CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR524.1044e]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 524 -- OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

Fluocinolone Topical and Otic Dosage Forms

Sec. 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]