Label: ZEP FUZION ANTIMICROBIAL HAND CLEANER- 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 September 3, 2021

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  • Active ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic Hand Wash

  • Uses

    • Hand washing to decrease bacteria on skin.
    • For use in food processing facilities.
  • Warnings

    For external use only.

    Do not use in the eyes; if in eyes, rinse promptly and thoroughly with water.

  • When using this product

    • Do not swallow.
    • If swallowed, do not induce vomiting and if individual is conscious, give large quantities of water to drink and consult a physician immediately.
  • Stop use and ask a doctor

    Stop use and ask a doctor if skin irritation or redness persists for more than 72 hours.

  • Keep out of reach of children and pets

    Keep out of reach of children and pets. Children must be supervised in use of this product.

  • Directions

    • Wet hands with water.
    • Place hands under dispenser and apply liquid soap.
    • Massage soap into hands and wrists, emphasizing back of hands, knuckles, and cuticles.
    • Rinse hands thoroughly and dry.
  • Other information

    • Store at 20 to 25°C (68 to 77°F).
    • Do not freeze.
    • Dispose in accordance with all applicable federal, state and local regulations.
  • Inactive ingredients

    Water, Didecyldimonium Chloride, Cocamidopropyl Hydroxysultaine, Lauramine Oxide, PEG-6 Cocamide, Hydroxyethylcellulose, Methylchloroisothiazolinone and Methylisothiazolinone, Citric Acid

  • Questions or comments?

    Call 1-877-I-BUY-ZEP (1-877-428-9937)

  • PRINCIPAL DISPLAY PANEL

    106_3153

  • INGREDIENTS AND APPEARANCE
    ZEP FUZION ANTIMICROBIAL HAND CLEANER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66949-106
    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
    PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66949-106-164800 mL in 1 CASE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - Zep Inc. (030471374)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zep Inc.112125310manufacture(66949-106)
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