Label: ICING- hand sanitizer gel

  • Category: HUMAN OTC DRUG LABEL

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 March 10, 2010

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  • PURPOSE

    Purpose     Sanitizer

  • SPL UNCLASSIFIED SECTION

    Instructions:     Pour small amount of gel into the palm of your hands.  Rub hands together until dry.
    Mode d'emploi: Versez une petite quantite de gel au creux de vos mains.  Frottez vos mains jusqu'a ce qu'elles soient bien seches.
  • WARNINGS

    Warning:  Flammable. Do not use near fire, flame or while smoking.  Do not store where temperature exceeds 120 F.  For external use only.  Avoid contact with eyes.  In case of contact with eyes, flush with water.  Discontinue this product if rash, redness or irritation occurs.  If irritation persists, get immediate attention.  Keep out of reach of children.  DO NOT EAT.

    Advertissement:  Inflammable. Ne pas utiliser pres d'une fiamme, d'une etincelle ou en fumant.  Ne pas garder a des temperatures depassant les 49 C (120 F).  Pour usage exteme uniquement.  Evitez tout contact avec les yeux.  En cas de contact avec les yeux, rincez avec de l'eau.  Arretez l'utilisation de ce produit en cas d'irritation. Si l'irritation persiste, consulter immediatement un medecin.  gardez hors de portee des enfants. NE PAS INGERER.

  • INACTIVE INGREDIENT

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

    Made in USA
  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL

    Icings Label Front / BackEnter section text here

  • ACTIVE INGREDIENT

    Active Ingredient       Ethyl Alcohol (62%)
  • SPL UNCLASSIFIED SECTION

    Net Wt. 1 fl. oz. / (29ml)
  • INGREDIENTS AND APPEARANCE
    ICING 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10827-0003
    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:10827-0003-128 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33303/10/2010
    Labeler - Yusef Manufacturing Laboratories, LLC (144150674)
    Registrant - Yusef Manufacturing Laboratories, LLC (144150674)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yusef Manufacturing Laboratories, LLC144150674manufacture
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