21 C.F.R. § 524.1484e Neomycin sulfate and polymyxin B sulfate ophthalmic solution.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of the ophthalmic preparation contains 5.0 milligrams neomycin sulfate (3.5 milligrams neomycin base), and 10,000 Units of polymyxin B sulfate. (b) Sponsor. See No. 000856 in §510.600(c) of this chapter. (c) Conditions of use. (1) The drug is recommended for the treatment of bacterial infections associated with topical ophthalmological conditions such as corneal injuries, superficial keratitis, conjunctivitis, keratocon- junctivities, and blepharitis in the dog. (2) The recommended dosage is 1 to 2 drops per eye every 6 hours. (3) In treating ophthalmological conditions associated with bacterial infections the drug is contraindicated in those cases in which microorganisms are nonsusceptible to the antibiotics incorporated in the drug. (4) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13873, Mar. 27, 1975, as amended at 61 FR 5507, Feb. 13, 1996]
Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
§ 524.1484e Neomycin sulfate and polymyxin B sulfate ophthalmic solution.
