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Code of Federal Regulations Title 21. Food and Drugs § 21.524.154 Bacitracin, neomycin, and polymyxin B ophthalmic ointment

Current as of January 02, 2025 | Updated by Findlaw Staff

(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.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.524.154 Bacitracin, neomycin, and polymyxin B ophthalmic ointment - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-524-154/

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