Eprinex Pour-on for Beef & Dairy Cattle

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

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

Attach the open finish of the draw-off tubing to an appropriate dosing applicator. Attach draw-off tubing to the cap with the stem. Supplant 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 take demonstrated the margin of safe for eprinomectin in cattle. In toxicity studies, application of 3 times the recommended dose had no adverse effects on neonatal calves, and application of upwardly to 5 times the recommended dose 3 times at 7 day intervals had no adverse effects on eight week old calves. In the tolerance study, one of 6 cattle treated one time at 10 times the recommended dose showed clinical signs of mydriasis. Awarding of 3 times the recommended dose had no adverse outcome on breeding performance of cows or bulls.

Residue Warnings: When used according to characterization directions, neither a pre-slaughter drug withdrawal flow nor a milk discard time is required, therefore, meat and milk from cattle treated with EPRINEX (eprinomectin) Cascade-On may be used for homo consumption at whatever time following treatment. A withdrawal period has not been established for pre-ruminating calves. Do not utilize in calves to be processed for veal.

Alert:

Go on 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 optics immediately with water. The Safe Data Sheet (SDS) contains more detailed occupational safety information.

To report suspected agin drug events, for technical assistance, or to obtain a re-create of the SDS, contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251. For boosted information nigh adverse drug experience reporting for animal drugs, contact FDA at ane-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 employ to areas of the backline covered with mud or manure.

EPRINEX Pour-On is not recommended for utilise in species other than cattle. Astringent adverse reactions have been reported in other species treated with products containing compounds of this class.

Restricted Drug (California) — Utilize only every bit directed.

When to Treat Cattle with Grubs

EPRINEX Pour-On is effective confronting all stages of cattle grubs. Even so, proper timing of treatment is important. For the most effective results, cattle should be treated as soon as possible later on the finish of the heel fly (warble fly) season. While this is non 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 evolution.

Cattle treated with EPRINEX Pour-On at the end of the fly season may be re-treated with EPRINEX Cascade-On during the winter without danger of grub-related reactions. For further information and advice on a planned parasite control program, consult your veterinary.

OTHER WARNINGS

Parasite resistance may develop to any dewormer, and has been reported for nearly classes of dewormers.

Treatment with a dewormer used in conjunction with parasite direction practices appropriate to the

geographic area and the brute(s) to be treated may dull 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 whatever dewormer. Following the use of whatsoever dewormer, effectiveness of treatment should be monitored (for case, with the apply of a fecal egg count reduction test or another appropriate method).

A decrease in a drug's effectiveness over time as calculated past fecal egg count reduction tests may

indicate the development of resistance to the dewormer administered. Your parasite management plan should exist adjusted appropriately based on regular monitoring.

Ecology Safety

Studies signal 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 bear on fish and sure aquatic organisms. Do non permit cattle to enter lakes, streams or ponds for at to the lowest degree 6 hours after handling. Do non 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 benign 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 characterization directions, the production is not expected to have an adverse impact on populations of dung-dependent insects.

Agin REACTIONS

No adverse reactions were observed during clinical trials.

STORAGE Atmospheric condition

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

For the 250 mL/viii.5 fl oz (126623) or one L/33.8 fl oz (126865) bottle with a mensurate-clasp-pour system, the Metering Cup should not remain attached to the container when not in employ. Detach the Metering Loving cup after each use and replace the aircraft 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.eight fl oz (126865) bottle with a measure-clasp-pour organisation, or in a 2.5 Fifty/84.5 fl oz (126624), 5 L/169 fl oz (126622), or x L/338 fl oz (154210) collapsible pack or 20 L/676 fl oz (126619) container intended for use with appropriate automatic dosing equipment.

Marketed past: Boehringer Ingelheim Brute Wellness U.s. Inc.
Duluth, GA 30096

Made in New Zealand/ Made in U.s.

®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 Command of Internal and External Parasites

Residue Information:
Non for employ in calves to be processed for veal.
Cypher Slaughter Withdrawal
Zero Milk Discard

Contains x Doses (550 lb)

Approved past FDA nether NADA # 141-079

250 mL (8.v fl oz)

Primary Display Panel – 250 mL Container Label

Production 126623

Eprinex^®

Pour-On for Beefiness
and Dairy Cattle
(eprinomectin)

Parasiticide
Contains five mg eprinomectin/mL

For Treatment and Control of Internal and External Parasites

Rest Information:
Non for apply in calves to be candy for veal.
Nada Slaughter Withdrawal
Zero Milk Discard

Approved by FDA under Naught # 141-079

250 mL (eight.5 fl oz)

EPRINEX Pour-ON FOR Beefiness AND DAIRY CATTLE eprinomectin solution

Product Information Product Type OTC ANIMAL DRUG Detail Lawmaking (Source) NDC:0010-4751 Road of Administration TOPICAL DEA Schedule

Agile Ingredient/Active Moiety Ingredient Name Basis of Strength Forcefulness eprinomectin (eprinomectin) eprinomectin 5 mg in one mL

Packaging # Particular Lawmaking Package Clarification Multilevel Packaging i NDC:0010-4751-01 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 1 250 mL in i 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 Canteen, PLASTIC two 1000 mL in 1 BOTTLE, PLASTIC This package is contained inside the CARTON (0010-4751-02) iii NDC:0010-4751-03 1 BOTTLE, PLASTIC in 1 CARTON contains a Canteen, PLASTIC 3 2500 mL in ane BOTTLE, PLASTIC This package is contained within the CARTON (0010-4751-03) 4 NDC:0010-4751-04 i Bottle, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 4 5000 mL in ane BOTTLE, PLASTIC This package is contained within the CARTON (0010-4751-04) 5 NDC:0010-4751-05 20000 mL in 1 Bottle, PLASTIC None vi NDC:0010-4751-06 one Bottle, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC vi 10000 mL in ane Canteen, PLASTIC This package is independent within the CARTON (0010-4751-06)

Marketing Data Marketing Category Application Number or Monograph Citation Marketing Kickoff Date Marketing End Date Nada NADA141079 05/xx/2020

Labeler — Boehringer Ingelheim Creature Health U.s.a. Inc. (007134091)

Revised: 02/2022 Boehringer Ingelheim Animal Health USA Inc.

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Parcel information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare production label entry contains a unique identifier which can be used to secure further details straight from the U.S. National Institutes of Health and/or the FDA.

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