Label: WET WIPES- benzethonium chloride swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 19, 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, for children under 2 years ask a doctor before use. for children use under adult supervision
  • Directions

    Do not expose to direct sunlight, preferably place them in a cool place. Do not use on furniture. Do not flush down toilets, dispose in trash receptacles. Remove lid and open the seal Pull up the corner of the center sheet, twist it and thread through the dispenser split in the lid. Pull sheet out at an angle. When finished close lid flap to retain moisture. Adults and children 2 years and over - Use on hand and face to clean and refresh, allow skin to air dry. 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:20276-432
    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:20276-432-8080 in 1 CANISTER
    2NDC:20276-432-4040 in 1 CANISTER
    3NDC:20276-432-3535 in 1 CANISTER
    4NDC:20276-432-3030 in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/29/2011
    Labeler - Delta Brands, Inc (102672008)
    Establishment
    NameAddressID/FEIBusiness Operations
    Harbin Jinhua Enterprises Co., Ltd529502405manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Huzhou Aupower Sanitary Commodity Co., Ltd529722141manufacture
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