Label: KERATEX KFD- acetone and tea tree oil liquid

  • NDC Code(s): 27426-081-20, 27426-081-50
  • Packager: Penleigh Irving Ltd
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 18, 2018

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

  • SAFE HANDLING WARNING

    Keep away from children. Keep container tightly closed. Highly flammable liquid and vapour. Keep away from heat/sparks/open flames/hot surfaces - No smoking. Causes eye irritation. If in eyes: rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing. Avoid breathing vapours. May cause drowsiness or dizziness. Causes skin irritation. Wear protective gloves/protective clothing/eye protection/face protection. IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water. IF INHALED: Remove person to fresh air and keep comfortable for breathing.

  • PRINCIPAL DISPLAY PANEL

    Keratex Frog Disinfectant

    Powerful disinfectant squirt for the frog

    Site-specific nozzle targets those hard-to-reach areas

    Instructions for use: Start with a clean, dry hoof. Do not apply to open wounds. Remove diseased tissue before application. Apply twice weekly or as required.

    Frog Disinfectant Ingredients Statement: Acetone CAS No. 67-64-1. Tea Tree Oil CAS No. 686-47-73-4.

    For use on equine hooves only. Keep away from horse's eyes, nose and mouth. Not to be used on animals intended for human consumption. Store in a cool dry place away from animal feedingstuff.

    1.69 fl oz (50ml)

    MADE IN UK

    Penleigh Irving Ltd.

    Dilton Marsh, Wiltshire, BK13 3SN, UK

    +44 (0) 1373 827649 email: info@keratex.com

    www.keratex.com

    label

  • INGREDIENTS AND APPEARANCE
    KERATEX  KFD
    acetone and tea tree oil liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:27426-081
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETONE (UNII: 1364PS73AF) (ACETONE - UNII:1364PS73AF) ACETONE99 mg  in 100 mL
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL1 mg  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27426-081-5050 mL in 1 BOTTLE, PLASTIC
    2NDC:27426-081-20200 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/1999
    Labeler - Penleigh Irving Ltd (505992479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Penleigh Irving Ltd505992479api manufacture, manufacture