21 C.F.R. § 524.1044d Gentamicin sulfate, betamethasone valerate ointment.
Title 21 - Food and Drugs
(a) Specifications. Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin base and betamethasone valerate equivalent to 1 milligram of betamethasone. (b) Sponsor. See No. 000061 in §510.600(c) of this chapter. (c) Conditions of use. (1) The drug is used or indicated for use in dogs in the treatment of acute and chronic canine otitis externa and canine infected superficial lesions caused by bacteria sensitive to gentamicin. (2)(i) For the treatment of acute and chronic canine otitis externa the drug is administered by instillation of 3 to 8 drops into the ear canal twice daily for 7 days. The external ear and ear canal should be properly cleaned and dried before treatment. Remove foreign material, debris, crusted exudates, etc., with suitable nonirritating solutions. Excessive hair should be clipped from the treatment area of the external ear. (ii) For the treatment of canine infected superficial lesions, the lesion and adjacent area should be properly cleaned before treatment. Excessive hair should be removed. A sufficient amount of the drug should be applied to cover the treatment area. The drug should be administered twice daily for 7 to 14 days. (3) If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Observe patients for signs of adrenocorticoid overdosage. The antibiotic susceptibility of the pathogenic organism should be determined prior to use of this preparation. Administration of recommended doses beyond 7 days may result in delayed wound healing. Animals treated longer than 7 days should be monitored closely. (4) For use by or on the order of a licensed veterinarian. [47 FR 26378, June 18, 1982, as amended at 52 FR 7832, Mar. 13, 1987]
Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
§ 524.1044d Gentamicin sulfate, betamethasone valerate ointment.
