Label: PREMIUM HAND SANITIZER- ethanol gel

  • NDC Code(s): 68599-5201-1, 68599-5201-2, 68599-5201-3, 68599-5201-4
  • Packager: MCKESSON MEDICAL-SURGICAL INC.
  • 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 April 25, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient                                       Purpose

    Ethanol 70% ...................................... hand sanitizer

  • PURPOSE

    Uses

    • an antiseptic hand sanitizer for topical application
    • helps prevent infection and cross-contamination
    • reduces transient microorganisms on intact skin
    • recommended for repeated use
  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    McKesson Premium Hand Sanitizer

    With Vitamin E, Moisturizers, & Emollients

    For frequent use

  • DOSAGE & ADMINISTRATION

    Directions

    Wet hands thoroughly with product. Allow to dry without wiping. Use no water or towels.

  • WARNINGS

    Warnings

    For external use only.

    Flammable, keep away from fire or flame.

    When using this product avoid contact with eyes. In case of eye contact, flush with water for 15 minutes.

    Discontinue use and see a doctor if irritation occurs.

    Avoid contact with broken skin.

  • INACTIVE INGREDIENT

    Inactive ingredients

    purified water, carbomer, glycerin, isopropyl myristate, tocopherol (vitamin E), diisopropyl sebacate, isopropanol, propylene glycol, aminomethyl propanol, fragrance, blue 1.

  • PRINCIPAL DISPLAY PANEL

    53-28037-1853-28032-453-28033-853-28035-1000

  • INGREDIENTS AND APPEARANCE
    PREMIUM HAND SANITIZER 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-5201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-5201-1118 g in 1 PACKAGE; Type 0: Not a Combination Product01/09/2015
    2NDC:68599-5201-2237 g in 1 PACKAGE; Type 0: Not a Combination Product01/09/2015
    3NDC:68599-5201-3532 g in 1 PACKAGE; Type 0: Not a Combination Product01/09/2015
    4NDC:68599-5201-41000 g in 1 PACKAGE; Type 0: Not a Combination Product01/09/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/09/2015
    Labeler - MCKESSON MEDICAL-SURGICAL INC. (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions007118524manufacture(68599-5201)
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