Code of Federal Regulations · Section
§ 524.1044i — i Gentamicin And Betamethasone Ophthalmic Solution
21 C.F.R. § 524.1044i
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(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.
Authorizing Statute
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New animal drugs21 U.S.C. § 360b