Label: ANTIBACTERIAL- benzalkonium chloride 0.13% 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 July 19, 2021

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  • Active ingredients

    Benzalkonium chloride 0.13%.................Anitbacterial Hand soap

  • Purpose

    Antibacterial Hand Soap

  • Use

    help eliminate bacteria on hands.

  • Warnings

    For external use only: hands only

  • When using this product

    • avoid contact with eyes.  If contact occurs, rinse eyes with water
  • Stop use and ask a doctor if

    • irritation or redness develops
    • condition persists for more than 72 hours
  • Keep out of reach of children

    • Except under adult supervision.
    • If swallowed, get medical help or contact a Poison Control Center right away
  • Directions

    • Wet hand and apply soap.
    • Lather front and back between your fingers and under your nails.
    • Scrub for at least 20 second 
    • rinse and dry.
  • INACTIVE INGREDIENT

    Water, Cetrimonium chloride , Cocamidopropyl betaine, Sodium chloride, glycerin,PEG-40

    Fragrance, Polyquatemium-10 , PEG-8 , Citric Acid, Tetrasodium EDTA, Cocamidopropyl PG-Dimonium Chrolide,

    Methylchloroisothiazolinone, Methlisothiazolinone, Aloe Vera, Blue 1,Red 33(CI 17200).

  • Principal display panel

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  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    benzalkonium chloride 0.13% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76772-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE (UNII: 205Z54J075)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76772-031-181890 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/16/2021
    Labeler - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
    Registrant - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
    Establishment
    NameAddressID/FEIBusiness Operations
    TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI533120570manufacture(76772-031)
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