BUBISON 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.-BUBISON HAND SANITIZER Gel] 500 ml : 74004-570-01

05

BUBISON HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74004-570
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 g  in 500 mL
Inactive Ingredients
Ingredient NameStrength
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:74004-570-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/16/2020
Labeler - Ester Co., Ltd. (688425766)
Establishment
NameAddressID/FEIBusiness Operations
Ester Co., Ltd. 688425766manufacture(74004-570)

Revised: 4/2020
Document Id: a3bc2077-7e95-f154-e053-2995a90ac461
Set id: a3bc3260-c4db-481a-e053-2995a90a99d3
Version: 1
Effective Time: 20200417
 
Ester Co., Ltd.