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Food and Drug Administration, HHS § 310.545

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Food and Drug Administration, HHS § 310.545 Food and Drug Administration, HHS § 310.545 201(p) of the Federal Food, Drug, and Benzocaine Cosmetic Act (the act), for which an Benzoic acid approved application or abbreviated Boric acid application under section 505 of the act Calcium polysulfide Calcium thiosulfate and part 314 of this chapter is required Camphor 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 502 of the act. Estrone (c) Clinical investigations designed Magnesium aluminum silicate to obtain evidence that any drug prod- Magnesium sulfate uct labeled, represented, or promoted Phenol 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- forth in part 312 of this chapter. dient) (d) After May 7, 1991, any such OTC Salicylic acid (over 2 up to 5 percent) drug product containing cloves, cori- Sodium borate 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 taining lobeline (in the form of lobeline Sodium carbonate 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 data to establish general recognition of Homatropine methylbromide Hyoscyamine sulfate the safety and effectiveness of these in- Lactobacillus acidophilus gredients for the specified uses: Lactobacillus bulgaricus (1) Topical acne drug products. Alcloxa 1 These ingredients are nonmonograph ex- Alkyl isoquinolinium bromide cept when used to prepare acidulated phos- Aluminum chlorohydrex phate fluoride treatment rinses identified in Aluminum hydroxide § 355.10(a)(3) of this chapter. 37 VerDate Mar<15>2010 13:06 May 27, 2010 Jkt 220069 PO 00000 Frm 00047 Fmt 8010 Sfmt 8010 Y:\SGML\220069.XXX 220069 wwoods2 on DSK1DXX6B1PROD with CFR § 310.545 21 CFR Ch. I (4–1–10 Edition) Opium, powdered Thymol Opium tincture Thymol (lozenge) Paregoric Thymol (mouthwash) Phenyl salicylate Turpentine oil Scopolamine hydrobromide Zinc phenolsulfonate (B) Approved as of August 23, 1995. (ii) Approved as of April 19, 2004; April Bornyl acetate (topical) Cedar leaf oil (topical) 18, 2005, for products with annual sales Creosote, beechwood (topical) less than $25,000. Ephedrine (oral) Attapulgite, activated Ephedrine hydrochloride (oral) Bismuth subnitrate Ephedrine sulfate (oral) Calcium hydroxide Racephedrine hydrochloride (oral/topical) 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 Potassium carbonate dient(s) labeled with claims or direc- Rhubarb fluidextract tions for use for sinusitis or for relief 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 Iodides (calcium iodide anyhydrous, hydroid- June 9, 2005, for products with annual ic acid syrup, iodized lime, potassium io- sales less than $25,000. 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) Potassium guaiacolsulfonate dients. Sodium citrate Methapyrilene hydrochloride Squill preparations (squill, squill extract) Methapyrilene fumarate Terpin hydrate preparations (terpin hydrate, Thenyldiamine hydrochloride terpin hydrate elixir) Tolu preparations (tolu, tolu balsam, tolu (B) Ingredients. balsam tincture) Turpentine oil (spirits of turpentine) Phenyltoloxamine dihydrogen citrate Methapyrilene hydrochloride (iv) Bronchodilator drug products—(A) Methapyrilene fumarate Approved as of October 2, 1987. Thenyldiamine hydrochloride Aminophylline (ii) Nasal decongestant drug products— Belladonna alkaloids (A) Approved as of May 7, 1991. Euphorbia pilulifera Metaproterenol sulfate Allyl isothiocyanate Methoxyphenamine hydrochloride Camphor (lozenge) Pseudoephedrine hydrochloride Creosote, beechwood (oral) Pseudoephedrine sulfate Eucalyptol (lozenge) Theophylline, anhydrous Eucalyptol (mouthwash) Theophylline calcium salicylate Eucalyptus oil (lozenge) Theophylline sodium glycinate Eucalyptus oil (mouthwash) Menthol (mouthwash) (B) Approved as of January 29, 1996. Peppermint oil (mouthwash) Any combination drug product con- Thenyldiamine hydrochloride taining theophylline (e.g., theophylline 38 VerDate Mar<15>2010 13:06 May 27, 2010 Jkt 220069 PO 00000 Frm 00048 Fmt 8010 Sfmt 8010 Y:\SGML\220069.XXX 220069 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 310.545 and ephedrine, or theophylline and Pepsin ephedrine and phenobarbital). Sodium bicarbonate (C) Approved as of June 19, 1996. Any Sodium citrate Sorbitol ingredient(s) in a pressurized metered- dose inhaler container. (ii) Approved as of November 10, 1993. (D) Approved as of October 29, 2001. Alcohol Any oral bronchodilator active ingre- Aluminum hydroxide dient (e.g., ephedrine, ephedrine hydro- Amylase chloride, ephedrine sulfate, Anise seed racephedrine hydrochloride, or any Aromatic powder other ephedrine salt) in combination Asafetida with any analgesic(s) or analgesic-anti- Aspergillus oryza enzymes (except lactase 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 asis drug products. Betaine hydrochloride 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) (8) Digestive aid drug products—(i) Ap- Hectorite proved as of May 7, 1991. Horsetail Huckleberry Bismuth sodium tartrate Hydrastis fluid extract Calcium carbonate Hydrochloric acid Cellulase Iodine Dehydrocholic acid Iron ox bile Dihydroxyaluminum sodium carbonate Johnswort Duodenal substance Juniper Garlic, dehydrated Kaolin, colloidal Glutamic acid hydrochloride Knotgrass Hemicellulase Lactic acid Homatropine methylbromide Lactose Magnesium hydroxide Lavender compound, tincture of Magnesium trisilicate Linden Ox bile extract Lipase Pancreatin Lysine hydrochloride Pancrelipase Mannitol Papain Mycozyme Peppermint oil Myrrh, fluid extract of 39 VerDate Mar<15>2010 13:06 May 27, 2010 Jkt 220069 PO 00000 Frm 00049 Fmt 8010 Sfmt 8010 Y:\SGML\220069.XXX 220069 wwoods2 on DSK1DXX6B1PROD
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