21 C.F.R. § 524.1044e Gentamicin sulfate spray.
Title 21 - Food and Drugs
(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. (1) The drug is indicated for the treatment of pink eye in cattle (infectious bovine keratoconjunctivitis) caused by Moraxella bovis. (2) One actuation of the sprayer delivers 0.7 milliliter containing 0.75 milligram gentamicin. The sprayer should be held upright 3 to 6 inches from the affected eye, with the opening directed towards the eye, and pumped once. It is advisable to treat once a day for up to 3 days. (3) 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 veterinarian. [48 FR 41157, Sept. 14, 1983, as amended 52 FR 7833, Mar. 13, 1987]
Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
§ 524.1044e Gentamicin sulfate spray.
