lome, TOGO
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/26/2014

Desc: Liquide Victago
Notes: Product label making medical claims and therefore the product is considered as a new drug within the meaning of Section 201(p) without an effective NDA.


TRINIDAD & TOBAGO


Coconut Growers Association
Date Published : 07/06/2010
Eastern Main Rd, Laventillepo Box 229 , Port Of Spain, TRINIDAD & TOBAGO
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 07/06/2010

Desc: Seprod Carbolic Germicidal Soap
Notes: Trinidad & Tobago

62 H - - 99 Anti-Microbial N.E.C.
Date Published: 07/13/2010

Desc: Seprod Carbolic Germicidal Soap
Notes: Trinidad & Tobago

Diana Candy Company Limited
Date Published : 12/09/2011
Yorke Avenue , 19B O'meara Industrial Estate , Arima, TT-ARI TRINIDAD & TOBAGO
33 E - - 06 Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 12/09/2011

Desc: Real Honey and Real Lime Candy
Notes: Trinidad and Tobago


TUNISIA


Unite de Fabrication de Medicaments SA
Date Published : 01/27/2015
Zone Industrielle , Kalaa El Kebira , Sousse, Sousse TUNISIA
65 F - - 06 Water, Purified (Eyewash)
Date Published: 05/08/2023

Desc: Cederroth Eye Wash
Notes: 11/25/2013

65 F - - 06 Water, Purified (Eyewash)
Date Published: 01/27/2015

Desc: Eye Wash

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/08/2023

Desc: Cederroth Eye Wash
Notes: 11/25/2013

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/27/2015

Desc: Eye Wash

86 K - - YG Device, Irrigation, Ocular Surgery
Date Published: 05/08/2023

Desc: Cederroth Eye Wash
Notes: 11/25/2013


TURKEY


Beyazlar Gida Teks. Kuyum. ve Day. Tuk. Mal. San. Tic. Ltd. Sti.
Date Published : 01/04/2022
Mustafapasa Mahallesi , 713. Sokak No. 15/A , Gebze, Kocaeli TURKEY
31 K - - 02 Tea, Green
Date Published: 01/04/2022

Desc: Green Tea; 100% Herbal Stick Tea
Notes: The product appears to be an unapproved new drug, as the following statements on the product label includes claims such as: “Stick tea has the ability to protect against diseases … Contains catechins and flavonoid substances. These substances are anti-cancer, blood pressure, heart disease prevention agents…GREEN STICK TEA BENEFITS…Prevents cells from become cancerous …Green Stick Tea prevents cardiovascular disease and chronic diseases…Regular consumption of green tea has an anti-cancer effect…It has an effect on lowereing blood pressure…”. The product appears to be an unapproved new drug, as the following statements on the product website includes claims such as: “Prevents cells from become cancerous ”, “Green Stick Tea teaprevents [sic] cardiovascular disease and chronic diseases”, “Green tea … has anti-cancer effect” and “Effect on lowering blood pressure”.

31 K - - 99 Tea, N.E.C.
Date Published: 01/04/2022

Desc: Apple Tea; 100% Herbal Stick Tea
Notes: The product appears to be an unapproved new drug, as the following statements on the product website includes claims such as: “Prevent cancer”, “Regulates blood sugar”, “Treat cough … with colds”, “Protective against diabetes and heart disease. Gastritis and effective to ulcers” and "Lower cholesterol".

31 K - - 99 Tea, N.E.C.
Date Published: 01/04/2022

Desc: Pomegranate Tea; 100% Herbal Stick Tea
Notes: The product appears to be an unapproved new drug, as the following statements on the product label includes claims such as: “Pomegranate stick tea, which is beneficial for anemia and enriched with rosehip that reduces cholesterol…POMEGRANATE STICK TEA BENEFITS…protects against diseases…prevents the proliferation of harmful cells in the body…Provides blood pressure balance… protects against vitamin C colds…”. ”. The product appears to be an unapproved new drug, as the following statements on the product website includes claims such as: “Protects against diseases …”, “It prevents the proliferation of harmful cells in the body”, “Provides blood pressure balance” and “Protect against vitamin C colds …”.

31 M - - 01 Tea With Fruit (peels, chunks, bits or pieces)
Date Published: 01/04/2022

Desc: Pomegranate Tea; 100% Herbal Stick Tea
Notes: The product appears to be an unapproved new drug, as the following statements on the product label includes claims such as: “Pomegranate stick tea, which is beneficial for anemia and enriched with rosehip that reduces cholesterol…POMEGRANATE STICK TEA BENEFITS…protects against diseases…prevents the proliferation of harmful cells in the body…Provides blood pressure balance… protects against vitamin C colds…”. ”. The product appears to be an unapproved new drug, as the following statements on the product website includes claims such as: “Protects against diseases …”, “It prevents the proliferation of harmful cells in the body”, “Provides blood pressure balance” and “Protect against vitamin C colds …”.

31 M - - 01 Tea With Fruit (peels, chunks, bits or pieces)
Date Published: 01/04/2022

Desc: Apple Tea; 100% Herbal Stick Tea
Notes: The product appears to be an unapproved new drug, as the following statements on the product website includes claims such as: “Prevent cancer”, “Regulates blood sugar”, “Treat cough … with colds”, “Protective against diabetes and heart disease. Gastritis and effective to ulcers” and "Lower cholesterol".

31 M - - 99 Blended Teas, N.E.C.
Date Published: 01/04/2022

Desc: Apple Tea; 100% Herbal Stick Tea
Notes: The product appears to be an unapproved new drug, as the following statements on the product website includes claims such as: “Prevent cancer”, “Regulates blood sugar”, “Treat cough … with colds”, “Protective against diabetes and heart disease. Gastritis and effective to ulcers” and "Lower cholesterol".

31 M - - 99 Blended Teas, N.E.C.
Date Published: 01/04/2022

Desc: Pomegranate Tea; 100% Herbal Stick Tea
Notes: The product appears to be an unapproved new drug, as the following statements on the product label includes claims such as: “Pomegranate stick tea, which is beneficial for anemia and enriched with rosehip that reduces cholesterol…POMEGRANATE STICK TEA BENEFITS…protects against diseases…prevents the proliferation of harmful cells in the body…Provides blood pressure balance… protects against vitamin C colds…”. ”. The product appears to be an unapproved new drug, as the following statements on the product website includes claims such as: “Protects against diseases …”, “It prevents the proliferation of harmful cells in the body”, “Provides blood pressure balance” and “Protect against vitamin C colds …”.

31 P - - 04 Tea, Camomille, Chamomile (Tea Substitute)
Date Published: 01/04/2022

Desc: Chamomile Tea; 100% Herbal Stick Tea
Notes: The product appears to be an unapproved new drug, as the following statements on the product label includes claims such as: “Eliminate the problem of insomnia”, “Prevents the formation of cancer cells”, “If toothache is experienced, reduce pain by using it as a mouthwash”, “Prevent skin imperfections and inflammation”, “Cold chamomile tea vapour has a healing effect”, “It has the effect of relieving inflammation of the throat” and “Regulate the amount of insulin in your blood”. The product appears to be an unapproved new drug, as the following statements on the product website includes claims such as: “Prevent the formation of cancer cells”, “If toothache is experienced, reduce pain when used as mouthwash”, “Skin imperfections prevent inflammation”, “Has a healing effect”, “Relieving inflammation of the throat” and “Reduce the amount of insulin in your body”.

54 E - - 04 Camomille (Herbal & Botanical Teas)
Date Published: 01/04/2022

Desc: Chamomile Tea; 100% Herbal Stick Tea
Notes: The product appears to be an unapproved new drug, as the following statements on the product label includes claims such as: “Eliminate the problem of insomnia”, “Prevents the formation of cancer cells”, “If toothache is experienced, reduce pain by using it as a mouthwash”, “Prevent skin imperfections and inflammation”, “Cold chamomile tea vapour has a healing effect”, “It has the effect of relieving inflammation of the throat” and “Regulate the amount of insulin in your blood”. The product appears to be an unapproved new drug, as the following statements on the product website includes claims such as: “Prevent the formation of cancer cells”, “If toothache is experienced, reduce pain when used as mouthwash”, “Skin imperfections prevent inflammation”, “Has a healing effect”, “Relieving inflammation of the throat” and “Reduce the amount of insulin in your body”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/04/2022

Desc: Green Tea; 100% Herbal Stick Tea
Notes: The product appears to be an unapproved new drug, as the following statements on the product label includes claims such as: “Stick tea has the ability to protect against diseases … Contains catechins and flavonoid substances. These substances are anti-cancer, blood pressure, heart disease prevention agents…GREEN STICK TEA BENEFITS…Prevents cells from become cancerous …Green Stick Tea prevents cardiovascular disease and chronic diseases…Regular consumption of green tea has an anti-cancer effect…It has an effect on lowereing blood pressure…”. The product appears to be an unapproved new drug, as the following statements on the product website includes claims such as: “Prevents cells from become cancerous ”, “Green Stick Tea teaprevents [sic] cardiovascular disease and chronic diseases”, “Green tea … has anti-cancer effect” and “Effect on lowering blood pressure”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/04/2022

Desc: Pomegranate Tea; 100% Herbal Stick Tea
Notes: The product appears to be an unapproved new drug, as the following statements on the product label includes claims such as: “Pomegranate stick tea, which is beneficial for anemia and enriched with rosehip that reduces cholesterol…POMEGRANATE STICK TEA BENEFITS…protects against diseases…prevents the proliferation of harmful cells in the body…Provides blood pressure balance… protects against vitamin C colds…”. ”. The product appears to be an unapproved new drug, as the following statements on the product website includes claims such as: “Protects against diseases …”, “It prevents the proliferation of harmful cells in the body”, “Provides blood pressure balance” and “Protect against vitamin C colds …”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/04/2022

Desc: Chamomile Tea; 100% Herbal Stick Tea
Notes: The product appears to be an unapproved new drug, as the following statements on the product label includes claims such as: “Eliminate the problem of insomnia”, “Prevents the formation of cancer cells”, “If toothache is experienced, reduce pain by using it as a mouthwash”, “Prevent skin imperfections and inflammation”, “Cold chamomile tea vapour has a healing effect”, “It has the effect of relieving inflammation of the throat” and “Regulate the amount of insulin in your blood”. The product appears to be an unapproved new drug, as the following statements on the product website includes claims such as: “Prevent the formation of cancer cells”, “If toothache is experienced, reduce pain when used as mouthwash”, “Skin imperfections prevent inflammation”, “Has a healing effect”, “Relieving inflammation of the throat” and “Reduce the amount of insulin in your body”.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/04/2022

Desc: Apple Tea; 100% Herbal Stick Tea
Notes: The product appears to be an unapproved new drug, as the following statements on the product website includes claims such as: “Prevent cancer”, “Regulates blood sugar”, “Treat cough … with colds”, “Protective against diabetes and heart disease. Gastritis and effective to ulcers” and "Lower cholesterol".

DERMACOS ILAC MEDIKAL VE KOZMETI
Date Published : 04/17/2018
San V Mehmet Akif Mah C , Istanbul, TURKEY
53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)
Date Published: 04/17/2018

Desc: BIOTA BOTANICALS ADVANCED HERBAL CARE LEAVE-IN SERUM (Hair Prep)
Notes: Medical claims made on product label

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 04/17/2018

Desc: BIOTA BOTANICALS ADVANCED HERBAL CARE LEAVE-IN SERUM (Hair Prep)
Notes: Medical claims made on product label

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/17/2018

Desc: BIOTA BOTANICALS ADVANCED HERBAL CARE LEAVE-IN SERUM (Hair Prep)
Notes: Medical claims made on product label

Derma-Cos Ilac Medikal Ve Kozmetik San. Ve Ic Tic A.S.
Date Published : 03/02/2015
Emek Mah Sivat Yolu Cad No.9 , Istanbul, TURKEY
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 03/02/2015

Desc: Biota Botanicals Herbal Conditioner For Thinning Damaged Hair
Notes: The aforementioned products appear to be unapproved new drugs as the product labels and associated website; http;//biotalabna.com; list the following claims; Encourages faster growing hair; More than 97% of subjects reported their hair grew faster; as well as thicker; fuller and stronger when using shampoo and serum combined; More than 83% of subjects reported their hair grew faster as well as thicker and stronger when using Biota Herbal Shampoo.

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 03/02/2015

Desc: Biota Botanicals Herbal Shampoo For Thinning & Damaged Hair
Notes: The aforementioned products appear to be unapproved new drugs as the product labels and associated website; http;//biotalabna.com; list the following claims; Encourages faster growing hair; More than 97% of subjects reported their hair grew faster; as well as thicker; fuller and stronger when using shampoo and serum combined; More than 83% of subjects reported their hair grew faster as well as thicker and stronger when using Biota Herbal Shampoo

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 03/02/2015

Desc: Biota Botanicals Herbal Conditioner For Thinning Damaged Hair
Notes: The aforementioned products appear to be unapproved new drugs as the product labels and associated website; http;//biotalabna.com; list the following claims; Encourages faster growing hair; More than 97% of subjects reported their hair grew faster; as well as thicker; fuller and stronger when using shampoo and serum combined; More than 83% of subjects reported their hair grew faster as well as thicker and stronger when using Biota Herbal Shampoo.

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 03/02/2015

Desc: Biota Botanicals Advanced Herbal Serum For Thinning & Damaged Hair
Notes: The aforementioned product appears to be an unapproved new drug as the product label and associated website, http://biotalabna.com, list the following claim: 'New hope for faster – growing … hair. Biota Botanicals contains herbal complex Bioxsine that brings new hope to those who want to combat thinning … hair …'.

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 03/02/2015

Desc: Biota Botanicals Herbal Shampoo For Thinning & Damaged Hair
Notes: The aforementioned products appear to be unapproved new drugs as the product labels and associated website; http;//biotalabna.com; list the following claims; Encourages faster growing hair; More than 97% of subjects reported their hair grew faster; as well as thicker; fuller and stronger when using shampoo and serum combined; More than 83% of subjects reported their hair grew faster as well as thicker and stronger when using Biota Herbal Shampoo. ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/02/2015

Desc: Biota Botanicals Herbal Shampoo For Thinning & Damaged Hair
Notes: The aforementioned products appear to be unapproved new drugs as the product labels and associated website; http;//biotalabna.com; list the following claims; Encourages faster growing hair; More than 97% of subjects reported their hair grew faster; as well as thicker; fuller and stronger when using shampoo and serum combined; More than 83% of subjects reported their hair grew faster as well as thicker and stronger when using Biota Herbal Shampoo. ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/02/2015

Desc: Biota Botanicals Herbal Conditioner For Thinning Damaged Hair
Notes: The aforementioned products appear to be unapproved new drugs as the product labels and associated website; http;//biotalabna.com; list the following claims; Encourages faster growing hair; More than 97% of subjects reported their hair grew faster; as well as thicker; fuller and stronger when using shampoo and serum combined; More than 83% of subjects reported their hair grew faster as well as thicker and stronger when using Biota Herbal Shampoo.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/02/2015

Desc: Biota Botanicals Advanced Herbal Serum For Thinning & Damaged Hair
Notes: The aforementioned product appears to be an unapproved new drug as the product label and associated website, http://biotalabna.com, list the following claim: 'New hope for faster – growing … hair. Biota Botanicals contains herbal complex Bioxsine that brings new hope to those who want to combat thinning … hair …'. ;

HAAL IZA
Date Published : 04/23/2020
Nakkasyolu No 10 , Istanbul, TURKEY
65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 07 Myobloc
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

Turkuaz Medikal Kozmetik Ve
Date Published : 09/19/2017
No:34/3 Yakuplu Mahallesi Beysan , Istanbul, TURKEY
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2017

Desc: Delay Personal Spray
Notes: Medical claims made in products labels.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2017

Desc: Delay Personal Cream
Notes: Medical claims made in products labels

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2017

Desc: Delay Personal Lubricant Gel
Notes: Medical claims made in products labels.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2017

Desc: Gynotight Vagina Tightener Disposable Vaginal Douche
Notes: Medical claims made in products labels

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2017

Desc: Enhancement Personal Lubricant Gel
Notes: Medical claims made in products labels

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2017

Desc: Genital Bleaching Cream
Notes: Medical claims made in products labels.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2017

Desc: Gynobakingsoda Sodium Bicarbonate Disposable Vaginal Douche
Notes: Medical claims made in products labels

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2017

Desc: Gynolact Disinfectanct Vaginal Cream
Notes: Medical claims made in products labels

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2017

Desc: Gynofoam Daily Disinfectant Foam for Vaginal Areas
Notes: Medical claims made in products labels


UKRAINE


Capsular
Date Published : 02/08/2017
Zheleznodorogniy Lane 3/4 , Dergachi, Kharkivska Oblast UKRAINE
16 R - - 01 Surimi (Used for Further Processing into Imitation Seafood)
Date Published: 02/08/2017

Desc: Imitation Caviar Products
Notes: Claims found on associated website

16 R - - 99 Other Engineered Seafood Products, N.E.C.
Date Published: 02/08/2017

Desc: Imitation Caviar Products
Notes: Claims found on associated website

16 Y - - 01 Caviar, Fishery Products, n.e.c.
Date Published: 02/08/2017

Desc: Imitation Caviar Products
Notes: Claims found on associated website

FARMAK PAT
Date Published : 09/30/2009
Bud 63 Vul Frunze , Kyiv, Kyiv UKRAINE
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/30/2009

Notes: 8/24/2007. Corvalol. Korvalol. Covalolum. Detentions of this product should use the 502(f)(1) misbranding charge. FDA has determined that the Corvalol product contains undeclared phenobarbital. The agency is aware that the product is being sold Over the Counter (OTC) in Eastern European American communities for the treatment of angina; chest pains and as a sedative. This product is not approved for OTC use in the US FDA previously issued a health hazzard alert for Corvalol on July 28 1997.

61 M - - 31 Phenobarbital (Anti-Convulsant)
Date Published: 09/30/2009

Notes: 8/24/2007. Corvalol. Korvalol. Covalolum. Detentions of this product should use the 502(f)(1) misbranding charge. FDA has determined that the Corvalol product contains undeclared phenobarbital. The agency is aware that the product is being sold Over the Counter (OTC) in Eastern European American communities for the treatment of angina; chest pains and as a sedative. This product is not approved for OTC use in the US FDA previously issued a health hazzard alert for Corvalol on July 28 1997.

Odessa factory of mineral water "Kuyalnik"
Date Published : 09/30/2009
Lymanna vul. 166 , Odesa, Odeska UKRAINE
29 W - - 01 Bottled Water
Date Published: 09/30/2009

Notes: The product labeling states the following;

29 W - - 02 Bottled Spring or Mineral Water
Date Published: 09/30/2009

Notes: The product labeling states the following;

Ukrfarm Export Ltd
Date Published : 05/06/2016
Saburova St 19 3 , Kiev, UKRAINE
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 05/06/2016

Desc: Skin Cream (Product contains Fluconazole 50 mg tablets)
Notes: Problem(s); Product declared as skin cream but actually is Fluconazole 50 mg tablets.

61 W - - 45 Fluconazole (Anti-Fungal) (Not Antibiotic)
Date Published: 05/06/2016

Desc: Skin Cream (Product contains Fluconazole 50 mg tablets)
Notes: Problem(s); Product declared as skin cream but actually is Fluconazole 50 mg tablets.

66 S - - 28 Nitroglycerin (Tab) (Vasodilator)
Date Published: 06/01/2016

Desc: EKXNM Nitroglycerin


UNITED ARAB EMIRATES


AKAD Cosmetics
Date Published : 03/24/2014
Po Box 171899 , Dubai, Dubai UNITED ARAB EMIRATES
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 03/24/2014

Desc: Zafayer Anti-Hair Loss Natural Oil Extract
Notes: Country; United Arab Emirates;Shipper: Al Sariya Trading FEI #3010613635

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 03/24/2014

Desc: Zafayer Hair Tonic Natural Oil Extract
Notes: Country; United Arab Emirates; Shipper: Al Sariya Trading FEI #3010613635

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 03/24/2014

Desc: Zafayer Longer Hair with Keratin Natural Oil Extract
Notes: Country; United Arab Emirates;Shipper: Al Sariya Trading FEI #3010613635

Al Sariya Trading
Date Published : 03/24/2014
Po Box 45496 , Dubai, UNITED ARAB EMIRATES
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 04/25/2014

Desc: Dabur Vatika Hot Oil Treatment Hair Fall Control
Notes:                                                                                                                                                                                                     

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 03/24/2014

Desc: Zafayer Hair Tonic Natural Oil Extract
Notes: COUNTRY; United Arab Emirates; Mfr: AKAD Cosmetics FEI #3010666145

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 03/24/2014

Desc: Zafayer Longer Hair with Keratin Natural Oil Extract
Notes: COUNTRY; United Arab Emiratesp;Mfr: AKAD Cosmetics FEI #3010666145

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 03/24/2014

Desc: Zafayer Anti-Hair Loss Natural Oil Extract
Notes: COUNTRY; United Arab Emirates;Mfr: AKAD Cosmetics FEI #3010666145

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 04/25/2014

Desc: Vatika Dandruff Guard Shampoo
Notes:                                                                                                                                                                                                       

Avalon International Llc
Date Published : 05/31/2018
Po Box 111047 , Dubai, UNITED ARAB EMIRATES
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 05/31/2018

Desc: Brightol for Brighter & Whiter Teeth

BEST MAD HONEY
Date Published : 04/07/2023
Chhetrapti , Abu Dhabi, Abu Dhabi UNITED ARAB EMIRATES
36 C - - 99 Honey, N.E.C.
Date Published: 04/07/2023

Desc: Best Mad Honey

66 H - - 99 Sweetener N.E.C.
Date Published: 04/07/2023

Desc: Best Mad Honey

Dabur International
Date Published : 10/14/2012
Jebel Ali Free Zone 7 , Between R/A 6 , Dubai, UNITED ARAB EMIRATES
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 10/14/2012

Desc: Dabur Herbal Toothpaste Clove

53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 10/14/2012

Desc: Dabur Herbal Toothpaste Basil

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 10/14/2012

Desc: Dabur Herbal Toothpaste Basil

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 10/14/2012

Desc: Dabur Herbal Toothpaste Clove

63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic)
Date Published: 10/14/2012

Desc: Dabur Herbal Toothpaste Clove

63 R - - 06 Stannous Fluoride (Dental Caries Prophylactic)
Date Published: 10/14/2012

Desc: Dabur Herbal Toothpaste Basil

63 S - - 99 Dental Protectant N.E.C.
Date Published: 10/14/2012

Desc: Dabur Herbal Toothpaste Basil

63 S - - 99 Dental Protectant N.E.C.
Date Published: 10/14/2012

Desc: Dabur Herbal Toothpaste Clove

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/14/2012

Desc: Dabur Herbal Toothpaste Basil

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/14/2012

Desc: Dabur Herbal Toothpaste Clove

Khat Almosem General Trading Llc
Date Published : 06/09/2016
PO Box 113432 , Dubai, UNITED ARAB EMIRATES
53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 05/18/2017

Desc: Senorita Rose and Olive Hair Oil
Notes: Drug claims made on product labels.

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 05/18/2017

Desc: Senorita Lavender and Cactus Hair Oil
Notes: Drug claims made on product labels

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 06/09/2016

Desc: Ginger Shampoo
Notes: Medical claims on product labels

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 05/18/2017

Desc: Senorita Rose and Olive Hair Oil
Notes: Drug claims made on product labels.

53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 05/18/2017

Desc: Senorita Lavender and Cactus Hair Oil
Notes: Drug claims made on product labels

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 06/30/2016

Desc: Papaya Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/18/2017

Desc: Senorita Rose and Olive Hair Oil
Notes: Drug claims made on product labels.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/18/2017

Desc: Senorita Lavender and Cactus Hair Oil
Notes: Drug claims made on product labels

Mirage General Trading
Date Published : 03/07/2016
(Nasser Square) , Lily Center 107 , Dayrah, UNITED ARAB EMIRATES
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 03/07/2016

Desc: EL-BARAKA BLACK SEED SOAP NATURAL SOAP FOR BODY

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/07/2016

Desc: EL-BARAKA BLACK SEED SOAP NATURAL SOAP FOR BODY

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 03/07/2016

Desc: EL-BARAKA BLACK SEED SOAP NATURAL SOAP FOR BODY

Natural Health Products
Date Published : 09/13/2019
The Village , Ofc #8.; Emirates Hills Rd , Dubai, Dubai UNITED ARAB EMIRATES
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/13/2019

Notes: Uptrol Dietary Supplement aka Uptrol Male-Enhancement Formula; 11/12/2008

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/13/2019

Notes: Uptrol Dietary Supplement aka Uptrol Male-Enhancement Formula; 11/12/2008

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Uptrol Dietary Supplement aka Uptrol Male-Enhancement Formula; 11/12/2008

61 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Uptrol Dietary Supplement aka Uptrol Male-Enhancement Formula; 11/12/2008

62 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Uptrol Dietary Supplement aka Uptrol Male-Enhancement Formula; 11/12/2008

63 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Uptrol Dietary Supplement aka Uptrol Male-Enhancement Formula; 11/12/2008

64 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Uptrol Dietary Supplement aka Uptrol Male-Enhancement Formula; 11/12/2008

65 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Uptrol Dietary Supplement aka Uptrol Male-Enhancement Formula; 11/12/2008

66 - - - -- Human and Animal Drugs
Date Published: 09/13/2019

Notes: Uptrol Dietary Supplement aka Uptrol Male-Enhancement Formula; 11/12/2008

Naturelle LLC
Date Published : 04/25/2014
Near Rak Ceramic Naturelle Dabur Building , Ras Al Khaimah, UNITED ARAB EMIRATES
20 B - - 99 Berries, Dried or Paste, N.E.C.
Date Published: 12/12/2023

Desc: Dabur Chyawanprash Spread

21 F - - 99 Mixed Fruit Purees, N.E.C.
Date Published: 12/12/2023

Desc: Dabur Chyawanprash Spread

22 J - - 99 Other Fruit and Fruit Products, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 12/12/2023

Desc: Dabur Chyawanprash Spread

24 M - - 99 Fruits Used as Vegetables, N.E.C. (Microgreen)
Date Published: 12/12/2023

Desc: Dabur Chyawanprash Spread

25 F - - 99 Mixed Vegetables, Dried or Paste, N.E.C.
Date Published: 12/12/2023

Desc: Dabur Chyawanprash Spread

27 Y - - 99 Condiments, N.E.C.
Date Published: 12/12/2023

Desc: Dabur Chyawanprash Spread

28 B - - 99 Spices, Ground, Cracked, Etc., N.E.C.
Date Published: 12/12/2023

Desc: Dabur Chyawanprash Spread

37 B - - 99 Multiple Food Specialities, Side Dishes and Desserts, N.E.C.
Date Published: 12/12/2023

Desc: Dabur Chyawanprash Spread

37 K - - 99 Pastes, n.e.c.
Date Published: 12/12/2023

Desc: Dabur Chyawanprash Spread

53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring)
Date Published: 04/25/2014

Desc: Dabur Vatika Hot Oil Treatment Hair Fall Control

53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 04/25/2014

Desc: Vatika Dandruff Guard Shampoo

53 E - - -- Hair Preps(Non-Coloring)
Date Published: 09/26/2017

Desc: Dabur Vatika Naturals Dandruff Guard Styling Hair Cream

53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 11/20/2015

Desc: DABUR HERBAL MINT

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C.
Date Published: 11/20/2015

Desc: DABUR HERBAL MINT

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/12/2023

Desc: Dabur Chyawanprash Spread

63 S - - 99 Dental Protectant N.E.C.
Date Published: 11/20/2015

Desc: DABUR HERBAL MINT & LEMON FRESH GEL TOOTHPASTE

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/26/2017

Desc: Dabur Vatika Naturals Dandruff Guard Styling Hair Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/12/2023

Desc: Dabur Chyawanprash Spread

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/20/2015

Desc: DABUR HERBAL MINT

Onlinepharmashop.com
Date Published : 09/30/2009
Cigdem Aksoy , Burj el Arab, King suite , Dubai 6676543, UNITED ARAB EMIRATES
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                           

Yusra Trading Llc
Date Published : 05/24/2012
Po Box 181451 , Dubai, UNITED ARAB EMIRATES
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 05/24/2012

Desc: Facial Wash With Whitening Claim
Notes: United Arab Emirates

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 05/24/2012

Desc: Facial Wash With Whitening Claim
Notes: United Arab Emirates

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 05/24/2012

Desc: Facial Wash With Whitening Claim
Notes: United Arab Emirates

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/24/2012

Desc: Facial Wash With Whitening Claim
Notes: United Arab Emirates


UNITED KINGDOM


AINSLY LTD
Date Published : 09/12/2023
1 Phipp Street , London, UNITED KINGDOM
64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Waldo Hydration Drop

AINSLY LTD
Date Published : 09/12/2023
71-75 Shelton Street , Coventgarden , London, UNITED KINGDOM
64 W D L 99 Irrigation Solution N.E.C., Human - Rx/Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Waldo Hydration Drop

Allicin International Limited
Date Published : 09/27/2011
C/O Wasdell Packagingunit 6 - 8 Euroway , Swindonswindon, UNITED KINGDOM
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/27/2011

Desc: Allicin Powder Capsules
Notes: United Kingdom

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 12/14/2011

Desc: Garlic Gel Supplement
Notes: United Kingdom

56 Y - - 99 Antibiotic N.E.C.
Date Published: 12/14/2011

Desc: Garlic Liquid Supplement
Notes: United Kingdom

56 Y - - 99 Antibiotic N.E.C.
Date Published: 12/14/2011

Desc: Garlic Gel Supplement
Notes: United Kingdom

61 H A J 99 Anti-Bacterial, N.E.C., Human - Non/Rx Single Ingredient, NonSterile Ointment
Date Published: 09/27/2011

Desc: Allicin Powder Capsules
Notes: United Kingdom

Allimax International Limited
Date Published : 09/27/2011
Playden House Military Road , Military Road , Rye, East Sussex UNITED KINGDOM
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/27/2011

Desc: Allicin Powder Capsules
Notes: United Kingdom

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 12/14/2011

Desc: Garlic Gel Supplement
Notes: United Kingdom

56 Y - - 99 Antibiotic N.E.C.
Date Published: 12/14/2011

Desc: Garlic Liquid Supplement
Notes: United Kingdom

56 Y - - 99 Antibiotic N.E.C.
Date Published: 12/14/2011

Desc: Garlic Gel Supplement
Notes: United Kingdom

61 H A J 99 Anti-Bacterial, N.E.C., Human - Non/Rx Single Ingredient, NonSterile Ointment
Date Published: 09/27/2011

Desc: Allicin Powder Capsules
Notes: United Kingdom

Any Sweet Cures
Date Published : 09/30/2009
101 Foxwood Lane , York, UNITED KINGDOM
36 A - - 99 Sugar Products, N.E.C.
Date Published: 09/30/2009

Notes: 9/27/2006

Balance Healthcare Limited
Date Published : 09/13/2019
11 Langston Priory Workshops , Station Road , Chipping Norton, Oxfordshire UNITED KINGDOM
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/13/2019

Notes: 3/17/2015

Bell, Sons & Co. (Druggists) Ltd.
Date Published : 09/15/2021
Gifford House , Slaidburn Crescent , Southport, Merseyside UNITED KINGDOM
55 P - - 93 Eucalyptus Oil (Pharmaceutic Necessity - Flavor)
Date Published: 09/15/2021

Desc: Silver Bird 100 % Eucalyptus Oil B.P.
Notes: The product appears to be a drug, as per section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1) because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. A labeling statement documenting the intended use of the product include, but may not be limited to, the following: “A natural remedy for colds, coughs, catarrh and headaches.”

60 B - - 01 Ammonium Chloride (Acidifier)
Date Published: 09/27/2021

Desc: Menthodex Cough Mixture

62 M - - 08 Menthol (Anti-Pruritic)
Date Published: 09/27/2021

Desc: Menthodex Cough Mixture

62 U - - 99 Anti-Tussive/Cold N.E.C.
Date Published: 09/27/2021

Desc: Menthodex Cough Mixture

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/27/2021

Desc: Menthodex Cough Mixture

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/15/2021

Desc: Silver Bird 100 % Eucalyptus Oil B.P.
Notes: The product appears to be a drug, as per section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1) because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. A labeling statement documenting the intended use of the product include, but may not be limited to, the following: “A natural remedy for colds, coughs, catarrh and headaches.”

Bionational Ltd
Date Published : 09/30/2009
Unit 34 Uplandside Manor Rd , Clopton , Woodbridge, UNITED KINGDOM
54 - - Y -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), NEC
Date Published: 03/16/2022

Desc: "Nu-Eyes" "Can-C Eyedrops"
Notes: 9/14/2007

55 Q P - 58 Glycerin (Pharmaceutic Necessity - Solvent), Pharma Necess
Date Published: 09/13/2019

Desc: "Nu-Eyes" "Can-C Eyedrops"
Notes: 9/14/2007

55 R P - 12 Carboxymethylcellulose Sodium (Pharmaceutic Necessity - Suspending Agent), Pharma Necess
Date Published: 09/13/2019

Desc: "Nu-Eyes" "Can-C Eyedrops"
Notes: 9/14/2007

66 - - V -- Human and Animal Drugs, Compressed Medical Gas
Date Published: 03/16/2022

Desc: "Nu-Eyes" "Can-C Eyedrops"
Notes: 9/14/2007

Bobby'S Healthy Shop
Date Published : 04/14/2011
Pound House , Kenn, UNITED KINGDOM
62 F - - 17 Hydrogen Peroxide (Sol) (Anti-Infective, Topical)
Date Published: 04/14/2011

Desc: 35% Hydrogen Peroxide
Notes: United Kingdom

Bowling Chemist
Date Published : 09/30/2009
7 Wardour Street , London, UNITED KINGDOM
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: All drugs. GPI=DR. 2/16/2005. Background: Based on accompanying documents, the product appears to be a new drug without an approved application. An internet based pharmacy, IVFMeds is reportedlt filling orderes using certain unapproved foreign versions of Serono fertility products through another UK based pharmacy called Bowling Chemicals Ltd. In addition, after reviewing the firms website www.ivfmeds.com, it appears that IVFMeds also promotes and offers for sale into the US foreign versions of other various unapproved drug products.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

CZTL Ltd.
Date Published : 12/09/2022
61 Bridge Street , Kington, Herefordshire UNITED KINGDOM
61 R - - 07 Methylene Blue (Antidote)
Date Published: 12/09/2022

Desc: MB Cure Methylene Blue Powder

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/09/2022

Desc: MB Cure Methylene Blue Powder

88 K - - FC Methylene Blue, Tissue Stain
Date Published: 12/09/2022

Desc: MB Cure Methylene Blue Powder

Central Pharmacy
Date Published : 12/03/2014
225 West End Lane , London, UNITED KINGDOM
61 H - - 24 Isoniazid (Anti-Bacterial)
Date Published: 12/03/2014

Desc: Isozid
Notes:                                                                                                                                                                                                                  

61 P - - 17 Insulin (Inj) (Anti-Diabetic)
Date Published: 12/03/2014

Desc: Lantus Solostar
Notes:                                                                                                                                                                                                                  

62 I - - 99 Anti-Neoplastic N.E.C.
Date Published: 12/03/2014

Desc: Mabthera
Notes:                                                                                                                                                                                                                       

62 T - - 04 Octreotide Acetate (Anti-Secretory)
Date Published: 12/03/2014

Desc: Sandostatin
Notes:                                                                                                                                                                                                                  

62 Z - - 07 Filgrastim
Date Published: 12/03/2014

Desc: Neulasta
Notes:                                                                                                                                                                                                                  

Cultech Limited
Date Published : 09/20/2012
Unit 2-3 , Christchurch Rd , Port Talbot, W Glam UNITED KINGDOM
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/20/2012

Desc: HMF Candigen Cream Vaginal Cream

64 L - - 99 Glucocorticoid N.E.C.
Date Published: 09/20/2012

Desc: HMF Candigen Cream Vaginal Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/20/2012

Desc: HMF Candigen Cream Vaginal Cream

DCS EXPORT
Date Published : 12/15/2021
Ocean House; Noral Way , Banbury, Oxfordshire UNITED KINGDOM
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/15/2021

Desc: Dove Antiperspirant/Deodorant
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…ANTI-PERSPIRANT … 48h POWERFUL PROTECTION…’.

53 J - - 02 Deodorants (underarm)(Not Antiperspirant) (Personal Cleanliness)
Date Published: 12/15/2021

Desc: Dove Antiperspirant/Deodorant
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…ANTI-PERSPIRANT … 48h POWERFUL PROTECTION…’.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/15/2021

Desc: Dove Antiperspirant/Deodorant
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…ANTI-PERSPIRANT … 48h POWERFUL PROTECTION…’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/15/2021

Desc: Dove Antiperspirant/Deodorant
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…ANTI-PERSPIRANT … 48h POWERFUL PROTECTION…’.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 03/16/2022

Desc: Dove Antiperspirant/Deodorant
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…ANTI-PERSPIRANT … 48h POWERFUL PROTECTION…’. 12/15/2021

Edward Cook and Company
Date Published : 09/30/2009
8 Salisbury Square , London, London UNITED KINGDOM
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009

Notes: 7/3/2008. Roberts Medicated Soap. The term "Medicated" and the active ingrediant "potassium mercuric iodide solution" on the labeling represents and suggests that the product is intended for "drug" uses. The immediate container label also identifies the product for removing unsightly pimples, spots, dandruff, scurf, and other parasites, left free of infection, prevents sickness from spreading, and stops any irritation. These are drug claims under the 201(g)(1) which defines a drug as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.

Elliot Irving Ltd.
Date Published : 09/30/2009
Suite 6-5A Skypark , Glasgow, UNITED KINGDOM
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/27/2019

Desc: Crusader Medicated Soap
Notes: 7/3/2008; Crusader medicated soap. The term "Medicated" and the active ingredient "potassium mercuric iodide solution" on the labeling represents and suggests that the product is intended for "drug" uses. These are drug claims under the 201(g)(1) which defines a drug as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.

Estee Lauder Uk Travel Retail
Date Published : 11/06/2017
73 Grosvenor Street , London, UNITED KINGDOM
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/06/2017

Desc: Advanced Night Repair Eye Serum

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/06/2017

Desc: Advanced Night Repair Eye Serum

Ethos Life Long Products
Date Published : 02/06/2017
Flat 4 , The Lawn, St. Andrews Roa The , Paigntonpaignton, UNITED KINGDOM
54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 02/06/2017

Desc: Ethos Mega Focus Liposomal Oral Dietary Supplement
Notes: The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Ethos Mega Focus … the ultimate super-nutrition for clearer sharper vision' and '… Healthy Eyes … Healthy Brain … Healthy Body'.

54 A - - 99 Vitamin, N.E.C.
Date Published: 02/06/2017

Desc: Ethos Mega Focus Liposomal Oral Dietary Supplement
Notes: The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Ethos Mega Focus … the ultimate super-nutrition for clearer sharper vision' and '… Healthy Eyes … Healthy Brain … Healthy Body'.

54 B - - 99 Mineral N.E.C.
Date Published: 02/06/2017

Desc: Ethos Mega Focus Liposomal Oral Dietary Supplement
Notes: The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Ethos Mega Focus … the ultimate super-nutrition for clearer sharper vision' and '… Healthy Eyes … Healthy Brain … Healthy Body'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/06/2017

Desc: Ethos Mega Focus Liposomal Oral Dietary Supplement
Notes: The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Ethos Mega Focus … the ultimate super-nutrition for clearer sharper vision' and '… Healthy Eyes … Healthy Brain … Healthy Body'.

Eurocaps Limited
Date Published : 08/04/2021
Crown Business Park , Tredegar, None of the above UNITED KINGDOM
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/04/2021

Desc: Aurum Daily Psychobiotic Dietary Supplement
Notes: Claims found on product label and firm website.                                                                                                                                                               Eurocaps Ltd. is a repacker/shipper.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/04/2021

Desc: Aurum Daily Psychobiotic Dietary Supplement
Notes: Claims found on product label and firm website.                                                                                                                                                               Eurocaps Ltd. is a repacker/shipper.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/04/2021

Desc: Aurum Daily Psychobiotic Dietary Supplement
Notes: Claims found on product label and firm website.                                                                                                                                                               Eurocaps Ltd. is a repacker/shipper.

FITNESS FACTORY GROUP
Date Published : 04/11/2017
Unit 108, Brunswick Business Park , Tower Street, , Liverpool, UNITED KINGDOM
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/11/2017

Desc: M-Drol

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/11/2017

Desc: Testaflex Hormone Augmentation

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/11/2017

Desc: Testaflex Hormone Augmentation

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/11/2017

Desc: M-Drol

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 04/11/2017

Desc: M-Drol

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 04/11/2017

Desc: Testaflex Hormone Augmentation

Glaxo Operations U.K. Ltd.
Date Published : 12/02/2016
Harmire Road , Barnard Castle, County Durham UNITED KINGDOM
64 L - - 67 Clobetasol Propionate (Glucocorticoid)
Date Published: 12/02/2016

Desc: Dermovate Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/02/2016

Desc: Dermovate Cream

Glaxo Smith Kline UK
Date Published : 09/30/2009
889 Greenford Road , Greenford, UNITED KINGDOM
64 L - - -- Glucocorticoid
Date Published: 09/30/2009

Notes: 10/15/1999 Dermovate Cream

Glaxosmithkline
Date Published : 01/14/2010
G S K House , 980 Great West Road , Brentford, Middlesex UNITED KINGDOM
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 01/14/2010

Desc: MacLeans Fresh Mint Toothpaste
Notes: Country; United Kingdom The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1).

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/14/2010

Notes: The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1).

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1).

61 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1).

62 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1).

63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic)
Date Published: 01/14/2010

Desc: MacLeans Fresh Mint Toothpaste
Notes: Country; United Kingdom The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1).

63 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1).

64 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1).

65 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1).

66 - - - -- Human and Animal Drugs
Date Published: 01/14/2010

Notes: The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1).

I.A.S. Limited
Date Published : 09/04/2019
c/o Les Autelets , Suite I, VA GY9 OSF , VA GY9 OSF, UNITED KINGDOM
54 - - Y -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), NEC
Date Published: 09/04/2019

Desc: "Nu-Eyes" & "Can-C Eyedrops"
Notes: 9/14/2007

55 Q P - 58 Glycerin (Pharmaceutic Necessity - Solvent), Pharma Necess
Date Published: 09/04/2019

Desc: "Nu-Eyes" & "Can-C Eyedrops"
Notes: 9/14/2007

55 R P - 12 Carboxymethylcellulose Sodium (Pharmaceutic Necessity - Suspending Agent), Pharma Necess
Date Published: 09/04/2019

Desc: "Nu-Eyes" & "Can-C Eyedrops"
Notes: 9/14/2007

66 - - V -- Human and Animal Drugs, Compressed Medical Gas
Date Published: 09/04/2019

Desc: "Nu-Eyes" & "Can-C Eyedrops"
Notes: 9/14/2007

IAS, c/o Les Autelets
Date Published : 09/30/2009
P O Box 6 , Sark Gy9 0SF, UNITED KINGDOM
54 - - Y -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), NEC
Date Published: 09/04/2019

Desc: "Nu-Eyes" & "Can-C Eyedrops"
Notes: 9/14/2007

55 Q P - 58 Glycerin (Pharmaceutic Necessity - Solvent), Pharma Necess
Date Published: 09/04/2019

Desc: "Nu-Eyes" & "Can-C Eyedrops"
Notes: 9/14/2007

55 R P - 12 Carboxymethylcellulose Sodium (Pharmaceutic Necessity - Suspending Agent), Pharma Necess
Date Published: 09/04/2019

Desc: "Nu-Eyes" & "Can-C Eyedrops"
Notes: 9/14/2007

62 I - - -- A-Neoplastic
Date Published: 09/30/2009

Notes: Curaderm-BEC5 Cream 8/30/2007                            

64 X - - 06 Salicylic Acid (Keratolytic)
Date Published: 09/30/2009

Notes: Curaderm-BEC5 Cream 8/30/2007                            

64 X - - -- Keratolytic
Date Published: 09/30/2009

Notes: Curaderm-BEC5 Cream 8/30/2007                            

66 - - V -- Human and Animal Drugs, Compressed Medical Gas
Date Published: 09/04/2019

Desc: "Nu-Eyes" & "Can-C Eyedrops"
Notes: 9/14/2007

Interlab
Date Published : 09/30/2009
Newport, Pagnell , Bucks, England UNITED KINGDOM
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/05/2019

Notes: All drugs; 6/22/1998

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/05/2019

Notes: All drugs; 6/22/1998

61 - - - -- Human and Animal Drugs
Date Published: 09/05/2019

Notes: All drugs; 6/22/1998

62 - - - -- Human and Animal Drugs
Date Published: 09/05/2019

Notes: All drugs; 6/22/1998

63 - - - -- Human and Animal Drugs
Date Published: 09/05/2019

Notes: All drugs; 6/22/1998

64 - - - -- Human and Animal Drugs
Date Published: 09/05/2019

Notes: All drugs; 6/22/1998

65 - - - -- Human and Animal Drugs
Date Published: 09/05/2019

Notes: All drugs; 6/22/1998

66 - - - -- Human and Animal Drugs
Date Published: 09/05/2019

Notes: All drugs; 6/22/1998

International Antiaging Systems
Date Published : 09/30/2009
6 Houghton Hall Park , Dunstable, Bedfordshire UNITED KINGDOM
54 - - Y -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), NEC
Date Published: 09/05/2019

Desc: "Nu-Eyes" & "Can-C Eyedrops"
Notes: 9/12/2007

55 Q P - 58 Glycerin (Pharmaceutic Necessity - Solvent), Pharma Necess
Date Published: 09/05/2019

Desc: "Nu-Eyes" & "Can-C Eyedrops"
Notes: 9/12/2007

55 R P - 12 Carboxymethylcellulose Sodium (Pharmaceutic Necessity - Suspending Agent), Pharma Necess
Date Published: 09/05/2019

Desc: "Nu-Eyes" & "Can-C Eyedrops"
Notes: 9/12/2007

66 - - V -- Human and Animal Drugs, Compressed Medical Gas
Date Published: 09/05/2019

Desc: "Nu-Eyes" & "Can-C Eyedrops"
Notes: 9/12/2007

International Antiaging Systems (IAS)
Date Published : 09/30/2009
P O Box 2995 , Muswell Hill, London UNITED KINGDOM
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/30/2009

Notes: ALL

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

61 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

62 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

63 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

64 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

65 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

66 - - - -- Human and Animal Drugs
Date Published: 09/30/2009

Ipsen Limited
Date Published : 04/23/2020
190 Bath Road , Slough, UNITED KINGDOM
53 - - - -- Cosmetics
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 07 Myobloc
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

Ipsen Limited
Date Published : 04/23/2020
1 Bath Road , Maidenhead, Berkshire UNITED KINGDOM
53 - - - -- Cosmetics
Date Published: 04/23/2020

Desc: Botulinum Toxin Types A & B

65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Botulinum Toxin Types A & B

65 Q - - 07 Myobloc
Date Published: 04/23/2020

Desc: Botulinum Toxin Types A & B

Kerry Edwards Ltd
Date Published : 04/16/2012
1 Ambleside Roadthe Gatewayoswestry , Oswestryoswestry, UNITED KINGDOM
46 Y - - 99 Food Additives For Human Use, N.E.C.
Date Published: 04/16/2012

Desc: Methoxetamine (MXE)
Notes: United Kingdom

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 04/16/2012

Notes: Methoxetamine (MXE);United Kingdom

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 04/16/2012

Notes: Methoxetamine (MXE);United Kingdom

61 - - - -- Human and Animal Drugs
Date Published: 04/16/2012

Notes: Methoxetamine (MXE);United Kingdom

62 - - - -- Human and Animal Drugs
Date Published: 04/16/2012

Notes: Methoxetamine (MXE);United Kingdom

63 - - - -- Human and Animal Drugs
Date Published: 04/16/2012

Notes: Methoxetamine (MXE);United Kingdom

64 - - - -- Human and Animal Drugs
Date Published: 04/16/2012

Notes: Methoxetamine (MXE);United Kingdom

65 - - - -- Human and Animal Drugs
Date Published: 04/16/2012

Notes: Methoxetamine (MXE);United Kingdom

66 - - - -- Human and Animal Drugs
Date Published: 04/16/2012

Notes: Methoxetamine (MXE);United Kingdom

MSAP
Date Published : 09/30/2009
144 Richmond Hill Rd , Sumner , Christchurch, Canterbury 8008, UNITED KINGDOM
64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes: 2/8/2007                            

Mcneil Products
Date Published : 11/03/2014
Maidenhead , Berkshireberkshire, UNITED KINGDOM
66 B - - 44 Nicotine Delivery System
Date Published: 11/03/2014

Desc: Nicorette Nasal Spray
Notes: The referenced product appears to be an unapproved new drug as the product labeling lists claims such as; 'Nicorette Nasal Spray is for the rapid relief of nicotine withdrawal symptoms as an aid to giving up smoking;' 'To relieve cravings and nicotine withdrawal symptoms;' and 'You are more likely to quit smoking when using this product with help from your pharmacist; doctor; a trained counsellor or a support programme'.

Medex Scientific (Uk) Limited
Date Published : 06/07/2018
The Old Grain Store , 4 Denne Road , Horsham, West Sussex UNITED KINGDOM
66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 06/07/2018

Desc: Fucus Patch
Notes: Medical claims made on product labeling.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 06/07/2018

Desc: Sleep and Stress Relief Patch
Notes: Medical claims made on product labeling.

Medica Depot
Date Published : 04/23/2020
Tts Dukes Green Ave , Feltham, UNITED KINGDOM
65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A

Mentolatum Company LTD.
Date Published : 09/04/2012
1 Redwood Avenue , None Of The Above , Glasgow, SLK UNITED KINGDOM
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/04/2012

Desc: Deeprel Cosmetic Cream
Notes: United Kingdom

Mitchell International Pharmaceuticals Limited
Date Published : 09/30/2009
Unit , 7 Kingston Road , Portsmouth, POR UNITED KINGDOM
53 L C - -- Skin Care Prep, Cream
Date Published: 09/30/2009

Notes: Beta Zone; Beta-Vate; Mercury Top Gel; Topsone Gel; Omic Gel Edkeen; Topsovate Cream Edkeen 11/15/1999

64 L - - 06 Betamethasone Dipropionate (Glucocorticoid)
Date Published: 09/30/2009

Notes: Betazone; Beta-Vate and Topsone Gel 11/15/1999

64 L - - 28 Fluocinonide (Glucocorticoid)
Date Published: 09/30/2009

Notes: Mercury Top Gel and Omic Gel Edkeen 11/15/1999

64 L - - 99 Glucocorticoid N.E.C.
Date Published: 09/30/2009

Notes: Topsovate Cream Edkeen 11/15/1999

Nanotech Health Ltd
Date Published : 04/15/2016
International House , 223 Regent Street , London, UNITED KINGDOM
54 A - - 99 Vitamin, N.E.C.
Date Published: 04/15/2016

Desc: Nanoxyn Alpha Modified Release Tablets "Nutritional Supplement"
Notes: Claims on product label

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/15/2016

Desc: Nanoxyn Alpha Modified Release Tablets "Nutritional Supplement"
Notes: Claims on product label

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/15/2016

Desc: Nanoxyn Alpha Modified Release Tablets "Nutritional Supplement"
Notes: Claims on product label

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/15/2016

Desc: Nanoxyn Alpha Modified Release Tablets "Nutritional Supplement"
Notes: Claims on product label

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 04/15/2016

Desc: Nanoxyn Alpha Modified Release Tablets "Nutritional Supplement"
Notes: Claims on product label

Nutrition Group PLC.
Date Published : 07/07/2021
Transcontinental House , Olympic Way; Lancashire , Blackpool, UNITED KINGDOM
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 07/07/2021

Desc: Skinade Targeted Solutions Clear- Liquid Skincare Dietary Supplement
Notes: The firm’s website: https://skinade.com/ includes drug claims such as (not an all-inclusive list): ‘The ingredients…zinc…helps control bacteria’

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 07/07/2021

Desc: Skinade Targeted Solutions Clear- Capsule Skincare Dietary Supplement
Notes: The firm’s website: https://skinade.com/ includes drug claims such as (not an all- inclusive list): “The ingredients…zinc…helps control bacteria’.

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 07/07/2021

Desc: Skinade Targeted Solutions Clear- Capsule Skincare Dietary Supplement
Notes: The firm’s website: https://skinade.com/ includes drug claims such as (not an all- inclusive list): “The ingredients…zinc…helps control bacteria’.

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 07/07/2021

Desc: Skinade Targeted Solutions Clear- Liquid Skincare Dietary Supplement
Notes: The firm’s website: https://skinade.com/ includes drug claims such as (not an all-inclusive list): ‘The ingredients…zinc…helps control bacteria’

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/07/2021

Desc: Skinade Targeted Solutions Clear- Capsule Skincare Dietary Supplement
Notes: The firm’s website: https://skinade.com/ includes drug claims such as (not an all- inclusive list): “The ingredients…zinc…helps control bacteria’.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/07/2021

Desc: Skinade Targeted Solutions Clear- Liquid Skincare Dietary Supplement
Notes: The firm’s website: https://skinade.com/ includes drug claims such as (not an all-inclusive list): ‘The ingredients…zinc…helps control bacteria’

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/07/2021

Desc: Skinade Targeted Solutions Clear- Liquid Skincare Dietary Supplement
Notes: The firm’s website: https://skinade.com/ includes drug claims such as (not an all- inclusive list): “The ingredients…zinc…helps control bacteria’.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/07/2021

Desc: Skinade Targeted Solutions Clear- Capsule Skincare Dietary Supplement
Notes: The firm’s website: https://skinade.com/ includes drug claims such as (not an all- inclusive list): “The ingredients…zinc…helps control bacteria’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/07/2021

Desc: Skinade Targeted Solutions Clear- Capsule Skincare Dietary Supplement
Notes: The firm’s website: https://skinade.com/ includes drug claims such as (not an all- inclusive list): “The ingredients…zinc…helps control bacteria’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/07/2021

Desc: Skinade Targeted Solutions Clear- Liquid Skincare Dietary Supplement
Notes: The firm’s website: https://skinade.com/ includes drug claims such as (not an all-inclusive list): ‘The ingredients…zinc…helps control bacteria’

Ore-An Personal Care Ltd.
Date Published : 09/25/2012
15/20 Branxholme Ind Estate , West Yorkshire, UNITED KINGDOM
53 L D - 99 Other Skin Care Preparations, N.E.C., Liquid, Lotion
Date Published: 09/25/2012

Desc: Skinny Beach Tinted Gel

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/25/2012

Desc: Skinny Beach Tinted Gel

Pangaea Laboratories
Date Published : 05/18/2012
58 Crewys Rd , Londonlondon, UNITED KINGDOM
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/18/2012

Desc: Medik8 Growth Factor Youth Activating Serum with Triple Filtered EGF
Notes: United Kingdom

Pharm-Assay International Ltd.
Date Published : 07/30/2019
The Gemini Building Houghton Hall Park , Dunstable Beds, UNITED KINGDOM
54 - - Y -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), NEC
Date Published: 07/30/2019

Desc: Nu-Eyes & Can-C Eyedrops
Notes: Admin/Tec Contact; Damien Trevatt;                                                      ;                                     ;                            ;                             ; 9/12/2007 ; ;

55 Q P - 58 Glycerin (Pharmaceutic Necessity - Solvent), Pharma Necess
Date Published: 07/30/2019

Desc: Nu-Eyes & Can-C Eyedrops
Notes: Admin/Tec Contact; Damien Trevatt;                                                      ;                                     ;                            ;                             ; 9/12/2007 ;

55 R P - 12 Carboxymethylcellulose Sodium (Pharmaceutic Necessity - Suspending Agent), Pharma Necess
Date Published: 07/30/2019

Desc: Nu-Eyes & Can-C Eyedrops
Notes: Admin/Tec Contact; Damien Trevatt;                                                      ;                                     ;                            ;                             ; 9/12/2007 ;

66 - - V -- Human and Animal Drugs, Compressed Medical Gas
Date Published: 07/30/2019

Desc: Nu-Eyes & Can-C Eyedrops
Notes: Admin/Tec Contact; Damien Trevatt;                                                      ;                                     ;                            ;                             ; 9/12/2007 ;

Poons Beuty Cosmetics
Date Published : 08/15/2016
Ashburton Grove , London, UNITED KINGDOM
53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 08/15/2016

Desc: Skin Doctor Toner-Natural Witch Hazel Toner

Power Health Products Ltd
Date Published : 10/27/2022
Airfield Estate , Pocklington Industrial Estate; E. , York, UNITED KINGDOM
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 10/27/2022

Desc: Emu Oil Capsules
Notes: This product appears to be an unapproved new drug, as its promotional website includes statements such as: “Emu oil capsules boast anti-inflammatory properties.”, “Our capsules… prevent inflammation”, “Rich in anti-inflammatory Omega-3’s”, “Emu oil…has been used to… provid[e] pain relief” and “Customers are using these for multiple aches and pains where it may not be practical to use the Emu balm. or in conjunction for extra benefits. Also for IBS and Crohns.”; and its promotional label includes statements such as: “May help reduce joint and inflammation associated with arthritis.”

60 L - - 99 Analgesic, N.E.C.
Date Published: 10/27/2022

Desc: Emu Oil Capsules
Notes: This product appears to be an unapproved new drug, as its promotional website includes statements such as: “Emu oil capsules boast anti-inflammatory properties.”, “Our capsules… prevent inflammation”, “Rich in anti-inflammatory Omega-3’s”, “Emu oil…has been used to… provid[e] pain relief” and “Customers are using these for multiple aches and pains where it may not be practical to use the Emu balm. or in conjunction for extra benefits. Also for IBS and Crohns.”; and its promotional label includes statements such as: “May help reduce joint and inflammation associated with arthritis.”

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 10/27/2022

Desc: Emu Oil Capsules
Notes: This product appears to be an unapproved new drug, as its promotional website includes statements such as: “Emu oil capsules boast anti-inflammatory properties.”, “Our capsules… prevent inflammation”, “Rich in anti-inflammatory Omega-3’s”, “Emu oil…has been used to… provid[e] pain relief” and “Customers are using these for multiple aches and pains where it may not be practical to use the Emu balm. or in conjunction for extra benefits. Also for IBS and Crohns.”; and its promotional label includes statements such as: “May help reduce joint and inflammation associated with arthritis.”

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/27/2022

Desc: Emu Oil Capsules
Notes: This product appears to be an unapproved new drug, as its promotional website includes statements such as: “Emu oil capsules boast anti-inflammatory properties.”, “Our capsules… prevent inflammation”, “Rich in anti-inflammatory Omega-3’s”, “Emu oil…has been used to… provid[e] pain relief” and “Customers are using these for multiple aches and pains where it may not be practical to use the Emu balm. or in conjunction for extra benefits. Also for IBS and Crohns.”; and its promotional label includes statements such as: “May help reduce joint and inflammation associated with arthritis.”

Profound Products
Date Published : 09/12/2023
Po Box 19 , Sarksark, UNITED KINGDOM
64 D B L 99 Emollient, Lubricant, N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liquid
Date Published: 09/12/2023

Desc: Can-C Eye Drops

66 V B Y 99 Miscellaneous Patent Medicines, Etc., Human - Non/Rx Combination Ingredient, NEC
Date Published: 09/12/2023

Desc: Can-C Eye Drops

86 M - - SI Solution, Cleaning/Lubricating, Articifial Eye
Date Published: 09/12/2023

Desc: Can-C Eye Drops

Pureclinica
Date Published : 07/12/2016
2nd Floor , Crusader House; 145-157 St. John Street , London, UNITED KINGDOM
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/12/2016

Desc: Trixelin Acne & Scar Reversal Cream

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/12/2016

Desc: Tummy Tuck Intensive Tummy Tightening Cream

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 07/12/2016

Desc: Lumecil High Strength Skin Lightening Cream

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/12/2016

Desc: Pureclinica High Absorption 5 HTP Tablets

RESHIP UK
Date Published : 07/21/2022
68 Tanners Drive , Milton Keynes, MIK UNITED KINGDOM
53 - - - -- Cosmetics
Date Published: 07/21/2022

Notes: TurboTan Nasal Spray

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/21/2022

Notes: TurboTan Nasal Spray

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/21/2022

Desc: TurboTan Nasal Spray

80 Q - - IY Nasal spray, systemic delivery, CDER or CBER led
Date Published: 07/21/2022

Desc: TurboTan Nasal Spray

RESHIP.COM
Date Published : 07/21/2022
The Gateway , 68 Tanners Drive , Milton Keynes, UNITED KINGDOM
53 - - - -- Cosmetics
Date Published: 07/21/2022

Notes: TurboTan Nasal Spray

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/21/2022

Notes: TurboTan Nasal Spray

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/21/2022

Desc: TurboTan Nasal Spray

80 Q - - IY Nasal spray, systemic delivery, CDER or CBER led
Date Published: 07/21/2022

Desc: TurboTan Nasal Spray

Reckitt Benckiser
Date Published : 03/24/2016
103 Bath Rd , Berks, UNITED KINGDOM
60 S - - 99 Antacid, N.E.C.
Date Published: 03/24/2016

Desc: Gripe Water

61 F - - 21 Chloroxylenol (Anti-Bacterial) (Not Antibiotic)
Date Published: 11/12/2019

Desc: Dettol Liquid Antiseptic Disinfectant

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/24/2016

Desc: Gripe Water

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/12/2019

Desc: Dettol Liquid Antiseptic Disinfectant

Reckitt Benckiser Healthcare (UK) Ltd.
Date Published : 01/22/2010
Dansom Lane , Khl , Hull, KHL UNITED KINGDOM
53 - - - -- Cosmetics
Date Published: 01/22/2010

Notes: E45 Dermatological Cream; 1/22/2010

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/22/2010

Notes: E45 Dermatological Cream; 1/22/2010

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 01/22/2010

Notes: E45 Dermatological Cream; 1/22/2010

61 F - - 21 Chloroxylenol (Anti-Bacterial) (Not Antibiotic)
Date Published: 11/12/2019

Desc: Dettol Liquid Antiseptic Disinfectant

61 - - - -- Human and Animal Drugs
Date Published: 01/22/2010

Notes: E45 Dermatological Cream; 1/22/2010

62 - - - -- Human and Animal Drugs
Date Published: 01/22/2010

Notes: E45 Dermatological Cream; 1/22/2010

63 - - - -- Human and Animal Drugs
Date Published: 01/22/2010

Notes: E45 Dermatological Cream; 1/22/2010

64 - - - -- Human and Animal Drugs
Date Published: 01/22/2010

Notes: E45 Dermatological Cream; 1/22/2010

65 - - - -- Human and Animal Drugs
Date Published: 01/22/2010

Notes: E45 Dermatological Cream; 1/22/2010

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/22/2010

Desc: E45 Dermatological Cream
Notes: Country; United Kingdom

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/12/2019

Desc: Dettol Liquid Antiseptic Disinfectant

66 - - - -- Human and Animal Drugs
Date Published: 01/22/2010

Notes: E45 Dermatological Cream; 1/22/2010

Rhythm & Blue Inc Ltd
Date Published : 03/13/2014
Unit 6 Holm Oak Bus Pk Woods Way , West Susex, UNITED KINGDOM
53 D - - 99 Other Fragrance Preparations, N.E.C.
Date Published: 03/13/2014

Desc: TempleSpa Quietude Room Spray 100 mL
Notes: COUNTRY; UNITED KINGDOM

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2014

Desc: TempleSpa Quietude Room Spray 100 mL
Notes: COUNTRY; UNITED KINGDOM

SHIPBOB
Date Published : 12/15/2023
Brand Path Edison Rd Ha , Birmingham, UNITED KINGDOM
53 M - - 02 Indoor Tanning Preparations (Suntan Preparations)
Date Published: 12/15/2023

Desc: PERMATAN Tanning Sublingual Oral Spray

53 M - - 02 Indoor Tanning Preparations (Suntan Preparations)
Date Published: 12/15/2023

Desc: PERMATAN Tanning Nasal Spra; Triple Strength

53 M - - 02 Indoor Tanning Preparations (Suntan Preparations)
Date Published: 12/15/2023

Desc: PERMATAN Sublingual Drops; Triple Strength

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/15/2023

Desc: PERMATAN Tanning Sublingual Oral Spray

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/15/2023

Desc: PERMATAN Tanning Nasal Spra; Triple Strength

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/15/2023

Desc: PERMATAN Sublingual Drops; Triple Strength

STD Pharmaceutical Products Ltd.
Date Published : 11/06/2018
Plough Lane , Hereford, UNITED KINGDOM
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 11/06/2018

Notes: Sodium Tetradecyl Sulfate Injection; The product is shipped under various brand names to include: STD Injection, Thromboject 1% and 3%, and Fibro-Vein. Sodium Tetradecyl Sulfate products intended for use as a human drug product that either are the subject of an approved new drug application or exempt from such application (i.e. active IND) are not subject to DWPE under this listing.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Sodium Tetradecyl Sulfate Injection; The product is shipped under various brand names to include: STD Injection, Thromboject 1% and 3%, and Fibro-Vein. Sodium Tetradecyl Sulfate products intended for use as a human drug product that either are the subject of an approved new drug application or exempt from such application (i.e. active IND) are not subject to DWPE under this listing.

61 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Sodium Tetradecyl Sulfate Injection; The product is shipped under various brand names to include: STD Injection, Thromboject 1% and 3%, and Fibro-Vein. Sodium Tetradecyl Sulfate products intended for use as a human drug product that either are the subject of an approved new drug application or exempt from such application (i.e. active IND) are not subject to DWPE under this listing.

62 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Sodium Tetradecyl Sulfate Injection; The product is shipped under various brand names to include: STD Injection, Thromboject 1% and 3%, and Fibro-Vein. Sodium Tetradecyl Sulfate products intended for use as a human drug product that either are the subject of an approved new drug application or exempt from such application (i.e. active IND) are not subject to DWPE under this listing.

63 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Sodium Tetradecyl Sulfate Injection; The product is shipped under various brand names to include: STD Injection, Thromboject 1% and 3%, and Fibro-Vein. Sodium Tetradecyl Sulfate products intended for use as a human drug product that either are the subject of an approved new drug application or exempt from such application (i.e. active IND) are not subject to DWPE under this listing.

64 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Sodium Tetradecyl Sulfate Injection; The product is shipped under various brand names to include: STD Injection, Thromboject 1% and 3%, and Fibro-Vein. Sodium Tetradecyl Sulfate products intended for use as a human drug product that either are the subject of an approved new drug application or exempt from such application (i.e. active IND) are not subject to DWPE under this listing.

65 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Sodium Tetradecyl Sulfate Injection; The product is shipped under various brand names to include: STD Injection, Thromboject 1% and 3%, and Fibro-Vein. Sodium Tetradecyl Sulfate products intended for use as a human drug product that either are the subject of an approved new drug application or exempt from such application (i.e. active IND) are not subject to DWPE under this listing.

66 - - - -- Human and Animal Drugs
Date Published: 11/06/2018

Notes: Sodium Tetradecyl Sulfate Injection; The product is shipped under various brand names to include: STD Injection, Thromboject 1% and 3%, and Fibro-Vein. Sodium Tetradecyl Sulfate products intended for use as a human drug product that either are the subject of an approved new drug application or exempt from such application (i.e. active IND) are not subject to DWPE under this listing.

Sara Beauty Online
Date Published : 01/19/2012
68 Oswald Road , Southall, Middlesex UNITED KINGDOM
53 - - - -- Cosmetics
Date Published: 01/19/2012

Notes: Stillmans Skin Bleach Cream

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/19/2012

Notes: Stillmans Skin Bleach Cream

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Stillmans Skin Bleach Cream

61 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Stillmans Skin Bleach Cream

62 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Stillmans Skin Bleach Cream

63 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Stillmans Skin Bleach Cream

64 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Stillmans Skin Bleach Cream

65 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Stillmans Skin Bleach Cream

66 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Stillmans Skin Bleach Cream

Stiefel, a GSK company
Date Published : 04/01/2019
Unk , Brentford, UNITED KINGDOM
62 W - - 17 Aluminum Chloride Astringent/Anti-Perspirant)
Date Published: 04/01/2019

Desc: Drichlor Antiperspirant

62 W - - 99 Astringent/Anti-Perspirant N.E.C.
Date Published: 04/01/2019

Desc: Drichlor Antiperspirant

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/01/2019

Desc: Drichlor Antiperspirant

Teleport Logistics Ltd
Date Published : 04/23/2020
Unit 4 Devonshire Court , 22 Victoria Road; 0 , Feltham, Middlesex UNITED KINGDOM
65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 04/24/2020

Desc: Botulinum Toxin Type A

The Green People Company Limited
Date Published : 10/04/2012
Pondtail Farm Coolham Road , West Grinstead, West Sussex UNITED KINGDOM
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 10/04/2012

Desc: 7 Active Fix Repair Serum

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 10/04/2012

Desc: 7 Active Fix Repair Serum

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 10/04/2012

Desc: 7 Active Fix Repair Serum

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 10/04/2012

Desc: 7 Active Fix Repair Serum

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/04/2012

Desc: 7 Active Fix Repair Serum

The Oxford Health Company
Date Published : 09/05/2018
Rowood House , B1 Rowood Estate; Murdock Road , Bicester, Oxfordshire UNITED KINGDOM
54 A - - 99 Vitamin, N.E.C.
Date Published: 09/05/2018

Desc: Magnesium Ease

54 A - - 99 Vitamin, N.E.C.
Date Published: 09/05/2018

Desc: Prebiotic Probiotic

54 A - - 99 Vitamin, N.E.C.
Date Published: 09/05/2018

Desc: Sleep Drops

54 A - - 99 Vitamin, N.E.C.
Date Published: 09/05/2018

Desc: Defence Drops

54 B - - 08 Magnesium (Mineral)
Date Published: 09/05/2018

Desc: Magnesium Ease

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/05/2018

Desc: Sleep Drops

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/05/2018

Desc: Magnesium Ease

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/05/2018

Desc: Prebiotic Probiotic

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/05/2018

Desc: Defence Drops

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/05/2018

Desc: Sleep Drops

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/05/2018

Desc: Magnesium Ease

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/05/2018

Desc: Defence Drops

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/05/2018

Desc: Prebiotic Probiotic

The Sun Studio
Date Published : 09/30/2009
113 Newland Street , Withamwitham, UNITED KINGDOM
66 V D K 99 Miscellaneous Patent Medicines, Etc., Human - Rx/Combination Ingredient, Sterile Liquid
Date Published: 09/30/2009

Desc: Detox Food Patches (Bodytox)
Notes: CDER has determined that this product is an unapproved new drug based on labeling which suggests that the patch be placed on parts of the body to positively affect bodily structures and functions. CDER is not aware of any scientific evidence that this product is safe and effective for the uses suggested in its labeling. CDER has also determined that this product lacks adequate directions for use. 8/10/09

Unilever Dept ER
Date Published : 12/15/2021
Unknown , Wirral, UNITED KINGDOM
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 12/15/2021

Desc: Dove Antiperspirant/Deodorant
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…ANTI-PERSPIRANT … 48h POWERFUL PROTECTION…’.

53 J - - 02 Deodorants (underarm)(Not Antiperspirant) (Personal Cleanliness)
Date Published: 12/15/2021

Desc: Dove Antiperspirant/Deodorant
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…ANTI-PERSPIRANT … 48h POWERFUL PROTECTION…’.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/15/2021

Desc: Dove Antiperspirant/Deodorant
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…ANTI-PERSPIRANT … 48h POWERFUL PROTECTION…’.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/15/2021

Desc: Dove Antiperspirant/Deodorant
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…ANTI-PERSPIRANT … 48h POWERFUL PROTECTION…’.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 12/15/2021

Desc: Dove Antiperspirant/Deodorant
Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…ANTI-PERSPIRANT … 48h POWERFUL PROTECTION…’.

WELLINGTON PHARMACY
Date Published : 04/23/2020
39 KNIGHTSBRIDGE , London, UNITED KINGDOM
53 - - - -- Cosmetics
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 07 Myobloc
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

WHITMAN LABORATORIES LTD.
Date Published : 06/08/2012
Bedford Road , Petersfield, Hampshire UNITED KINGDOM
53 L D - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations), Liquid, Lotion
Date Published: 06/08/2012

Desc: Advanced Night Repair Whitening Cream
Notes: Great Britain

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2012

Desc: Advanced Night Repair Whitening Cream
Notes: Great Britain

Welbeck Pharmacy
Date Published : 04/23/2020
39 Marylebone High St , London, UNITED KINGDOM
53 - - - -- Cosmetics
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 02 Botox
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

65 Q - - 07 Myobloc
Date Published: 04/23/2020

Desc: Botulinum Toxin Type A & B

Zetra B.V.
Date Published : 01/14/2010
Amserdam Holland , London, UNITED KINGDOM
53 E - - -- Hair Preps(Non-Coloring)
Date Published: 01/14/2010

Desc: New Green Formula; Brylcream; Anti-Dandruff
Notes: Notes; Labeling claims the product is ?Clinically proven to clear dandruff.? Remaining labeling not in English. Country: Holland

66 V - - -- Patent Medicines, Etc
Date Published: 01/14/2010

Desc: New Green Formula; Brylcream; Anti-Dandruff
Notes: Notes; Labeling claims the product is ?Clinically proven to clear dandruff.? Remaining labeling not in English. Country: Holland


UNITED STATES


Aplicare Products, LLC
Date Published : 11/03/2014
550 Research Pkwy , Meriden, CT 06450-7172 UNITED STATES
66 C - - 99 Stool Softener N.E.C.
Date Published: 11/03/2014

Desc: Aplicare Nine ML Liquid Castile Soap
Notes: The referenced product appears to be an unapproved new drug as the product label includes the following claim; '[U]ses for ... enema'.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/03/2014

Desc: Aplicare Nine ML Liquid Castile Soap
Notes: The referenced product appears to be an unapproved new drug as the product label includes the following claim; '[U]ses for ... enema'.

78 F - - CE Kit, Enema, (For Cleaning Purpose)
Date Published: 11/03/2014

Desc: Aplicare Nine ML Liquid Castile Soap
Notes: The referenced product appears to be an unapproved new drug as the product label includes the following claim; '[U]ses for ... enema'.

Basic Reset Inc.
Date Published : 09/20/2012
1212 Riverchase Blvd , Madison, TN 37115-2042 UNITED STATES
50 M - - 07 Calcium Carbonate
Date Published: 09/20/2012

Desc: Aqualyte Water Enhancer (Calcium Carbonate)
Notes: Note; Various disease claims made by the importer identified above caused Aqualyte Water Enhancer (Calcium Carbonate Water) to be a new drug within the meaning of Section 201(p) without an effective new drug application per section 505(a) of the FD&C Act. Therefore; District may detain shipments of Aqualyte (Calcium Carbonate Water) shipped by Aqua Global Inc.; and imported by Biogenyx Resource Co.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/20/2012

Desc: Aqualyte Water Enhancer (Calcium Carbonate)
Notes: Note; Various disease claims made by the importer identified above caused Aqualyte Water Enhancer (Calcium Carbonate Water) to be a new drug within the meaning of Section 201(p) without an effective new drug application per section 505(a) of the FD&C Act. Therefore; District may detain shipments of Aqualyte (Calcium Carbonate Water) shipped by Aqua Global Inc.; and imported by Biogenyx Resource Co.

Basic Reset Inc.
Date Published : 09/19/2012
1212 Riverchase Blvd , Madison, TN 37115-2042 UNITED STATES
50 M - - 07 Calcium Carbonate
Date Published: 09/19/2012

Desc: Aqualyte Water Enhancer Calcium Carbonate
Notes: Note; Various disease claims made by the importer identified above caused Aqualyte Water Enhancer (Calcium Carbonate Water) to be a new drug within the meaning of Section 201(p) without an effective new drug application per section 505(a) of the FD&C Act. Therefore; District may detain shipments of Aqualyte (Calcium Carbonate Water) shipped by Aqua Global Inc.; and imported by Biogenyx Resource Co.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/19/2012

Desc: Aqualyte Water Enhancer Calcium Carbonate
Notes: Note; Various disease claims made by the importer identified above caused Aqualyte Water Enhancer (Calcium Carbonate Water) to be a new drug within the meaning of Section 201(p) without an effective new drug application per section 505(a) of the FD&C Act. Therefore; District may detain shipments of Aqualyte (Calcium Carbonate Water) shipped by Aqua Global Inc.; and imported by Biogenyx Resource Co.

Church & Dwight Co., Inc.
Date Published : 11/26/2019
500 Charles Ewing Blvd , Ewing, NJ 08628-3448 UNITED STATES
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/26/2019

Desc: Simply Saline Nasal Mist nasal spray

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 11/26/2019

Desc: Simply Saline Nasal Mist nasal spray

Clayton Tannery
Date Published : 12/16/2015
1902 Gentilly Cir , Austin, TX 78727-4420 UNITED STATES
53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 12/16/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Disease/Drug claims associated with importer/consignee websites

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 12/16/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Disease/Drug claims associated with importer/consignee websites

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/16/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Disease/Drug claims associated with importer/consignee websites

54 J - - 12 Kratom (Herbal and Botanical Teas II, continued)
Date Published: 01/25/2016

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with importer/consignee in the entry.

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 01/25/2016

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with importer/consignee in the entry.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/16/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Disease/Drug claims associated with importer/consignee websites

Dong-A America Corp.
Date Published : 10/07/2010
12631 Imperial Hwy , Santa Fe Springs, CA 90670-4710 UNITED STATES
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 10/07/2010

Notes: All Drug Products; United States

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 10/07/2010

Notes: All Drug Products; United States

61 - - - -- Human and Animal Drugs
Date Published: 10/07/2010

Notes: All Drug Products; United States

62 - - - -- Human and Animal Drugs
Date Published: 10/07/2010

Notes: All Drug Products; United States

63 - - - -- Human and Animal Drugs
Date Published: 10/07/2010

Notes: All Drug Products; United States

64 - - - -- Human and Animal Drugs
Date Published: 10/07/2010

Notes: All Drug Products; United States

65 - - - -- Human and Animal Drugs
Date Published: 10/07/2010

Notes: All Drug Products; United States

66 - - - -- Human and Animal Drugs
Date Published: 10/07/2010

Notes: All Drug Products; United States

Freedom Vapor
Date Published : 04/18/2022
4000 Emerson Ave Ste C , Parkersburg, WV 26104-1161 UNITED STATES
53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 04/18/2022

Desc: Leaf Powder for face mask (Kratom)
Notes: Drug/disease claims associated with importer/consignee website(s).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/18/2022

Desc: Leaf Powder for face mask (Kratom)
Notes: Drug/disease claims associated with importer/consignee website(s).

54 J - - 12 Kratom (Herbal and Botanical Teas II, continued)
Date Published: 04/18/2022

Desc: Leaf Powder for face mask (Kratom)
Notes: Drug/disease claims associated with importer/consignee website(s).

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 04/18/2022

Desc: Leaf Powder for face mask (Kratom)
Notes: Drug/disease claims associated with importer/consignee website(s).

Gunilla Of Sweden
Date Published : 06/22/2011
6520 W 110th St , Leawood, KS 66211-1898 UNITED STATES
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 06/22/2011

Desc: Lerosett 100% Organic Clay Treatment
Notes: United States

H&R Global Incorporated Indianapolis USA
Date Published : 08/02/2017
Unknown , Tampa, FL 33617 UNITED STATES
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/02/2017

Desc: Natural Max Slimming Extra Capsules
Notes: Product was found to contain undeclared Phenolphthalein. Information found on the internet at                                                           indicates the product manufacturer is; Green Herb Bio-Technology Ltd. 2# Channgjiang Rd.; Baiyun Strict; Guangzhou; Chaozhou; Guangdong; China 341562 FEI; none

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/02/2017

Desc: Natural Max Slimming Extra Capsules
Notes: Product was found to contain undeclared Phenolphthalein. Information found on the internet at                                                           indicates the product manufacturer is; Green Herb Bio-Technology Ltd. 2# Channgjiang Rd.; Baiyun Strict; Guangzhou; Chaozhou; Guangdong; China 341562 FEI; none

Holly Chavez
Date Published : 10/16/2015
39 Sixth St , Gainesville, GA 30504-7131 UNITED STATES
31 K - - 02 Tea, Green
Date Published: 10/16/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Product declared as raw soap material however, there are drug claims on importer associated website..

53 D - - 99 Other Fragrance Preparations, N.E.C.
Date Published: 10/16/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Product declared as raw soap material however, there are drug claims on importer associated website.

53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 10/16/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Product declared as raw soap material however, there are drug claims on importer associated website.

53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 10/16/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Product declared as raw soap material however, there are drug claims on importer associated website.

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 10/16/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Product declared as raw soap material however, there are drug claims on importer associated website..

54 J - - 12 Kratom (Herbal and Botanical Teas II, continued)
Date Published: 01/25/2016

Desc: Mitragyna Speciosa (Kratom)
Notes: Product declared as raw soap material however; there are drug claims on importer associated website.

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 01/25/2016

Desc: Mitragyna Speciosa (Kratom)
Notes: Product declared as raw soap material however; there are drug claims on importer associated website.

66 B - - 99 Stimulant N.E.C.
Date Published: 10/16/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Product declared as raw soap material however, there are drug claims on importer associated website.

JS4 SOURCING INC
Date Published : 10/03/2019
16641 W Hardy Rd , Houston, TX 77060-6230 UNITED STATES
54 J - - 12 Kratom (Herbal and Botanical Teas II, continued)
Date Published: 10/03/2019

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with importer/consignee in the entry.

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 10/03/2019

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with importer/consignee in the entry.

Keith Poulos
Date Published : 10/09/2015
6954 George Washington Hwy , Keysville, VA 23947-3837 UNITED STATES
53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 10/09/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with importer/consignee in the entry.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/09/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with importer/consignee in the entry.

54 J - - 12 Kratom (Herbal and Botanical Teas II, continued)
Date Published: 01/25/2016

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with importer/consignee in the entry.

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 01/25/2016

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with importer/consignee in the entry.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/09/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with importer/consignee in the entry.

Lunar Botanicles
Date Published : 06/01/2016
5224 Tower Trl , Austin, TX 78723-6039 UNITED STATES
53 H - - 03 Nail Creams and Lotions (Manicuring Preparations)
Date Published: 06/08/2016

Desc: Kratom (declared as Patchouli Powder)
Notes: Disease/Drug claims associated with importer/consignee websites.

54 J - - 12 Kratom (Herbal and Botanical Teas II, continued)
Date Published: 06/08/2016

Desc: Kratom (declared as Patchouli Powder)
Notes: Disease/Drug claims associated with importer/consignee websites.

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 06/08/2016

Desc: Kratom (declared as Patchouli Powder)
Notes: Disease/Drug claims associated with importer/consignee websites.

Mood & Mind LLC
Date Published : 05/05/2015
56 Mcguire Cir , Pisgah Forest, NC 28768-9746 UNITED STATES
54 J - - 12 Kratom (Herbal and Botanical Teas II, continued)
Date Published: 01/25/2016

Desc: Kratom Leaf Powder (Mitragyna Speciosa Powder Leaf)
Notes: Drug/disease claims associated with importer/consignee in the entry.

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 01/25/2016

Desc: Kratom Leaf Powder (Mitragyna Speciosa Powder Leaf)
Notes: Drug/disease claims associated with importer/consignee in the entry.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/05/2015

Desc: Kratom Leaf Powder (Mitragna Speciosa Powder Leaf)

Moon Botanicals LLC
Date Published : 12/16/2015
1902 Gentilly Cir , Austin, TX 78727-4420 UNITED STATES
53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 12/16/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Disease/Drug claims associated with importer/consignee websites

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 12/16/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Disease/Drug claims associated with importer/consignee websites.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/16/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Disease/Drug claims associated with importer/consignee websites.

54 J - - 12 Kratom (Herbal and Botanical Teas II, continued)
Date Published: 01/25/2016

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with importer/consignee in the entry

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 01/25/2016

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with importer/consignee in the entry

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/16/2015

Desc: Mitragyna Speciosa (Kratom)
Notes: Disease/Drug claims associated with importer/consignee websites.

Nathan John Watters
Date Published : 06/09/2015
5308 28th Ave S , Gulfport, FL 33707-5428 UNITED STATES
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 06/09/2015

Desc: Mitragyna Speciosa (Kratom)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/09/2015

Desc: Mitragyna Speciosa (Kratom)

54 J - - 12 Kratom (Herbal and Botanical Teas II, continued)
Date Published: 01/25/2016

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with importer/consignee in the entry.

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 01/25/2016

Desc: Mitragyna Speciosa (Kratom)
Notes: Drug/disease claims associated with importer/consignee in the entry

PACKAGE SOLUTIONS LLC
Date Published : 04/26/2018
2131 Blount Rd , Pompano Beach, FL 33069-5112 UNITED STATES
54 A - - 99 Vitamin, N.E.C.
Date Published: 04/26/2018

Desc: MaxSize Male Enhancement Formula

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/26/2018

Desc: MaxSize Male Enhancement Formula

65 P - - 99 Regulator N.E.C.
Date Published: 04/26/2018

Desc: MaxSize Male Enhancement Formula

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/26/2018

Desc: MaxSize Male Enhancement Formula

Pharmaceutical Buyers, Inc.
Date Published : 11/28/2014
123 Maple Ave Ste 204 , Cedarhurst, NY 11516-2240 UNITED STATES
61 H - - 24 Isoniazid (Anti-Bacterial)
Date Published: 11/28/2014

Desc: Isozid
Notes:                                                                                                                                                                                

61 P - - 17 Insulin (Inj) (Anti-Diabetic)
Date Published: 11/28/2014

Desc: Lantus Solostar
Notes:                                                                                                                                                                                

62 I - - 99 Anti-Neoplastic N.E.C.
Date Published: 11/28/2014

Desc: Mabthera
Notes:                                                                                                                                                                                    

62 T - - 04 Octreotide Acetate (Anti-Secretory)
Date Published: 11/28/2014

Desc: Sandostatin
Notes:                                                                                                                                                                                

62 Z - - 07 Filgrastim
Date Published: 11/28/2014

Desc: Neulasta
Notes:                                                                                                                                                                                

Raining Rose Inc
Date Published : 10/08/2014
100 30th Street Dr Se , Cedar Rapids, IA 52403-1403 UNITED STATES
53 U - - 12 Skin Care Preparations, Cosmetic products containing animal by-products (other animal by-products)
Date Published: 10/08/2014

Desc: Caprina Goat's Milk Lip Balm
Notes: The aforementioned product appears to be an unapproved new drug as the product label indicates that the Rosemary Extract ingredient is a "[A]ntibacterial?said to improve circulation".

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/08/2014

Desc: Caprina Goat's Milk Lip Balm
Notes: The aforementioned product appears to be an unapproved new drug as the product label indicates that the Rosemary Extract ingredient is a "[A]ntibacterial?said to improve circulation".

SK Pharmaceuticals, Inc.
Date Published : 03/27/2013
500 Industrial Dr Ste 100 , Richardson, TX 75081-6644 UNITED STATES
31 K - - 01 Tea, Black
Date Published: 03/27/2013

Desc: Thien Long Tea (Thien Long Tra)

31 K - - 04 Tea, Mixed (Green and Black, Etc.)
Date Published: 03/27/2013

Desc: Thien Long Tea (Thien Long Tra)

31 K - - 99 Tea, N.E.C.
Date Published: 03/27/2013

Desc: Thien Long Tea (Thien Long Tra)

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 03/27/2013

Desc: Thien Long Tea (Thien Long Tra)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/27/2013

Desc: Thien Long Tea (Thien Long Tra)

Stillman Co., Inc.
Date Published : 01/19/2012
323 E Galena Blvd , Aurora, IL 60505-3417 UNITED STATES
53 - - - -- Cosmetics
Date Published: 01/19/2012

Notes: Stillman¿s Skin Bleach Cream

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/19/2012

Notes: Stillman¿s Skin Bleach Cream

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Stillman¿s Skin Bleach Cream

61 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Stillmans Skin Bleach Cream

62 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Stillmans Skin Bleach Cream

63 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Stillmans Skin Bleach Cream

64 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Stillmans Skin Bleach Cream

65 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Stillmans Skin Bleach Cream

66 - - - -- Human and Animal Drugs
Date Published: 01/19/2012

Notes: Stillmans Skin Bleach Cream

Timpo Bioengineering Co Ltd
Date Published : 12/10/2009
798 Feukuoydyn Avenue , Smyrna, GA 30080 UNITED STATES
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/10/2009

Notes: Black Ant Capsules Note: Analysis by the FCC lab found the product to contain undeclared Sildenafil, the active ingredient in Viagra. The product is being marketed at a number of websites including:

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/27/2022

60 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

Notes: Black Ant Capsules Note: Analysis by the FCC lab found the product to contain undeclared Sildenafil, the active ingredient in Viagra. The product is being marketed at a number of websites including:

61 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

Notes: Black Ant Capsules Note: Analysis by the FCC lab found the product to contain undeclared Sildenafil, the active ingredient in Viagra. The product is being marketed at a number of websites including:

62 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

Notes: Black Ant Capsules Note: Analysis by the FCC lab found the product to contain undeclared Sildenafil, the active ingredient in Viagra. The product is being marketed at a number of websites including:

63 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

Notes: Black Ant Capsules Note: Analysis by the FCC lab found the product to contain undeclared Sildenafil, the active ingredient in Viagra. The product is being marketed at a number of websites including:

64 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

Notes: Black Ant Capsules Note: Analysis by the FCC lab found the product to contain undeclared Sildenafil, the active ingredient in Viagra. The product is being marketed at a number of websites including:

65 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

Notes: Black Ant Capsules Note: Analysis by the FCC lab found the product to contain undeclared Sildenafil, the active ingredient in Viagra. The product is being marketed at a number of websites including:

66 - - - -- Human and Animal Drugs
Date Published: 12/10/2009

Notes: Black Ant Capsules Note: Analysis by the FCC lab found the product to contain undeclared Sildenafil, the active ingredient in Viagra. The product is being marketed at a number of websites including:

Twincraft Inc.
Date Published : 10/16/2014
2 Tigan St , Winooski, VT 05404-1326 UNITED STATES
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 10/16/2014

Desc: Canus Goat's Milk Soap With Lavender Oil
Notes: The aforementioned product appears to be an unapproved new drug as the product label indicates that the Lavender Oil ingredient is "[K]nown for its antibacterial and calming properties. Lavender Oil is also helpful in treating acne; psoriasis; eczema and other skin inflammations".

53 U - - 10 Personal Cleanliness, Cosmetic products containing animal by-products (other animal by-products)
Date Published: 10/16/2014

Desc: Canus Goat's Milk Soap With Lavender Oil
Notes: The aforementioned product appears to be an unapproved new drug as the product label indicates that the Lavender Oil ingredient is "[K]nown for its antibacterial and calming properties. Lavender Oil is also helpful in treating acne; psoriasis; eczema and other skin inflammations".

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/16/2014

Desc: Canus Goat's Milk Soap With Lavender Oil
Notes: The aforementioned product appears to be an unapproved new drug as the product label indicates that the Lavender Oil ingredient is "[K]nown for its antibacterial and calming properties. Lavender Oil is also helpful in treating acne; psoriasis; eczema and other skin inflammations".

Us Lab Research
Date Published : 04/09/2010
7409 Kingston Ct , Mentor, OH 44060-5227 UNITED STATES
56 F - - 99 Peptide N.E.C.
Date Published: 04/09/2010

Desc: Melanotan (I and II)
Notes: The product is imported as non-human reseach purposes only and then the unapproved new drug is sold on internet

64 R - - 99 Hormone N.E.C.
Date Published: 04/09/2010

Desc: Melanotan (I and II)
Notes: The product is imported as non-human reseach purposes only and then the unapproved new drug is sold on internet

kdc/one Chatsworth, Inc.
Date Published : 08/11/2010
20320 Prairie St , Chatsworth, CA 91311-6026 UNITED STATES
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 08/11/2010

Desc: Aromatherapy Headache Relief
Notes: Country; United States

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/11/2010

Desc: Aromatherapy Headache Relief
Notes: Country; United States

paul sturgis
Date Published : 05/05/2015
7616 Southland Blvd , #102 , Orlando, FL 32809 UNITED STATES
54 J - - 12 Kratom (Herbal and Botanical Teas II, continued)
Date Published: 01/25/2016

Desc: Kratom Leaf Powder (Mitragyna Speciosa Powder Leaf)
Notes: Drug/disease claims associated with importer/consignee in the entry.

54 K - - 12 Kratom (Herbal and Botanicals, not Teas II)
Date Published: 01/25/2016

Desc: Kratom Leaf Powder (Mitragyna Speciosa Powder Leaf)
Notes: Drug/disease claims associated with importer/consignee in the entry.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/05/2015

Desc: Kratom Leaf Powder (Mitragna Speciosa Powder Leaf)


VANUATU


Curaderm Global Ltd
Date Published : 08/28/2014
Po Box 7031 Port Vila , Vanuatu, VANUATU
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 08/29/2014

Desc: Curaderm Anti-Ageing (AA) Cleansing Gel
Notes: Unapproved New Drug

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 08/29/2014

Desc: Curaderm Global Curasol BEC Sunscreen
Notes: Unapproved New Drug

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 08/29/2014

Desc: Curaderm Anti-Ageing (AA) Cleansing Gel
Notes: Unapproved New Drug

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 08/29/2014

Desc: Curaderm Global Curasol BEC Sunscreen
Notes: Unapproved New Drug

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 08/29/2014

Desc: Curaderm Anti-Ageing (AA) Cleansing Gel
Notes: Unapproved New Drug

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/29/2014

Desc: Curaderm Anti-Ageing (AA) Cleansing Gel
Notes: Unapproved New Drug

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/29/2014

Desc: Curaderm Global Curasol BEC Sunscreen
Notes: Unapproved New Drug

62 I - - 99 Anti-Neoplastic N.E.C.
Date Published: 08/28/2014

Desc: Cauraderm BEC 5 Cream
Notes: New Zealand; 5/20/2011

65 L - - 99 Protectant N.E.C.
Date Published: 08/29/2014

Desc: Curaderm Global Curasol BEC Sunscreen
Notes: Unapproved New Drug

66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C.
Date Published: 08/29/2014

Desc: Curaderm Global Curasol BEC Sunscreen
Notes: Unapproved New Drug

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/29/2014

Desc: Curaderm Anti-Ageing (AA) Cleansing Gel
Notes: Unapproved New Drug

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/29/2014

Desc: Curaderm Global Curasol BEC Sunscreen
Notes: Unapproved New Drug

Dr. Calmez Limited
Date Published : 09/30/2009
P.O. Box 7095 , Port Vila, Efate Island, Shefa Province , Efate Island, Shefa Province, VANUATU
62 I - - -- A-Neoplastic
Date Published: 09/30/2009

Notes: Curaderm-BEC5 Cream 8/30/2007                                             

64 X - - 06 Salicylic Acid (Keratolytic)
Date Published: 09/30/2009

Notes: Curaderm-BEC5 Cream 8/30/2007                                             

64 X - - -- Keratolytic
Date Published: 09/30/2009

Notes: Curaderm-BEC5 Cream 8/30/2007                                             

Dr. Calmez Ltd
Date Published : 09/30/2009
PKF House, Lini Highway , Port Vila , Sheffa, VANUATU
62 I - - -- A-Neoplastic
Date Published: 09/30/2009

Notes: 8/30/2007 Curaderm-BEC5 Cream

64 X - - 06 Salicylic Acid (Keratolytic)
Date Published: 09/30/2009

Notes: 8/30/2007 Curaderm-BEC5 Cream

64 X - - -- Keratolytic
Date Published: 09/30/2009

Notes: 8/30/2007 Curaderm-BEC5 Cream

Healthy Choice Pharmacy.COM INC
Date Published : 09/30/2009
PO Box 457 , Port Vila, VANUATU
65 V - - 13 Clozapine (Sedative)
Date Published: 09/30/2009

Notes: 2/8/2007                                

Nice Price Pharmacy
Date Published : 09/30/2009
2n Flr, Windsor House , Port Vila, VANUATU
65 V - - 13 Clozapine (Sedative)
Date Published: 09/30/2009

Notes:                            

Rx2World &or Night and Day Pharmacy.com &or Freedompharmacy
Date Published : 09/30/2009
Monarch Holdings, 2nd Floor, Windsor Hs. , Lini Highway, P.B. Box 257 , Port Vila, VANUATU
60 V - - 99 Anterior Pituitary Suppressor N.E.C.
Date Published: 06/15/2020

Desc: Abarelix
Notes:                                                                                                                                                         

64 R - - 21 Somatropin (Hormone)
Date Published: 06/15/2020

Notes:                                                                                                                                                         

64 X - - 11 Isotretinoin (Keratolytic)
Date Published: 09/30/2009

Notes:                                                                                                                                                         

Unicorn Pacific Corporation
Date Published : 07/03/2013
Lot 26 Bukura , Devil's Point Road , Port Vila, VU-SEE VANUATU
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/03/2013

Desc: TBL-12 Dietary Supplement
Notes: Vanuatu

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/03/2013

Desc: TBL-12 Dietary Supplement
Notes: Vanuatu

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/03/2013

Desc: TBL-12 Dietary Supplement
Notes: Vanuatu


VENEZUELA


Industrias Coramodio C.A
Date Published : 12/22/2014
Calle 8, Sector Sur , Edificio Rodano, Piso 3, La Urbina , Caracas, Distrito Federal VENEZUELA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 12/22/2014

Desc: LymaCream Hot Body Cream

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 12/22/2014

Desc: LymaGel Premium Slimming Gel with Liposomes

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/22/2014

Desc: LymaCream Hot Body Cream

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 12/22/2014

Desc: LymaGel Premium Slimming Gel with Liposomes

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/22/2014

Desc: LymaGel Premium Slimming Gel with Liposomes

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/22/2014

Desc: LymaCream Hot Body Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/22/2014

Desc: LymaCream Hot Body Cream

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/22/2014

Desc: LymaGel Premium Slimming Gel with Liposomes


VIETNAM


Hung Phat Tea Corporation
Date Published : 11/04/2016
Group 4, Ward 8, Binh My Commune , Cu Chi District , Ho Chi Minh, VIETNAM
29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 11/04/2016

Desc: Pure Noni Juice
Notes: Medical claims on product labels

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/04/2016

Desc: Pure Noni Juice
Notes: Medical claims on product labels

Rita Food And Drink Co., Ltd
Date Published : 04/10/2023
No. 8, Thong Nhat Boulevard , Song Than 2 Industrial Park , Di An Ward, Di An District VIETNAM
14 B - - 01 Imitation Milk, Fluid Milk Type Product
Date Published: 04/10/2023

Desc: OKA Milk Coconut Milk Original

14 B - - 01 Imitation Milk, Fluid Milk Type Product
Date Published: 04/10/2023

Desc: OKA Milk Cashew Milk With Avocado

30 Y - - 02 Coconut Milk Beverage Base
Date Published: 04/10/2023

Desc: OKA Milk Cashew Milk With Avocado

30 Y - - 02 Coconut Milk Beverage Base
Date Published: 04/10/2023

Desc: OKA Milk Coconut Milk Original

41 G - - 99 Medical Foods, N.E.C.
Date Published: 04/10/2023

Desc: OKA Milk Coconut Milk Original

41 G - - 99 Medical Foods, N.E.C.
Date Published: 04/10/2023

Desc: OKA Milk Cashew Milk With Avocado

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/10/2023

Desc: OKA Milk Coconut Milk Original

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/10/2023

Desc: OKA Milk Cashew Milk With Avocado

Royalty Vn Co Ltd
Date Published : 03/27/2013
194, Cong Hoa St , Ho Chi Minh, VIETNAM
31 K - - 01 Tea, Black
Date Published: 03/27/2013

Desc: Thien Long Tea (Thien Long Tra)

31 K - - 04 Tea, Mixed (Green and Black, Etc.)
Date Published: 03/27/2013

Desc: Thien Long Tea (Thien Long Tra)

31 K - - 99 Tea, N.E.C.
Date Published: 03/27/2013

Desc: Thien Long Tea (Thien Long Tra)

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 03/27/2013

Desc: Thien Long Tea (Thien Long Tra)

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/27/2013

Desc: Thien Long Tea (Thien Long Tra)

T&A VN IMPORT EXPORT COMPANY LIMITED
Date Published : 02/12/2020
No. 299 Lot G14 Song Giong Residential , 2, A2 Street, An Phu Ward, District , Hochiminh, VIETNAM
21 S - - 38 Dragon Fruit, Subtropical and Tropical Fruit
Date Published: 02/12/2020

Desc: Lucky Taro Dragon Fruit (White & Red Flesh Varieties)
Notes: The product appears to be an unapproved new drug as the label of the product includes claims such as (not an all-inclusive list): '10 HEALTH BENEFITS OF DRAGON DRUIT ... ANTI-INFLAMMATORY ... CANCER PREVENTION ...'.

Thein Duoc Co Ltd
Date Published : 01/15/2016
Section F3 N5 St , Tan Uyen, VIETNAM
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/15/2016

Desc: Crila for Prostate
Notes: Country; Vietnam; 12/5/2013

Vinh Tien Co., Ltd.
Date Published : 05/10/2012
39-41 Pham Ngoc Thach, Dalat City , Lamdong Province , Dalat, VN-35 VIETNAM
24 U - - 01 Artichoke, Dried or Paste
Date Published: 05/10/2012

Desc: Artichoke Flower
Notes: Vietnam

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 05/10/2012

Desc: Artichoke Flower
Notes: Vietnam

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 05/10/2012

Desc: Artichoke Flower
Notes: vietnam


ZIMBABWE


Aloch Agro
Date Published : 10/14/2022
19 Nuffield Road , Workington, Harare ZIMBABWE
31 - - - -- Coffee/Tea
Date Published: 10/14/2022

Desc: NDORANI Intolwane

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 10/14/2022

Notes: NDORANI Intolwane

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 10/14/2022

Notes: NDORANI Intolwane

60 - - - -- Human and Animal Drugs
Date Published: 10/14/2022

Notes: NDORANI Intolwane

61 - - - -- Human and Animal Drugs
Date Published: 10/14/2022

Notes: NDORANI Intolwane

62 - - - -- Human and Animal Drugs
Date Published: 10/14/2022

Notes: NDORANI Intolwane

63 - - - -- Human and Animal Drugs
Date Published: 10/14/2022

Notes: NDORANI Intolwane

64 - - - -- Human and Animal Drugs
Date Published: 10/14/2022

Notes: NDORANI Intolwane

65 - - - -- Human and Animal Drugs
Date Published: 10/14/2022

Notes: NDORANI Intolwane

66 - - - -- Human and Animal Drugs
Date Published: 10/14/2022

Notes: NDORANI Intolwane

ZIM TUCKSHOP
Date Published : 10/14/2022
3495 Tynwald North , Harare, ZIMBABWE
31 - - - -- Coffee/Tea
Date Published: 10/14/2022

Desc: NDORANI Intolwane

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 10/14/2022

Notes: NDORANI Intolwane

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 10/14/2022

Notes: NDORANI Intolwane

60 - - - -- Human and Animal Drugs
Date Published: 10/14/2022

Notes: NDORANI Intolwane

61 - - - -- Human and Animal Drugs
Date Published: 10/14/2022

Notes: NDORANI Intolwane

62 - - - -- Human and Animal Drugs
Date Published: 10/14/2022

Notes: NDORANI Intolwane

63 - - - -- Human and Animal Drugs
Date Published: 10/14/2022

Notes: NDORANI Intolwane

64 - - - -- Human and Animal Drugs
Date Published: 10/14/2022

Notes: NDORANI Intolwane

65 - - - -- Human and Animal Drugs
Date Published: 10/14/2022

Notes: NDORANI Intolwane

66 - - - -- Human and Animal Drugs
Date Published: 10/14/2022

Notes: NDORANI Intolwane