Label: KERATEX KMSP- aluminum stearate and sulfur powder

  • 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 August 15, 2018

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  • SAFE HANDLING WARNING

    May cause respiratory irritation. Keep out of reach of children. Avoid breathing dust. Store in a dry place. Store in a closed container. Use only outdoors or in a well-ventilated area. If on skin: Wash with plenty of soap and water. If in eyes: Make sure to remove any contact lenses from the eyes before rinsing if it is safe and easy to do. Promptly wash eyes and with plenty of water while lifting the eye lids. Harmful if swallowed.

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  • PRINCIPAL DISPLAY PANEL

    Keratex Mud Shield Powder

    For legs that suffer in wet, muddy conditions

    A unique waterproofing powder which protects the horse's legs against mud and water. Simply puff onto clean, dry legs and rub into skin against the lay of the hair. Apply daily.

    For External Equine Use Only

    Ingredients Statement. This product contains: Aluminium Stearate CAS No. 637-12-7

    Magnesium Silicate hydroxide (talc) CAS 14807-96-6

    Sulphur CAS No. 7704-34-9

    Keep away from horse’s eyes, nose and mouth. Not to be used on animals intended for human consumption.

    Penleigh Irving Ltd

    Dilton Marsh, Wiltshire, BK13 3SN, UK

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

    Made in UK    15.87 oz (450g)

    www.keratex.com

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  • INGREDIENTS AND APPEARANCE
    KERATEX  KMSP
    aluminum stearate and sulfur powder
    Product Information
    Product Type OTC ANIMAL DRUG Item Code (Source) NDC:27426-060
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALUMINUM STEARATE (UNII: U6XF9NP8HM) (ALUMINUM STEARATE - UNII:U6XF9NP8HM) ALUMINUM STEARATE 0.05 g  in 2 g
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR .093 g  in 2 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:27426-060-45 450 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 08/01/1999
    Labeler - Penleigh Irving Ltd (505992479)
    Establishment
    Name Address ID/FEI Business Operations
    Penleigh Irving Ltd 505992479 api manufacture, manufacture
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