KOPERTOX (COPPER NAPHTHENATE) LIQUID [ZOETIS]

KOPERTOX (COPPER NAPHTHENATE) LIQUID [ZOETIS]
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NDC 54771-1100-1, 54771-1100-2
Set ID 20a0068d-0e86-4906-8253-f5acf284c23a
Category OTC ANIMAL DRUG LABEL
Packager Zoetis
Generic Name
Product Class
Product Number
Application Number ANADA200304
  • INDICATIONS & USAGE

    WATER-RESISTANT PROTECTION WITHOUT BANDAGING

    RECOMMENDED as an aid in treating horses and ponies with thrush due to organisms susceptible to copper naphthenate.

  • PRECAUTIONS

    Do not use in horses intented for human consumption.

    CAUTION:  COMBUSTIBLE MIXTURE

  • Ingredients:

    Copper Naphthenate..................................... 37.5% w/w

  • INACTIVE INGREDIENT

    Inert Ingredients............................................ 62.5% w/w

    Total............................................................... 100%

  • INFORMATION FOR OWNERS/CAREGIVERS

    FOR EXTERNAL USE ONLY

    For Animal Use Only.

    Keep Out of Reach of Children.

  • INDICATIONS & USAGE

    Indicated in the treatment of thrush in horses and ponies

  • GENERAL PRECAUTIONS

    CAUTION: Do not use in horses intended for human consumption.

    CAUTION: COMBUSTIBLE MIXTURE

    Use in a well-ventilated place.  Avoid fire, flame, sparks or heaters.

    If swallowed, do not induce vomiting, call physician immediately.  Avoid breathing vapor.  Avoid contact with skin and eyes.

    Keep out of reach of children and pets.

  • GENERAL DIRECTIONS:

    Clean the hoof thoroughly, removing debris and necrotic material prior to application of KOPERTOX®. Apply daily to affected hoofs with a narrow paint brush (about 1") until fully healed. Caution: Do not allow runoff of excess KOPERTOX® onto hair since contact with KOPERTOX® may cause some hair loss.  Do not contaminate feed.

  • STORAGE AND HANDLING

    Store at controlled room temperature 15° to 30°C (59° to 86°F).  Keep container tightly closed when not in use.

  • INFORMATION FOR OWNERS/CAREGIVERS

    NOTE: KOPERTOX® is easily removed from hands, clothing and surfaces with light grade fuel oil or any type of lighter fluid.

    CONTAINS FOIL SEAL – REMOVE BEFORE USE.

    SHAKE WELL BEFORE USE.

  • ADVERSE REACTIONS

    To report suspected adverse reactions or to obtain technical assistance, call 1-800-1-888-963-8471.

  • HOW SUPPLIED

    236 mL (8 oz)   Rev. 02-14  0754I 30175400

    473 mL (16 oz)  Rev. 02-14 0755J 30175500

    ANADA 200-304, Approved by FDA

    image of Zoetis Logo

    Distributed by:

    Zoetis Inc.

    Kalamazoo, MI 49007

    Manufactured by:

    First Priority, Inc.

    Elgin, IL 60123

  • PRINCIPAL DISPLAY PANEL

    Image of 236 mL bottle/case label (rev. 02/14)

    image of 236 mL bottle/case label

  • PRINCIPAL DISPLAY PANEL

    Image of 473 mL bottle/case label (rev. 02-14)

    image of 473 mL bottle/case label

  • INGREDIENTS AND APPEARANCE
    KOPERTOX 
    copper naphthenate liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54771-1100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COPPER NAPHTHENATE (UNII: 9J2IBN2H70) (COPPER - UNII:789U1901C5) COPPER NAPHTHENATE0.825 g  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-1100-112 in 1 CASE
    1236 mL in 1 BOTTLE, DISPENSING
    2NDC:54771-1100-212 in 1 CASE
    2473 mL in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20030409/18/2014
    Labeler - Zoetis (828851555)
    Establishment
    NameAddressID/FEIBusiness Operations
    FIRST PRIORITY INCORPORATED179925722manufacture

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