Label: EARTH EDITION HAND SANITIZER GEL- ethanol gel

  • Category: HUMAN OTC DRUG LABEL

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 May 10, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • PRINCIPAL DISPLAY PANEL

    EARTH EDITION HAND SANITIZER Gel

  • INGREDIENTS AND APPEARANCE
    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)