GroundRules
21 CFR 524.1044a: a Gentamicin ophthalmic solution.
Where this section sits in the code
- 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
(a) Specifications. Each milliliter of solution contains gentamicin sulfate equivalent to 3 milligrams of gentamicin.
(b) Sponsors. See Nos. 000061 and 086189 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats—(1) Amount. Administer 1 or 2 drops into the conjunctival sac 2 to 4 times a day.
(2) Indications for use. For the topical treatment of infections of the conjunctiva caused by susceptible bacteria.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Collected 2026-08-27T02:24:47Z. Source file · JSON