CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR524.1044c]

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

Fluocinolone Topical and Otic Dosage Forms

Sec. 524.1044c Gentamicin ophthalmic ointment.

(a) Specifications. Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin.

(b) Sponsors. See Nos. 000061 and 017033 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs and cats - (1) Amount. Apply approximately a 1/2-inch strip to the affected eye 2 to 4 times a day.

(2) Indications for use. For treatment of conjunctivitis caused by susceptible bacteria.

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

[69 FR 47363, Aug. 5, 2004, as amended at 77 FR 64717, Oct. 23, 2012; 85 FR 4208, Jan. 24, 2020; 88 FR 16549, Mar. 20, 2023]