Label: SALOON ANTIBACTERIAL HAND WASH EUCALYPTUS- benzalkonium chloride solution

  • 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 March 4, 2021

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  • Drug Facts

  • Active Ingredient:

    Benzalkonium chloride %0,13

    Purpose

    Antibacterial

  • Use

    For handwashing to decrease bacteria on the skin.

  • Warnings

    For external use only.

    When using this product

    • Do not use in the eyes.

    Stop use and ask a doctor if

    • Irritation and redness develop. If condition persist for more than 72 hours consult a doctor.

    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 5 milliliters (2 full pumps) to hands and forearms. Scrub thoroughly for 60 seconds. Rinse and repeat.
  • Inactive Ingredients

    Water, Glycerin, PEG-4 Rapeseedamide, Cocamidopropylamine Oxide, Lauramidopropylamine Oxide, Myristamidopropylamine Oxide, Lauryl Glucoside, Cetrimonium Chloride, PEG 120 Methyl Glucose Dioleate, Sodium PCA, Cocamine Oxide, Lauramine Oxide, Malic Acid, Tetrasodium EDTA, Sodium Benzoate, Potassium sorbate, Parfum, Yellow 4, Acid Blue 9.

  • Package Labeling:

    Bottle2

  • INGREDIENTS AND APPEARANCE
    SALOON ANTIBACTERIAL HAND WASH EUCALYPTUS 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81608-002
    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)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    MALIC ACID (UNII: 817L1N4CKP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81608-002-00400 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/01/2021
    Labeler - TIBET ITHALAT IHRACAT VE KOZMETIK SANAYI ANONIM SIRKETI (643295637)
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