21 CFR 524.575 - Cyclosporine ophthalmic ointment.

Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024

View all text of Part 524 [§ 524.86 - § 524.2620]

§ 524.575 - Cyclosporine ophthalmic ointment.

(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.

[60 FR 48651, Sept. 20, 1995, as amended at 62 FR 48940, Sept. 18, 1997; 79 FR 10967, Feb. 27, 2014]

authority: 21 U.S.C. 360b.

source: 40 FR 13873, Mar. 27, 1975, unless otherwise noted.

cite as: 21 CFR 524.575