NADA Number: 141-174

Proprietary Name Acarexx®
Acarexx™
Sponsor Boehringer Ingelheim Vetmedica, Inc.
Sponsor Address 7009 Albert Pick Road
Greensboro, NC    27409
USA
Ingredients Ivermectin
Species Cat and kitten, excluding under 4 weeks of age
Routes of Administration Topical
Dose Form Liquid (suspension)
Drug Form Liquid (suspension)
Dispensing Status RX
Patent Number 4761288
4897269
4937078
Exclusivity Granted for the treatment of adult ear mite (Otodectes cynotis) infestations in cats and kittens four weeks of age or older.
Dosage Amount,
Indications
& Limitations

524.1195 Ivermectin otic suspension.

Specifications: Each tube contains 0.5 milliliter of a 0.01 percent suspension of ivermectin.

Conditions of use Amount: Administer the contents of one 0.5-milliliter tube topically into each external ear canal.

Indications: For the treatment of adult ear mite (Otodectes cynotis) infestations in cats and kittens 4 weeks of age and older. Effectiveness against eggs and immature stages has not been proven.

Limitations: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Tolerances

A tolerance is established for 22,23-dihydroavermectin B1a (marker residue) in liver (target tissue) as follows: a. In cattle 100 parts per billion. b. In swine 20 parts per billion. c. In sheep 30 parts per billion. d. In reindeer 15 parts per billion. e. In American bison 15 parts per billion. Muscle residues are not indicative of the safety of other edible tissues. A tolerance is established for 22,23-dihydroavermectin B1a (marker residue) in muscle as follows: a. Swine 20 parts per billion b. Cattle 10 parts per billion