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: 12/05/2024
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.
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.
***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
[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
Calle Chivilcoy 4820
, Ciudad Autonoma Buenos Aires,
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 Rd
, Mulgrave,
Victoria 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 St
, Leichhardt,
New South Wales 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:
Homart Pharmaceuticals Pty. Ltd.
Date Published : 07/26/2024
59 Kirby St
, Rydalmere,
New South Wales AUSTRALIA
54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 07/26/2024
Desc: SpringLeaf Propolis Liquid Alcohol Free 40%
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/26/2024
Desc: SpringLeaf Propolis Liquid Alcohol Free 40%
Liberty Lifestyle Pty LTd.
Date Published : 09/30/2009
Gpo Box 103 Concord West
, Sydney,
New South Wales 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
Building D , L 4 12-24 Talavera Rd
, Macquarie Park,
New South Wales 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 Hipwood St
, Norman Park,
Queensland 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 Pde
, Seacliff,
South Australia 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 Pde
, Seacliff,
South Australia 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
PO Box W66 , 14-16 Military Rd.
, Watsons Bay,
New South Wales 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
Margaretenstrase 7/A-1040
, Vienna,
Wien 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
Unit 9a , Leuvensesteenweg 573
, Zaventem,
Vlaams-Brabant 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 , C.A.
, Belmopan,
Belize 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, Farmacias e Drogarias S/A
Date Published : 10/04/2013
Avenida Presidente Tancredo Neves, N 30 , Jardim Marajoara, Japeri
, 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
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
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
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 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
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
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 , PO Box 136MB ROC OMO
, Camp Morton,
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:
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: 09/20/2024
Desc: Bird & Be PCOS Support Myo-Inositol D-Chiro-Inositol
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)].
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
, Arborg,
Manitoba 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
PO Box 88614 Rpo Newton
, Surrey,
British Columbia 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
Cosmaceutical Research Lab Inc.
Date Published : 07/12/2024
12920 84 Ave
, Surrey,
British Columbia CANADA
60 Q - - 67 Lidocaine (Anesthetic)
Date Published: 07/12/2024
Desc: 5% Lidocaine Cream
60 Q - - 67 Lidocaine (Anesthetic)
Date Published: 11/27/2024
Desc: Dr. Numb Topical Anesthetic Cream (Lidocaine 5%) 10g
Notes: Product appears to be unapproved new drug in violation of section 505(a) of the FD&C Act. 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)].
60 Q - - 67 Lidocaine (Anesthetic)
Date Published: 11/27/2024
Desc: Dr. Numb Lidocaine Cream (Lidocaine 5%) 30g
Notes: Product appears to be unapproved new drug in violation of section 505(a) of the FD&C Act. 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)].
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
1250 University Street , Cp 370 Succ B
, 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
PO Box 278 Stn Main
, Yarmouth,
Nova Scotia 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 120a St Suite 2
, Surrey,
British Columbia 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
Medicap Laboratories
Date Published : 07/03/2024
3190 Devon Dr
, Windsor,
Ontario CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/03/2024
Desc: EZestro Capsules
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/03/2024
Desc: EZestro Capsules
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
7-13680 Bridgeport Rd
, 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 , 1250 University St.; PO Box 370
, Montreal River Harbour,
Ontario 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 Rd
, Victoria,
British Columbia 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.
Nutralab Canada Corp.
Date Published : 09/26/2024
980 Tapscott Rd
, Scarborough,
Ontario CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/26/2024
Desc: Active Green Pro Plant-Based Formula Immune & Antioxidants Dietary Supplement Powder (Natural French Vanilla Flavor)
Notes: The product appears to be a new drug within the meaning of Section 201(p) of the Act, without an NDA [Unapproved New Drug, Section 505(a)], as its LBL and manufacturer’ website include claims such as: “…For strengthening the immune system against infective agents and microorganisms.”, “…This is powerful in strengthening the immune function against vectors and microorganisms.”, “…Frequent colds and flu…” “Especially when there is a flu season around the corner…”, “Ensure that your body has the resources it needs to maintain optimal health, even during challenging times like flu season.”, “…I have been able to ward off seasonal illnesses more effectively.”, “Do you have frequent colds and flus, …slow wound healing, frequent infections, persistent fatigue…” and “Powerful in strengthening the immune function against infective agents and microorganisms.”
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/26/2024
Desc: Active Green Pro Plant-Based Formula Immune & Antioxidants Dietary Supplement Powder (Natural French Vanilla Flavor)
Notes: The product appears to be a new drug within the meaning of Section 201(p) of the Act, without an NDA [Unapproved New Drug, Section 505(a)], as its LBL and manufacturer’ website include claims such as: “…For strengthening the immune system against infective agents and microorganisms.”, “…This is powerful in strengthening the immune function against vectors and microorganisms.”, “…Frequent colds and flu…” “Especially when there is a flu season around the corner…”, “Ensure that your body has the resources it needs to maintain optimal health, even during challenging times like flu season.”, “…I have been able to ward off seasonal illnesses more effectively.”, “Do you have frequent colds and flus, …slow wound healing, frequent infections, persistent fatigue…” and “Powerful in strengthening the immune function against infective agents and microorganisms.”
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 , PO Box 89
, Pilot Mound,
Manitoba 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
RDFN FUM NATURAL PRODUCTS LTD
Date Published : 06/26/2024
11126 Hidden Valley Dr Nw
, Calgary,
Alberta CANADA
28 O - - 99 Essential Oils for Flavoring, n.e.c.
Date Published: 06/26/2024
Desc: FUM Tangy Citrus Core
28 O - - 99 Essential Oils for Flavoring, n.e.c.
Date Published: 06/26/2024
Desc: FUM Crisp Mint Core
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/26/2024
Desc: FUM Crisp Mint Core
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/26/2024
Desc: FUM Tangy Citrus Core
98 M - - 01 E-Liquid
Date Published: 06/26/2024
Desc: FUM Crisp Mint Core
98 M - - 01 E-Liquid
Date Published: 06/26/2024
Desc: FUM Tangy Citrus Core
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 Group 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
Winnipeg , 404-250 McDermot Ave
, Winnipeg,
Manitoba 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:
THE BIRD AND BE CO INC.
Date Published : 09/20/2024
122 Pinewood Ave
, York,
Ontario CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/20/2024
Desc: Bird & Be PCOS Support Myo-Inositol D-Chiro-Inositol
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)].
TYROS BIOPHARMA
Date Published : 12/05/2024
305-4702 Louis-B.-Mayer St
, Laval,
Quebec CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/05/2024
Desc: Uriexo Capsules
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2024
Desc: Uriexo Capsules
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
Hanwei Plaza Room 1701 , NO. 7 Guanghualu; Chaoyang
, Beijing,
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
Golden Eagle Bldg , 917-919 Rm
, Guangzhou,
Guangdong 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,
Guangdong 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
No. 68, Liangshazhong Road , 23, Liangtian Village, Zhongluotan Town, 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
No.2, Huonanzhuang , South Village, Taihe Town, Baiyun District
, 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
NO.8.Mu Long Tan , Xiushui Village , Renhe Town , Baiyun District
, GuangZhou,
Guagndong 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 - - - -- Drinks, Soft Drinks, and Waters
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 China Resources Laotongjun Pharmaceutical Co., Ltd.
Date Published : 06/04/2024
No. 88 Langyuan Road , Tonglu Economic Development Zone
, Hangzhou,
Cn-Zj CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/04/2024
Desc: Kangbingdu (Antiviral Oral Solution)
Notes: 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)], as its labeling includes claims such as: “Anti-viral oral solution” and “Is used for… cold, and influenza”.
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/04/2024
Desc: Kangbingdu (Antiviral Oral Solution)
Notes: 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)], as its labeling includes claims such as: “Anti-viral oral solution” and “Is used for… cold, and influenza”.
58 E - - 99 Antiviral, NEC
Date Published: 06/04/2024
Desc: Kangbingdu (Antiviral Oral Solution)
Notes: 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)], as its labeling includes claims such as: “Anti-viral oral solution” and “Is used for… cold, and influenza”.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/04/2024
Desc: Kangbingdu (Antiviral Oral Solution)
Notes: 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)], as its labeling includes claims such as: “Anti-viral oral solution” and “Is used for… cold, and influenza”.
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)