EXZOLT™ CATTLE-CA1

(fluralaner topical solution)

Product Description

A first-of-its-kind FDA conditionally approved pour-on for New World screwworm and cattle fever tick.

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.

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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.

Figure 1. Recommended site of administration

Recommended location for the topical application in a narrow strip along the dorsal midline from the withers to the base of the tail.

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 below can be consulted to assist in the calculation of the appropriate volume which must be applied based on the weight of animal being treated.

Body Weight (Pounds)	Dose Volume (mL)
220	5
330	7.5
440	10
550	12.5
660	15
770	17.5
880	20
990	22.5
1100	25
1320*	30

*Add 2.5 mL for each 110 pounds above 1320 pounds of body weight.

Administration of the product with 5L bottle with an applicator device

These bottles are designed for use with the Simcro Breaze™ Applicator Device (30 mL). This applicator device and delivery tubing (sold separately by Simcro as a kit) should be used with the 5L bottle. The 5L bottle is supplied with spigot cap attached to dip tube for its use with the applicator device. A strap is also included for use of the 5L bottle as a backpack.

The table below can be consulted to assist in the calculation of the appropriate volume which must be applied based on the weight of animal being treated.

Body Weight (Pounds)	Dose Volume (mL)
220	5
440	10
660	15
880	20
1100	25
1320*	30

*Add 1 mL for each 44 pounds above 1320 pounds of body weight.

See product label for 1L and 5L administration and overfill reduction instructions.

Supplied

1L bottles
5L bottles

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 dosing applicator when loaded with product at or below 30°C (86°F) and use within 1 week.

WITHDRAWAL PERIODS AND RESIDUE WARNINGS

Cattle must not be slaughtered for human consumption within 98 days of treatment. Not for use in female dairy cattle 20 months of age or older, including dry dairy cows; use in these cattle may cause drug residues in milk and/or 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 edible tissues.

Safety

Not for use in humans. Keep out of reach of children. 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.

The product is highly flammable. Keep away from heat, sparks, open flame or other sources of ignition.

To obtain a Safety Data Sheet (SDS) or for technical assistance, call Merck Animal Health at 1-800-211-3573.

Contact

Contact Merck Animal Health at 1-800-211-3573 or https://www.merck-animal-health-usa.com/contact/. To report suspected adverse drug experiences, contact Livestock Technical Service at 1-800-211-3573. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or https://www.fda.gov/reportanimalae.

Important Safety Information

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. For complete safety information and product dosing instructions, refer to the product label.