CFR

524.1204—Kanamycin sulfate, calcium amphomycin, and hydrocortisone acetate.

(a) Specifications. (1) Calcium amphomycin is the calcium salt of amphomycin. It conforms to the following specifications:

(i) Its potency is not less than 863 micrograms of amphomycin per milligram;

(ii) Its moisture content is not more than 10 percent; and

(iii) Its pH in a 2-percent aqueous suspension is 6.0 to 7.5.

(2) The drug is in a water-miscible ointment or cream base and each gram of ointment or cream contains: 5.0 milligrams of kanamycin activity as the sulfate, 5.0 milligrams of amphomycin activity as the calcium salt, and 10.0 milligrams of hydrocortisone acetate.

(b) Sponsor. See No. 000856 in § 510.600(c) of this chapter.

(c) Conditions of use. (1) It is indicated for use in dogs in the following conditions associated with bacterial infections caused by organisms susceptible to one or both antibiotics: Acute otitis externa, furunculosis, folliculitis, pruritus, anal gland infections, erythema, decubital ulcer, superficial wounds, and superficial abscesses.

(2) The ointment should be applied to the affected areas of the skin at least twice daily. In severe or widespread lesions it may be desirable to apply the ointment more than twice daily. After some improvement is observed, treatment can usually be reduced to once daily. Before application, hair in the affected area should be closely clipped and the area should be thoroughly cleansed of crusts, scales, dirt, or other detritus. When treating infections of the anal gland, the drug should be introduced into the orifice of the gland and not through any fistulous tract. If no response is evident in 7 days, diagnosis and therapy should be reevaluated.

(3) For use only by or on the order of a licensed veterinarian.

Code of Federal Regulations

[40 FR 13858, Mar. 27, 1975, as amended at 53 FR 12512, Apr. 15, 1988; 53 FR 27851, July 25, 1988; 64 FR 404, Jan. 5, 1999]

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