Animal NDC 57561-714-01 Agri-mectin

Ivermectin

Animal NDC Product Code 57561-714-01

Field Name Field Value
Animal NDC Code 57561-714-01
Proprietary Name Agri-mectin 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 Agrilabs
Product Type Otc Animal Drug
Active Ingredient(s)
  • Ivermectin
Marketing Category ANADA - ABBREVIATED 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 ANADA200326 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.

Agri-mectin Animal Product Label Images

Agri-mectin 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.

Product Labeling Index

Indications & Usage

INDICATIONS: Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism. AGRI-MECTIN® (ivermectin) Paste provides effective treatment and control of the following parasites in horses. Large Strongyles (adults) -Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds) - Coronocyclus spp. including C. coronatus, C. labiatus and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum; Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus; Cylicodontophorus spp.; Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus and Petrovinema poculatum; Small Strongyles - Fourth-stage larvae; Pinworms (adults and fourth-stage larvae) - Oxyuris equi; Ascarids (adults, third-stage and fourth-stage larvae) - Parascaris equorum; Hairworms (adults) - Trichostrongylus axei; Large-mouth Stomach Worms (adults) - Habronema muscae; Bots (oral and gastric stages) - Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae) - Dictyocaulus arnfieldi; Intestinal Threadworms (adults) - Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.

Dosage & Administration

DOSAGE AND ADMINISTRATION: This syringe contains sufficient paste to treat one 1250 lb horse at the recommended dose rate of 91 mcg ivermectin per lb (200 mcg/kg) body weight. Each weight marking on the syringe plunger delivers enough paste to treat 250 lb body weight. 1) While holding plunger, turn the knurled ring on the plunger 1/4 turn to the left and slide it so the side nearest the barrel is at the prescribed weight marking. 2) Lock the ring in place by making a 1/4 turn to the right. 3) Make sure that the horse's mouth contains no feed. 4) Remove the cover from the tip of the syringe. 5) Insert the syringe tip into the horse's mouth at the space between the teeth. 6) Depress the plunger as far as it will go, depositing paste on the back of the tongue. 7) Immediately raise the horse's head for a few seconds after dosing.PARASITE CONTROL PROGRAM: All horses should be included in a regular parasite control program with particular attention being paid to mares, foals and yearlings. Foals should be treated initially at 6 to 8 weeks of age, and routine treatment repeated as appropriate. Consult your veterinarian for a control program to meet your specific needs. AGRI-MECTIN® (ivermectin) Paste effectively controls gastrointestinal nematodes and bots of horses. Regular treatment will reduce the chances of verminous arteritis caused by Strongylus vulgaris.

Description

PRODUCT ADVANTAGES: Broad-spectrum Control - AGRI-MECTIN® (ivermectin) Paste kills important internal parasites, including bots and the arterial stages of S. vulgaris, with a single dose. AGRI-MECTIN® (ivermectin) Paste is a potent antiparasitic agent that is neither a benzimidazole nor an organophosphate.

User Safety Warnings

ANIMAL SAFETY: AGRI-MECTIN® (ivermectin) Paste may be used in horses of all ages, including mares at any stage of pregnancy. Stallions may be treated without adversely affecting their fertility.

Storage And Handling

Store between 20°C- 25°C (68°F - 77°F), excursions between 15°C- 30°C (59°F- 86°F) are permitted.

Warnings And Precautions

WARNING: Do not use in horses intended for human consumption. Not for use in humans. Keep this and all drugs out of reach of children.Apple FlavoredRefrain from smoking and eating when handling. Wash hands after use. Avoid contact with eyes. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse reactions in users, to obtain more information or to obtain MSDS, contact Agri Laboratories, Ltd. at 1-800-542-8916.PRECAUTIONS: AGRI-MECTIN® (ivermectin) Paste has been formulated specifically for use in horses only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

Environmental Warning

ENVIRONMENTAL SAFETY: lvermectin and excreted ivermectin residues may adversely affect aquatic organisms. Do not contaminate ground or surface water. Dispose of the syringe in an approved landfill or by incineration.

Information For Owners/Caregivers

INFORMATION FOR HORSE OWNERS: Swelling and itching reactions after treatment with AGRI-MECTIN® (ivermectin) Paste have occurred in horses carrying heavy infections of neck threadworm (Onchocerca sp. microfilariae). These reactions were most likely the result of microfilariae dying in large numbers. Symptomatic treatment may be advisable. Consult your veterinarian should any such reactions occur. Healing of summer sores involving extensive tissue changes may require other appropriate therapy in conjunction with treatment with AGRI-MECTIN® (ivermectin) Paste. Reinfection, and measures for its prevention, should also be considered. Consult your veterinarian if the condition does not improve.

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

Previous Code
57561-671-02
Next Code
57561-735-07