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Electronic Code of Federal Regulations

e-CFR data is current as of December 9, 2019

Title 21Chapter ISubchapter EPart 524 → §524.1484j


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


§524.1484j   Neomycin and prednisolone ophthalmic ointment.

(a) Specifications. Each gram of ointment contains prednisolone sodium phosphate equivalent to 2.5 milligrams prednisolone 21-phosphate and 5 milligrams neomycin sulfate equivalent to 3.5 milligrams neomycin base.

(b) Sponsor. See No. 000010 in §510.600(c) of this chapter.

(c) Conditions of use in dogs and cats—(1) Amount. A small quantity of the ointment should be expressed into the conjunctival sac 4 times a day (at intervals of 1 to 8 hours) for a few days until there is a favorable response, then the frequency of application may be reduced to twice daily as long as the condition remains under control. Treatment may require from a few days to several weeks.

(2) Indications for use. For use in superficial ocular inflammations or infections limited to the conjunctiva or the anterior segment of the eye, such as those associated with allergic reactions or gross irritants.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 10971, Feb. 27, 2014, as amended at 84 FR 39184, Aug. 9, 2019]

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