Subpart E, Section 310.545 · 21 CFR Part 310

Contents

310.545Drug 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

(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)(42) 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.

(41)September 6, 2017, for products subject to paragraph (a)(27)(iii) or (iv) of this section.

(42)December 20, 2018, for products subject to paragraphs (a)(27)(vi) through (x) of this section. Editorial Note:For Federal Register citations affecting § 310.545, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.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.

(ii)Approved as of November 10, 1993. Alcohol Aluminum hydroxide Amylase Anise seed Aromatic powder Asafetida Aspergillus oryza enzymes (except lactase enzyme derived from Aspergillus 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

(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

(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

(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

(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.

(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

(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

(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)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.

(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

(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

(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

(26)Anorectal drug products—(i) Anticholinergic drug products. Atropine Belladonna extract

(29)Sunscreen drug products. (i) Ingredients. Diethanolamine methoxycinnamate Digalloyl trioleate Ethyl 4-[bis(hydroxypropyl)] aminobenzoate Glyceryl aminobenzoate Lawsone with dihydroxyacetone Red petrolatum

(30)[Reserved]

(iii)Consumer antiseptic hand wash drug products. Approved as of September 6, 2017. Cloflucarban Fluorosalan Hexachlorophene Hexylresorcinol Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate) Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol) Methylbenzethonium chloride Nonylphenoxypoly (ethyleneoxy) ethanoliodine Phenol (greater than 1.5 percent) Phenol (less than 1.5 percent) Poloxamer iodine complex Povidone-iodine (5 to 10 percent) Secondary amyltricresols Sodium oxychlorosene Tribromsalan Triclocarban Triclosan Triple Dye Undecoylium chloride iodine complex

(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

(iv)Consumer antiseptic body wash drug products. Approved as of September 6, 2017. Cloflucarban Fluorosalan Hexachlorophene Hexylresorcinol Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol) Iodine tincture Methylbenzethonium chloride Nonylphenoxypoly (ethyleneoxy) ethanoliodine Phenol (greater than 1.5 percent) Phenol (less than 1.5 percent) Poloxamer iodine complex Povidone-iodine (5 to 10 percent) Secondary amyltricresols Sodium oxychlorosene Tribromsalan Triclocarban Triclosan Triple Dye Undecoylium chloride iodine complex

(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

(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

(ix)[Reserved]

(v)[Reserved]

(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.

(vi)Health care personnel hand wash drug products. Approved as of December 20, 2018. Cloflucarban Fluorosalan Hexachlorophene Hexylresorcinol Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate) Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol) Methylbenzethonium chloride Nonylphenoxypoly (ethyleneoxy) ethanoliodine Phenol Poloxamer-iodine complex Secondary amyltricresols Sodium oxychlorosene Tribromsalan Triclocarban Triclosan Undecoylium chloride iodine complex

(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 B1 mononitrate) 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

(vii)[Reserved]

(11)[Reserved]

(12)Laxative drug products—(i)(A) Bulk laxatives. Agar Carrageenan (degraded) Carrageenan (native) Guar gun

(viii)Surgical hand scrub drug products. Approved as of December 20, 2018. Cloflucarban Fluorosalan Hexachlorophene Hexylresorcinol Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate) Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol) Methylbenzethonium chloride Nonylphenoxypoly (ethyleneoxy) ethanoliodine Phenol Poloxamer-iodine complex Secondary amyltricresols Sodium oxychlorosene Tribromsalan Triclocarban Triclosan Undecoylium chloride iodine complex

(x)Patient antiseptic skin preparation drug products. Approved as of December 20, 2018. Cloflucarban Fluorosalan Hexachlorophene Hexylresorcinol Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol) Iodine tincture (USP) Iodine topical solution (USP) Mercufenol chloride Methylbenzethonium chloride Nonylphenoxypoly (ethyleneoxy) ethanoliodine Phenol Poloxamer-iodine complex Secondary amyltricresols Sodium oxychlorosene Tribromsalan Triclocarban Triclosan Triple dye Undecoylium chloride iodine complex Combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative Combination of mercufenol chloride and secondary amyltricresols in 50 percent alcohol

(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

(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

United States Government work; public domain under 17 U.S.C. § 105.

21 CFR Part 310 — New Drugs

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

Defined terms · 2

Key facts

History · 1 version

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