Label: SANNUO WART REMOVER- salicylic acid liquid

  • NDC Code(s): 83648-001-01
  • Packager: Shenzhen Baixingchen Technology 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 August 23, 2023

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  • ACTIVE INGREDIENT

    Salicylic Acid 17% w/v

  • DO NOT USE

    DO NOT USE

    On irritated skin or any area that is infected or reddened.

    If you are allergic to any of the ingredients in this product.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • PURPOSE

    Wart Remover

  • WARNINGS

    WARNINGS
    For external use only,don't contact with eyes or swallow.
    Children should use it under adult supervision.
    The liquid can get easily volatilized & crystallized,tighten the cap after use.
    Avoid long term contact with air while using.

  • DOSAGE & ADMINISTRATION

    Directions:
    Wash the affected area and dry it.
    Apply directly to the wart twice a day using the brush.
    Continue for 2-3 weeks or as needed.

  • INDICATIONS & USAGE

    Uses
    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

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:

    WATER,BRUCEA JAVANICA FRUIT,TEA TREE OIL,PHELLODENDRON AMURENSE BARK EXTRACT, ETHYL ALCOHOL,COMMON CNIDIUM FRUIT, GALLA CHINENSIS, BORNEOL,COPTIS CHINENSIS ROOT EXTRACT.

  • PRINCIPAL DISPLAY PANEL

    package

  • INGREDIENTS AND APPEARANCE
    SANNUO WART REMOVER 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83648-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3.4 g  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    BRUCEA JAVANICA FRUIT (UNII: 50268139XV)  
    PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    BORNEOL (UNII: M89NIB437X)  
    COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL)  
    CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83648-001-0120 mL in 1 BOTTLE; Type 0: Not a Combination Product08/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B08/24/2023
    Labeler - Shenzhen Baixingchen Technology Co., Ltd. (411899311)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Baixingchen Technology Co., Ltd.411899311manufacture(83648-001)
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