Label: IVERMECTIN 1.87%- ivermectin paste
- NDC Code(s): 11695-4861-1
- Packager: Covetrus North America
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Updated January 22, 2020
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INDICATIONS & USAGE
INDICATIONS: Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. 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 & ADMINISTRATION
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.
ADMINISTRAITON: (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. Ensure it is locked (it should no longer slide). (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. 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: Broad-spectrum Control– Ivermectin Paste kills important internal parasites, including bots and the arterial stages of S. vulgaris, with a single dose. Ivermectin Paste is a potent antiparasitic agent that is neither a benzimidazole nor an organophosphate.
ANIMAL SAFETY: 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.
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 Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse reactions in users, to obtain more information, or to obtain a MSDS, contact Covetrus North America at (855) 724-3461.
- ENVIRONMENTAL WARNING
INFORMATION FOR OWNERS/CAREGIVERS
INFORMATION FOR HORSE OWNERS: Swelling and itching reactions after treatment with Ivermectin Paste have occurred in horses carrying heavy infections of neck threadworm microfilariae (Onchocerca sp.) . 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 Ivermectin Paste. Reinfection, and measures for its prevention, should also be considered. Consult your veterinarian if the condition does not improve.
STORAGE AND HANDLING
STORAGE INFORMATION: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).
For additional information about adverse drug experience reporting for animals contact
FDA at 1-888-FDA-VETS or http://www.fda.gov/AnimalVeterinary/SafetyHealth
Covetrus North America
400 Metro Place North
Dublin, OH 43017
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-4861 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D) IVERMECTIN 1.87 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11695-4861-1 6.08 g in 1 SYRINGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200390 10/25/2019 Labeler - Covetrus North America (603750329) Registrant - Med-Pharmex, Inc (025353699) Establishment Name Address ID/FEI Business Operations Med-Pharmex, Inc 025353699 manufacture