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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2019]
[CITE: 21CFR524.1484k]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E--ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 524 -- OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 524.1484k Neomycin and prednisolone suspension.

(a) Specifications. Each milliliter of suspension contains 2.5 milligrams of prednisolone acetate and 5 milligrams of neomycin sulfate equivalent to 3.5 milligrams of neomycin base.

(b) Sponsor. See No. 054771 in 510.600(c) of this chapter.

(c) Conditions of use in dogs and cats --(1) Amount. For beginning treatment of acute ocular inflammations place 1 or 2 drops in the conjunctival sac 3 to 6 times during a 24 hour period. When improvement occurs, reduce the dosage to 1 drop 2 to 4 times daily. For otitis externa, place 2 to 6 drops in the external ear canal 2 or 3 times daily.

(2) Indications for use. For the treatment of treating infectious, allergic and traumatic keratitis and conjunctivitis, acute otitis externa, and chronic otitis externa.

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

[79 FR 10971, Feb. 27, 2014]

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