Label: ANTIBACTERIAL HANDWASH HOBBY- 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 October 27, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • USES

    • For Handwashing to decrease bacteria on the skin
  • WARNING

    For external use only.

  • WHEN USING

    • avoid contact with eyes.
    • In case of eye contact, flush with water
  • Stop use and ask a doctor if

    • 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 ,wet as needed
    • lather vigorously for at least 15 seconds
    • Wash skin, rinse throughly and dry.
  • Inactive Ingredients:

    Water（Aqua),Cocamidopropyl Betaine,Sodium Chloride,Fragrance, Citric Acid,Methylchloroisothiazolinone,Methylisothiazolinone,  Cocamide/DEA, FD&C Red No40,Glycerin ,Parfum,Tetrasodium EDTA,Sodium laureth sultate.

  • PRINCIPAL DISPLAY PANEL

    6

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HANDWASH  HOBBY
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71611-074
    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-3 SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71611-074-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/26/2020
    Labeler - Click Products LLC (080766174)
    Registrant - Click Products LLC (080766174)
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