Label: WART REMOVER- zitalon wart removal treatment liquid 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 October 25, 2022

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  • Active Ingredient(s)

    Salicylic Acid 12%

  • Purpose

    Wart remover

  • Use

    use :
    for the removal of common and plantar warts
    the common war is easy ily recognized by the rough macauli flowerlike " appearance of the surface
    the plantar wart is recognized by its location only on the bottom ofthe foot . its tenderness and the interru option of the foot pró nt pattern

  • Warnings

    Warnings
    For externall use

  • Do not use

    Do not use
    on irritated skin or on any area that is infected or reddened
    Do not use on moles skin tags , birthmarks , warts with hair growing from them , genital warts , or warts on the face or mucous membranes

  • WHEN USING

    Ask a doctor before you use
    if you have diabetes or poor blood circulation
    Stop use and ask a doctor
    if discomfort persists
    Keep out of reach of children
    If product gets into eyes , flush with water for 15 minutes
    IF swallowed , get medical help or contact a Poison Control Center right away

  • STOP USE

    Stop use and ask a doctor
    if discomfort persists

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children
    If product gets into eyes , flush with water for 15 minutes
    IF swallowed , get medical help or contact a Poison Control Center right away

  • Directions

    Directions :
    Wash the affected area and dry it
    Apply this product with a cotton swab to the wart
    Repeat this procedure twice daily as needed ( until wart is removed ) for up to 12 weeks

  • Other information

    Other information
    Store at room temperature and out of direct sunlight
    skin discoloration may occur during or affter use

  • Inactive ingredients

    Water

    BRUCEA JAVANICA FRUIT

    Coptis Chinensis Root Extract

    Phellodendron Amurense Bark Extract

    LONICERA JAPONICA TOP

    Triclosan

    Borneol

  • Package Label - Principal Display Panel

    81799-004-01

    81799-004-01

  • INGREDIENTS AND APPEARANCE
    WART REMOVER 
    zitalon wart removal treatment liquid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81799-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID12 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL)  
    WATER (UNII: 059QF0KO0R)  
    PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    BRUCEA JAVANICA FRUIT (UNII: 50268139XV)  
    BORNEOL (UNII: M89NIB437X)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    LONICERA JAPONICA TOP (UNII: 60Q6UP226V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81799-004-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product10/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B10/25/2022
    Labeler - Ehy Holdings LLC (117322715)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ehy Holdings LLC117322715manufacture(81799-004)
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