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21 CFR Ch. I (4–1–19 Edition) § 310.545

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21 CFR Ch. I (4–1–19 Edition) § 310.545 § 310.545 21 CFR Ch. I (4–1–19 Edition) for marketing. In the absence of an ap- Chloroxylenol proved new drug application or abbre- Cloxyquin viated new drug application, such prod- Coal tar uct is also misbranded under section Dibenzothiophene Estrone 502 of the act. Magnesium aluminum silicate (c) Clinical investigations designed Magnesium sulfate to obtain evidence that any drug prod- Phenol uct labeled, represented, or promoted Phenolate sodium for OTC use as a smoking deterrent is Phenyl salicylate safe and effective for the purpose in- Povidone-iodine tended must comply with the require- Pyrilamine maleate ments and procedures governing the Resorcinol (as single ingredient) use of investigational new drugs set Resorcinol monoacetate (as single ingre- dient) forth in part 312 of this chapter. Salicylic acid (over 2 up to 5 percent) (d) After May 7, 1991, any such OTC Sodium borate drug product containing cloves, cori- Sodium thiosulfate ander, eucalyptus oil, ginger (Ja- Tetracaine hydrochloride maica), lemon oil (terpeneless), licorice Thymol root extract, menthol, methyl salicy- Vitamin E late, quinine ascorbate, silver nitrate, Zinc oxide and/or thymol initially introduced or Zinc stearate initially delivered for introduction into Zinc sulfide interstate commerce that is not in (2) Anticaries drug products—(i) Ap- compliance with this section is subject proved as of May 7, 1991. to regulatory action. After December 1, 1993, any such OTC drug product con- Hydrogen fluoride Sodium carbonate taining lobeline (in the form of lobeline Sodium monofluorophosphate (6 percent sulfate or natural lobelia alkaloids or rinse) Lobelia inflata herb), povidone-silver ni- Sodium phosphate trate, silver acetate, or any other in- gredients initially introduced or ini- (ii) Approved as of October 7, 1996. tially delivered for introduction into Calcium sucrose phosphate interstate commerce that is not in Dicalcium phosphate dihydrate compliance with this section is subject Disodium hydrogen phosphate 1 to regulatory action. Phosphoric acid 1 Sodium dihydrogen phosphate [58 FR 31241, June 1, 1993] Sodium dihydrogen phosphate monohydrate Sodium phosphate, dibasic anhydrous rea- § 310.545 Drug products containing gent 1 certain active ingredients offered over-the-counter (OTC) for certain (3) Antidiarrheal drug products—(i) Ap- uses. proved as of May 7, 1991. (a) A number of active ingredients Aluminum hydroxide have been present in OTC drug prod- Atropine sulfate ucts for various uses, as described Calcium carbonate below. However, based on evidence cur- Carboxymethylcellulose sodium rently available, there are inadequate Glycine Homatropine methylbromide data to establish general recognition of Hyoscyamine sulfate the safety and effectiveness of these in- Lactobacillus acidophilus gredients for the specified uses: Lactobacillus bulgaricus (1) Topical acne drug products. Opium, powdered Opium tincture Alcloxa Paregoric Alkyl isoquinolinium bromide Phenyl salicylate Aluminum chlorohydrex Scopolamine hydrobromide Aluminum hydroxide Zinc phenolsulfonate Benzocaine Benzoic acid Boric acid 1 These ingredients are nonmonograph ex- Calcium polysulfide cept when used to prepare acidulated phos- Calcium thiosulfate phate fluoride treatment rinses identified in Camphor § 355.10(a)(3) of this chapter. 38 VerDate Sep<11>2014 15:24 Aug 05, 2019 Jkt 247074 PO 00000 Frm 00048 Fmt 8010 Sfmt 8010 Y:\SGML\247074.XXX 247074 rmajette on DSKBCKNHB2PROD with CFR Food and Drug Administration, HHS § 310.545 (ii) Approved as of April 19, 2004; April Cedar leaf oil (topical) 18, 2005, for products with annual sales Creosote, beechwood (topical) less than $25,000. Ephedrine (oral) Ephedrine hydrochloride (oral) Attapulgite, activated Ephedrine sulfate (oral) Bismuth subnitrate Racephedrine hydrochloride (oral/topical) Calcium hydroxide Calcium polycarbophil (C) Approved as of April 11, 2007; Oc- Charcoal (activated) tober 11, 2007, for products with annual Pectin sales less than $25,000. Any ingre- Polycarbophil dient(s) labeled with claims or direc- Potassium carbonate tions for use for sinusitis or for relief Rhubarb fluidextract of nasal congestion associated with si- (4) Antiperspirant drug products—(i) nusitis. Ingredients—Approved as of May 7, 1991. (iii) Expectorant drug products. Alum, potassium Ammonium chloride Aluminum bromohydrate Antimony potassium tartrate Aluminum chloride (alcoholic solutions) Beechwood creosote Aluminum chloride (aqueous solution) (aer- Benzoin preparations (compound tincture of osol only) benzoin, tincture of benzoin) Aluminum sulfate Camphor Aluminum sulfate, buffered (aerosol only) Chloroform Sodium aluminum chlorohydroxy lactate Eucalyptol/eucalyptus oil (ii) Approved as of December 9, 2004; Horehound June 9, 2005, for products with annual Iodides (calcium iodide anyhydrous, hydroid- sales less than $25,000. ic acid syrup, iodized lime, potassium io- dide) Aluminum sulfate buffered with sodium alu- Ipecac minum lactate Ipecac fluidextract Ipecac syrup (5) [Reserved] Menthol/peppermint oil (6) Cold, cough, allergy, bronchodilator, Pine tar preparations (extract white pine and antiasthmatic drug products—(i) compound, pine tar, syrup of pine tar, com- Antihistamine drug products—(A) Ingre- pound white pine syrup, white pine) dients. Potassium guaiacolsulfonate Sodium citrate Methapyrilene hydrochloride Squill preparations (squill, squill extract) Methapyrilene fumarate Terpin hydrate preparations (terpin hydrate, Thenyldiamine hydrochloride terpin hydrate elixir) (B) Ingredients. Tolu preparations (tolu, tolu balsam, tolu balsam tincture) Phenyltoloxamine dihydrogen citrate Turpentine oil (spirits of turpentine) Methapyrilene hydrochloride Methapyrilene fumarate (iv) Bronchodilator drug products—(A) Thenyldiamine hydrochloride Approved as of October 2, 1987. (ii) Nasal decongestant drug products— Aminophylline (A) Approved as of May 7, 1991. Belladonna alkaloids Euphorbia pilulifera Allyl isothiocyanate Metaproterenol sulfate Camphor (lozenge) Methoxyphenamine hydrochloride Creosote, beechwood (oral) Pseudoephedrine hydrochloride Eucalyptol (lozenge) Pseudoephedrine sulfate Eucalyptol (mouthwash) Theophylline, anhydrous Eucalyptus oil (lozenge) Theophylline calcium salicylate Eucalyptus oil (mouthwash) Menthol (mouthwash) Theophylline sodium glycinate Peppermint oil (mouthwash) (B) Approved as of January 29, 1996. Thenyldiamine hydrochloride Any combination drug product con- Thymol Thymol (lozenge) taining theophylline (e.g., theophylline Thymol (mouthwash) and ephedrine, or theophylline and Turpentine oil ephedrine and phenobarbital). (C) Approved as of June 19, 1996. Any (B) Approved as of August 23, 1995. ingredient(s) in a pressurized metered- Bornyl acetate (topical) dose inhaler container. 39 VerDate Sep<11>2014 15:24 Aug 05, 2019 Jkt 247074 PO 00000 Frm 00049 Fmt 8010 Sfmt 8010 Y:\SGML\247074.XXX 247074 rmajette on DSKBCKNHB2PROD with CFR § 310.545 21 CFR Ch. I (4–1–19 Edition) (D) Approved as of October 29, 2001. Alcohol Any oral bronchodilator active ingre- Aluminum hydroxide dient (e.g., ephedrine, ephedrine hydro- Amylase Anise seed chloride, ephedrine sulfate, Aromatic powder racephedrine hydrochloride, or any Asafetida other ephedrine salt) in combination Aspergillus oryza enzymes (except lactase with any analgesic(s) or analgesic-anti- enzyme derived from Aspergillus oryzae) pyretic(s), anticholinergic, antihis- Bacillus acidophilus tamine, oral antitussive, or stimulant Bean active ingredient. Belladonna alkaloids (7) Dandruff/seborrheic dermatitis/psori- Belladonna leaves, powdered extract Betaine hydrochloride asis drug products. Bismuth subcarbonate Alkyl isoquinolinium bromide Bismuth subgallate Allantoin Black radish powder Benzalkonium chloride Blessed thistle (cnicus benedictus) Benzethonium chloride Buckthorn Boric acid Calcium gluconate Calcium undecylenate Capsicum Captan Capsicum, fluid extract of Chloroxylenol Carbon Colloidal oatmeal Cascara sagrada extract Cresol, saponated Catechu, tincture Ethohexadiol Catnip Eucalyptol Chamomile flowers Juniper tar Charcoal, wood Lauryl isoquinolinium bromide Chloroform Menthol Cinnamon oil Mercury oleate Cinnamon tincture Methylbenzethonium chloride Citrus pectin Methyl salicylate Diastase Phenol Diastase malt Phenolate sodium Dog grass Pine tar Elecampane Povidone-iodine Ether Resorcinol Fennel acid Sodium borate Galega Sodium salicylate Ginger Thymol Glycine Undecylenic acid Hydrastis canadensis (golden seal) Hectorite (8) Digestive aid drug products—(i) Ap- Horsetail proved as of May 7, 1991. Huckleberry Hydrastis fluid extract Bismuth sodium tartrate Hydrochloric acid Calcium carbonate Iodine Cellulase Iron ox bile Dehydrocholic acid Johnswort Dihydroxyaluminum sodium carbonate Juniper Duodenal substance Kaolin, colloidal Garlic, dehydrated Knotgrass Glutamic acid hydrochloride Lactic acid Hemicellulase Lactose Homatropine methylbromide Lavender compound, tincture of Magnesium hydroxide Linden Magnesium trisilicate Lipase Ox bile extract Lysine hydrochloride Pancreatin Mannitol Pancrelipase Mycozyme Papain Peppermint oil Myrrh, fluid extract of Pepsin Nettle Sodium bicarbonate Nickel-pectin Sodium citrate Nux vomica extract Sorbitol Orthophosphoric acid Papaya, natural (ii) Approved as of November 10, 1993. Pectin 40 VerDate Sep<11>2014 15:24 Aug 05, 2019 Jkt 247074 PO 00000 Frm 00050 Fmt 8010 Sfmt 8010 Y:\SGML\247074.XXX 247074 rmajette on DSKBCKNHB2PROD with CFR Food and Drug Administration, HHS § 310.545 Peppermint Methapyrilene hydrochloride Peppermint
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