21 CFR § 524.1044g - Gentamicin, betamethasone, and clotrimazole ointment.

---
identifier: "/us/cfr/t21/s524.1044g"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.1044g - Gentamicin, betamethasone, and clotrimazole ointment."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.1044g"
section_name: "Gentamicin, betamethasone, and clotrimazole ointment."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "524"
part_name: "OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13873, Mar. 27, 1975, unless otherwise noted."
cfr_part: "524"
---


# 524.1044g Gentamicin, betamethasone, and 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 § 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-, 25-, or 215-g bottles.

(3) No. 069043 for use of 10-, 20-, 40-, or 215-g bottles.

(4) No. 025463 for use of 7.5- or 15-g tubes, or 215-g bottles.

(c) *Conditions of use in dogs*—(1) *Amount.* Instill ointment twice daily into the ear canal for 7 consecutive days.

(i) From 7.5- or 15-g tubes; 10-, 12.5-, 15-, 25-, or 30-g bottles: 4 drops for dogs weighing less than 30 pounds (lb) or 8 drops for dogs weighing 30 lb or more.

(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.

(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.

(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.

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

[58 FR 38973, July 21, 1993, as amended at 63 FR 31932, June 11, 1998; 68 FR 42970, July 21, 2003; 70 FR 8291, Feb. 18, 2005; 71 FR 13542, Mar. 16, 2006; 71 FR 16481, Apr. 3, 2006; 71 FR 38261, July 6, 2006; 71 FR 56867, Sept. 28, 2006; 78 FR 17597, Mar. 22, 2013; 79 FR 10969, Feb. 27, 2014; 81 FR 17608, Mar. 30, 2016]