{"data":{"id":"us/21-cfr-524.1044g","jurisdiction":"us","citation":"21 CFR 524.1044g","heading":"g Gentamicin, betamethasone, and clotrimazole ointment.","body":"(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.\n(b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (c) of this section.\n(1) No. 000061 for use of 7.5- or 15-gram (g) tubes, 12.5-, 30-, or 215-g bottles.\n(2) No. 069043 for use of 10-, 20-, 40-, or 215-g bottles.\n(3) No. 025463 for use of 7.5- or 15-g tubes, or 215-g bottles.\n(c) Conditions of use in dogs—(1) Amount. Instill ointment twice daily into the ear canal for 7 consecutive days.\n(i) From 7.5- or 15-g tubes; 10-, 12.5-, or 30-g bottles: 4 drops for dogs weighing less than 30 pounds (lb) or 8 drops for dogs weighing 30 lb or more.\n(ii) From 20-, 40-, or 215-g bottles: 2 drops for dogs weighing less than 30 lb or 4 drops for dogs weighing 30 lb or more.\n(ii) From 20- or 215-g bottles: 2 drops for dogs weighing less than 30 lb or 4 drops for dogs weighing 30 lb or more.\n(2) Indications for use. For the treatment of acute and chronic canine otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.\n(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS","PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"12529356cb9017a75e1d53edeaf53999ad63b5b089d928aa1fbb11d638ef15a0","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-524.1044f","next":"us/21-cfr-524.1044h"},"notice":"GroundRules: Original legal text. Not legal advice."}