Label: ZIMECTERIN- ivermectin paste
- NDC Code(s): 0010-7096-01
- Packager: Boehringer Ingelheim Animal Health USA Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated January 3, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
INDICATIONS:
Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. ZIMECTERIN® (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 and third- 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:
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.
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.
-
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. ZIMECTERIN® (ivermectin paste) effectively controls gastrointestinal nematodes and bots of horses. Regular treatment will reduce the chances of verminous arteritis caused by Strongylus vulgaris.
- PRODUCT ADVANTAGES:
- STORAGE INFORMATION:
-
ADMINISTRATION:
-
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. Refrain from smoking and eating when handling. Wash hands after use. Avoid contact with eyes. The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse reactions in users, to obtain more information, or to obtain an SDS, contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251.
- PRECAUTIONS:
-
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, 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:
-
INFORMATION FOR HORSE OWNERS:
Swelling and itching reactions after treatment with ZIMECTERIN® (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 ZIMECTERIN®. Reinfection, and measures for its prevention, should also be considered. Consult your veterinarian if the condition does not improve.
-
SPL UNCLASSIFIED SECTION
Product 7096101
® ZIMECTERIN is a registered trademark of the Boehringer Ingelheim Group.
© 2019 Boehringer Ingelheim Animal Health USA Inc.
All Rights Reserved.Approved by FDA under NADA # 134-314
Marketed by: Boehringer Ingelheim Animal Health USA Inc. Duluth, GA, 30096
Made in Brazil
SEALED FOR SECURITY.
IF BROKEN, DO NOT ACCEPT - PRINCIPAL DISPLAY PANEL - 6.08 g Syringe Carton
-
INGREDIENTS AND APPEARANCE
ZIMECTERIN
ivermectin pasteProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:0010-7096 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ivermectin (UNII: 8883YP2R6D) (ivermectin - UNII:8883YP2R6D) ivermectin 18.7 mg in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0010-7096-01 6.08 g in 1 SYRINGE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA134314 04/23/2021 Labeler - Boehringer Ingelheim Animal Health USA Inc. (007134091)