Label: COMPOUND W ONE STEP PADS- salicylic acid plaster

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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 April 3, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic acid 40%

  • Purpose

    Wart remover

  • Use

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

    For external use only

    Do not use

    • on irritated skin or on 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
    • if you have diabetes or poor blood circulation

    Stop use and ask a doctor if

    discomfort persists

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • wash affected area
    • may soak wart in warm water for 5 minutes
    • dry area thoroughly
    • remove medicated pad from backing paper by pulling from center of pad
    • apply
    • repeat procedure every 48 hours as needed (until wart is removed) for up to 12 weeks
  • Other information

    • store at room temperature
    • avoid excessive heat 37°C( 99°F)
  • Inactive ingredients

    lanolin, polybutene, rosin ester, rubber

  • Questions?

    1-800-443-4908 CompoundW.com

    ©2016 Distributed by Medtech Products Inc.
    Tarrytown, NY 10591, a Prestige Brands Company
    Made in Japan

  • PRINCIPAL DISPLAY PANEL


    Compound W®
    Salicylic Acid Wart Remover

    One Step Pads

    14 MEDICATED PADS

    Principle display panel: Compound W® Salicylic Acid Wart Remover One Step Pads 14 MEDICATED PADS

  • INGREDIENTS AND APPEARANCE
    COMPOUND W ONE STEP PADS 
    salicylic acid plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-594
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.4 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    GLYCERYL ROSINATE (UNII: SD112V492J)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-594-1414 in 1 BOX; Type 0: Not a Combination Product03/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358B03/15/2014
    Labeler - Medtech Products Inc. (122715688)
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