eCFR - Qualomics

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Title 21: Food and Drugs

« Home / Title 21 - Food and Drugs--Volume 6 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS / PART 524 - OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS / § 524.154 Bacitracin, neomycin, and polymyxin B ophthalmic ointment.

§ 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.

(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]