Label: BENZALKONIUM CHLORIDE- antibacterial hand soap refill liquid

  • NDC Code(s): 50157-206-25
  • Packager: Brands International Corporation
  • 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 3, 2016

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride - 0.13%

  • PURPOSE

    Purpose - Antibacterial

  • INDICATIONS & USAGE

    Use for handwashing to decrease bacteria on the skin

  • WARNINGS

    Warning - For external use only - hands only

  • WHEN USING

    When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

  • STOP USE

    Stop use and ask a doctor if

    • irritaion or redness develops
    • condition persists for more than 72 hours
  • 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

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet Hands
    • Apply palmful to hands
    • scrub thoroughly
    • rinse thoroughly
  • INACTIVE INGREDIENT

    Inactive Ingredients: Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citrtic Acid, Glycerin, Fragrance (Parfum), Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow# 5 (Cl 19140), Red# 4 (Cl 14700)

  • Visibly Clean Antibacterial Hand Soap Refill

    Visibly Clean Antibacterial Hand Soap

  • INGREDIENTS AND APPEARANCE
    BENZALKONIUM CHLORIDE 
    antibacterial hand soap refill liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-206
    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)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-206-25739 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/03/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/03/2016
    Labeler - Brands International Corporation (243748238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International Corporation243748238manufacture(50157-206)