Label: ANTIBACTERIAL HANDWASH LAVENDER BOUQUET- benzalkonium chloride liquid

  • NDC Code(s): 76176-042-01
  • Packager: Ningbo Liyuan Daily Chemical Products Co.,Ltd.
  • 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%

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  • Purpose

    Antibacterial

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  • USES

    for hand washing to decrease bacteria on the skin.

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  • WARNING

    For external use only.

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  • WARNINGS

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

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  • STOP USE

    and ask a doctor if irritation and redness develops.

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  • KEEP OUT OF REACH OF CHILDREN.

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

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  • DIRECTIONS

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

    Water´╝łAqua),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.

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  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HANDWASH  LAVENDER BOUQUET
    benzalkonium chloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76176-042
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76176-042-01 400 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 08/01/2018
    Labeler - Ningbo Liyuan Daily Chemical Products Co.,Ltd. (530766098)
    Registrant - Ningbo Liyuan Daily Chemical Products Co.,Ltd. (530766098)
    Establishment
    Name Address ID/FEI Business Operations
    Ningbo Liyuan Daily Chemical Products Co.,Ltd. 530766098 manufacture(76176-042)
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