Label: ANTI-BACTERIAL HAND- benzalkonium chloride soap

  • 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 October 9, 2020

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  • ACTIVE INGREDIENTS

    BENZALKONIUM CHLORIDE 0.25%

  • DIRECTIONS

    LATHER VIGOROUSLY AND WASH SKIN. RINSE AND DRY THOROUGHLY.

  • PURPOSE

    ANTIBACTERIAL

  • USES

    FOR HAND WASHING TO DECREASE BACTERIA ON THE SKIN.

  • INACTIVE INGREDIENTS

    WATER

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • WARNINGS

    FOR EXTERNAL USE ONLY

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Hand Sani

  • INGREDIENTS AND APPEARANCE
    ANTI-BACTERIAL HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90055-209
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    WATER (UNII: 059QF0KO0R)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90055-209-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product10/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/09/2020
    Labeler - Collective Science Integration (133591508)
    Establishment
    NameAddressID/FEIBusiness Operations
    P&P International133591508manufacture(90055-209)
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