Label: DEX- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL

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 December 10, 2022

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  • Active Ingredient(s)

    Benzalkonium Chloride %0.13....Purpose: Antibacterial

  • Purpose

    Antibacterial, Liquid Soap

  • Use

    It 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.

  • Do not use

    If swallowed, get medical help or contact a Poison Control Center right away.

  • WHEN USING

    When using this product, avoid contact with eyes. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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.

  • Directions

    • wash hands and rinse
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Aqua, Lauramine Oxide, Cetrimonium Chloride, Glycerin, PEG - 150 Distearate, Fragrance, Citric Acid, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1(CI 42051)

  • Package Label - Principal Display Panel

    500 ml Antibacterial Liquid Soap NDC: 76964-300-01

  • INGREDIENTS AND APPEARANCE
    DEX 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76964-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W) 8 g  in 100 g
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) 3 g  in 100 g
    FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95) 0.4 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 100 g
    WATER (UNII: 059QF0KO0R) 84.37 g  in 100 g
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) 2 g  in 100 g
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W) 0.1 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76964-300-01500 g 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 - TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI (535142780)
    Registrant - TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI (535142780)
    Establishment
    NameAddressID/FEIBusiness Operations
    TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI535142780manufacture(76964-300)
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