§ 524.575 Cyclosporine ophthalmic ointment.
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Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.
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Specifications.(a) Each gram of ointment contains 2 milligrams of cyclosporine.
Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter.
Conditions of useAmount.1/4(c) —(1) Apply a -inch strip of ointment directly on the cornea or into the conjunctival sac of the affected eye(s) every 12 hours.
Indications for use.(2) For management of chronic keratoconjunctivitis sicca (KCS) and chronic superficial keratitis (CSK) in dogs.
Limitations.(3) 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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