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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 Mar 29, 2022.

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

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR524.1044a]



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

Fluocinolone Topical and Otic Dosage Forms

Sec. 524.1044a Gentamicin ophthalmic solution.

(a) Specifications. Each milliliter of solution contains gentamicin sulfate equivalent to 3 milligrams of gentamicin.

(b) Sponsors. See Nos. 000061 and 059399 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs and cats - (1) Amount. Administer 1 or 2 drops into the conjunctival sac 2 to 4 times a day.

(2) Indications for use. For the topical treatment of infections of the conjunctiva caused by susceptible bacteria.

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

[80 FR 18776, Apr. 8, 2015]

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