Label: BENZALKONIUM CHLORIDE- antibacterial hand soap liquid

  • 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 May 1, 2018

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride - 0.13%

  • PURPOSE

    Purpose - Antibacterial

  • INDICATIONS & USAGE

    Use for handwashing to decrease bacteria on the skin

  • WARNINGS

    Warning - For external use only - hands only

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if

    • irritaion or redness develops
    • condition persists for more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet Hands
    • Apply palmful to hands
    • scrub thoroughly
    • rinse thoroughly
  • INACTIVE INGREDIENT

    Inactive Ingredients: Water (Aqua),Acrylates/C10-30 Alkyl Acrylate crosspolymer, Citrtic Acid, Cocamidopropyl Betaine,Cocamide MEA,Decyl Glucoside, DMDM Hydantoin,Sodium Benzoate, Sodium Laureth Sulfate, Sodium Chloride, Sodium Hydroxide, Glycerin, Fragrance,Panthenol (Parfum),PEG-12 Methyl Glucose Dioleate, Polyquatenium 10, Tetrasodium EDTA, Blue 1, Red# 4 (Cl 14700)

  • PRINCIPAL DISPLAY PANEL

    Cuticura

  • INGREDIENTS AND APPEARANCE
    BENZALKONIUM CHLORIDE 
    antibacterial hand soap liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-210
    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
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-210-01221 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/30/2018
    Labeler - Brands International Corporation (243748238)
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