21 CFR 524.1044e
§ 524.1044e Gentamicin spray.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 524.1044e, § 524.1044e Gentamicin spray, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87606
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.