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 January 13, 2022

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  • ACTIVE INGREDIENT

    BENZALKONIUM CHLORIDE (0.13% M/M)

  • PURPOSE

    ANTIMICROBIAL

  • USES

    SIMPLY SOFT LIQUID SOAP CLEANS HANDS WITHOUT DRYING YOUR SKIN. PERFECT FOR ALL SKIN TYPES.

  • WARNINGS

    KEEP AWAY FROM DIRECT SUNLIGHT. IN CASE OF CONTACT WITH EYES, RINSE EYES WITH PLENTY OF WATER.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DIRECTIONS

    WET YOUR HANDS WITH CLEAN WATER. FILL OPEN PALM WITH ONE PUMPFUL OF SIMPLY SOFT LIQUID SOAP. LATHER YOUR HANDS BY RUBBING THEM TOGETHER WITH THE SOAP. RINSE YOUR HANDS UNDER CLEAN, RUNNING WATER.

  • INACTIVE INGREDIENTS

    AQUA (WATER), LAURYL GLUCOSIDE, COCAMIDOPROPYL BETAINE, LAURAMINE OXIDE, GLYCERIN, PEG 120 METHYL GLUCOSE DIOLEATE, CITRIC ACID, PARFUM, TETRASODIUM EDTA, BENZYL ALCOHOL, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, LIMONENE, CITRAL, FD&C YELLOW NO. 6, D&C RED NO. 33.

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Antibacterial Hand Soap_500mL

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58037-104
    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)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    CITRAL (UNII: T7EU0O9VPP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58037-104-11500 mL in 1 BOTTLE; Type 0: Not a Combination Product02/06/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/06/2021
    Labeler - Pride Products Corp. (109020099)
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