Title 21

SECTION 524.1484j

524.1484j Neomycin and prednisolone ophthalmic ointment.

§ 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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