• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-
New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2013]
[CITE: 21CFR310.545]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE

PART 310 -- NEW DRUGS

Subpart E--Requirements for Specific New Drugs or Devices

Sec. 310.545 Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.

(a) A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses:

(1)Topical acne drug products.

Alcloxa

Alkyl isoquinolinium bromide

Aluminum chlorohydrex

Aluminum hydroxide

Benzocaine

Benzoic acid

Boric acid

Calcium polysulfide

Calcium thiosulfate

Camphor

Chloroxylenol

Cloxyquin

Coal tar

Dibenzothiophene

Estrone

Magnesium aluminum silicate

Magnesium sulfate

Phenol

Phenolate sodium

Phenyl salicylate

Povidone-iodine

Pyrilamine maleate

Resorcinol (as single ingredient)

Resorcinol monoacetate (as single ingredient)

Salicylic acid (over 2 up to 5 percent)

Sodium borate

Sodium thiosulfate

Tetracaine hydrochloride

Thymol

Vitamin E

Zinc oxide

Zinc stearate

Zinc sulfide

(2)Anticaries drug products --(i)Approved as of May 7, 1991.

Hydrogen fluoride

Sodium carbonate

Sodium monofluorophosphate (6 percent rinse)

Sodium phosphate

(ii)Approved as of October 7, 1996.

Calcium sucrose phosphate

Dicalcium phosphate dihydrate

Disodium hydrogen phosphate1

Phosphoric acid1

Sodium dihydrogen phosphate

Sodium dihydrogen phosphate monohydrate

Sodium phosphate, dibasic anhydrous reagent1

(3)Antidiarrheal drug products --(i)Approved as of May 7, 1991 .

Aluminum hydroxide

Atropine sulfate

Calcium carbonate

Carboxymethylcellulose sodium

Glycine

Homatropine methylbromide

Hyoscyamine sulfate

Lactobacillus acidophilus

Lactobacillus bulgaricus

Opium, powdered

Opium tincture

Paregoric

Phenyl salicylate

Scopolamine hydrobromide

Zinc phenolsulfonate

(ii)Approved as of April 19, 2004; April 18, 2005,for products with annual sales less than $25,000 .

Attapulgite, activated

Bismuth subnitrate

Calcium hydroxide

Calcium polycarbophil

Charcoal (activated)

Pectin

Polycarbophil

Potassium carbonate

Rhubarb fluidextract

(4)Antiperspirant drug products --(i)Ingredients --Approved as of May 7, 1991.

Alum, potassium

Aluminum bromohydrate

Aluminum chloride (alcoholic solutions)

Aluminum chloride (aqueous solution) (aerosol only)

Aluminum sulfate

Aluminum sulfate, buffered (aerosol only)

Sodium aluminum chlorohydroxy lactate

(ii)Approved as of December 9, 2004; June 9, 2005, for products with annual sales less than $25,000 .

Aluminum sulfate buffered with sodium aluminum lactate

(5) [Reserved]

(6)Cold, cough, allergy, bronchodilator, and antiasthmatic drug products --(i)Antihistamine drug products --(A)Ingredients.

Methapyrilene hydrochloride

Methapyrilene fumarate

Thenyldiamine hydrochloride

(B)Ingredients.

Phenyltoloxamine dihydrogen citrate

Methapyrilene hydrochloride

Methapyrilene fumarate

Thenyldiamine hydrochloride

(ii)Nasal decongestant drug products --(A)Approved as of May 7, 1991 .

Allyl isothiocyanate

Camphor (lozenge)

Creosote, beechwood (oral)

Eucalyptol (lozenge)

Eucalyptol (mouthwash)

Eucalyptus oil (lozenge)

Eucalyptus oil (mouthwash)

Menthol (mouthwash)

Peppermint oil (mouthwash)

Thenyldiamine hydrochloride

Thymol

Thymol (lozenge)

Thymol (mouthwash)

Turpentine oil

(B)Approved as of August 23, 1995.

Bornyl acetate (topical)

Cedar leaf oil (topical)

Creosote, beechwood (topical)

Ephedrine (oral)

Ephedrine hydrochloride (oral)

Ephedrine sulfate (oral)

Racephedrine hydrochloride (oral/topical)

(C) Approved as of April 11, 2007; October 11, 2007, for products with annual sales less than $25,000. Any ingredient(s) labeled with claims or directions for use for sinusitis or for relief of nasal congestion associated with sinusitis.

(iii)Expectorant drug products.

Ammonium chloride

Antimony potassium tartrate

Beechwood creosote

Benzoin preparations (compound tincture of benzoin, tincture of benzoin)

Camphor

Chloroform

Eucalyptol/eucalyptus oil

Horehound

Iodides (calcium iodide anyhydrous, hydroidic acid syrup, iodized lime, potassium iodide)

Ipecac

Ipecac fluidextract

Ipecac syrup

Menthol/peppermint oil

Pine tar preparations (extract white pine compound, pine tar, syrup of pine tar, compound white pine syrup, white pine)

Potassium guaiacolsulfonate

Sodium citrate

Squill preparations (squill, squill extract)

Terpin hydrate preparations (terpin hydrate, terpin hydrate elixir)

Tolu preparations (tolu, tolu balsam, tolu balsam tincture)

Turpentine oil (spirits of turpentine)

(iv)Bronchodilator drug products --(A)Approved as of October 2, 1987.

Aminophylline

Belladonna alkaloids

Euphorbia pilulifera

Metaproterenol sulfate

Methoxyphenamine hydrochloride

Pseudoephedrine hydrochloride

Pseudoephedrine sulfate

Theophylline, anhydrous

Theophylline calcium salicylate

Theophylline sodium glycinate

(B) Approved as of January 29, 1996. Any combination drug product containing theophylline (e.g., theophylline and ephedrine, or theophylline and ephedrine and phenobarbital).

(C) Approved as of June 19, 1996. Any ingredient(s) in a pressurized metered-dose inhaler container.

(D) Approved as of October 29, 2001. Any oral bronchodilator active ingredient (e.g., ephedrine, ephedrine hydrochloride, ephedrine sulfate, racephedrine hydrochloride, or any other ephedrine salt) in combination with any analgesic(s) or analgesic-antipyretic(s), anticholinergic, antihistamine, oral antitussive, or stimulant active ingredient.

(7)Dandruff/seborrheic dermatitis/psoriasis drug products.

Alkyl isoquinolinium bromide

Allantoin

Benzalkonium chloride

Benzethonium chloride

Boric acid

Calcium undecylenate

Captan

Chloroxylenol

Colloidal oatmeal

Cresol, saponated

Ethohexadiol

Eucalyptol

Juniper tar

Lauryl isoquinolinium bromide

Menthol

Mercury oleate

Methylbenzethonium chloride

Methyl salicylate

Phenol

Phenolate sodium

Pine tar

Povidone-iodine

Resorcinol

Sodium borate

Sodium salicylate

Thymol

Undecylenic acid

(8)Digestive aid drug products --(i)Approved as of May 7, 1991.

Bismuth sodium tartrate

Calcium carbonate

Cellulase

Dehydrocholic acid

Dihydroxyaluminum sodium carbonate

Duodenal substance

Garlic, dehydrated

Glutamic acid hydrochloride

Hemicellulase

Homatropine methylbromide

Magnesium hydroxide

Magnesium trisilicate

Ox bile extract

Pancreatin

Pancrelipase

Papain

Peppermint oil

Pepsin

Sodium bicarbonate

Sodium citrate

Sorbitol

(ii)Approved as of November 10, 1993.

Alcohol

Aluminum hydroxide

Amylase

Anise seed

Aromatic powder

Asafetida

Aspergillus oryza enzymes (except lactase enzyme derived fromAspergillus oryzae )

Bacillus acidophilus

Bean

Belladonna alkaloids

Belladonna leaves, powdered extract

Betaine hydrochloride

Bismuth subcarbonate

Bismuth subgallate

Black radish powder

Blessed thistle (cnicus benedictus)

Buckthorn

Calcium gluconate

Capsicum

Capsicum, fluid extract of

Carbon

Cascara sagrada extract

Catechu, tincture

Catnip

Chamomile flowers

Charcoal, wood

Chloroform

Cinnamon oil

Cinnamon tincture

Citrus pectin

Diastase

Diastase malt

Dog grass

Elecampane

Ether

Fennel acid

Galega

Ginger

Glycine

Hydrastis canadensis (golden seal)

Hectorite

Horsetail

Huckleberry

Hydrastis fluid extract

Hydrochloric acid

Iodine

Iron ox bile

Johnswort

Juniper

Kaolin, colloidal

Knotgrass

Lactic acid

Lactose

Lavender compound, tincture of

Linden

Lipase

Lysine hydrochloride

Mannitol

Mycozyme

Myrrh, fluid extract of

Nettle

Nickel-pectin

Nux vomica extract

Orthophosphoric acid

Papaya, natural

Pectin

Peppermint

Peppermint spirit

Phenacetin

Potassium bicarbonate

Potassium carbonate

Protease

Prolase

Rhubarb fluid extract

Senna

Sodium chloride

Sodium salicylate

Stem bromelain

Strawberry

Strychnine

Tannic acid

Trillium

Woodruff

(iii) Charcoal, activated

(9) [Reserved]

(10)External analgesic drug products --(i)Analgesic and anesthetic drug products.

Aspirin

Chloral hydrate

Chlorobutanol

Cyclomethycaine sulfate

Eugenol

Hexylresorcinol

Methapyrilene hydrochloride

Salicylamide

Thymol

(ii)Counterirritant drug products.

Chloral hydrate

Eucalyptus oil

(iii)Male genital desensitizer drug products.

Benzyl alcohol

Camphorated metacresol

Ephedrine hydrochloride

(iv)Diaper rash drug products. Any ingredient(s) labeled with claims or directions for use in the treatment and/or prevention of diaper rash.

(v)Fever blister and cold sore treatment drug products.

Allyl isothiocyanate

Aspirin

Bismuth sodium tartrate

Camphor (exceeding 3 percent)

Capsaicin

Capsicum

Capsicum oleoresin

Chloral hydrate

Chlorobutanol

Cyclomethycaine sulfate

Eucalyptus oil

Eugenol

Glycol salicylate

Hexylresorcinol

Histamine dihydrochloride

Menthol (exceeding 1 percent)

Methapyrilene hydrochloride

Methyl nicotinate

Methyl salicylate

Pectin

Salicylamide

Strong ammonia solution

Tannic acid

Thymol

Tripelennamine hydrochloride

Trolamine salicylate

Turpentine oil

Zinc sulfate

(vi)Insect bite and sting drug products.

Alcohol

Alcohol, ethoxylated alkyl

Benzalkonium chloride

Calamine

Ergot fluidextract

Ferric chloride

Panthenol

Peppermint oil

Pyrilamine maleate

Sodium borate

Trolamine salicylate

Turpentine oil

Zinc oxide

Zirconium oxide

(vii)Poison ivy, poison oak, and poison sumac drug products.

Alcohol

Aspirin

Benzethonium chloride

Benzocaine (0.5 to 1.25 percent)

Bithionol

Calamine

Cetalkonium chloride

Chloral hydrate

Chlorobutanol

Chlorpheniramine maleate

Creosote, beechwood

Cyclomethycaine sulfate

Dexpanthenol

Diperodon hydrochloride

Eucalyptus oil

Eugenol

Glycerin

Glycol salicylate

Hectorite

Hexylresorcinol

Hydrogen peroxide

Impatiens biflora tincture

Iron oxide

Isopropyl alcohol

Lanolin

Lead acetate

Merbromin

Mercuric chloride

Methapyrilene hydrochloride

Panthenol

Parethoxycaine hydrochloride

Phenyltoloxamine dihydrogen citrate

Povidone-vinylacetate copolymers

Pyrilamine maleate

Salicylamide

Salicylic acid

Simethicone

Sulfur

Tannic acid

Thymol

Trolamine salicylate

Turpentine oil

Zirconium oxide

Zyloxin

(11) [Reserved]

(12)Laxative drug products --(i)(A)Bulk laxatives.

Agar

Carrageenan (degraded)

Carrageenan (native)

Guar gun

(i)(B)Bulk laxatives --Approved as of March 29, 2007.

Granular dosage forms containing psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond), psyllium seed husks, plantago husks, or plantago seed including, but not limited to, any granules that are:

(1 ) Swallowed dry prior to drinking liquid,

(2 ) Dispersed, suspended, or partially dissolved in liquid prior to swallowing,

(3 ) Chewed, partially chewed, or unchewed, and then washed down (or swallowed) with liquid, or

(4 ) Sprinkled over food.

(ii)Saline laxative.

Tartaric acid

(iii)Stool softener.

Poloxamer 188

(iv)(A)Stimulant laxatives--Approved as of May 7, 1991.

Aloin

Bile salts/acids

Calcium pantothenate

Calomel

Colocynth

Elaterin resin

Frangula

Gamboge

Ipomea

Jalap

Ox bile

Podophyllum resin

Prune concentrate dehydrate

Prune powder

Rhubarb, Chinese

Sodium Oleate

(iv)(B)Stimulant laxatives--Approved as of January 29, 1999.

Danthron

Phenolphthalein

(C)Stimulant laxatives --Approved as of November 5, 2002.

Aloe ingredients (aloe, aloe extract, aloe flower extract)

Cascara sagrada ingredients (casanthranol, cascara fluidextract aromatic, cascara sagrada bark, cascara sagrada extract, cascara sagrada fluidextract).

(13) [Reserved]

(14)Oral health care drug products (nonantimicrobial).

Antipyrine

Camphor

Cresol

Dibucaine

Dibucaine hydrochloride

Eucalyptol

Lidocaine

Lidocaine hydrochloride

Methly salicylate

Myrrh tincture

Pyrilamine maleate

Sorbitol

Sugars

Tetracaine

Tetracaine hydrochloride

Thymol

(15)Topical otic drug products --(i)For the prevention of swimmer's ear and for the drying of water-clogged ears, approved as of May 7, 1991 .

Acetic acid

(ii)For the prevention of swimmer's ear, approved as of August 15, 1995.

Glycerin and anhydrous glycerin

Isopropyl alcohol

(16)Poison treatment drug products.

Ipecac fluidextract

Ipecac tincture

Zinc sulfate

(17)Skin bleaching drug products.

Mercury, ammoniated

(18)Skin protectant drug products --(i)(A)Ingredients--Approved as of May 7, 1991 .

Allantoin (wound healing claims only)

Sulfur

Tannic acid

Zinc acetate (wound healing claims only)

(B)Ingredients--Approved as of June 4, 2004; June 6, 2005,for products with annual sales less than $25,000 .

Beeswax

Bismuth subnitrate

Boric acid

Cetyl alcohol

Glyceryl stearate

Isopropyl palmitate

Live yeast cell derivative

Shark liver oil

Stearyl alcohol

(ii)Astringent drug products.

Acetone

Alcohol

Alum, ammonium

Alum, potassium

Aluminum chlorhydroxy complex

Aromatics

Benzalkonium chloride

Benzethonium chloride

Benzocaine

Benzoic acid

Boric acid

Calcium acetate (except calcium acetate monohydrate when combined with aluminum sulfate tetradecahydrate to provide an aluminum acetate solution as described in 347.20(b) of this chapter)

Camphor gum

Clove oil

Colloidal oatmeal

Cresol

Cupric sulfate

Eucalyptus oil

Eugenol

Ferric subsulfate (Monsel's Solution)

Honey

Isopropyl alcohol

Menthol

Methyl salicylate

Oxyquinoline sulfate

P-t-butyl-m-cresol

Peppermint oil

Phenol

Polyoxeythylene laurate

Potassium ferrocyanide

Sage oil

Silver nitrate

Sodium borate

Sodium diacetate

Talc

Tannic acid glycerite

Thymol

Topical starch

Zinc chloride

Zinc oxide

Zinc phenolsulfonate

Zinc stearate

Zinc sulfate

(iii)Diaper rash drug products.

Aluminum hydroxide

Cocoa butter

Cysteine hydrochloride

Glycerin

Protein hydrolysate

Racemethionine

Sulfur

Tannic acid

Zinc acetate

Zinc carbonate

(iv)Fever blister and cold sore treatment drug products.

Bismuth subnitrate

Boric acid

Pyridoxine hydrochloride

Sulfur

Tannic acid

Topical starch

Trolamine

Zinc sulfate

(v)Insect bite and sting drug products --(A)Ingredients--Approved as of November 10, 1993.

Alcohol

Alcohol, ethoxylated alkyl

Ammonia solution, strong

Ammonium hydroxide

Benzalkonium chloride

Camphor

Ergot fluid extract

Ferric chloride

Menthol

Peppermint oil

Phenol

Pyrilamine maleate

Sodium borate

Trolamine

Turpentine oil

Zirconium oxide

(B)Ingredients--Approved as of June 4, 2004; June 6, 2005,for products with annual sales less than $25,000 .

Beeswax

Bismuth subnitrate

Boric acid

Cetyl alcohol

Glyceryl stearate

Isopropyl palmitate

Live yeast cell derivative

Shark liver oil

Stearyl alcohol

(vi)Poison ivy, poison oak, and poison sumac drug products --(A)Ingredients--Approved as of November 10, 1993.

Alcohol

Anion and cation exchange resins buffered

Benzethonium chloride

Benzocaine

Benzyl alcohol

Bismuth subnitrate

Bithionol

Boric acid

Camphor

Cetalkonium chloride

Chloral hydrate

Chlorpheniramine maleate

Creosote

Diperodon hydrochloride

Diphenhydramine hydrochloride

Eucalyptus oil

Ferric chloride

Glycerin

Hectorite

Hydrogen peroxide

Impatiens biflora tincture

Iron oxide

Isopropyl alcohol

Lanolin

Lead acetate

Lidocaine

Menthol

Merbromin

Mercuric chloride

Panthenol

Parethoxycaine hydrochloride

Phenol

Phenyltoloxamine dihydrogen citrate

Povidone-vinylacetate copolymers

Salicylic acid

Simethicone

Tannic acid

Topical starch

Trolamine

Turpentine oil

Zirconium oxide

Zyloxin

(B)Ingredients--Approved as of June 4, 2004; June 6, 2005,for products with annual sales less than $25,000 .

Beeswax

Bismuth subnitrate

Boric acid

Cetyl alcohol

Glyceryl stearate

Isopropyl palmitate

Live yeast cell derivative

Shark liver oil

Stearyl alcohol

(19) [Reserved]

(20)Weight control drug products .

Alcohol

Alfalfa

Alginic acid

Anise oil

Arginine

Ascorbic acid

Bearberry

Biotin

Bone marrow, red

Buchu

Buchu, potassium extract

Caffeine

Caffeine citrate

Calcium

Calcium carbonate

Calcium caseinate

Calcium lactate

Calcium pantothenate

Carboxymethylcellulose sodium

Carrageenan

Cholecalcierol

Choline

Chondrus

Citric acid

Cnicus benedictus

Copper

Copper gluconate

Corn oil

Corn syrup

Corn silk, potassium extract

Cupric sulfate

Cyanocobalamin (vitamin B12)

Cystine

Dextrose

Docusate sodium

Ergocalciferol

Ferric ammonium citrate

Ferric pyrophosphate

Ferrous fumarate

Ferrous gluconate

Ferrous sulfate (iron)

Flax seed

Folic acid

Fructose

Guar gum

Histidine

Hydrastis canadensis

Inositol

Iodine

Isoleucine

Juniper, potassium extract

Karaya gum

Kelp

Lactose

Lecithin

Leucine

Liver concentrate

Lysine

Lysine hydrochloride

Magnesium

Magnesium oxide

Malt

Maltodextrin

Manganese citrate

Mannitol

Methionine

Methylcellulose

Mono- and di-glycerides

Niacinamide

Organic vegetables

Pancreatin

Pantothenic acid

Papain

Papaya enzymes

Pepsin

Phenacetin

Phenylalanine

Phosphorus

Phytolacca

Pineapple enzymes

Plantago seed

Potassium citrate

Pyridoxine hydrochloride (vitamin B6)

Riboflavin

Rice polishings

Saccharin

Sea minerals

Sesame seed

Sodium

Sodium bicarbonate

Sodium caseinate

Sodium chloride (salt)

Soybean protein

Soy meal

Sucrose

Thiamine hydrochloride (vitamin B1)

Thiamine mononitrate (vitamin B1mononitrate)

Threonine

Tricalcium phosphate

Tryptophan

Tyrosine

Uva ursi, potassium extract

Valine

Vegetable

Vitamin A

Vitamin A acetate

Vitamin A palmitate

Vitamin E

Wheat germ

Xanthan gum

Yeast

(21)Ophthalmic drug products. (i)Ophthalmic anesthetic drug products.

Antipyrine

Piperocaine hydrochloride

(ii)Ophthalmic anti-infective drug products.

Boric acid

Mild silver protein

Yellow mercuric oxide

(iii)Ophthalmic astringent drug products.

Infusion of rose petals

(iv)Ophthalmic demulcent drug products.

Polyethylene glycol 6000

(v)Ophthalmic vasoconstrictor drug products.

Phenylephrine hydrochloride (less than 0.08 percent)

(22)Topical antifungal drug products. (i)Diaper rash drug products. Any ingredient(s) labeled with claims or directions for use in the treatment and/or prevention of diaper rash.

(ii)Ingredients.

Alcloxa

Alum, potassium

Aluminum sulfate

Amyltricresols, secondary

Basic fuchsin

Benzethonium chloride

Benzoic acid

Benzoxiquine

Boric acid

Camphor

Candicidin

Chlorothymol

Coal tar

Dichlorophen

Menthol

Methylparaben

Oxyquinoline

Oxyquinoline sulfate

Phenol

Phenolate sodium

Phenyl salicylate

Propionic acid

Propylparaben

Resorcinol

Salicylic acid

Sodium borate

Sodium caprylate

Sodium propionate

Sulfur

Tannic acid

Thymol

Tolindate

Triacetin

Zinc caprylate

Zinc propionate

(iii) Any ingredient(s) labeled with claims or directions for use on the scalp or on the nails.

(iv)Ingredients.

Camphorated metacresol

Chloroxylenol

m -cresol

Nystatin

(23)Internal analgesic drug products --(i)Approved as of November 10, 1993.

Aminobenzoic acid

Antipyrine

Aspirin, aluminum

Calcium salicylate

Codeine

Codeine phosphate

Codeine sulfate

Iodoantipyrine

Lysine aspirin

Methapyrilene fumarate

Phenacetin

Pheniramine maleate

Pyrilamine maleate

Quinine

Salsalate

Sodium aminobenzoate

(ii)Approved as of February 22, 1999.

Any atropine ingredient

Any ephedrine ingredient

(24)Orally administered menstrual drug products --(i)Approved as of November 10, 1993 .

Alcohol

Alfalfa leaves

Aloes

Asclepias tuberosa

Asparagus

Barosma

Bearberry (extract of uva ursi)

Bearberry fluidextract (extract of bearberry)

Blessed thistle (cnicus benedictus)

Buchu powdered extract (extract of buchu)

Calcium lactate

Calcium pantothenate

Capsicum oleoresin

Cascara fluidextract, aromatic (extract of cascara)

Chlorprophenpyridamine maleate

Cimicifuga racemosa

Codeine

Collinsonia (extract stone root)

Corn silk

Couch grass

Dog grass extract

Ethyl nitrite

Ferric chloride

Ferrous sulfate

Gentiana lutea (gentian)

Glycyrrhiza (licorice)

Homatropine methylbromide

Hydrangea, powdered extract (extract of hydrangea)

Hydrastis canadensis (golden seal)

Hyoscyamine sulfate

Juniper oil (oil of juniper)

Magnesium sulfate

Methapyrilene hydrochloride

Methenamine

Methylene blue

Natural estrogenic hormone

Niacinamide

Nutmeg oil (oil of nutmeg)

Oil of erigeron

Parsley

Peppermint spirit

Pepsin, essence

Phenacetin

Phenindamine tartrate

Phenyl salicylate

Piscidia erythrina

Pipsissewa

Potassium acetate

Potassium nitrate

Riboflavin

Saw palmetto

Senecio aureus

Sodium benzoate

Sodium nitrate

Sucrose

Sulferated oils of turpentine

Taraxacum officinale

Theobromine sodium salicylate

Theophylline

Thiamine hydrochloride

Triticum

Turpentine, venice (venice turpertine)

Urea

(ii)Approved as of February 22, 1999.

Any atropine ingredient

Any ephedrine ingredient

(25)Pediculicide drug products --(i)Approved as of November 10, 1993.

Benzocaine

Benzyl alcohol

Benzyl benzoate

Chlorophenothane (dichlorodiphenyl trichloroethane)

Coconut oil soap, aqueous

Copper oleate

Docusate sodium

Formic acid

Isobornyl thiocyanoacetate

Picrotoxin

Propylene glycol

Sabadilla alkaloids

Sulfur, sublimed

Thiocyanoacetate

(ii)Approved as of June 14, 1994. The combination of pyrethrum extract (formerly named pyrethrins) and piperonyl butoxide in an aerosol dosage formulation.

(26)Anorectal drug products --(i)Anticholinergic drug products.

Atropine

Belladonna extract

(ii)Antiseptic drug products.

Boric acid

Boroglycerin

Hydrastis

Phenol

Resorcinol

Sodium salicylic acid phenolate

(iii)Astringent drug products.

Tannic acid

(iv)Counterirritant drug products.

Camphor (greater than 3 to 11 percent)

Hydrastis

Menthol (1.25 to 16 percent)

Turpentine oil (rectified) (6 to 50 percent)

(v)Keratolytic drug products.

Precipitated sulfur

Sublimed sulfur

(vi)Local anesthetic drug products.

Diperodon

Phenacaine hydrochloride

(vii)Other drug products.

Collinsonia extract

Escherichia coli vaccines

Lappa extract

Leptandra extract

Live yeast cell derivative

Mullein

(viii)Protectant drug products.

Bismuth oxide

Bismuth subcarbonate

Bismuth subgallate

Bismuth subnitrate

Lanolin alcohols

(ix)Vasoconstrictor drug products.

Epinephrine undecylenate

(x)Wound healinq drug products.

Cholecalciferol

Cod liver oil

Live yeast cell derivative

Peruvian balsam

Shark liver oil

Vitamin A

(xi)Combination drug products. Any combination drug product containing hydrocortisone and pramoxine hydrochloride.

(27)Topical antimicrobial drug products --(i)First aid antiseptic drug products .

Ammoniated mercury

Calomel (mercurous chloride)

Merbromin (mercurochrome)

Mercufenol chloride (ortho-chloromercuriphenol, ortho-hydroxyphenylmercuric chloride)

Mercuric chloride (bichloride of mercury, mercury chloride)

Mercuric oxide, yellow

Mercuric salicylate

Mercuric sulfide, red

Mercury

Mercury oleate

Mercury sulfide

Nitromersol

Para-chloromercuriphenol

Phenylmercuric nitrate

Thimerosal

Vitromersol

Zyloxin

(ii)Diaper rash drug products .

Para-chloromercuriphenol

Any other ingredient containing mercury

(28)Vaginal contraceptive drug products --(i)Approved as of October 22, 1998.

Dodecaethylene glycol monolaurate (polyethylene glycol 600 monolaurate)

Laureth 10S

Methoxypolyoxyethyleneglycol 550 laurate

Phenylmercuric acetate

Phenylmercuric nitrate

Any other ingredient containing mercury

(ii)Approved as of November 5, 2002.

Octoxynol 9

(29)Sunscreen drug products. --(i)Ingredients.

Diethanolamine methoxycinnamate

Digalloyl trioleate

Ethyl 4-[bis(hydroxypropyl)] aminobenzoate

Glyceryl aminobenzoate

Lawsone with dihydroxyacetone

Red petrolatum

(ii) Any ingredients labeled with any of the following or similar claims. Instant protection or protection immediately upon application.

Claims for "all-day" protection or extended wear claims citing a specific number of hours of protection that is inconsistent with the directions for application in 21 CFR 201.327.

(30) [Reserved]

(b) Any OTC drug product that is labeled, represented, or promoted for the uses specified and containing any active ingredient(s) as specified in paragraph (a) of this section is regarded as a new drug within the meaning of section 210(p) of the Federal Food, Drug, and Cosmetic Act (the Act), for which an approved new drug application under section 505 of the Act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application, such product is also misbranded under section 502 of the Act.

(c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted for the OTC uses and containing any active ingredient(s) as specified in paragraph (a) of this section is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter.

(d) Any OTC drug product that is not in compliance with this section is subject to regulatory action if initially introduced or initially delivered for introduction into interstate commerce after the dates specified in paragraphs (d)(1) through (d)(39) of this section.

(1) May 7, 1991, for products subject to paragraphs (a)(1) through (a)(2)(i), (a)(3)(i), (a)(4)(i), (a)(6)(i)(A), (a)(6)(ii)(A), (a)(7) (except as covered by paragraph (d)(3) of this section), (a)(8)(i), (a)(10)(i) through (a)(10)(iii), (a)(12)(i)(A), (a)(12)(ii) through (a)(12)(iv)(A), (a)(14) through (a)(15)(i), (a)(16) through (a)(18)(i)(A), (a)(18)(ii) (except as covered by paragraph (d)(22) of this section), (a)(18)(iii), (a)(18)(iv), (a)(18)(v)(A), and (a)(18)(vi)(A) of this section.

(2) February 10, 1992, for products subject to paragraph (a)(20) of this section.

(3) December 4, 1992, for products subject to paragraph (a)(7) of this section that contain menthol as an antipruritic in combination with the antidandruff ingredient coal tar identified in 358.710(a)(1) of this chapter. This section does not apply to products allowed by 358.720(b) of this chapter after April 5, 2007.

(4) February 28, 1990, for products subject to paragraph (a)(6)(iii) of this section, except those that contain ipecac.

(5) September 14, 1993, for products subject to paragraph (a)(6)(iii) of this section that contain ipecac.

(6) December 9, 1993, for products subject to paragraph (a)(6)(i)(B) of this section.

(7) March 6, 1989, for products subject to paragraph (a)(21) of this section, except those that contain ophthalmic anti-infective ingredients listed in paragraph (a)(21)(ii).

(8) June 18, 1993, for products subject to paragraph (a)(21) of this section that contain ophthalmic anti-infective ingredients.

(9) June 18, 1993, for products subject to paragraph (a)(10)(iv) of this section.

(10) June 18, 1993, for products subject to paragraph (a)(22)(i) of this section.

(11) November 10, 1993, for products subject to paragraphs (a)(8)(ii), (a)(10)(v) through (a)(10)(vii), (a)(18)(ii) (except products that contain ferric subsulfate as covered by paragraph (d)(22) of this section and except products that contain calcium acetate monohydrate as covered by paragraph (d)(39) of this section) through (a)(18)(v)(A), (a)(18)(vi)(A), (a)(22)(ii), (a)(23)(i), (a)(24)(i), and (a)(25) of this section.

(12) March 2, 1994, for products subject to paragraph (a)(22)(iii) of this section.

(13) August 5, 1991, for products subject to paragraph (a)(26) of this section, except for those that contain live yeast cell derivative and a combination of hydrocortisone and pramoxine hydrochloride.

(14) September 2, 1994, for products subject to paragraph (a)(26)(vii) and (a)(26)(x) of this section that contain live yeast cell derivative.

(15) September 23, 1994, for products subject to paragraph (a)(22)(iv) of this section.

(16) June 14, 1994, for products subject to paragraph (a)(25)(ii) of this section.

(17) April 19, 2004, for products subject to paragraph (a)(3)(ii) of this section. April 18, 2005, for products with annual sales less than $25,000.

(18) August 15, 1995, for products subject to paragraph (a)(15)(ii) of this section.

(19) October 2, 1987, for products subject to paragraph (a)(6)(iv)(A) of this section.

(20) January 29, 1996, for products subject to paragraph (a)(6)(iv)(B) of this section.

(21) April 21, 1994, for products subject to paragraph (a)(8)(iii) of this section.

(22) April 21, 1993, for products subject to paragraph (a)(18)(ii) of this section that contain ferric subsulfate.

(23) August 23, 1995, for products subject to paragraph (a)(6)(ii)(B) of this section.

(24) October 7, 1996, for products subject to paragraph (a)(2)(ii) of this section.

(25) June 19, 1996, for products subject to paragraph (a)(6)(iv)(C) of this section.

(26) February 22, 1999, for products subject to paragraphs (a)(23)(ii) and (a)(24)(ii) of this section.

(27) [Reserved]

(28) October 22, 1998, for products subject to paragraphs (a)(27) and (a)(28)(i) of this section.

(29) January 29, 1999, for products subject to paragraph (a)(12)(iv)(B) of this section.

(30) November 5, 2002, for products subject to paragraph (a)(12)(iv)(C) of this section.

(31) December 31, 2002, for products subject to paragraph (a)(29)(i) of this section.

(32) June 4, 2004, for products subject to paragraphs (a)(18)(i)(B), (a)(18)(v)(B), and (a)(18)(vi)(B) of this section. June 6, 2005, for products with annual sales less than $25,000.

(33) October 29, 2001, for products subject to paragraph (a)(6)(iv)(D) of this section.

(34) December 9, 2004, for products subject to paragraph (a)(4)(ii) of this section. June 9, 2005, for products with annual sales less than $25,000.

(35) [Reserved]

(36) November 5, 2002, for products subject to paragraph (a)(28)(ii) of this section.

(37) September 25, 2003, for products subject to paragraph (a)(26)(xi) of this section.

(38) October 1, 2007, for products subject to paragraph (a)(12)(i)(B) of this section.

(39) September 6, 2010, for products subject to paragraph (a)(18)(ii) of this section that contain calcium acetate monohydrate, except as provided in 347.20(b) of this chapter.

(40) December 17, 2012, for products subject to paragraph (a)(29)(ii) of this section. December 17, 2013, for products with annual sales less than $25,000.

1These ingredients are nonmonograph except when used to prepare acidulated phosphate fluoride treatment rinses identified in 355.10(a)(3) of this chapter.

[55 FR 46919, Nov. 7, 1990]

Editorial Note:

ForFederal Registercitations affecting 310.545, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and atwww.fdsys.gov .

Effective Date Note:

At 61 FR 9571, Mar. 8, 1996, in 310.545 in paragraph (a)(6)(ii)(B), the entry for "l-desoxyephedrine (topical)" was stayed until further notice.

-
-