CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS > 524.575—Cyclosporine ophthalmic ointment.

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 to 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. Place ointment directly on cornea or into the conjunctival sac. Safety of use in puppies, pregnant or breeding animals has not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[60 FR 48651, Sept. 20, 1995, as amended at 62 FR 48940, Sept. 18, 1997]