CFR

524.1580e—Nitrofurazone ointment with butacaine sulfate.

(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

Code of Federal Regulations

Footnote(s): 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

Code of Federal Regulations

[49 FR 9417, Mar. 13, 1984, as amended at 71 FR 13542, Mar. 16, 2006]

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