Label: INDIVIDUAL FREE AND CLEAR FOAMING ANTIBACTERIAL SKIN CLEANSER- benzalkonium chloride soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 18, 2024

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  • Active ingredient

    Benzalkonium Chloride 0.13% w/w

  • Uses

    Antibacterial skin cleanser

    Effective in destroying harful bacteria to prevent antibacterial cleansing

  • Warnings

    For external use only.

    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs.

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Read entire label before using this product.

    Apply 5 milliliters (teaspoonful) or palmful to hands and forearms.

    Scrub thoroughly for 20 seconds and rinse with clean water.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Citric Acid, FD&C Red 40, FD&C Yellow 5, Fragrance, Glycerin, Laurmine Oxide, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium Glutamate Diacetate, Water

  • Purpose

    Antibacterial

  • Keep out of reach of children

    Keep out of the reach of children

  • Label

    751

  • INGREDIENTS AND APPEARANCE
    INDIVIDUAL FREE AND CLEAR FOAMING ANTIBACTERIAL SKIN CLEANSER 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84194-709
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84194-709-291000 mL in 1 BAG; Type 0: Not a Combination Product05/21/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)05/21/2024
    Labeler - Ferguson Enterprises (008955171)
    Registrant - Betco Corporation (005050158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation005050158manufacture(84194-709) , label(84194-709)
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