CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR524.1200b]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 524 -- OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

Fluocinolone Topical and Otic Dosage Forms

Sec. 524.1200b Kanamycin ophthalmic solution.

(a) Specifications. Each milliliter of solution contains 10 milligrams kanamycin activity as kanamycin sulfate.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs - (1) Amount. Instill a few drops into the affected eye every 3 hours or more frequently if deemed advisable. Administer as frequently as possible for the first 48 hours, after which the frequency of applications may be decreased. Treatment should be continued for at least 48 hours after the eye appears normal.

(2) Indications for use. For the treatment of various eye infections (conjunctivitis, blepharitis, dacryocystitis, keratitis, and corneal ulcerations) due to bacteria sensitive to kanamycin. For prophylaxis in traumatic conditions, removal of foreign bodies, and intraocular surgery.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 10970, Feb. 27, 2014]