FELIX HAND SANITIZER GEL- alcohol gel 
Ester Co., Ltd.

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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[Ester Co., Ltd.-FELIX HAND SANITIZER GEL] 500 ml : BOTTLE+PUMP : 74004-702-01

FELIX HAND SANITIZER GEL 500 ml

FELIX HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74004-702
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
EDETOL (UNII: Q4R969U9FR)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74004-702-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/21/2020
Labeler - Ester Co., Ltd. (688425766)
Establishment
NameAddressID/FEIBusiness Operations
Ester Co., Ltd. 688425766manufacture(74004-702)

Revised: 5/2020
Document Id: a62507d9-048c-139f-e053-2995a90a2bc9
Set id: a6250431-e7ea-3df1-e053-2a95a90a1659
Version: 1
Effective Time: 20200521
 
Ester Co., Ltd.