Label: ONE-STEP WART REMOVER CLEAR- one-step wart remover patch

  • NDC Code(s): 56104-243-14
  • 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 26, 2023

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  • ​Active ingredient

    Salicylic acid 40%w/w

  • 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.
  • Warnings

    For external use only.

    Do not use

    • if you are a diabetic or have poor blood circulation, except under the advice and supervision of a doctor or podiatrist

    Do not use on

    • irritated, infected or reddened skin
    • genital warts and warts on the face
    • moles, birthmarks and warts with hair growing from them
    • mucous membranes such as nose, anus, genitals and lips

    Keep out of reach of children

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

    Stop use and ask a doctor

    If discomforts persists see your doctor or podiatrist.

  • Directions

    • wash affected area: may soak wart in warm water for 5 minutes
    • dry area thoroughly
    • remove bandage strips by peeling backing off at slit
    • adhere medicated patch directly over wart
    • 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, polyethylene foam

  • Questions?

    call 1-866-964-0939

  • Principal Display Panel

    ​Premier

    One-Step Clear

    Wart Remover

    Medicated

    ​Salicylic Acid

    • Maximum Strength
    • Cushions, conceals and protects, while removing warts
    • Waterproof to seal and protect

    14 MEDICATED ONE-STEP

    CLEAR BANDAGES

    PREMIER_One Step Wart Remover_BOX_BOSWRP-1-01.jpg

  • INGREDIENTS AND APPEARANCE
    ONE-STEP WART REMOVER CLEAR 
    one-step wart remover patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-243
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.4 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56104-243-145.6 g in 1 BOX; Type 0: Not a Combination Product01/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B01/01/2013
    Labeler - Premier Brands of America Inc. (117557458)
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