21 CFR § 524.1044f - Gentamicin and betamethasone spray.

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


# 524.1044f Gentamicin and betamethasone spray.

(a) *Specifications.* Each milliliter of spray contains gentamicin sulfate equivalent to 0.57 milligram (mg) gentamicin base and betamethasone valerate equivalent to 0.284 mg betamethasone.

(b) *Sponsors.* See Nos. 000061, 017033, 054925, 058005, and 058829 in § 510.600(c) of this chapter.

(c) *Conditions of use in dogs*—(1) *Amount.* Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. Administer two spray actuations two to four times daily for 7 days.

(2) *Indications for use.* For the treatment of infected superficial lesions caused by bacteria susceptible to gentamicin.

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

[71 FR 13542, Mar. 16, 2006, as amended at 72 FR 5929, Feb. 8, 2007; 74 FR 22822, May 15, 2009; 77 FR 3598, Jan. 25, 2012; 88 FR 16549, Mar. 20, 2023]