Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 524  /  Sec. 524.154 Bacitracin, neomycin, and polymyxin B ophthalmic ointment.

(a) Specifications. Each gram of ointment contains:

(1) 500 units of bacitracin, 3.5 milligrams of neomycin, and 10,000 units of polymyxin B sulfate; or

(2) 400 units of bacitracin zinc, 3.5 milligrams of neomycin, and 10,000 units of polymyxin B sulfate.

(b) Sponsors. See sponsor numbers in Sec. 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 and 043264 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.

(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]