Label: ZEP PROFESSIONAL E-2 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 December 5, 2013

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  • Active ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    Antiseptic Handwash

  • Uses

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

    For external use only.

  • DO NOT USE

    Can cause eye irritation. Avoid contact with eyes.

  • WHEN USING

    When using this product

    • Do not use in or around eyes. If eye contact occurs, rinse well with water for at least 15 minutes. Consult a physician.
    • Do no swallow this product. If swallowed, do not induce vomiting. If individual is conscious, give large quantities of water to drink and consult a physician immediately.
  • STOP USE

    Discontinue use if irritation and redness develops. If condition persists for more than 72 hours, consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    • Wet hands with water
    • Dispense one or two squirts in palm of hand
    • Massag soap into hands and wrists, emphasizing back of hands, knuckles and cuticles
    • Hands must be thoroughly rinsed with potable water
  • Other information

    • Keep container closed
    • Store at room temperature
    • Do not freeze
    • Do not reuse empty container
    • Dispose in accordance with all applicable federal, state & local regulations
  • Inactive ingredients

    Water, Cocamidopropyl Betaine, Didecyldimethylammonium Chloride, PEG-6 Cocamide, Ethanol, Hydroxyethylcellusolose, DMDM Hydantoin (and) Iodopropynyl Butylcarbamate, Citric Acid

  • PRINCIPAL DISPLAY PANEL

    r112.jpg

  • INGREDIENTS AND APPEARANCE
    ZEP PROFESSIONAL E-2 HAND CLEANER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66949-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.013 g  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DIDECYLDIMETHYLAMMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
    ALCOHOL (UNII: 3K9958V90M)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    GLUTARAL (UNII: T3C89M417N)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66949-112-011000 mL in 1 BOTTLE, PLASTIC
    2NDC:66949-112-243785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/07/2009
    Labeler - Zep Inc. (030471374)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zep Inc.030471374manufacture(66949-112)
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