Label: KERATEX KHH- aluminium chloride, glycerin, formaldehyde, alcohol and methyl alcohol liquid

  • Category: OTC ANIMAL DRUG LABEL

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 February 16, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Penleigh Irving Ltd.

    Dilton Marsh, Wiltshire, BK13 3SN, UK

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

    www.keratex.com

  • PRINCIPAL DISPLAY PANEL

    Keratex Hoof Hardener

    For soundness and reliability

    Strengthens and protects shod and unshod hooves; prevents cracks and hoof breakage so that shoes stay on tight and the horse remains sound.

    Ideal for: Weak hooves. Horses that are worked barefoot. Brood mares, foals and yearlings. Soft soles prone to bruising.

    Keratex Hoof Hardener strengthens the molecular structure of the hoof horn and soles by cross-linking keratin. With no surface coating residue, the foot is still able to ‘breathe’. You will quickly notice an improvement in your horse’s hooves.

    Instructions For Use: Apply to the lower half of the hoof and sole, avoiding coronary band and frog. Use daily for one week then twice weekly for general maintenance.

    Keep away from horse's eyes, nose and mouth. Not to be used on animals intended for human consumption. For external application to equine hooves only.

    Toxic if swallowed. Causes severe skin burns and eye damage. May cause an allergic skin reaction. Suspected of causing genetic defects. May cause cancer. Causes damage to organs. Obtain special instructions before use. Do not breathe vapour. Avoid direct contact. 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 in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If exposed or concerned: Get medical advice/attention. Do not induce vomiting. Do not eat, drink or smoke when using this product. Dispose of contents/container in accordance with local regulations. For professional use only. Keep away from children. Store locked up. Keep container tightly closed. Use only in a well-ventilated area.

    Hoof Hardener Ingredients Statement. This product contains: Aluminium chloride hexahydrate CAS No. 7784-13-6. Glycerine (glycerol) CAS No. 56-81-5. Formaldehyde CAS No. 50-00-0. Ethyl alcohol CAS No. 64-17-5. Methyl alcohol CAS No. 67-56-1. Methyl salicylate CAS No. 119-36-8. Water.

    Patent: No. 2250196

    8.45 fl oz (250ml)

    KHH Full Label

  • INGREDIENTS AND APPEARANCE
    KERATEX  KHH
    aluminium chloride, glycerin, formaldehyde, alcohol and methyl alcohol liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:27426-040
    Route of AdministrationTopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM CHLORIDE (UNII: 3CYT62D3GA) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM CHLORIDE0.408 g  in 1.675 mL
    GLYCERIN (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) GLYCERIN0.211 g  in 1.675 mL
    FORMALDEHYDE (UNII: 1HG84L3525) (FORMALDEHYDE - UNII:1HG84L3525) FORMALDEHYDE0.068 g  in 1.675 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.065 g  in 1.675 mL
    METHYL ALCOHOL (UNII: Y4S76JWI15) (METHYL ALCOHOL - UNII:Y4S76JWI15) METHYL ALCOHOL0.003 g  in 1.675 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27426-040-25250 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