21 C.F.R. § 524.1880   Prednisolone-neomycin sulfate ophthalmic ointment.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 524.1880   Prednisolone-neomycin sulfate ophthalmic ointment.

(a) Specifications. Prednisolone-neomycin sulfate ophthalmic ointment contains 2 milligrams prednisolone and 5 milligrams neomycin sulfate (equivalent to 3.5 milligrams neomycin base) in each gram of ointment.

(b) Sponsor. See No. 017030 in §510.600(c) of this chapter.

(c) Conditions of use. The drug is recommended for use in superficial ocular inflammations or infections limited to the conjunctiva or the anterior segment of the eye of cats and dogs, such as those associated with allergic reactions or gross irritants. A small quantity of the ointment should be expressed into the conjunctival sac four times a day for 7 days. After 7 days, if clinical improvement is not noted, reevaluation of the diagnosis should be considered. 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. For use only by or on the order of a licensed veterinarian.

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