21 CFR § 524.1044d - Gentamicin and betamethasone ointment.

---
identifier: "/us/cfr/t21/s524.1044d"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.1044d - Gentamicin and betamethasone ointment."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.1044d"
section_name: "Gentamicin and betamethasone 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"
---


# 524.1044d Gentamicin and betamethasone ointment.

(a) *Specifications.* Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin base and betamethasone valerate equivalent to 1 milligram of betamethasone.

(b) *Sponsor.* See No. 000061 in § 510.600(c) of this chapter.

(c) *Conditions of use in dogs*—(1) *Amount*—(i) *Otitis externa.* Instill 3 to 8 drops into the ear canal twice daily for 7 days.

(ii) *Infected superficial lesions.* Apply to cover the treatment area twice daily for 7 to 14 days.

(2) *Indications for use.* For the treatment of acute and chronic otitis externa and infected superficial lesions caused by bacteria sensitive to gentamicin.

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

[47 FR 26378, June 18, 1982, as amended at 52 FR 7832, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2014]