Label: DEFNSE ANTISEPTIC HAND SANITIZER- ethyl alcohol 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 July 28, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to decrease bacteria on the skin
    • recommended for repeated use
    • for use when soap and water are not available
  • Warnings

    Flammable, keep away from fire/flame
    For external use only

    Do not use

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

    When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours

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

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping
    • supervise children under 6 years of age when using this product to avoid swallowing
  • Other information

    • store between 15-30°C (59-86°F)
    • avoid freezing and excessive heat above 40°C (104°F)
  • Inactive ingredients

    denatonium benzoate, fragrance, glycerin, hydrogen peroxide, hydroxyethyl cellulose, water

  • Questions?

    You may also report serious side effects to this phone number.
    Mon-Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    HOLISTIC LIVING

    NPN: 80099248

    Manufactured by: Lusty Libation Inc. 620 Supertest Rd., Unit 5, Toronto, ON, Canada M3J 2M5

    Product of Canada.

    www.holisticlivingltd.com

  • Packaging

    untitled

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    DEFNSE ANTISEPTIC HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77846-888
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77846-888-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2020
    2NDC:77846-888-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2020
    3NDC:77846-888-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2020
    4NDC:77846-888-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2020
    5NDC:77846-888-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2020
    6NDC:77846-888-404000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/26/2020
    Labeler - Lusty Libation Ltd. (203992437)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lusty Libation Ltd.203992437manufacture(77846-888)
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