X3 CLEAN (BENZALKONIUM CHLORIDE) AEROSOL, FOAM [X3 LABS INC.]

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X3 CLEAN (BENZALKONIUM CHLORIDE) AEROSOL, FOAM [X3 LABS INC.]
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NDC 26550-001-12, 26550-001-14, 26550-001-16, 26550-001-18, 26550-001-20
Set ID a8eedcfd-3b97-497a-9a34-d59b0dd78439
Category HUMAN OTC DRUG LABEL
Packager X3 Labs Inc.
Generic Name
Product Class
Product Number
Application Number PART333
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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

       Antimicrobial

  • Use

    To decrease bacteria on the skin that could cause disease.

  • Warnings

    For external use only.

    Do not use in or near eyes. In case of contact with eyes, flush thoroughly with water.

  • STOP USE

    Stop use and ask doctor if skin irritation develops.

  • Keep out of reach of children

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

  • DOSAGE & ADMINISTRATION

    Directions

    Apply a small amount to palms and rub hands thoroughly until completely dry.

  • WARNINGS AND PRECAUTIONS

    Other Information   Do not freeze.

  • INACTIVE INGREDIENT

    Inactive Ingredients
    Purified Water, Glycerin, Cocamidopropyl Betaine.

  • QUESTIONS

    Questions? www.x3clean.com

  • PRINCIPAL DISPLAY PANEL

    2.5 oz Hand Sanitizer Foam

  • PRINCIPAL DISPLAY PANEL

    8.5 oz Hand Sanitizer Foam

  • PRINCIPAL DISPLAY PANEL

    1L Bottle Hand Sanitizer Foam

  • PRINCIPAL DISPLAY PANEL

    1L Cartridge Hand Sanitizer Foam

  • PRINCIPAL DISPLAY PANEL

    4L Refill Hand Sanitizer Foam

  • INGREDIENTS AND APPEARANCE
    X3 CLEAN 
    benzalkonium chloride aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:26550-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:26550-001-1275 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2009
    2NDC:26550-001-14250 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2009
    3NDC:26550-001-161000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2009
    4NDC:26550-001-181000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product09/01/2009
    5NDC:26550-001-204000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/01/2009
    Labeler - X3 Labs Inc. (243700361)
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