EPRINEX Pour-On For Beef and Dairy Cattle: Product Information (Page 2 of 2)

20 Liter Pack (20 L/676 fl oz Pack)

Connect the dosing applicator and draw-off tubing to the container as follows:

Attach the open end of the draw-off tubing to an appropriate dosing applicator. Attach draw-off tubing to the cap with the stem. Replace the shipping cap with the cap having the draw-off tubing.

Gently prime the dosing applicator, checking for leaks. Follow the dosing applicator manufacturer’s directions for adjusting the dose and proper use and maintenance of the dosing applicator and draw-off tubing.

ANIMAL SAFETY

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 EPRINEX (eprinomectin) Pour-On 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 report suspected adverse drug events, for technical assistance, or to obtain a copy of the SDS, contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or online at 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.

EPRINEX 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.

When to Treat Cattle with Grubs

EPRINEX 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 EPRINEX Pour-On at the end of the fly season may be re-treated with EPRINEX 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.

OTHER WARNINGS

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/flock, 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.

Environmental Safety

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.

ADVERSE REACTIONS

No adverse reactions were observed during clinical trials.

STORAGE CONDITIONS

Store bottle or pack in the carton to protect from light and at temperatures up to 86°F/30°C. Storage at temperatures up to 104°F/40°C is permitted for a short period of time, however, such exposure should be minimized.

For the 250 mL/8.5 fl oz (126623) or 1 L/33.8 fl oz (126865) bottle with a measure-squeeze-pour system, the Metering Cup should not remain attached to the container when not in use. Detach the Metering Cup after each use and replace the shipping cap to close the container top.

HOW SUPPLIED

EPRINEX (eprinomectin) Pour-On for Beef and Dairy Cattle is available in a 250 mL/8.5 fl oz (126623) or 1 L/33.8 fl oz (126865) bottle with a measure-squeeze-pour system, or in a 2.5 L/84.5 fl oz (126624), 5 L/169 fl oz (126622), or 10 L/338 fl oz (154210) collapsible pack or 20 L/676 fl oz (126619) container intended for use with appropriate automatic dosing equipment.

Marketed by: Boehringer Ingelheim Animal Health USA Inc.
Duluth, GA 30096

Made in New Zealand/ Made in USA

®EPRINEX is a registered trademark of Boehringer Ingelheim Animal Health USA Inc.

©2019 Boehringer Ingelheim Animal Health USA Inc. All Rights Reserved.

1050-2355-10/ 1050-9149-03

Rev. 09-2019

Principal Display Panel — 250 mL Bottle Carton

Product 126623

Eprinex®

Pour-On for Beef
and Dairy Cattle
(eprinomectin)

Parasiticide
Contains 5 mg eprinomectin/mL

For Treatment and Control of Internal and External Parasites

Residue Information:
Not for use in calves to be processed for veal.
Zero Slaughter Withdrawal
Zero Milk Discard

Contains 10 Doses (550 lb)

Approved by FDA under NADA # 141-079

250 mL (8.5 fl oz)

Picture of 250 mL display carton
(click image for full-size original)

Principal Display Panel – 250 mL Container Label

Product 126623

Eprinex®

Pour-On for Beef
and Dairy Cattle
(eprinomectin)

Parasiticide
Contains 5 mg eprinomectin/mL

For Treatment and Control of Internal and External Parasites

Residue Information:
Not for use in calves to be processed for veal.
Zero Slaughter Withdrawal
Zero Milk Discard

Approved by FDA under NADA # 141-079

250 mL (8.5 fl oz)

Picture of 250 mL front container label
(click image for full-size original)
Picture of 250 mL back container label
(click image for full-size original)
EPRINEX POUR-ON FOR BEEF AND DAIRY CATTLE
eprinomectin solution
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:0010-4751
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
eprinomectin (eprinomectin) eprinomectin 5 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0010-4751-01 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 250 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0010-4751-01)
2 NDC:0010-4751-02 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
2 1000 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0010-4751-02)
3 NDC:0010-4751-03 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
3 2500 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0010-4751-03)
4 NDC:0010-4751-04 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
4 5000 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0010-4751-04)
5 NDC:0010-4751-05 20000 mL in 1 BOTTLE, PLASTIC None
6 NDC:0010-4751-06 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
6 10000 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0010-4751-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141079 05/20/2020
Labeler — Boehringer Ingelheim Animal Health USA Inc. (007134091)

Revised: 07/2020 Boehringer Ingelheim Animal Health USA Inc.

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