Label: D-THRUSH- copper naphthenate liquid

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

Drug Label Information

Updated October 5, 2023

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  • VETERINARY INDICATIONS

    (copper naphthenate)

    Water-Resistant Protection

    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
    Not for Use in Humans
    Keep Out of Reach of Children
    Approved by FDA under ANADA # 200-304

  • NET CONTENTS:

    16 oz (473 mL)

  • Indications:

    D-Thrush™ is indicated in the treatment of thrush in horses and ponies.

  • General Directions:

    Clean the hoof thoroughly, removing debris and necrotic material prior to application of D-Thrush™. Apply daily to affected hoofs with a narrow paint brush (about 1") until fully healed.

  • Caution:

    Do not allow runoff of excess D-Thrush onto hair since contact with D-Thrush may cause some hair loss.
    Do not contaminate feed.

  • NOTE:

    D-Thrush™ 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 events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact First Priority, Inc. at (800) 650-4899 or www.prioritycare.com. 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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  • Active Ingredient:

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

    Inactive Ingredients:

    ..........................62.5% w/w

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

  • 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.

  • STORAGE:

    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

    Distributed by: Durvet, Inc.
    Blue Springs, MO 64014
    www.durvet.com
    1-800-821-5570

    Rev. ISS23XB03

  • 16 oz (473 mL)

    image of bottle/case label

  • INGREDIENTS AND APPEARANCE
    D-THRUSH 
    copper naphthenate liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:30798-640
    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:30798-640-3112 in 1 CASE
    1473 mL in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20030410/31/2023
    Labeler - DURVET INCORPORATED (056387798)
    Establishment
    NameAddressID/FEIBusiness Operations
    FIRST PRIORITY INCORPORATED179925722manufacture
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