21 CFR § 524.1044a - Gentamicin ophthalmic solution.

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


# 524.1044a Gentamicin ophthalmic solution.

(a) *Specifications.* Each milliliter of solution contains gentamicin sulfate equivalent to 3 milligrams of gentamicin.

(b) *Sponsors.* See Nos. 000061 and 086189 in § 510.600(c) of this chapter.

(c) *Conditions of use in dogs and cats*—(1) *Amount.* Administer 1 or 2 drops into the conjunctival sac 2 to 4 times a day.

(2) *Indications for use.* For the topical treatment of infections of the conjunctiva caused by susceptible bacteria.

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

[80 FR 18776, Apr. 8, 2015, as amended at 89 FR 14410, Feb. 27, 2024]