... [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: 21CFR524.1044h] [Page 338] 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. 524.1044h Gentamicin sulfate, mometasone furoate, clotrimazole otic suspension. (a) Specifications. Each gram contains gentamicin sulfate, United States Pharmacopeia (USP) equivalent to 3 milligram (mg) gentamicin base, mometasone furoate monohydrate equivalent to 1 mg mometasone, and 10 mg clotrimazole, USP. (b) Sponsor. See No. 000061 in Sec. 510.600 (c) of this chapter. (c) Conditions of use in dogs (1) Amount. For dogs weighing less than 30 pounds (lb ), instill 4 drops from the 7.5, 15, or 30-gram (g) bottle into the ear canal (2 drops from the 215-g ...

... [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: 21CFR524.1044g] [Page 338] 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. 524.1044g Gentamicin sulfate, betamethasone valerate, clotrimazole ointment. (a) Specifications. Each gram (g) of ointment contains gentamicin sulfate equivalent to 3 milligrams (mg) gentamicin base, betamethasone valerate equivalent to 1 mg betamethasone, and 10 mg clotrimazole. (b) Sponsors. See sponsors in Sec. 510.600 (c) of this chapter for uses as in paragraph (c) of this section. (1) No. 000061 for use of 7.5-or 15-gram (g) tubes, 12.5, 30, or 215-g bottles. (2) No. 054925 for use of 7.5-or 15-g tubes; 10, 15, ...

... [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: 21CFR524.450] [Page 329] 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. 524.450 Clotrimazole cream. (a) Specifications. Each gram of cream contains 10 milligrams of clotrimazole. (b) Sponsor. See 000859 in Sec. 510.600 (c). (c) Conditions of use (1) Amount. Apply \ 1 / 4 \-inch ribbon of cream per square inch of lesion once daily for 2 to 4 weeks. (2) Indications of use. For the treatment of fungal infections of dogs and cats caused by Microsporum canis and Trichophyton mentagrophytes. (3) Limitations. Wash hands thoroughly after use to avoid spread of infection. Federal law restricts this drug to use by or on the order of a ...

... 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] ...

... 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 524.86 Amitraz liquid. 524.154 Bacitracin or bacitracin zinc-neomycin sulfate-polymyxin B sulfate ophthalmic ointment. 524.155 Bacitracin zinc-polymyxin B sulfate-neomycin sulfate-hydrocortisone or hydrocortisone acetate ophthalmic ointment. 524.390 Chloramphenicol ophthalmic and topical dosage forms. 524.390a Chloramphenicol ophthalmic ointment. 524.390b Chloramphenicol ophthalmic solution. 524.390d Chloramphenicol-prednisolone ophthalmic ointment. 524.402 Chlorhexidine. 524.450 Clotrimazole cream. 524.463 Copper naphthenate. 524.520 Cuprimyxin cream. 524.575 Cyclosporine ophthalmic ointment. 524.590 Diclofenac. 524.660 Dimethyl sulfoxide ophthalmic and topical dosage forms. 524.660a Dimethyl sulfoxide solution. 524.660b Dimethyl sulfoxide gel. 524.770 Doramectin. 524.775 Emodepside and praziquantel. 524.802 Enrofloxacin, silver sulfadiazine emulsion. 524.814 Eprinomectin. 524.900 Famphur. 524.920 Fenthion. 524.960 Flumethasone, neomycin sulfate, and polymyxin B sulfate ophthalmic solutions. 524.981 Fluocinolone acetonide ophthalmic and topical dosage forms. 524.981a Fluocinolone acetonide cream. 524.981b Fluocinolone acetonide solution. 524.981c Fluocinolone acetonide, neomycin sulfate cream. 524.981d Fluocinolone acetonide, dimethyl sulfoxide solution. 524.981e Fluocinolone acetonide, ...