§ 524.2640 - Tylosin, neomycin eye powder.

(a) Specifications. Tylosin is the antibiotic substance produced by growth of Streptromyces fradiae or the same antibiotic substance produced by any other means. Tylosin, present as the tartrate salt, conforms to the appropriate antibiotic standard. Tylosin contains at least 95 percent tylosin as a combination of tylosin A, tylosin B, tylosin C, and tylosin D of which at least 80 percent is tylosin A as determined by a method entitled “Determination of Factor Content in Tylosin by High Performance Liquid Chromatography,” which is incorporated by reference. Copies are available from the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20001.

(b) Sponsor. See No. 000986 in § 510.600(c) of this chapter.

(c) Conditions of use. (1) It is used in cattle for the treatment of pinkeye (infectious keratoconjunctivitis).

(2) It is administered by holding the eyelids open and dusting powder into both eyes. The treatment is repeated daily for up to 7 days depending on the severity of the infection. Affected animals should be protected from direct sunlight, dust, and flies. In an affected herd, all animals with or without signs of the disease should receive at least one treatment.

(3) If there is severe eye damage or if the condition persists or increases, discontinue administering the drug and consult a veterinarian.