Label: IBEALEE WART REMOVER- wart remover patch

  • NDC Code(s): 83675-014-01, 83675-014-02, 83675-014-03
  • Packager: Guangzhou Hanhai Trading Co., Ltd
  • 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 27, 2023

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  • Active Ingredient

    Salicylic Acid 40%

  • Purpose

    WART REMOVER

  • Use

    How to use:
    Directions
    • wash affected area and dry thoroughly
    • apply tag patch
    • after 24 hours, remove tag patch
    • repeat procedure every 24 hours for up to 14 days for
    tags /warts removal and up to 12 weeks for warts, until
    the problem hascleared.
    • may hot compress wart in warm water for 5 minutes
    to assist in removal

  • Warnings

    Caution:
    1. Not recommended to be used simuitaneously
    with other medication.
    2. If skin becomes red and swollen, or if burning,
    aching and other forms of irritation occur,
    cease using and seek medical advice at once.
    3. It is normal to find bubbles in the colloid.
    4. Keep out of reach of chidren.

  • Keep Oot Of Reach Of Children

    Do not place this product within the reach of children

  • Do not use

    If allergy occurs, please stop using it

  • Inactive ingredients

    Tea Tree Oil,Calendula,Cica
    Oil,Castor Oil,
    Argan Oil

  • Directions

    Apply gently to skin

  • PRINCIPAL DISPLAY PANEL

    010203

  • INGREDIENTS AND APPEARANCE
    IBEALEE WART REMOVER 
    wart remover patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83675-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID40 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    OITICICA OIL (UNII: Q4F4N7T4JN)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83675-014-01144 in 1 PATCH; Type 0: Not a Combination Product09/26/2023
    2NDC:83675-014-02180 in 1 PATCH; Type 0: Not a Combination Product09/26/2023
    3NDC:83675-014-03540 in 1 PATCH; Type 0: Not a Combination Product09/26/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B09/26/2023
    Labeler - Guangzhou Hanhai Trading Co., Ltd (419707381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Hanhai Trading Co., Ltd419707381label(83675-014) , manufacture(83675-014)
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