CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR524.1580a]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 524 -- OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

Fluocinolone Topical and Otic Dosage Forms

Sec. 524.1580a Nitrofurazone ointment.

(a) Specifications. The drug contains 0.2 percent nitrofurazone in a water-soluble base.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter.

(1) See Nos. 054925, 058005, 059051, 061133, and 069043 for use on dogs, cats, or horses.

(2) See No. 017135 for use on dogs and horses.

(3) See Nos. 017153 and 058829 for use on horses.

(c) [Reserved]

(d) Conditions of use - (1) Amount. Apply directly on the lesion with a spatula or first place on a piece of gauze. The preparation should remain on the lesion for at least 24 hours. Use of a bandage is optional.

(2) Indications for use. For prevention or treatment of surface bacterial infections of wounds, burns, and cutaneous ulcers of dogs, cats, or horses.

(3) Limitations. For use only on dogs, cats, and horses. Do not use on horses intended for human consumption. Federal law prohibits the use of this product in food-producing animals. In case of deep or puncture wounds or serious burns, use only as recommended by veterinarian. If redness, irritation, or swelling persists or increases, discontinue use; consult veterinarian.

[46 FR 43402, June 27, 1980. Redesignated at 79 FR 10971, Feb. 27, 2014]

Editorial Note:

For Federal Register citations affecting § 524.1580a, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.