... CITE: 21CFR333.210] [Page 228] TITLE 21 -FOOD AND DRUGS CHAPTER I -FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 333_TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE-Subpart C_Topical Antifungal Drug Products Sec. 333.210 Antifungal active ingredients. The active ingredient of the product consists of any one of the following within the specified concentration established for each ingredient: (a) Clioquinol 3 percent. (b) Haloprogin 1 percent. (c) Miconazole nitrate 2 percent. (d) Povidone-iodine 10 percent. (e) Tolnaftate 1 percent. (f) Undecylenic acid, calcium undecylenate, copper undecylenate, and zinc undecylenate may be used individually or in any ratio that provides a total undecylenate concentration of 10 to 25 percent. (g) Clotrimazole 1 percent. [58 FR 49898, Sept. 23, 1993, as amended at 67 FR 5943, Feb. 8, 2002] ...

... 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 phosphate \ 1 \-\ 1 \ These ingredients are nonmonograph ...

... mastic composition designed for application to a substrate in a thin layer that is converted to a clear or opaque solid protective, decorative, or functional adherent film after application. Included in this category are clear coats, topcoats, primers, varnishes, sealers, adhesives, lacquers, stains, shellacs, inks, and temporary protective coatings. (3) Iodine products classified as iodophors that exist as an iodine complex to include poloxamer-iodine complex, polyvinyl pyrrolidone-iodine complex (i.e, povidone-iodine ), undecoylium chloride iodine, nonylphenoxypoly (ethyleneoxy) ethanol-iodine complex, iodine complex [[ Page 138 ]] with phosphate ester of alkylaryloxy polyethylene glycol, and iodine complex with ammonium ether sulfate / polyoxyethylene sorbitan monolaurate. (4) Iodine products that consist of organically bound iodine (a non-ionic complex) (e.g, iopamidol, iohexol, and amiodarone) (e) The Administrator may, at any time, terminate or modify the exemption for any chemical mixture which has been granted an exemption pursuant to the concentration limits as specified in paragraph (c) of this section or pursuant ...