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Electronic Code of Federal Regulations

e-CFR data is current as of December 4, 2019

Title 21Chapter ISubchapter EPart 524 → §524.1044e


Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS


§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.

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

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