Label: X3 CLEAN- hand sanitizer spray spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 24, 2009

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  • PURPOSE

    Purpose Antimicrobial
  • INDICATIONS & USAGE

    Use To decrease bacteria on the skin that could cause disease.
  • WARNINGS

    Warnings For external use only. Do not freeze.

    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

    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.

  • INACTIVE INGREDIENT

    Purified Water, Glycerin, Cocamidopropyl Bentaine.

  • PRINCIPAL DISPLAY PANEL

    0.27 oz Hand Sanitizer Spray
  • INGREDIENTS AND APPEARANCE
    X3 CLEAN 
    hand sanitizer spray spray
    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 uL  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:26550-001-108 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33309/01/2009
    Labeler - X3 Labs Inc. (243700361)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canadian Custom Packaging Company207062514manufacture
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