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

  • 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 March 14, 2022

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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

    Foaming Antibacterial Skin Cleanser

  • INGREDIENTS AND APPEARANCE
    INDIVIDUAL FREE AND CLEAR FOAMING ANTIBACTERIAL SKIN CLEANSER 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79258-751
    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:79258-751-291000 mL in 1 BAG; Type 0: Not a Combination Product03/02/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/02/2022
    Labeler - Brady Industries Inc. (034932657)
    Registrant - Betco Corporation (005050158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation005050158manufacture(79258-751) , label(79258-751) , analysis(79258-751) , pack(79258-751)
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