Label: WART REMOVER GEL- salicylic acid gel

  • NDC Code(s): 79481-0616-1
  • Packager: Meijer Distribution 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 August 30, 2023

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  • Active ingredient

    Salicylic acid 17% w/w

  • Purpose

    Wart remover

  • Uses

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

    Do not use

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

    When using this product

    • if product gets into the eye, flush with water for 15 minutes
    • avoid inhaling vapors
    • cap tube tightly and store at room temperature away from heat

    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 right away.

  • Directions

    • after washing affected area, soak wart in for 5 minutes in comfortably warm water
    • dry area thoroughly
    • apply one drop of gel at a time to sufficiently cover each wart
    • let dry
    • repeat this procedure once or twice daily (until wart is removed) for up to 12 weeks
  • Other information

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

  • Inactive ingredients

    camphor, castor 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

    Meijer

    Maximum Strength

    wart remover gel

    Salicylic Acid 17%/Wart Remover

    Safely removes common & plantar warts

    Convenient & easy
    No drip formula

    NET WT 0.25 OZ (7g)

    image 1

  • INGREDIENTS AND APPEARANCE
    WART REMOVER GEL 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0616
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID170 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYL ACETATE (UNII: 76845O8NMZ)  
    HYPOPHOSPHOROUS ACID (UNII: 8B1RL9B4ZJ)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PYROXYLIN (UNII: KYR8BR2X6O)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-0616-11 in 1 CARTON08/27/2023
    17 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B08/27/2023
    Labeler - Meijer Distribution Inc (006959555)
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