Label: DEFENSE HAND SANITIZER- isopropyl alcohol liquid

  • NDC Code(s): 80579-001-01
  • Packager: Walla Walla Environmental, 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 August 31, 2022

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  • Drug Facts

  • Active Ingredients

    Isopropyl Alcohol 75% v/v

    Purpose

    Antiseptic

  • Use[s]:

    Use as hand sanitizer to reduce bacteria on skin when soap and water are not available, recommended for repeated use

  • Warnings:

    For external use only.

    Flammable. Keep away from fire or flame.

    Do not use

    • On children less than 2 years 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 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, hydrogen peroxide, lemongrass oil, glycerin. 

  • Package Labeling:

    Box3

  • INGREDIENTS AND APPEARANCE
    DEFENSE HAND SANITIZER 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80579-001
    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)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80579-001-013785.41 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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