21 CFR § 524.1044i - Gentamicin and betamethasone ophthalmic solution.

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


# 524.1044i Gentamicin and betamethasone ophthalmic solution.

(a) *Specifications.* Each milliliter (mL) of solution contains gentamicin sulfate equivalent to 3 milligrams (mg) of gentamicin base and 1 mg betamethasone acetate equivalent to 0.89 mg betamethasone alcohol.

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

(c) *Conditions of use in dogs*—(1) *Amount.* Instill one or two drops of solution in the conjunctival sac three or four times a day.

(2) *Indications for use.* For treatment of external eye infections and inflammation.

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

[75 FR 54492, Sept. 8, 2010, as amended at 80 FR 13230, Mar. 13, 2015]