21 C.F.R. § 524.1580e Nitrofurazone ointment with butacaine sulfate.
Title 21 - Food and Drugs
(a) Specifications. The drug contains 0.2 percent nitrofurazone and 0.5 percent butacaine sulfate in a water-soluble base. (b) Sponsor. See No. 054925 in §510.600(c) of this chapter. (c) Conditions of use—(1) Indications for use. For prevention or treatment of surface bacterial infections of ears, wounds, burns, and cutaneous ulcers of dogs, cats, and horses.1 1 These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information. (2) Limitations. Apply directly on the lesion with a spatula or first place on a piece of gauze. Use of a bandage is optional. The preparation should remain on the lesion for at least 24 hours. The dressing may be changed several times daily or left on the lesion for a longer period. For use only on dogs, cats, and horses (not for food use). In case of deep or puncture wounds or serious burns, use only as recommended by a veterinarian. If redness, irritation, or swelling persists or increases, discontinue use; consult veterinarian.1 [49 FR 9417, Mar. 13, 1984, as amended at 71 FR 13542, Mar. 16, 2006]
Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
§ 524.1580e Nitrofurazone ointment with butacaine sulfate.
