---
kind: "section"
citation: "21 C.F.R. § 524.575"
title: "21"
number: "524.575"
heading: "Cyclosporine ophthalmic ointment."
url: "https://uscodex.org/cfr/21/524.575"
---

# §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)](/cfr/21/510.600.md?p=c) of this chapter.
- (c) **Conditions of use—**
  - (1) **Amount.** Apply a 1/4-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.

## Notes

### Amendments

[60 FR 48651, Sept. 20, 1995, as amended at 62 FR 48940, Sept. 18, 1997; 79 FR 10967, Feb. 27, 2014]

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13873, Mar. 27, 1975, unless otherwise noted.

### Amendments

[60 FR 48651, Sept. 20, 1995, as amended at 62 FR 48940, Sept. 18, 1997; 79 FR 10967, Feb. 27, 2014]