1. Home
  2. Animal Drug Index - I
  3. Ivomec

Animal NDC 0010-4745-01 Ivomec

Ivermectin

Animal Product Information

Field Name Field Value
Animal NDC Code 0010-4745-01
Proprietary Name Ivomec What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Ivermectin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Boehringer Ingelheim Animal Health Usa Inc.
Product Type Otc Animal Drug
Usage Information
    IVOMEC Drench 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.
Active Ingredient(s)
  • Ivermectin
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA131392 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Ivomec Images

Ivomec Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



0.08% Solution

Parasiticide for Sheep

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.

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

©2024 Boehringer Ingelheim Animal Health USA Inc. All rights reserved.

Marketed by:

Boehringer Ingelheim Animal Health USA Inc.

Duluth, GA 30096

Origin China

1030-2533-05 / Rev 10/2024


Product Description:



IVOMEC Drench is a ready-to-use, free-flowing solution of ivermectin for use in sheep. 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 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 may be used in any standard drenching equipment or in any equipment which provides a consistent dose volume. IVOMEC Drench 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 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 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.


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.