21 C.F.R. § 524.154

Current through September 30, 2024
Section 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 086189 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.

21 C.F.R. §524.154

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; 88 FR 84701, Dec. 6, 2023
88 FR 84701, 12/6/2023