21 CFR § 524.575 - Cyclosporine ophthalmic ointment.

---
identifier: "/us/cfr/t21/s524.575"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.575 - Cyclosporine ophthalmic ointment."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.575"
section_name: "Cyclosporine ophthalmic ointment."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "524"
part_name: "OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13873, Mar. 27, 1975, unless otherwise noted."
cfr_part: "524"
---


# 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 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.

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