Label: ALCOHOL- hand sanitizer 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 November 7, 2022

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  • DOSAGE & ADMINISTRATION

    1

  • WARNINGS

    2

  • INACTIVE INGREDIENT

    3

  • INDICATIONS & USAGE

    5

  • ACTIVE INGREDIENT

    6

  • PURPOSE

    7

  • KEEP OUT OF REACH OF CHILDREN

    8

  • PRINCIPAL DISPLAY PANEL

    package label.jpg

  • INGREDIENTS AND APPEARANCE
    ALCOHOL 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77146-123
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL42 mL  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77146-123-0160 in 1 BOTTLE, PUMP05/05/2020
    1NDC:77146-123-0260 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/23/2020
    Labeler - Aterian Group Inc (080055690)
    Registrant - Aterian Group Inc (080055690)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aterian Group Inc080055690label(77146-123) , manufacture(77146-123)