... [Code of Federal Regulations] [Title 21, Volume 6] [Revised as of April 1, 2009] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR524.1443] [Page 341-342] TITLE 21 -FOOD AND DRUGS CHAPTER I -FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 524_OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS-Table of Contents Sec. 524.1443 Miconazole. (a) Specifications (1) Each gram of cream contains miconazole nitrate equivalent to 20 milligrams miconazole base. (2) Each gram of lotion or spray contains miconazole nitrate equivalent to 1 percent miconazole base. (b) Sponsors. See Sec. 510.600 (c) of this chapter for use as in paragraph (c) of this section: (1) No. 000061 for use of cream, lotion, and spray; (2) Nos. 054925 and 058829 for use of lotion and spray. (c) Conditions of use in dogs and cats (1) Amount. Apply once daily by rubbing into ...

... Revised as of April 1, 2009] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR333.280] [Page 230] 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. 333.280 Professional labeling. The labeling provided to health professionals (but not to the general public) may contain the following additional indication: (a) For products containing haloprogin or miconazole nitrate identified in Sec. 333.210 (a) and (c). `` For the treatment of superficial skin infections caused by yeast (Candida albicans) ' (b) [Reserved] ...

... . Government Printing Office via GPO Access [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] ...

... 524.1044d Gentamicin sulfate, betamethasone valerate ointment. 524.1044e Gentamicin sulfate spray. 524.1044f Gentamicin and betamethasone spray. 524.1044g Gentamicin sulfate, betamethasone valerate, clotrimazole ointment. 524.1044h Gentamicin sulfate, mometasone furoate, clotrimazole otic suspension. 524.1140 Imidacloprid and ivermectin. 524.1146 Imidacloprid and moxidectin. 524.1193 Ivermectin topical solution. 524.1195 Ivermectin otic suspension. 524.1200 Kanamycin ophthalmic and topical dosage forms. 524.1200a Kanamycin ophthalmic ointment. 524.1200b Kanamycin ophthalmic aqueous solution. 524.1204 Kanamycin sulfate, calcium amphomycin, and hydrocortisone acetate. 524.1240 Levamisole. 524.1376 2-Mercaptobenzothiazole solution. 524.1443 Miconazole. 524.1446 Milbemycin oxime solution. 524.1451 Moxidectin. 524.1465 Mupirocin. 524.1484 Neomycin sulfate ophthalmic and topical dosage forms. 524.1484a Neomycin sulfate ophthalmic ointment. 524.1484b Neomycin sulfate, isoflupredone acetate, tetracaine hydrochloride, and myristyl-gamma-picolinium chloride, topical powder. 524.1484c Neomycin sulfate, isoflupredone acetate, tetracaine hydrochloride ointment. 524.1484d Neomycin sulfate, hydrocortisone acetate, tetracaine hydrochloride ear ointment. 524.1484e Neomycin sulfate and polymyxin B sulfate ophthalmic solution. 524.1484f Neomycin sulfate, prednisolone acetate, tetracaine hydrochloride eardrops. 524.1484g Neomycin sulfate-thiabendazole-dexamethason solution. 524.1484h Neomycin, penicillin, polymyxin, hydrocortisone ...