SALICYLIC ACID (WART REMOVER GEL PEN) GEL [HARMON STORE INC.]

SALICYLIC ACID (WART REMOVER GEL PEN) GEL [HARMON STORE INC.]
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NDC 63940-023-04
Set ID b0f98775-3c8e-4c59-ae2e-a32be3febd06
Category HUMAN OTC DRUG LABEL
Packager Harmon Store Inc.
Generic Name
Product Class
Product Number
Application Number PART358B
  • 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
    • on irritated, infected or reddened skin
    • on genital warts and warts on the face

    When using this product

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

    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

    • wash affected area
    • may soak wart in for 5 minutes
    • dry area thoroughly
    • remove cap from pen
    • remove insert pin from the tip
    • twist and click pen until wart remover gel is dispense onto the tip of the applicator. Initial use will require several rotations for the gel to load
    • apply a small amount at a time with applicator to sufficiently cover each wart
    • let dry
    • repeat this procedure once or twice daily as needed (until wart is removed) for up to 12 weeks
    • for storage ensure applicator is free of excess gel before placing the insert pin back into the tip
  • 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

    Harmon

    Face Values

    Maximum Strength

    Wart

    Remover

    GEL PEN

    Salicylic Acid

    • Safely Removes Common and Plantar Warts
    • No-Drip Gel

    1 Prefilled Pen

    NET WT 0.04 OZ (1.25 g)

    Wart Remover Pen

  • INGREDIENTS AND APPEARANCE
    SALICYLIC ACID 
    wart remover gel pen gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.17 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYL ACETATE (UNII: 76845O8NMZ)  
    HYPOPHOSPHOROUS ACID (UNII: 8B1RL9B4ZJ)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PYROXYLIN (UNII: KYR8BR2X6O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-023-041.25 g in 1 APPLICATOR; Type 0: Not a Combination Product09/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B09/01/2015
    Labeler - Harmon Store Inc. (804085293)

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