21 CFR § 524.1044e - Gentamicin spray.

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


# 524.1044e Gentamicin spray.

(a) *Specification.* Each milliliter of sterile aqueous solution contains gentamicin sulfate equivalent to 1.07 milligrams of gentamicin.

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

(c) *Related tolerances.* See § 556.300 of this chapter.

(d) *Conditions of use in cattle*—(1) *Amount.* Hold the sprayer upright 3 to 6 inches from the affected eye, with the opening directed towards the eye, and pump once. Treat once daily for up to 3 days.

(2) *Indications for use.* For the treatment of pinkeye in cattle (infectious bovine keratoconjunctivitis) caused by *Moraxella bovis.*

(3) *Limitations.* Conditions other than bacterial infections of the bovine eye and infectious keratoconjunctivitis caused by *Moraxella bovis* may produce similar signs. If conditions persists or increases, discontinue use and consult a veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[48 FR 41157, Sept. 14, 1983, as amended at 52 FR 7833, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2014; 84 FR 32993, July 11, 2019; 88 FR 27700, May 3, 2023]