§524.575. Cyclosporine ophthalmic ointment.

21 C.F.R. § 524.575

(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.

Notes, amendments, and revision history

[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.

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