CLAIRES - 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.

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Claire's Hand Sanitizer (Berry, Vanilla, Strawberry)

Use     Decreases bacteria on hands

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).

Flammable     Keep away from fire or flame.

Directions     Rub a dime size drop into hands.

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

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

Made in U.S.A.

Claire's Hand Sanitizer LabelsEnter section text here

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

Revised: 2/2010
Document Id: 66fbcd67-91ef-4c3c-a973-7e2657d6242a
Set id: 243bf656-eab6-4694-ab7c-4df134ac77df
Version: 1
Effective Time: 20100215
 
Yusef Manufacturing Laboratories, LLC