Label: ACTIVEX ANTIBACTERIAL HAND WASH- benzalkonium chloride liquid

  • NDC Code(s): 64309-002-01
  • Packager: Evyap Sabun Yag Gliserin Sanayi Ve Ticaret Anonim Sirketi
  • 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 October 26, 2020

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  • Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antiseptic

  • Use

    For hand washing to decrease bacteria on the skin

  • Warnings

    For external use only

    Do not use

    in the eyes

    Stop use and ask a doctor if

    - Irritation and redness develop

    - Condition persists for more than 72 hours

    Keep out of reach of children.

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

  • Directions

    - Wet hands and forearms.

    - Apply 5mL or palmful to hands and forearms.

    - Scrub thoroughly for 30 to 60 seconds.

    - Rinse and Repeat.

  • Other information

    - Store in dry and cool place in the original packaging.

    - Keep from light including direct sunlight.

  • Inactive ingredients

    Water, glycerin, PEG-4 rapeseedamide, cocamidopropylamine oxide, lauryl glucoside, cetrimonium chloride, PEG-120 methyl glucose dioleate, cocamine oxide, styrene/acrylamide copolymer, lauramine oxide, lauramidopropylamine oxide, malic acid, fragrance, sodium benzoate, myristamidopropylamine oxide, sodium salicylate, phenoxyethanol, sodium chloride, tetrasodium EDTA, sodium PCA.

  • Questions or comments

    1 (224) - 408-0663

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ACTIVEX ANTIBACTERIAL HAND WASH 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64309-002
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-4 RAPESEEDAMIDE (UNII: 89575CN928)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    MALIC ACID (UNII: 817L1N4CKP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)  
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64309-002-01300 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/01/2020
    Labeler - Evyap Sabun Yag Gliserin Sanayi Ve Ticaret Anonim Sirketi (628145740)