X3 CLEAN FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) AEROSOL, FOAM [CSR COSMETIC SOLUTIONS INC.]

X3 CLEAN FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) AEROSOL, FOAM [CSR COSMETIC SOLUTIONS INC.]
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NDC 49354-055-75
Set ID 3c636145-03fe-47c7-81fc-279fef69b1c3
Category HUMAN OTC DRUG LABEL
Packager CSR Cosmetic Solutions Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
  • Drug Facts

  • 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 the eyes. In case of contact with eyes, flush thoroughly with water.

    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.

  • Directions

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

  • Other Information

    Do not freeze.

  • Inactive Ingredients

    Purified Water, Glycerin, Cocamidopropyl Betaine.

  • Questions?

    www.x3clean.com

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    X3 CLEAN FOAMING HAND SANITIZER 
    benzalkonium chloride aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49354-055
    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:49354-055-7575 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/01/2019
    Labeler - CSR Cosmetic Solutions Inc. (243501959)

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