Label: DUOFILM WART REMOVER- salicylic acid liquid

  • NDC Code(s): 11523-0635-2
  • Packager: MSD Consumer Care, Inc.
  • 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 01/13

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  • Drug Facts
  • Active ingredient

    Salicylic acid 17% (w/w)

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  • Purpose

    Wart Remover

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  • Uses

    • for removal of common and plantar warts
    • common warts can be easily recognized by the rough cauliflower-like appearance of the surface
    • plantar warts can be recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern
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  • Warnings

    For external use only

    Flammable Keep away from fire or flame

    Do not use

    • if you have diabetes
    • if you have poor blood circulation
    • on irritated skin or any area that is infected or reddened
    • on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes

    When using this product

    • if product gets in eyes, flush with water for 15 minutes
    • do not inhale vapors
    • cap bottle tightly when not in use and store at room temperature away from heat

    Stop use and ask a doctor if discomfort lasts

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • wash affected area
    • may soak wart in warm water for 5 minutes
    • dry thoroughly
    • apply one drop at a time with applicator to sufficiently cover each wart
    • let dry
    • self-adhesive cover-up discs may be used to conceal wart
    • repeat procedure once or twice daily as needed (until wart is removed) for up to 12 weeks
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  • Other information

    • store between 20° to 25°C (68° to 77°F)
    • keep tightly closed
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  • Inactive ingredients

    castor oil, ethyl lactate, flexible collodion, polybutene. (Contains alcohol 18% v/v and ether 53% v/v from flexible collodion).

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  • Questions?

    866-360-3226

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  • PRINCIPAL DISPLAY PANEL - 9.8 mL Bottle Carton

    LIQUID

    DuoFilm®
    SALICYLIC ACID WART REMOVER

    • Safe and reliable removal of
      common and plantar warts
    • Cover-up discs protect warts
      as they heal

    1/3 FL OZ (9.8 mL)
    20 cover-up discs

    Principal Display Panel - 9.8 mL Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    DUOFILM WART REMOVER 
    salicylic acid liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11523-0635
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Salicylic Acid (Salicylic Acid) Salicylic Acid 150.28 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    castor oil  
    ethyl lactate  
    alcohol  
    ether  
    Product Characteristics
    Color YELLOW (clear yellow) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11523-0635-2 1 in 1 CARTON
    1 9.8 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part358B 08/14/1990
    Labeler - MSD Consumer Care, Inc. (968091715)
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