EARTH EDITION HAND SANITIZER GEL- ethanol gel 
Earth Edition Inc.

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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EARTH EDITION HAND SANITIZER Gel
480 mL
76841-4806-1

EARTH EDITION HAND SANITIZER Gel

EARTH EDITION HAND SANITIZER GEL 
ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76841-4806
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
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALLANTOIN (UNII: 344S277G0Z)  
ORANGE OIL (UNII: AKN3KSD11B)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
PANTHENOL (UNII: WV9CM0O67Z)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76841-4806-1480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/10/2020
Labeler - Earth Edition Inc. (695625846)
Establishment
NameAddressID/FEIBusiness Operations
Skin n Skin Co., Ltd.631090037manufacture(76841-4806)

Revised: 5/2020
Document Id: a5583d17-6023-1902-e053-2a95a90a9f01
Set id: a5583d17-6022-1902-e053-2a95a90a9f01
Version: 1
Effective Time: 20200510
 
Earth Edition Inc.