• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report

  • Print
  • Share
  • E-mail

Refusal Details as Recorded in OASIS by FDA

for Refusal AR6-2112931-1/7/1

Manufacturer FEI2000019715
Manufacturer NameDr Nona International LTD  
Manufacturer Address line 1Levi Moshe 11  
Manufacturer Address line 2  
Manufacturer's CityRishon Le Zion  
Manufacturer Province/StateIL-M  
Manufacturer Country/AreaIsrael  
Product Code53ID02  
Importer's Product DescriptionMOUTH WASH ELIXIR  
Refusal Date26-Jun-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx AR6-2112931-1/7/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.