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e-CFR data is current as of August 6, 2020

Title 21Chapter ISubchapter EPart 524 → §524.575


Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS


§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 14 -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]

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