Label: SALICYLIC ACID- wart remover gel pen gel

  • 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 July 16, 2021

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  • ​Active ingredient

    Salicylic acid 17%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
    • Plantar wart is recognized by its location only on the bottom of the foot, its tenderness and the interruption of the footprint pattern
  • Warnings

    For external use only.

    ​ Flammable​

    • keep away from fire or flame

    ​Do not use

    • if you are a diabetic or have poor blood circulation, except under the advice and supervision of a doctor or podiatrist
    • on moles, birthmarks and warts with hair growing from them
    • on mucous membranes such as nose, anus, genitals and lips
    • on irritated, infected or reddened skin
    • on genital warts and warts on the face

    ​Ask doctor before use if you have:

    • diabetes
    • poor blood circulation

    When using this product

    • avoid contact with eyes
    • avoid inhaling vapors
    • if product gets into the eyes, flush with water for 15 minutes

    ​Stop use and consult a doctor if

    discomfort persists

    ​Keep out of reach of children.

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

  • Directions

    • after washing affected area
    • may soak wart in warm water for 5 minutes
    • dry area thoroughly
    • remove cap from pen
    • remove insert pin from the tip and discard
    • twist and click pen until wart remover gel is dispensed onto the tip of the applicator. Initial use will require several rotations for the gel to load
    • apply a small amount at a to sufficiently cover each wart
    • let dry
    • repeat this procedure once or twice daily (until wart is removed) for up to 12 weeks
    • for storage, ensure applicator is free of excess gel before placing the cap back on
    • keep outer package for complete Drug Facts information
  • Other information

    • store between 59°F to 86°F (15°C to 30°C)
    • if gel hardens at tip of applicator, dispense product and remove blockage
  • ​Inactive ingredients

    camphor, castro oil, ethyl acetate, hydroxypropyl cellulose, hypophosphorous acid, isopropyl alcohol, nitrocellulose, polysorbate 80, SDA 3C ethyl alcohol

  • Questions?

    call 1-866-964-0939

  • ​Principal Display Panel

    ​CVS Health

    MAXIMUM STRENGTH
    Wart Remover Gel Pen

    SALICYLIC ACID

    • Safely removes common and plantar warts
    • No-drip gel

    1 PRE-FILLED PEN

    Net WT .04 OZ (1.25g)

    WART REMOVER GEL PEN

  • INGREDIENTS AND APPEARANCE
    SALICYLIC ACID 
    wart remover gel pen gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-185
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.21 g  in 1.25 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYL ACETATE (UNII: 76845O8NMZ)  
    HYPOPHOSPHOROUS ACID (UNII: 8B1RL9B4ZJ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PYROXYLIN (UNII: KYR8BR2X6O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-185-041.25 g in 1 APPLICATOR; Type 0: Not a Combination Product10/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B10/01/2014
    Labeler - CVS Pharmacy (062312574)
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