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21 C.F.R. § 524.1580b   Nitrofurazone ointment.

Title 21 - Food and Drugs

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

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§ 524.1580b   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. 000010, 000069, 050749, 054925, 058005, and 061623 for use on dogs, cats, or horses.

(2) See No. 017135 for use on dogs and 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 (not for food use). 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, as amended at 49 FR 6476, Feb. 22, 1984; 50 FR 49373, Dec. 2, 1985; 52 FR 18691, May 19, 1987; 53 FR 32610, Aug. 26, 1988; 53 FR 40728, Oct. 18, 1988; 54 FR 29544, July 13, 1989; 54 FR 37097, Sept. 7, 1989; 55 FR 8462, Mar. 8, 1990; 55 FR 20455, May 17, 1990; 56 FR 37473, Aug. 7, 1991; 56 FR 50653, Oct. 8, 1991; 59 FR 33197, June 28, 1994; 60 FR 55659, Nov. 2, 1995; 62 FR 35077, June 30, 1997; 66 FR 14074, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 68 FR 36913, June 20, 2003; 69 FR 47362, Aug. 5, 2004; 70 FR 50183, Aug. 26, 2005; 71 FR 13542, Mar. 16, 2006]

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