Label: MEGACLEAN HAND SANITIZER- ethanol gel

  • 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 May 31, 2020

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  • PRINCIPAL DISPLAY PANEL

    300 mL

  • INGREDIENTS AND APPEARANCE
    MEGACLEAN HAND SANITIZER 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77799-370
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL210 mL  in 300 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77799-370-01300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/31/2020
    Labeler - MEGACITY GROUP LLC (094579228)
    Establishment
    NameAddressID/FEIBusiness Operations
    BL Cosmetic Co., Ltd695735124manufacture(77799-370)