Label: INSTANT HAND SANITIZER HARMON- ethyl alcohol 65.00% liquid

  • 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 October 6, 2017

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  • Active ingredients                        Purpose

    Ethyl Alcohol 65.00%                   Antiseptoc

  • PURPOSE

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

  • Uses

    To decrease the risk of skin infection in minor cuts, scrapes and burns

  • WrningsFor external use only - hands

  • DOSAGE & ADMINISTRATION

    Directions
    Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

  • Inactive ingredients

    Aloe Barbadensis Leaf Extract
    Aminomethyl Propanol
    Carbomer
    Fragrance
    Glycerin
    Isopropyl Alcohol
    Isopropyl Myristate
    Propylene Glycol
    Tocopheryl Acetate
    Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER  HARMON
    ethyl alcohol 65.00% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER 934 (UNII: Z135WT9208)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-111-0128 g in 1 BOTTLE; Type 0: Not a Combination Product02/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/09/2016
    Labeler - Harmon (804085293)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(63940-111) , label(63940-111)