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Electronic Code of Federal Regulations

e-CFR data is current as of December 5, 2019

Title 21Chapter ISubchapter EPart 524 → §524.1044i


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


§524.1044i   Gentamicin and betamethasone ophthalmic solution.

(a) Specifications. Each milliliter (mL) of solution contains gentamicin sulfate equivalent to 3 milligrams (mg) of gentamicin base and 1 mg betamethasone acetate equivalent to 0.89 mg betamethasone alcohol.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Instill one or two drops of solution in the conjunctival sac three or four times a day.

(2) Indications for use. For treatment of external eye infections and inflammation.

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

[75 FR 54492, Sept. 8, 2010, as amended at 80 FR 13230, Mar. 13, 2015]

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