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.
*EXZOLT CATTLE-CA1 is conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-617.
Who is Exzolt Cattle-CA1 (fluralaner topical solution) for?
Cattle
Why use Exzolt Cattle-CA1 (fluralaner topical solution)?
A first-of-its-kind FDA conditionally approved pour-on for New World screwworm and cattle fever tick.
How does Exzolt Cattle-CA1 (fluralaner topical solution) work?
Exzolt Cattle-CA1 is a pour-on that delivers the active ingredient fluralaner to act systemically against New World screwworm and cattle fever tick infestations.
Merck Animal Health
Fluralaner
How is Exzolt Cattle-CA1 (fluralaner topical solution) sold?
Sold in 1 litre or 5 litre bottles.
What are the side effects of Exzolt Cattle-CA1 (fluralaner topical solution)?
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.
What special precautions are there?
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.
Immediately contact your closest emergency animal hospital. You may also contact Merck Animal Health Pharmacovigilance: Livestock Technical Services, 800-211-3573
How can I store Exzolt Cattle-CA1 (fluralaner topical solution)?
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 litre dosing applicator (sold seperately) when loaded with product at or below 30°C (86°F) and use within 1 week.
Dosage and Administration: Exzolt Cattle-CA1 is a ready-to-use topical formulation intended for single use only for direct application to the hair and skin in a narrow strip extending along the dorsal midline from the withers to the base of the tail (see Figure 1). The recommended rate of administration is 1 mL/44.1 lbs. (1 mL/20 kg) body weight, which is equivalent to 1.13 mg of fluralaner for each pound (2.5 mg/kg) body weight.
Effectiveness has not been evaluated in cattle with wet hides.
Administration of the product with 1L bottles with built-in dosing chamber: To ensure administration of a correct dose, body weight should be determined as accurately as possible, and accuracy of the dosing volume should be checked before administration. Round the dose up to the nearest volume increment on the dosing chamber, which goes up in 2.5 mL increments. The table on the label can be consulted to assist in the calculation of the appropriate volume which must be applied based on the weight of animal being treated.
Each mL of Exzolt Cattle-CA1 contains 50 mg of fluralaner.
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ORM-D CONSUMER COMMODITY containing hazardous or flammable materials will be shipped in packages bearing the label ORM-D CONSUMER COMMODITY (Other Regulated Materials for domestic transport only) which means the packages contain hazardous or flammable materials in a limited quantity that presents a limited hazard during transportation due to its form, quantity, and packaging. ORM-D product(s) must be shipped by ground transportation only, and can’t be shipped internationally.
