OMEDI HAND SANITIZER- ethyl alcohol gel 
Natural Korea 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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[OMEDI HAND SANITIZER 80 ml : 74646-0080-1

80 ml

OMEDI HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74646-0080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL56 mL  in 80 mL
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MENTHOL (UNII: L7T10EIP3A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ARGININE (UNII: 94ZLA3W45F)  
GRAPEFRUIT (UNII: O82C39RR8C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74646-0080-180 mL in 1 TUBE; Type 0: Not a Combination Product04/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/16/2020
Labeler - Natural Korea Co., Ltd. (688729438)
Establishment
NameAddressID/FEIBusiness Operations
Natural Korea Co., Ltd.688729438manufacture(74646-0080)

Revised: 4/2020
Document Id: a43f41ac-6d39-6f81-e053-2a95a90a4643
Set id: a43f41ac-6d38-6f81-e053-2a95a90a4643
Version: 1
Effective Time: 20200420
 
Natural Korea Co., Ltd.