21 CFR 524.960
§ 524.960 Flumethasone, neomycin, and polymyxin B ophthalmic solution.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 524.960, § 524.960 Flumethasone, neomycin, and polymyxin B ophthalmic solution, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87590
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.