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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal 112-8355029-4/1/1

Manufacturer FEI3003772750
Manufacturer NameSyneron Medical Ltd.  
Manufacturer Address line 1Sultam Industrial Park  
Manufacturer Address line 2  
Manufacturer's CityYokneam, Illit  
Manufacturer Province/State  
Manufacturer Country/AreaIsrael  
Product Code53LD99  
Importer's Product Description418732955605 HAIR REMOVAL PREP GEL  
Refusal Date02-Nov-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-8355029-4/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
COSMETLBLG   5(c)(3)(B); 801(a)(3) Misbranding   It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.