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Electronic Code of Federal Regulations

e-CFR data is current as of December 10, 2019

Title 21Chapter ISubchapter EPart 524 → §524.154


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


§524.154   Bacitracin, neomycin, and polymyxin B ophthalmic ointment.

(a) Specifications. Each gram of ointment contains:

(1) 500 units bacitracin, 3.5 milligrams (mg) neomycin sulfate (equivalent to 3.5 mg neomycin base), and 10,000 units polymyxin B sulfate; or

(2) 400 units bacitracin zinc, 5 mg neomycin sulfate (equivalent to 3.5 mg neomycin base), and 10,000 units polymyxin B sulfate.

(b) Sponsors. See sponsor numbers in §510.600(c) of this chapter as follows:

(1) No. 054771 for use of product described in paragraph (a)(1) as in paragraph (c) of this section.

(2) Nos. 000061, 043264, and 059399 for use of product described in paragraph (a)(2) as in paragraph (c) of this section.

(c) Conditions of use in dogs and cats—(1) Amount. Apply a thin film over the cornea 3 or 4 times daily.

(2) Indications for use. Treatment of superficial bacterial infections of the eyelid and conjunctiva of dogs and cats when due to susceptible organisms.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37333, Aug. 18, 1992, as amended at 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, Feb. 27, 2014; 80 FR 61297, Oct. 13, 2015]

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