 |
Code of Federal Regulations (Last Updated: May 6, 2024) |
 |
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 |
|
Part 524 - Ophthalmic and Topical Dosage Form New Animal Drugs |
|
Fluocinolone Topical and Otic Dosage Forms |
§ 524.1044i - Gentamicin and betamethasone ophthalmic solution.
Latest version.
-
§ 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]