Label: KOPERTOX- copper naphthenate liquid

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated December 4, 2023

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE

    (copper naphthenate)

    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

  • ACTIVE INGREDIENT:

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

  • INACTIVE INGREDIENTS:

    ........... 62.5% w/w
    Total .....................................................100.0%

  • PRECAUTIONS

    FOR EXTERNAL USE ONLY
    Not for Use in Humans.
    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.

  • CONTACT INFORMATION:

    To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS) contact Zoetis Inc. at
    1-888-963-8471. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

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  • HOW SUPPLIED

    236 mL (8 oz)   Rev. 03/2023  5164100

    473 mL (16 oz)  Rev. 03/2023  5161100

    Approved by FDA under ANADA # 200-304

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    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    Manufactured by:
    First Priority, Inc.
    Elgin, IL 60123

  • 236 mL (8 oz)

    image of 236 mL bottle/case label

  • 473 mL (16 oz)

    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
    ANADAANADA20030410/12/2023
    Labeler - Zoetis (828851555)
    Establishment
    NameAddressID/FEIBusiness Operations
    FIRST PRIORITY INCORPORATED179925722manufacture