Label: DEFENSE HAND SANITIZER- isopropyl alcohol liquid

  • NDC Code(s): 80579-000-01, 80579-000-02
  • Packager: Walla Walla Environmental, Inc.
  • 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 August 31, 2022

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  • Drug Facts

  • Active ingredient(s)

    Isopropyl Alcohol 75% v/v

    Purpose

    Antiseptic

  • Use(s)

    Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

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

    Do not use

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

    When using this product

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

    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.

    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 between 15-30C (50-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    water, lemongrass essential oil, glycerin, hydrogen peroxide

  • Package Labeling:60ml

    Box

  • Package Labeling:236.5ml

    Box2

  • INGREDIENTS AND APPEARANCE
    DEFENSE HAND SANITIZER 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80579-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80579-000-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/25/202012/30/2026
    2NDC:80579-000-02236.588 mL in 1 BOTTLE; Type 0: Not a Combination Product03/25/202012/30/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/25/202012/30/2026
    Labeler - Walla Walla Environmental, Inc. (055661987)
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