Label: ANTIBACTERIAL HANDWASH LAVENDER BOUQUET- benzalkonium chloride liquid

  • NDC Code(s): 52000-042-01
  • Packager: Universal Distribution Center LLC
  • 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 August 1, 2018

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • USES

    for hand washing to decrease bacteria on the skin.

  • WARNING

    For external use only.

  • WARNINGS

    When using this product avoid contact with eyes. In case of eye contact, flush with clean water.

  • STOP USE

    and ask a doctor if irritation and redness develops.

  • KEEP OUT OF REACH OF CHILDREN.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • DIRECTIONS

    • pump into hands
    • lather vigorously for at least 5 seconds
    • rinse and dry thoroughly.
  • Inactive Ingredients:

    Water(Aqua),Sodium Laureth Sulfate,Cocamidopropyl Betaine,Coconut Monoethanol Amide,Sodium Chloride,Fragrance,Citric Acid,Methylchloroisothiazolinone,Methylisothiazolinone,D&C Red No.33,FD&C Blue No.1.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HANDWASH  LAVENDER BOUQUET
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-042
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-042-01400 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/01/2018
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Universal Distribution Center LLC (019180459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Daily Chemical Products Co.,Ltd.530766098manufacture(52000-042)