Label: BIOMIRACLE STAYSAFE HAND SANITIZER- alcohol 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 July 13, 2020

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  • PRINCIPAL DISPLAY PANEL

    1 GALLON

  • INGREDIENTS AND APPEARANCE
    BIOMIRACLE STAYSAFE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77978-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL2649 mL  in 3785 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77978-108-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/13/2020
    Labeler - MJM SOURCING, LLC (078861054)
    Establishment
    NameAddressID/FEIBusiness Operations
    WHITE COSPHARM CO.,LTD.688442259manufacture(77978-108)
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