subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "524"
part_subject: "OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "524.1044e"
section_subject: "Gentamicin spray."
cfr_reference: "21 CFR 524.1044e"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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)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.