IVOMEC- ivermectin solution

IVOMEC by

Drug Labeling and Warnings

IVOMEC by is a Animal medication manufactured, distributed, or labeled by Boehringer Ingelheim Animal Health USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drench for Sheep
0.08% Solution

Approved by FDA under NADA # 131-392

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

FOR ORAL USE IN SHEEP ONLY. NOT FOR HUMAN USE.

Product Description:

IVOMEC Drench for Sheep is a ready-to-use, free-flowing solution of ivermectin. It is formulated to deliver the recommended dose rate of 0.2 mg ivermectin per 1 kg body weight given orally at a volume of 3.0 mL per 26 lb body weight.

Indications:

IVOMEC Drench for Sheep provides treatment and control of adult and fourth-stage larvae of the following parasites: Gastrointestinal Roundworms - Haemonchus contortus, Ostertagia circumcincta, Trichostrongylus axei, T. colubriformis, Cooperia curticei, Nematodirus spathiger, N. battus, and Oesophagostomum columbianum; Lungworms - Dictyocaulus filaria; and all the larval stages of Nasal Bot - Oestrus ovis. It also provides treatment and control of adult forms only of the following Gastrointestinal Roundworms - Haemonchus placei, Cooperia oncophora, Strongyloides papillosus, Oesophagostomum venulosum, Trichuris ovis, and Chabertia ovina.

Dosage and Administration:

IVOMEC Drench for Sheep may be used in any standard drenching equipment or in any equipment which provides a consistent dose volume. IVOMEC Drench for Sheep is administered orally at a dose of 3.0 mL (2.4 mg ivermectin) per 26 lb body weight or 200 mcg ivermectin per kilogram of body weight.

Coughing may be observed in some animals during and for several minutes following drenching.

Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.

Residue Warning:

Do not treat sheep within 11 days of slaughter.

The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse effects in users, to obtain an SDS, or for assistance call 1-888-637-4251.

Precautions:

IVOMEC Drench for Sheep has been formulated specifically for use in sheep only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

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.

Keep this and all drugs out of reach of children.

Refrain from smoking and eating when handling. Avoid contact with eyes. Immediately wash hands and any spills on the skin with plenty of soap and water following use.

Restricted Drug (California) - Use only as directed.

Environmental Safety:

Studies indicate that when ivermectin comes in contact with the soil, it readily and tightly binds to the soil and becomes inactive over time. Free ivermectin may adversely affect fish and certain water-borne organisms on which they feed. Do not permit water runoff from feedlots to enter lakes, streams or ground water. Do not contaminate water by direct application or by the improper disposal of drug containers. Spills should be contained and soaked up with absorbent towels or into loose soil. Gloves should be worn to prevent skin exposure. All the collected materials (contaminated towels and soil), as well as all empty drug containers should be placed in an impervious film (plastic) bag and disposed of by incineration or in an approved landfill.

Storage Information:

Store at 68° – 77° F (20° – 25° C). Excursions between 59° – 86° F (15° – 30° C) are permitted.

SPL UNCLASSIFIED SECTION

®IVOMEC and Sheep Head Logo are registered
trademarks of Boehringer Ingelheim Animal Health USA Inc.

©2019 Boehringer Ingelheim Animal Health USA Inc. All rights reserved.

Marketed by:

Boehringer Ingelheim Animal Health USA Inc.

Duluth, GA 30096

Made in New Zealand

1030-2533-04
Rev. 10/2018

Principal Display Panel – 5 L carton

Approved by FDA under NADA # 131-392

ivomec®
(ivermectin)

Drench for Sheep
0.08% Solution

Parasiticide

For the Treatment and Control
of Worms and Bots of Sheep

433-100 lb Doses

5 L (169 fl oz)

INGREDIENTS AND APPEARANCE

IVOMEC 
ivermectin solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 0010-4745
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ivermectin (UNII: 8883YP2R6D) (ivermectin - UNII:8883YP2R6D)	ivermectin	0.0008 mg  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0010-4745-01	1 L in 1 BOTTLE, PLASTIC
2	NDC: 0010-4745-02	1 in 1 CARTON
2		5 L in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA131392	05/01/2021

Labeler - Boehringer Ingelheim Animal Health USA Inc. (007134091)