Label: DALAN THERAPY ANTIBACTERIAL HAND WASH, COOL PROTECTION- 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 April 6, 2020

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  • Drug Facts

  • Active ingredients

    Benzalkonium Chloride 0.13%

    Purpose

    Antibacterial

  • Uses

    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 persists 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 (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 60 seconds. Rinse and Repeat

  • Inactive ingredients:

    Water, Cocamidopropyl Betaine, Lauryl Amine Oxide, Cocamine Oxide, Cocamidopropylamine Oxide, Sodium Chloride, Glycerine, Lactic Acid, Sodium Lactate, PEG-120 Methyl Glucose Dioleate, Fragrance, Laureth-7 Citrate, Tetrasodium EDTA, Benzophenone-3, Triethylene Glycol, Propylene Glycol, Benzyl Alcohol, Methylchloroisothiazolinone, Methylsothiazolinone, Linalool, Blue 1.

  • Package Labeling:

    Label4

  • INGREDIENTS AND APPEARANCE
    DALAN THERAPY ANTIBACTERIAL HAND WASH, COOL PROTECTION 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51209-015
    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)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    OXYBENZONE (UNII: 95OOS7VE0Y)  
    TRIETHYLENE GLYCOL (UNII: 3P5SU53360)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51209-015-00300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/03/2020
    Labeler - DALAN KIMYA ENDUSTRI ANONIM SIRKETI (566219285)
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