Label: GEHWOL NAIL PROTECTION PEN- clotrimazole liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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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  • Gehwol me Nail Protection Pen
  • ACTIVE INGREDIENT

    Clotrimazole 1%

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  • Purpose

    Antifungal

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  • Uses

    • Protects against fungal infection
    • Brittle and dry nails becomes supple.
    • Help to gain natural silk sheen.
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  • Warning

    For external use only.

    When using this product

    avoid contact with eyes

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  • PRECAUTIONS

    Stop use and ask a doctor

    If redness or irritation develops

    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 over the nail once or twice daily so that the nail is moistened all over

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  • Other Information

    Store at 20-25° C (68°-77° F)

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  • Inactive Ingredients

    Isobutane, Alcohol denat, Isopropyl Myristate, Octyldodecanol, PEG-40 Hydrogenated Castor Oil, Panthenol, Bisabolol, Aqua (Water), Parfum (Fragrance), Undecylenamide DEA, Tocopheryl Acetate, Propylene Glycol

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  • INGREDIENTS AND APPEARANCE
    GEHWOL NAIL PROTECTION PEN 
    clotrimazole liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:45264-009
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    ALCOHOL (UNII: 3K9958V90M)  
    JOJOBA OIL (UNII: 724GKU717M)  
    LAURETH-2 (UNII: D4D38LT1L5)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45264-009-21 1 in 1 BOX
    1 3 mL in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333C 03/07/2008
    Labeler - Eduard Gerlach GmbH (315343350)
    Registrant - Eduard Gerlach GmbH (315343350)
    Establishment
    Name Address ID/FEI Business Operations
    Eduard Gerlach GmbH 315343350 manufacture(45264-009)
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