Label: IVERCARE - ivermectin paste 

  • NDC Code(s): 17135-757-21
  • Packager: Farnam Companies, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/12

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  • INDICATIONS & USAGE

    ANADA 200-390, Approved by the FDA
    NDC 17135-757-21

    IVERCARE (ivermectin)
    Paste 1.87% - Anthelmintic and Boticide
    Removes worms and bots with a single dose.
    Contents will treat up to 1500 ib body weight.
    For Oral Use in Horses Only

    Each Syringe Contains0.26 OZ (7.30 g) IVERCARE (ivermectin)
    Paste 1.87%
    Net Wt: 0.26 oz (7.30g)

    INDICATIONS: Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. IverCare (ivermectin) Paste 1.87% 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.

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  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: This syringe contains sufficient paste to treat one 1500 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. IverCare (ivermectin) Paste 1.87% 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–  IverCare (ivermectin)  Paste 1.87%  kills important internal parasites, including bots and the arterial stages of S. vulgaris, with a single dose.  IverCare (ivermectin)  Paste 1.87%  is a potent antiparasitic agent that is neither a benzimidazole nor an organophosphate.

    ANIMAL SAFETY: IverCare (ivermectin)  Paste 1.87% may be used in horses of all ages, including mares at any stage of pregnancy. Stallions may be treated without adversely affecting their fertility.

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  • WARNINGS

    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 Farnam Companies, Inc. at 800-234-2269.

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  • PRECAUTIONS

    PRECAUTIONS: IverCare (ivermectin) Paste 1.87% 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.

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  • ENVIRONMENTAL WARNING

    Environmental Safety: Ivermectin 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.

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  • 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.

    2010 Farnam Companies, Inc. 10-0855 99 0000448.00 rev 5/10
    IverCare is a registered trademark of Farnam Companies, Inc.

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  • PRINCIPAL DISPLAY PANEL

    IverCare
    (ivermectin) Paste 1.87%

    Anthelmintic and Boticide


    IverCare Label


    IverCare Carton


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  • INGREDIENTS AND APPEARANCE
    IVERCARE 
    ivermectin paste
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:17135-757
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Ivermectin (Ivermectin) Ivermectin 1.87 g  in 100 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17135-757-21 7.30 g in 1 SYRINGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200390 08/31/2012
    Labeler - Farnam Companies, Inc. (008399933)
    Registrant - Med-Pharmex, Inc (025353699)
    Establishment
    Name Address ID/FEI Business Operations
    Med-Pharmex, Inc 025353699 manufacture
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