CLASSY 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.-Classy Hand Sanitizer Gel] 1 Gallon : 74004-128-01

Classy Hand Sanitizer Gel

CLASSY HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74004-128
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL2649.5 mL  in 3785 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:74004-128-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/05/2020
Labeler - Ester Co., Ltd. (688425766)
Establishment
NameAddressID/FEIBusiness Operations
Ester Co., Ltd. 688425766manufacture(74004-128)

Revised: 6/2020
Document Id: a74d3ed1-617d-c476-e053-2a95a90aca17
Set id: a74d5325-7f91-ab37-e053-2995a90a85f5
Version: 1
Effective Time: 20200604
 
Ester Co., Ltd.