Label: ANTIBACTERIAL FOAMING HAND WASH- benzalkonium chloride 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 March 17, 2015

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Uses

    For handwashing to decrease bacteria on the skin.

  • Warnings

    For external use only.


  • When using this product

    Avoid contact with eyes. If contact occurs flush eyes with water.

    Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.


  • Keep out of the reach of children

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

  • Directions

    Wet hands. Apply palmful to hands and forearms. Scrub thoroughly. Rinse and repeat. Dry thoroughly.

  • Inactive Ingredients

    Aloe Barbadensis (Aloe Vera) Leaf Extract, Benzophenone-3, Citric Acid, Cocamidopropylamine Oxide, Cocamidopropyl Betaine, Water, Disodium EDTA, Glycerin, Hamamelis Virginiana (Witch Hazel) Extract, Methylchloroisothiazolinone, Methylisothiazolinone, Olea Europaea (Olive) Leaf Extract, Polyaminopropyl Biguanide,  Propylene Glycol, Sodium Lauroamphoacetate, Thymus Vulgaris (Thyme Oil).

  • HOW SUPPLIED

  • PRINCIPAL DISPLAY PANEL

    image of 15019

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL FOAMING HAND WASH  
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43333-450
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 13 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OXYBENZONE (UNII: 95OOS7VE0Y)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    WATER (UNII: 059QF0KO0R)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43333-450-06200 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/17/2015
    Labeler - Tonic Bath and Body Products Shenzhen Ltd. (528197042)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tonic Bath and Body Products Shenzhen Ltd.528197042manufacture(43333-450)
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