Label: GERM-X SOFT WIPES ALCOHOL FREE ANTIBACTERIAL (benzalkonium chloride- 0.13% cloth

  • NDC Code(s): 11344-801-01, 11344-801-02, 11344-801-03
  • Packager: VI-JON
  • 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 July 9, 2015

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  • Drug Facts

  • Drug Facts

  • Active Ingredients

    Benzalkonium Chloride (0.13%)

  • Purpose

    Antiseptic

  • Use

    to decrease bacteria on the skin

  • Warnings

    For external use only

    When using this product

    • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
    • avoid contact with broken skin

    Stop use and ask a doctor if skin irritation develops.

  • Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions:

    • wipe hands thoroughly with product and allow to dry
    • for children under 6, use only under adult supervision
    • not recommended for infants
  • Inactive ingredients

    water, polysorbate 20, glycerin, phenoxyethanol, aloe barbadensis leaf juice, fragrance, methylparaben, tocopheryl acetate, tetrasodium EDTA, disodium cocoamphodiacetate, butylparaben, citric acid, ethylparaben, propylparaben

  • SPL UNCLASSIFIED SECTION

    Questions? 1-866 MY GERMX • 1-866-694-3769

  • SPL UNCLASSIFIED SECTION

    *Effective at eliminating 99.99% of many common harmful germs and bacteria in as little as 15 seconds.

    Distributed by: Vi-Jon

    St. Louis, MO 63114

    www.germx.com

    Made in USA with US and foriegn components.

    L0012408SA

  • germ-x ALCOHOL FREE • ANTIBACTERIAL Soft Wipes

    Germ-X Soft Wipes are quilted ultra strong wipes for antibacterial cleansing of hands.
    Germ-X Soft Wipes are clinically proven to moisturize while killing 99.99% of germs in as little as 15 seconds leaving your skin feeling refreshed.
    Germ-X Soft Wipes are convenient, easy to carry and can be used anytime, anywhere:

    • Home
    • Office
    • Picnics
    • Beach Bag
    • Boating
    • Health Club
    • Car
    • Sports Bags
    • Camping
    • Workshop

  • SPL UNCLASSIFIED SECTION

    Use Instructions

  • SPL UNCLASSIFIED SECTION

    Moisturizing WITH VITAMIN E

    germ-x

    ALCOHOL FREE • ANTIBACTERIAL

    SOFT WIPES

    FOR HANDS • ULTRA SOFT • ULTRA STRONG

    KILLS 99.99% OF GERMS*

    40 SOFT CLOTHS

    5.5 In X 7.9 In (14 cm X 20 cm)

  • Package Label

    Package Label - 40 Count

    package-label-40

    Package Label - 72 Count

    package-label-72

    Package Label - 20 Count - Top

    package-label-20-top

    Package Label - 20 Count - Designer Packagepackage-label-20-pack

  • INGREDIENTS AND APPEARANCE
    GERM-X SOFT WIPES ALCOHOL FREE ANTIBACTERIAL 
    benzalkonium chloride (0.13%) cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.0013 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-801-0130 mg in 1 POUCH; Type 1: Convenience Kit of Co-Package04/01/2005
    2NDC:11344-801-0240 mg in 1 CAN; Type 1: Convenience Kit of Co-Package04/01/2005
    3NDC:11344-801-0372 mg in 1 CAN; Type 1: Convenience Kit of Co-Package04/01/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/2005
    Labeler - VI-JON (150931459)
    Registrant - Albaad (143406457)
    Establishment
    NameAddressID/FEIBusiness Operations
    Albaad143406457manufacture(11344-801)
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