Label: HAND SANITIZER- isopropyl alcohol gel

  • NDC Code(s): 74689-000-16, 74689-000-32
  • Packager: Maryland Correctional Enterprises
  • 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 29, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients:

    Isopropyl Alcohol >/= 70.1%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Water, Betaine Anhydrous, Anionic Water Soluble Polymer,
    Amino Methyl Propanol, DL Alpha Tocopherol Acetate

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame

  • PURPOSE

    Use[s] • Hand sanitizer to help reduce bacteria that potentially
    can cause disease.

  • DO NOT USE

    Do not use
    • in children less than 2 months of age
    • on open skin wounds

  • INDICATIONS & USAGE

    For use when soap and water are not
    available.

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In
    case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may
    be signs of a serious condition.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions
    • Place enough product on hands to cover all surfaces. Rub
    hands together until dry.
    • Supervise children under 6 years of age when using this
    product to avoid swallowing

  • STORAGE AND HANDLING

    Other information
    • Store between 59-86F (15-30C)
    • Avoid freezing and excessive heat above 140F (40C)

  • PRINCIPAL DISPLAY PANEL

    16 oz Bottle

  • PRINCIPAL DISPLAY PANEL

    32 oz Bottle

  • PRINCIPAL DISPLAY PANEL

    Case

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74689-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70.1 mL  in 70.1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    BETAINE (UNII: 3SCV180C9W)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74689-000-32946 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/03/2020
    2NDC:74689-000-16473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/03/2020
    Labeler - Maryland Correctional Enterprises (021961458)
    Establishment
    NameAddressID/FEIBusiness Operations
    Maryland Correctional Enterprises021961458manufacture(74689-000)