Bimeda, Inc.

Tolerance and toxicity studies have demonstrated the margin of safety for eprinomectin in cattle. In toxicity studies, application of 3 times the recommended dose had no adverse effects on neonatal calves, and application of up to 5 times the recommended dose 3 times at 7 day intervals had no adverse effects on 8 week old calves. In the tolerance study, one of 6 cattle treated once at 10 times the recommended dose showed clinical signs of mydriasis. Application of 3 times the recommended dose had no adverse effect on breeding performance of cows or bulls.

RESIDUE WARNINGS:
When used according to label directions, neither a pre-slaughter drug withdrawal period nor a milk discard time is required, therefore, meat and milk from cattle treated with Eprimectin Pour-On (eprinomectin) may be used for human consumption at any time following treatment. A withdrawal period has not been established for pre-ruminating calves. Do not use in calves to be processed for veal.

WARNING:
Keep this and all drugs out of the reach of children.
NOT FOR USE IN HUMANS. As with any topical medication intended for treatment of animals, skin contact should be avoided. If accidental skin contact occurs, wash immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with water. The Safety Data Sheet (SDS) contains more detailed occupational safety information. To obtain a Safety Data Sheet(s), contact Bimeda, Inc. at 1-888-524-6332. CONTACT INFORMATION
Contact Bimeda, Inc. at 1-888-524-6332. To report suspected adverse drug experiences, contact Bimeda, Inc. at 1-888-524-6332. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS, or www.fda.gov/reportanimalae

PRECAUTIONS
This product is for topical application only. Do not administer orally or by injection.
Do not apply to areas of the backline covered with mud or manure.
Eprimectin Pour-On is not recommended for use in species other than cattle. Severe adverse reactions have been reported in other species treated with products containing compounds of this class.
Restricted Drug (California) - Use only as directed.

Eprimectin Pour-On is effective against all stages of cattle grubs. However, proper timing of treatment is important. For the most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble fly) season. While this is not peculiar to eprinomectin, destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions. Killing Hypoderma lineatum when it is in the esophageal tissues may cause bloat; killing H. bovis when it is in the vertebral canal may cause staggering or paralysis. Cattle should be treated either before or after these stages of grub development.
Cattle treated with Eprimectin Pour-On at the end of the fly season may be re-treated with Eprimectin Pour-On during the winter without danger of grub-related reactions. For further information and advice on a planned parasite control program, consult your veterinarian.

Studies indicate that when eprinomectin comes in contact with soil, it readily and tightly binds to the soil and becomes inactive over time. Free eprinomectin may adversely affect fish and certain aquatic organisms. Do not permit cattle to enter lakes, streams or ponds for at least 6 hours after treatment. Do not contaminate water by direct application or by the improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration.
As with other avermectins, eprinomectin is excreted in the dung of treated animals and can inhibit the reproduction and growth of pest and beneficial insects that use dung as a source of food and for reproduction. The magnitude and duration of such effects are species and life-cycle specific. When used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependent insects.

Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers.
Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance.
Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method).
A decrease in a drug’s effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.

ADVERSE REACTIONS
No adverse reactions were observed during clinical trials.

STORAGE CONDITIONS
Store pack/container in the carton in an upright position to protect from light and at temperatures up to 77°F/25°C. Storage at temperatures up to 104°F/40°C is permitted for a short period of time, however, such exposure should be minimized. Use within 6 months of opening.

HOW SUPPLIED
Eprimectin Pour-On (eprinomectin) for Beef and Dairy Cattle is available in a 2.5 L or 5 L backpack, or 10 L container intended for use with appropriate automatic dosing equipment. Approved by FDA under ANADA # 200-626

Manufactured by:
Bimeda, Inc.
Le Sueur, MN 56058
www.bimeda.com
Rev 03/25

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