Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 524.1044h: h Gentamicin, mometasone, and clotrimazole otic suspension.

(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.
(b) Sponsors. See Nos. 000061 and 054925 in § 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 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.
(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).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Where this section sits in the code

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

(b) Sponsors. See Nos. 000061 and 054925 in § 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 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.

(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).

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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