ICING - hand sanitizer gel 
Yusef Manufacturing Laboratories, LLC

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.

----------

Icing Hand Sanitizer - Aseptisant Pour Les Mains (Berry, Citrus, Clean)

Purpose     Sanitizer

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.

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 Ingredients     Water, Fragrance, Carbomer, Triethanolamine, Lactose, Microcrystalline Cellulose, Ultramarines, Tocopheryl Acetate

Made in USA

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

Icings Label Front / BackEnter section text here

Active Ingredient       Ethyl Alcohol (62%)

Net Wt. 1 fl. oz. / (29ml)
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

Revised: 3/2010
Document Id: 2595d684-91d4-4557-bf05-d74b0d7103a1
Set id: 31e465f2-2269-4879-bf23-f5d7aafa8591
Version: 1
Effective Time: 20100310
 
Yusef Manufacturing Laboratories, LLC