Label: DR. DRIS HAND SANITIZER- ethyl alcohol 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 March 26, 2021

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 68% v/v

  • Purpose

    Ethyl Alcohol 68% v/v................Antiseptic

  • Uses

    Hand sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.

  • Warnings

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

  • DO NOT USE

    Do not use:

    • on children less than 2 months of age
    • on open skin wounds

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

  • 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

  • Other Information

    • store in a cool dry place. Do not overheat.

  • Inactive Ingredients

    Purified Water, Hydroxyethyl Cellulose, Coconut Pulp Extract, Lavender Oil, Eucalyptus Oil, Aloe Vera Leaf Juice,

  • PRINCIPAL DISPLAY PANEL

    PDP

  • INGREDIENTS AND APPEARANCE
    DR. DRIS HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81383-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL2720 mL  in 4000 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    COCONUT (UNII: 3RT3536DHY)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81383-002-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/26/2021
    2NDC:81383-002-02240 mL in 1 BOTTLE; Type 0: Not a Combination Product03/26/2021
    3NDC:81383-002-03475 mL in 1 BOTTLE; Type 0: Not a Combination Product03/26/2021
    4NDC:81383-002-044000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/26/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/26/2021
    Labeler - Hanson Venture Enterprise Inc (204263995)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natures Formulae Health Products Ltd.241385587manufacture(81383-002)
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