{"data":{"id":"us/21-cfr-524.1044h","jurisdiction":"us","citation":"21 CFR 524.1044h","heading":"h Gentamicin, mometasone, and clotrimazole otic suspension.","body":"(a) Specifications. Each gram of suspension contains gentamicin sulfate, United States Pharmacopeia (USP) equivalent to 3 milligram (mg) gentamicin base, mometasone furoate monohydrate or mometasone furoate anhydrous, USP, equivalent to 1 mg mometasone, and 10 mg clotrimazole, USP.\n(b) Sponsors. See Nos. 000061 and 054925 in § 510.600(c) of this chapter.\n(c) Conditions of use in dogs—(1) Amount. For dogs weighing less than 30 pounds (lb), instill 4 drops from the 7.5 gram (g), 15 g, or 30 g bottles (2 drops from the 215 g bottle) once daily into the ear canal. For dogs weighing 30 lb or more, instill 8 drops from the 7.5 g, 15 g, or 30 g bottles (4 drops from the 215 g bottle) once daily into the ear canal. Therapy should continue for 7 consecutive days.\n(2) Indications for use. For the treatment of otitis externa caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P. aeruginosa], coagulase-positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).\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":"d79dcedace337f93a02f45907f04ef4f3260fa45a2dd2bb77f65c127f40ec021","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-524.1044g","next":"us/21-cfr-524.1044i"},"notice":"GroundRules: Original legal text. Not legal advice."}