GroundRules
21 CFR 524.960: Flumethasone, neomycin, and polymyxin B 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 ophthalmic preparation contains 0.10 milligram flumethasone, 5.0 milligrams neomycin sulfate (3.5 milligrams neomycin base), and 10,000 units of polymyxin B sulfate, with or without hydroxypropyl methylcellulose.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount—(i) Preparation containing hydroxypropyl methylcellulose. Dogs: 1 to 2 drops per eye, every 6 hours.
(ii) Preparation without hydroxyproply methylcellulose. Dogs and cats: 2 to 3 drops per eye, every 4 hours.
(2) Indications for use. Treatment of the inflammation, edema, and secondary bacterial infections associated with topical ophthalmological conditions of the eye such as corneal injuries, incipient pannus, superficial keratitis, conjunctivitis, acute nongranulomatous anterior uveitis, kerato- conjunctivitis, and blepharitis.
(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