eCFR Reference Browser

---

title: "21 CFR §524.575"

source: "https://www.ecfr.gov/current/title-21/section-524.575"

title_number: "21"

volume_number: "6"

chapter_number: "Unknown"

subchapter_code: "E"

subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"

part_code: "524"

part_subject: "OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS"

subpart_code: "B"

subpart_subject: "Specific Administrative Rulings and Decisions"

section_number: "524.575"

section_subject: "Cyclosporine ophthalmic ointment."

cfr_reference: "21 CFR 524.575"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 500 to 599"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§524.575 - Cyclosporine ophthalmic ointment.