21 C.F.R. § 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
(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.