Exzolt Cattle-CA1, Fluralaner Topical Solution

Exzolt Cattle-CA1 is indicated for the prevention and treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) and treatment and control of cattle fever tick (Rhipicephalus microplus) in beef cattle 2 months of age and older and replacement dairy heifers less than 20 months of age. Not for use in bulls intended for breeding 1 year of age and older, dairy calves, and veal calves. Exzolt Cattle-CA1 (fluralaner topical solution) contains fluralaner, an antiparasitic of the isoxazoline class. Each mL of Exzolt Cattle-CA1 contains 50 mg of fluralaner. Applicator for 5 liter bottle sold separately.

EXZOLT CATTLE-CA1 is conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-617.

How Its Sold

Sold in 1 liter or 5 liter bottles.

Special Precautions

Not for use in humans. Keep out of reach of children. Accidental exposure may cause skin and eye irritation. Highly flammable. Keep away from heat, sparks, open flame or other sources of ignition. Use only for the prevention and treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) and treatment and control of cattle fever tick (Rhipicephalus microplus) in beef cattle 2 months of age and older and replacement dairy heifers less than 20 months of age. Not for use in bulls intended for breeding 1 year of age and older, dairy calves, and veal calves. Cattle must not be slaughtered for human consumption within 98 days of treatment. If cattle are continuously exposed to temperatures at or above 60° F after product administration, then cattle may be slaughtered for human consumption 44 days after treatment. Violative residues may result if cattle are exposed to temperatures below 60° F after administration and are slaughtered at 44 days. For complete safety information and product dosing instructions, refer to the product label.

This drug product is a skin and eye irritant; special care should be taken to avoid contact. Personal protective equipment should be worn, such as gloves, long sleeve shirt and pants, as well as glasses or goggles to prevent skin, eye and mucous membrane contact and/or drug absorption, while handling the product. In case of skin contact, wash with soap and water. If contact with eyes occurs, immediately rinse thoroughly with water. In case of accidental spill, immediately remove affected clothing and wash contacted skin with soap and water. In case of accidental ingestion, immediately rinse the mouth with plenty of water and seek medical advice.

Do not eat, drink, or smoke while handling the product. Wash hands thoroughly with soap and water immediately after use of the product.

Side Effects

Exzolt Cattle-CA1 (fluralaner) is generally safe for cattle, with studies showing no significant adverse effects even at 5x the dosage. However, mild, transient application site reactions like skin flaking, scabbing, or irritation may occur.

Overdose Information

Immediately contact your closest emergency animal hospital. You may also contact Merck Animal Health Pharmacovigilance: Livestock Technical Services, 800-211-3573

Storage

Store at or below 30°C (86°F), with excursions to 40°C (104°F). Use within 6 months after first opening. Store the 5 liter dosing applicator (sold separately) when loaded with product at or below 30°C (86°F) and use within 1 week.

Active Ingredients

Fluralaner