21 CFR 524.1484e
§ 524.1484e Neomycin and polymyxin B ophthalmic solution.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 524.1484e, § 524.1484e Neomycin and polymyxin B ophthalmic solution, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87634
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Full text
(a) Specifications. Each milliliter of the ophthalmic preparation contains 5.0 milligrams neomycin sulfate (3.5 milligrams neomycin base), and 10,000 Units of polymyxin B sulfate.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1) Amount. Instill 1 to 2 drops per eye every 6 hours.
(2) Indications for use. For the treatment of bacterial infections associated with topical ophthalmological conditions such as corneal injuries, superficial keratitis, conjunctivitis, keratoconjunctivitis, 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.