CFR

524.155—Bacitracin zinc-polymyxin B sulfate-neomycin sulfate-hydrocortisone or hydrocortisone acetate ophthalmic ointment.

(a) Sponsor. To firms identified in § 510.600(c) of this chapter as follows:

(1) To 000061; each gram of ointment contains 400 units of bacitracin zinc, 10,000 units of polymyxin B sulfate, 5 milligrams of neomycin sulfate (equivalent to 3.5 milligrams of neomycin base), and 10 milligrams of hydrocortisone.

(2) To 025463; each gram of ointment contains 400 units of bacitracin zinc, 10,000 units of polymyxin B sulfate, 5 milligrams of neomycin sulfate (equivalent to 3.5 milligrams of neomycin base), and 10 milligrams of hydrocortisone acetate.

(b) Conditions of use. Dogs and cats— (1) Amount. Apply a thin film over the cornea three or four times daily.

(2) Indications for use. For treating acute or chronic conjunctivitis caused by susceptible organisms.

(3) Limitations. All topical ophthalmic preparations containing corticosteroids with or without an antimicrobial agent are contraindicated in the initial treatment of corneal ulcers. They should not be used until the infection is under control and corneal regeneration is well underway. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[57 FR 37333, Aug. 18, 1992, as amended at 61 FR 8873, Mar. 6, 1996; 62 FR 61626, Nov. 19, 1997]

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