Label: PRITOX- copper naphthenate liquid

  • NDC Code(s): 58829-289-08, 58829-289-16
  • Packager: FIRST PRIORITY INCORPORATED
  • 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 10/14

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

  • INFORMATION FOR OWNERS/CAREGIVERS

    Water-Resistant Protection Without Bandaging

    Recommended as an Aid in Treating Horses and Ponies With Thrush Due to Organisms Susceptible to Copper Naphthenate.

    Do Not Use in Horses Intended for Human Consumption.

    FOR EXTERNAL USE ONLY

    CAUTION: COMBUSTIBLE MIXTURE

    For Animal Use Only • Keep Out of Reach of Children

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  • INDICATIONS:

    Pritox® is indicated in the treatment of thrush in horses and ponies.

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  • GENERAL DIRECTIONS:

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

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  • INFORMATION FOR OWNERS/CAREGIVERS

    NOTE: Pritox® 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.

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  • ADVERSE REACTIONS

    To report suspected adverse reactions or to obtain technical assistance, call 1-800-650-4899.

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  • ACTIVE INGREDIENT:

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

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  • INACTIVE INGREDIENTS:

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

    Total......................................... 100.0%

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  • 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.

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  • STORAGE:

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

    ANADA 200-304, Approved by FDA

    Manufactured By:

    FIRST PRIORITY, INC.,

    Elgin, IL 60123-1146

    www.prioritycare.com

    NOT RETURNABLE IF OUTDATED

    Reorder No. TP280PC (8 oz)

    Reorder No. TP281PC (16 oz)

    Priority Care and Pritox are registered trademarks of First Priority, Inc.

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  • Net Contents:

      8 oz (236 mL) Reorder No. TP280PC (rev. 10-12)

    16 oz (473 mL) Reorder No. TP281PC (rev. 10-13)

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  • PRINCIPAL DISPLAY PANEL

    Image of 236 mL of bottle/case label

    image of 236 mL bottle/case label

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  • PRINCIPAL DISPLAY PANEL

    Image of 473 mL bottle/case label

    image of 473 mL bottle/case label

    (Rev. 10-13)

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  • INGREDIENTS AND APPEARANCE
    PRITOX 
    copper naphthenate liquid
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:58829-289
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    COPPER NAPHTHENATE (COPPER) COPPER NAPHTHENATE 0.825 g  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58829-289-08 12 in 1 CASE
    1 236 mL in 1 BOTTLE, DISPENSING
    2 NDC:58829-289-16 12 in 1 CASE
    2 473 mL in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200304 10/01/2012
    Labeler - FIRST PRIORITY INCORPORATED (179925722)
    Establishment
    Name Address ID/FEI Business Operations
    FIRST PRIORITY INCORPORATED 179925722 manufacture
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