[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR524.575]

[Page 297]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 524_OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 524.575  Cyclosporine ophthalmic ointment.

    (a) Specifications. Each gram of ointment contains 2 milligrams of 
cyclosporine.
    (b) Sponsor. See No. 000061 in Sec. 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.

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