ZERO-PERCENT PORTABLE SANITIZER- alcohol 
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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[7] ZERO-PERCENT Portable Sanitizer
Set product
4 fragrance, 1 fragrance-free

ZERO-PERCENT Portable Sanitizer

ZERO-PERCENT PORTABLE SANITIZER 
alcohol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74004-047
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74004-047-021 in 1 BOX10/07/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, SPRAY 40 mL
Part 21 BOTTLE, SPRAY 40 mL
Part 31 BOTTLE, SPRAY 40 mL
Part 41 BOTTLE, SPRAY 40 mL
Part 51 BOTTLE, SPRAY 40 mL
Part 1 of 5
ZERO-PERCENT PORTABLE SANITIZER 
alcohol spray
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL28 mL  in 40 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
140 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/07/2020
Part 2 of 5
ZERO-PERCENT PORTABLE SANITIZER 
alcohol spray
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL28 mL  in 40 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
140 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/07/2020
Part 3 of 5
ZERO-PERCENT PORTABLE SANITIZER 
alcohol spray
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL28 mL  in 40 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
140 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/07/2020
Part 4 of 5
ZERO-PERCENT PORTABLE SANITIZER 
alcohol spray
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL28 mL  in 40 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
140 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/07/2020
Part 5 of 5
ZERO-PERCENT PORTABLE SANITIZER 
alcohol spray
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL28 mL  in 40 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
140 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/07/2020
Labeler - Ester Co., Ltd. (688425766)
Establishment
NameAddressID/FEIBusiness Operations
Ester Co., Ltd.688425766manufacture(74004-047)

Revised: 10/2020
Document Id: b10b5d2f-7040-3e50-e053-2995a90adbfa
Set id: b10b5d2f-703f-3e50-e053-2995a90adbfa
Version: 1
Effective Time: 20201006
 
Ester Co., Ltd.