Label: CLAIRES- hand sanitizer gel

  • 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 February 15, 2010

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  • SPL UNCLASSIFIED SECTION

    Use     Decreases bacteria on hands

  • WARNINGS

    Warnings     For external use only. Do not use in the eyes. Discontinue use if irritation and redness develop.  If condition persists more than 72 hours, consult a doctor. Keep out of reach of children. If swallowed, get medical help or call Poison Control Center immediately.  Store below 110 F (43 C).

  • SPL UNCLASSIFIED SECTION

    Flammable     Keep away from fire or flame.
  • SPL UNCLASSIFIED SECTION

    Directions     Rub a dime size drop into hands.

  • INACTIVE INGREDIENT

    Inactive Ingredients     Water, Fragrance, Carbomer, Triethanolamine, Lactose, Microcrystalline Cellulose, Ultramarines, Tocopheryl Acetate
  • SPL UNCLASSIFIED SECTION

    CBI Distributing Corp. 2400 W. Central Road
    Hoffman Estates, IL  60192-1930   U.S.A. 
  • SPL UNCLASSIFIED SECTION

    Made in U.S.A.

  • PRINCIPAL DISPLAY PANEL

    Claire's Hand Sanitizer LabelsEnter section text here

  • INGREDIENTS AND APPEARANCE
    CLAIRES 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10827-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LACTOSE (UNII: J2B2A4N98G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    (PHTHALOCYANINATO(2-)) COPPER (UNII: 3VEX9T7UT5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10827-0002-128 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33301/15/2010
    Labeler - Yusef Manufacturing Laboratories, LLC (144150674)
    Registrant - Yusef Manufacturing Laboratories, LLC (144150674)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yusef Manufacturing Laboratories, LLC144150674manufacture
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