HAUTIAN PURE HAND CLEAN 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.-HAUTIAN PURE HAND CLEAN Gel] 30 ml X 20 : 74004-136-20

03

HAUTIAN PURE HAND CLEAN GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74004-136
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL18.6 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 60 (UNII: CAL22UVI4M)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74004-136-2020 in 1 BOX04/16/2020
130 mL in 1 POUCH; Type 0: Not a Combination Product
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(74004-136)

Revised: 4/2020
Document Id: a3bbe5af-56c4-03b4-e053-2995a90a3ddc
Set id: a3bbe5a2-e12a-7727-e053-2a95a90a9d6f
Version: 1
Effective Time: 20200417
 
Ester Co., Ltd.