21 C.F.R. § 524.1200b Kanamycin ophthalmic aqueous solution.
Title 21 - Food and Drugs
(a) Specifications. The drug, which is in an aqueous solution including suitable and harmless preservatives and buffer substances, contains 10 milligrams of kanamycin activity (as the sulfate) per milliliter of solution. (b) Sponsor. See No. 000856 in §510.600(c) of this chapter. (c) Conditions of use. It is indicated for use in dogs in various eye infections due to kanamycin sensitive bacteria. It is used in treating conditions such as conjunctivities, blepharitis, dacryocystitis, keratitis, and corneal ulcerations and as a prophylactic in traumatic conditions, removal of foreign bodies, and intraocular surgery. 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. For use only by or on the order of a licensed veterinarian. [40 FR 13858, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988; 64 FR 404, Jan. 5, 1999]
Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
§ 524.1200b Kanamycin ophthalmic aqueous solution.
