(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) flunixin (equivalent to 83 mg flunixin meglumine).

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.286 of this chapter.

(d) Conditions of use—(1) Amount. Apply only once at a dose of 3.3 mg flunixin per kg body weight (1.5 mg/lb; 3 mL per 100 lbs) topically in a narrow strip along the dorsal midline from the withers to the tailhead.

(2) Indications for use. For the control of pyrexia associated with bovine respiratory disease and acute bovine mastitis, and the control of pain associated with foot rot in beef cattle 2 months of age and older and dairy cattle.

(3) Limitations. Not for use in beef and dairy bulls intended for breeding over 1 year of age. Milk that has been taken during treatment and for 48 hours after treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 8 days of treatment. Not for use in replacement dairy heifers 20 months of age or older or dry dairy cows; use in these cattle may cause drug residues in calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Approved only as a single topical dose in cattle. Repeated treatments may result in violative residues in milk or in edible tissues. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[83 FR 13635, Mar. 30, 2018, as amended at 88 FR 16549, Mar. 20, 2023]