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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

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

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2019]
[CITE: 21CFR524.1005]



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

Sec. 524.1005 Furazolidone powder.

(a) Specifications. The product contains either 4 or 10 percent furazolidone in inert dispersing agent and propellant.

(b) Sponsors. (1) See No. 051031 in 510.600(c) of this chapter for use as in paragraphs (c)(1), (c)(2)(i), (c)(2)(ii), and (c)(3) of this section.

(2) See No. 017135 for use of the 4 percent product as in paragraph (c)(2)(iv) of this section.

(c) Conditions of use --(1) Amount. Hold container about 6 to 12 inches from the eye or affected area and apply only enough powder to impart a light yellow color.

(2) Indications of use --(i) Dogs. For treatment or prevention of bacterial infection of superficial wounds, abrasions, lacerations, and pyogenic dermatitis.

(ii) Horses. For treatment or prevention of bacterial infection of superficial wounds, abrasions, lacerations, and following firing (heat or electrocautery).

(iii) [Reserved]

(iv) Horses and ponies. For treatment or prevention of bacterial infection of superficial wounds, abrasions, and lacerations caused by Staphylococcus aureus, Streptococcus spp. and Proteus spp. sensitive to furazolidone.

(3) Limitations. For topical application in horses, ponies, and dogs: Clean affected area thoroughly, apply drug once or twice daily, and repeat treatment as required. Use only as recommended by a veterinarian in treatment of puncture wounds, wounds requiring surgical debridement or suturing, those of a chronic nature involving proud flesh, generalized and chronic infections of the skin, and those skin conditions associated with intense itching. If redness, irritation, or swelling persists or increases, discontinue use and consult a veterinarian. Do not use in horses intended for human consumption.

[45 FR 49543, July 25, 1980, as amended at 50 FR 30153, July 24, 1985; 56 FR 50653, Oct. 8, 1991; 57 FR 31314, July 15, 1992; 60 FR 55659, Nov. 2, 1995; 65 FR 41588, July 6, 2000; 79 FR 10969, Feb. 27, 2014; 82 FR 11508, Feb. 24, 2017]

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