Label: GENITAL WART REMOVER OINTMENT.- genital wart remover cream cream

  • 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 June 29, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Salicylic acid 1%
    Chlorhexidine di(acetate) 1%

  • 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 reddened
    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.

  • Ask Doctor

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

  • Keep Oot 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(cotton swab), apply a layer of ointment to sufficiently cover each wart
    allow it to fully absorb and cover it with a bandage as needed.
    repeat this procedure once or twice daily as needed (until the wart is removed) for up to 12 weeks

  • Inactive ingredients

    Alcohol, Borneol, Carthamus tinctorius l., Cetostearyl alcohol, Cnidium monnieri, Cortex dictamni, Fructus kochiae scopariae, Fructus xanthii, Houttuynia cordata thunb., Isatis indigotica fortune, Lonicera japonica thunb, Radix isatidis, Sophora flavescens, Thenardite

  • Questions

    1 914-608-1258

  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

    01

  • INGREDIENTS AND APPEARANCE
    GENITAL WART REMOVER OINTMENT. 
    genital wart remover cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83299-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROACETIC ACID (UNII: 5GD84Y125G) (CHLOROACETIC ACID - UNII:5GD84Y125G) CHLOROACETIC ACID1 g  in 100 g
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BASSIA SCOPARIA FRUIT (UNII: 04W97Z676Y)  
    HOUTTUYNIA CORDATA WHOLE (UNII: O3E12ZLW5T)  
    SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750)  
    PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
    BORNEOL (UNII: M89NIB437X)  
    CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)  
    LONICERA JAPONICA WHOLE (UNII: UV4X7MQQ43)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALCOHOL (UNII: 3K9958V90M)  
    XANTHIUM STRUMARIUM FRUIT (UNII: TN770YC17C)  
    CARTHAMUS TINCTORIUS WHOLE (UNII: 5EMV416J82)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    ISATIS TINCTORIA ROOT (UNII: 8S10GFI6DX)  
    CABBAGE (UNII: GW0W1Y9I97)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83299-009-0120 g in 1 BOTTLE; Type 0: Not a Combination Product06/29/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01606/29/2023
    Labeler - Consilii LLC (118891890)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consilii LLC118891890label(83299-009) , manufacture(83299-009)