21 CFR 524.575

§ 524.575 Cyclosporine ophthalmic ointment.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 524.575, § 524.575 Cyclosporine ophthalmic ointment, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87577
Permanent ID: ys:prov:87577@1
SHA-256: 28e2b74e7ffdf3d0671ef30be2fb473c5fbbb86907f1b0c8d1c57879ecbc7f7d

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Full text

(a) Specifications. Each gram of ointment contains 2 milligrams of cyclosporine. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Apply a 1/4-inch strip of ointment directly on the cornea or into the conjunctival sac of the affected eye(s) every 12 hours. (2) Indications for use. For management of chronic keratoconjunctivitis sicca (KCS) and chronic superficial keratitis (CSK) in dogs. (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.