Label: ANTIBACTERIAL 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 March 29, 2022

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  • ACTIVE INGREDIENT

    BENZALKONIUM CHLORIDE  0.13%

  • PURPOSE

    ANTISEPTIC

  • USES

    HELPS ELIMINATE BACTERIA ON HANDS

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES. IN CASE OF CONTACT, FLUSH WITH WATER.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN EXCEPT UNDER ADULT SUPERVISION. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    WASH HANDS AND RINSE.

  • INACTIVE INGREDIENTS

    WATER (AQUA), SODIUM C14-16 OLEFIN SULFONATE, COCAMIDOPROPYL BETAINE, COCAMIDE MIPA, GLYCERIN, PHENOXYETHANOL, POLYSORBATE 20, CITRUS LIMON (LEMON) SEED OIL, D-LIMONENE, SODIUM CHLORIDE, CITRUS AURANTIUM DULCIS (ORANGE) OIL, CITRUS SINENSIS (BLOOD ORANGE) OIL, ETHYLHEXYL GLYCERIN, CITRIC ACID, POLYQUATERNIUM-10.

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Antibacterial Hand Soap_12oz

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50518-309
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LEMON OIL (UNII: I9GRO824LL)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    CITRUS SINENSIS SEED OIL (UNII: 9WMM6OQ58A)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50518-309-11355 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/01/2020
    Labeler - CUSTOM RESEARCH LABS INC (028611598)
    Registrant - CUSTOM RESEARCH LABS INC (028611598)
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