Label: KERATEX KCOHBCL- coconut oil, tea tree oil paste

  • 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 21, 2018

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

  • SAFE HANDLING WARNING

    Keep out of reach of children and away from pets. Avoid contact with skin, eyes and clothes. Keep away from sources of ignition. Keep in original container, tightly sealed in a well-ventilated area. Store away from heat and direct sunlight. If on skin: wash immediately with soap and water. If in eyes : flush with water for at least 15 minutes, keeping eyelids open. If irritation continues, seek medical advice. Use in a well-ventilated area to avoid inhalation. May cause eye/skin irritation or rash. May be harmful if swallowed.

  • PRINCIPAL DISPLAY PANEL

    Keratex Coconut Oil Hoof Balm. Clear.

    A high quality blend of coconut oil, beeswax and tea tree oil to condition, protect and care for hooves.

    Leaves hooves with a nourished, colour-enriched and deeply glossy looking finish.

    To apply, start with clean dry hooves. Brush onto hoof wall and sole twice a week.

    Available in clear and black.

    Ingredients Statement: Coconut Oil CAS No. 8001-31-8, Tea Tree Oil CAS 68647-73-4, White Beeswax CAS 8012-89-3, Carnauba CAS 8015-86-9, Petroleum Jelly Amber CAS 8009-03-8, Tallow-Oleine CAS 61789-97-7, Colophonium CAS 8050-90-7

    MADE IN THE UK

    14.10 oz (400g)

    Penleigh Irving Ltd, Dilton Marsh, Wiltshire, BA13 3SN, UK

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

    For use on equine hooves only.

    label

  • INGREDIENTS AND APPEARANCE
    KERATEX  KCOHBCL
    coconut oil, tea tree oil paste
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:27426-090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COCONUT OIL (UNII: Q9L0O73W7L) (COCONUT OIL - UNII:Q9L0O73W7L) COCONUT OIL45.2 g  in 147 g
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL3.1 g  in 147 g
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27426-090-40400 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/02/2017
    Labeler - Penleigh Irving Ltd (505992479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Penleigh Irving Ltd505992479api manufacture, manufacture