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Title 21: Food and Drugs
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 or bacitracin zinc-neomycin sulfate-polymyxin B sulfate ophthalmic ointment.
(a) Sponsor. To firms identified in ? 510.600(c) of this chapter as follows:
(1) To 000009; each gram contains 500 units of bacitracin, 3.5 milligrams of neomycin, and 10,000 units of polymyxin B.
(2) To 000061 and 025463; each gram contains 400 units of bacitracin zinc, 3.5 milligrams of neomycin, and 10,000 units of polymyxin B sulfate.
(b) Conditions of use. 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. Laboratory tests should be conducted including in vitro culturing and susceptibility tests on samples collected prior to treatment. 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]
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