Label: OMEDI HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 74646-0080-1
  • Packager: Natural Korea Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated April 20, 2020

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  • PRINCIPAL DISPLAY PANEL

    80 ml

  • INGREDIENTS AND APPEARANCE
    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)