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Electronic Code of Federal Regulations

e-CFR data is current as of January 16, 2020

Title 21Chapter ISubchapter EPart 524 → §524.1204


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


§524.1204   Kanamycin, amphomycin, and hydrocortisone ointment.

(a) Specifications. Each gram of ointment contains 5 milligrams kanamycin activity as kanamycin sulfate, 5 milligrams of amphomycin activity as the calcium salt, and 10 milligrams of hydrocortisone acetate.

(b) Sponsor. See No. 054771 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Apply 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.

(2) Indications for use. For the treatment of acute otitis externa, furunculosis, folliculitis, pruritus, anal gland infections, erythema, decubital ulcers, superficial wounds, and superficial abscesses associated with bacterial infections caused by organisms susceptible to one or both antibiotics.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 10970, Feb. 27, 2014]

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