Label: WART REMOVER 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 May 1, 2023

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  • Active Ingredient(s)

    Salicylic acid 12%

  • 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
    the 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.
    Keep away from fire and flame.

  • Do not use

    on irritated skin or on any area that is infected or reddenede
    on moles, birthmarks, warts with hair growing from them, warts on the face or mucous membranes

  • WHEN USING

    avoid contact with eyes. If the product gets into the eye,flush with water for 15 minutes
    avoid inhaling vapors
    cap the bottle tightly
    out of direct sunlight and store at room temperature away from heat

  • STOP USE

    if discomfort persists.
    if you have diabetes or poor blood circulation.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    wash the affected area
    may soak the wart in warm water for 5 minutes
    dry area thoroughly
    using the applicator(brush or cotton swab), apply one drop at a time to sufficiently cover each wart
    allow it to fully absorb and let dry
    repeat this procedure once or twice daily as needed (until the wart is removed) for up to 12 weeks

  • Other information

    Keep away from direct sunlight or heat.

    Store at room tempetature 15°-30°C (59°-86°F)

  • Inactive ingredients

    Cnidium monnieri, Podophyllum, Hawthorn, Stellera chamaejasm, Sophora flavescens, Earthy hibiscus bark, Honeysuckle

  • Stop use and ask a doctor

    if discomfort persists.
    if you have diabetes or poor blood circulation.

  • QUESTIONS

    1-914-608-1258

  • Package Label - Principal Display Panel

    83299-001-01

  • INGREDIENTS AND APPEARANCE
    WART REMOVER 
    wart remover liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83299-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE12 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LONICERA CONFUSA FLOWER (UNII: 3JV904IJ0V)  
    SOPHORA PACHYCARPA WHOLE (UNII: 4E0W7M7OOQ)  
    AGERATINA HERBACEA WHOLE (UNII: 1VI0ZA82GD)  
    PODOPHYLLUM HEXANDRUM ROOT (UNII: 4YOL15R9R8)  
    PSEUDOLARIX AMABILIS BARK (UNII: 49G13A93VE)  
    HAWTHORN LEAF WITH FLOWER (UNII: 6OM09RPY36)  
    THYME (UNII: CW657OBU4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83299-001-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02802/15/2023
    Labeler - Consilii LLC (118891890)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consilii LLC118891890manufacture(83299-001) , label(83299-001)
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