Label: WARTROL WART REMOVER- salicylic acid liquid

  • 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 September 1, 2011

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  • Active Ingredient

    Salicylic Acid 17%

  • Purpose

    Wart Remover

  • Uses

    • For the removal of common warts. The common wart is easily recognized by the rough cauliflower-like appearance of the surface.
    • For the removal of plantar warts on the bottom of the foot. The 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.

  • Do not use

    this product on irritated skin, on any area that is infected or reddened, if you are diabetic, or if you have poor blood circulation.

  • Do not use

    on moles, birthmarks, warts with hair growing from them, genital warts, or warts on teh face or mucous membranes. If product gets into the eye, flush with water for 15 minutes. Avoid inhaling vapors.
  • Stop use and ask a doctor

    if discomfort persists.

  • Extremely flammable.

    Keep away from fire or flame.

  • Keep out of reach of children.

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

  • Directions

    • Wash affected area. (Optional: Soak wart in warm water for 5 minutes.)
    • Dry area thoroughly.
    • Apply a small amount at a time with a brush to sufficiently to cover each wart.
    • Let dry. Repeat this procedure once or twice daily as needed (until wart is removed) for up to 12 weeks.
  • Inactive Ingredient

    Ethyl Alcohol, Flexible Collodion, Menthol, Polysorbate-80, Ascorbic Acid, Hydroxyproylcellulose

  • Storage

    Cap bottle tightly and store at room temperature away from heat.

  • Questions or Comments

    For  questions or comments, please call 1-800-756-4120 Monday-Friday 9:00 AM to 5:00 PM PST
  • PRINCIPAL DISPLAY PANEL

    Placeholder Text


    Wartrol.5oz label

  • INGREDIENTS AND APPEARANCE
    WARTROL  WART REMOVER
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2.51 mL  in 14.78 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    LYTTA VESICATORIA (UNII: 3Q034RO3BT)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24488-013-501 in 1 CARTON
    114.78 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B09/01/2011
    Labeler - Pacific Naturals (961956229)
    Registrant - Creations Garden Natural Products, Inc (961956229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creations Garden Natural Products, Inc961956229manufacture
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