Label: PROTECTIVE AND MOISTURIZING SKIN- clotrimazole oil

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/13

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  • Protective and Moisturizing Skin Oil
  • Drug Facts
  • Active Ingredient

    Clotrimazole 1%

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  • Purpose

    Antifungal

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  • Uses

    • Effectively treats most athlete's foot
    • cares for skin leaving it elastic and beautiful.
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  • Warnings

    For external use only.

    When using this product

    avoid contact with the eyes.

    Stop use and ask a doctor if

    • There is no improvement within 4 weeks
    • Irritation occurs

    Do not use on

    children under 2 years of age unless directed by a doctor.

    Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center right away.

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  • Directions

    Apply regularly 1-2 times daily and massage in for a few minutes until you can feel only a slight residue left. The nails and skin will recover and soon reveal their naturally healthy appearance.

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  • Other information

    Store between 20° to 25° C (68° to 77° F)

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  • Inactive Ingredients

    Isopropyl Myristate, Isopropyl Palmitate, Cocamide DEA, Alcohol denat., Triticum Vulgare (Wheat) Germ Oil, Laureth-2, Clotrimazol, Propylene Glycol, Panthenol, Bisabolol, Parfum, Undecylenamide DEA, Linalool

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  • GEHWOL med. Protective and Moisturizing Skin Oil

    Effectively treats most althlete's foot.

    Cares for skin leaving it elastic and beautiful.

    15ml 0.5 oz

    Made in Germany

    GEHWOL med Protective and Moisturizing Skin Oil, with wheatgerm oil, panthenol and bisabolol, cares for the skin, making it more supple and beacutiful and restoring its naturally healthy appearance.

    Dermatologically tested.

    image description

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  • INGREDIENTS AND APPEARANCE
    PROTECTIVE AND MOISTURIZING SKIN 
    clotrimazole oil
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:45264-001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ISOPROPYL PALMITATE  
    ISOPROPYL MYRISTATE  
    COCO DIETHANOLAMIDE  
    WHEAT BRAN  
    LAURETH-2  
    ALCOHOL  
    PANTHENOL  
    PROPYLENE GLYCOL  
    UNDECYLENIC ACID MONOETHANOLAMIDE  
    LINALOOL, (+/-)-  
    LEVOMENOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45264-001-17 1 in 1 BOX
    1 15 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 12/04/2008
    Labeler - Eduard Gerlach GmbH (315343350)
    Registrant - Eduard Gerlach GmbH (315343350)
    Establishment
    Name Address ID/FEI Business Operations
    Eduard Gerlach GmbH 315343350 manufacture(45264-001)
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