Label: MEDICATED WART REMOVER- salicylic acid patch

  • NDC Code(s): 56104-260-01
  • Packager: Premier Brands of America, Inc.
  • 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 January 25, 2023

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  • Active ingredient

    Salicylic acid 40%w/w

  • Purpose

    Wart remover

  • Use

    for the removal of common warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface.

  • Warnings

    For external use only.

    Do not use

    • on irritated, infected or reddened skin
    • on genital warts and warts on the face
    • on moles, birthmarks and warts with hair growing from them
    • on mucous membranes

    ​Ask a doctor before use if you have

    • diabetes
    • poor blood circulation

    Stop use and ask a doctor if

    discomforts persists

    ​Keep out of reach of children.​

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • wash affected area: may soak wart in warm water for 5 minutes
    • dry area thoroughly
    • if necessary, cut medicated patch directly over wart
    • cover patch with pad to conceal area
    • repeat this procedure every 48 hours as needed (until wart is removed) for up to 12 weeks
  • Other information

    store between 59°F to 86°F (15°C to 30°C)

  • Inactive ingredients

    acrylic adhesive, acrylic polymer, polyethylene, polyviny alcohol

  • Questions?

    call 1-866-964-0939

  • Principal Display Panel

    HyVee

    health

    Wart Remover

    Salicylic Acid

    Medicated

    • Patch/Pad Method Covers & Removes Warts
    • No Mess of Liquids
    • Safe & Effective

    18 Medicated Patches

    20 Concealing Pads

    image 1

  • INGREDIENTS AND APPEARANCE
    MEDICATED WART REMOVER 
    salicylic acid patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-260
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.4 g  in 18 
    Inactive Ingredients
    Ingredient NameStrength
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    VINYL ACETATE (UNII: L9MK238N77)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56104-260-0118 in 1 BOX; Type 0: Not a Combination Product07/13/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358F07/13/2022
    Labeler - Premier Brands of America, Inc. (117557458)
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