21 C.F.R. § 524.1044i

Current through September 30, 2024
Section 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.

21 C.F.R. §524.1044i

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