Label: WET WIPES- benzethonium chloride swab

  • Category: HUMAN OTC DRUG LABEL

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 16, 2011

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  • Active Ingredient

    Benzethonium Chloride 0.3%

  • Purpose

    Antibacterial

  • Uses

    decreases bacteria on the skin
  • Warnings

    For external use only

  • Do not use

    Over large areas of the body if you are allergic to any of the ingredients

  • When using this product


    When using this product do not get into eyes.
    If contact occurs, rinse thoroughly with water.

  • Stop use

    Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours

  • Keep out of reach of children

    Keep out of reach of children, if swallowed get medical help or contact a Poison Control Center right away. 
  • Directions

     For adults and children 2 years and over use on hands and face to clean and refresh, allow skin to air dry.  For children under 2 years of age ask a doctor before use.
  • Inactive Ingredients

    Water, Propylene Glycol, Cocamidopropyl Betaine, PEG-7 Glyceryl Cocoate, Fragrance, Benzyl Alcohol, Methylchloroisothiazolinine, Methylisothiazolinone, Tetrasodium EDTA, PEG-40 Hydrogenated Castor Oil, Cetrimonium Chloride, Citric Acid, Aloe Vera Extract, Alphatocopherol Acetate (Vitamin E)
  • PRINCIPAL DISPLAY PANEL

    Package Label
    image of package label

  • INGREDIENTS AND APPEARANCE
    WET WIPES 
    benzethonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-433
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.3 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20276-433-1010 in 1 BOX
    2NDC:20276-433-1212 in 1 BOX
    3NDC:20276-433-1515 in 1 BOX
    4NDC:20276-433-1818 in 1 BOX
    5NDC:20276-433-2020 in 1 BOX
    6NDC:20276-433-2424 in 1 BOX
    7NDC:20276-433-3636 in 1 BOX
    8NDC:20276-433-4848 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/29/2011
    Labeler - Delta Brands, Inc (102672008)
    Establishment
    NameAddressID/FEIBusiness Operations
    Huzhou Aupower Sanitary Commodity Co.,Ltd529722141manufacture
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