§524.1044i. Gentamicin and betamethasone ophthalmic solution.
21 C.F.R. § 524.1044i
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.
Sponsor. See No. 000061 in § 510.600(c) of this chapter.
Conditions of use in dogs—
Amount. Instill one or two drops of solution in the conjunctival sac three or four times a day.
Indications for use. For treatment of external eye infections and inflammation.
Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Notes, amendments, and revision history
Amendments
[75 FR 54492, Sept. 8, 2010, as amended at 80 FR 13230, Mar. 13, 2015]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13873, Mar. 27, 1975, unless otherwise noted.
Amendments
[75 FR 54492, Sept. 8, 2010, as amended at 80 FR 13230, Mar. 13, 2015]