Label: NATURAL DEFENSE HAND SANITIZER- isopropyl 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 August 8, 2020

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  • Active Ingredient

    Isopropyl alcohol 71% v/v

  • Purpose

    Antiseptic

  • Use

    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

    • in 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 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.

  • Directions

    Our product is made with aloe vera juice, so pour small amount in the palm of your hand & rub in until dry.

  • Other information

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

    Aloe Vera, Vegetable Glycerin, Vitamin E Oil, Eucalyptus Oil, Lavender Oil, Turmeric Oil, Tea Tree Oil, Jojoba Esters

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    NATURAL DEFENSE HAND SANITIZER 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80004-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL71 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TURMERIC OIL (UNII: 6KGS8SP16U)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80004-002-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2020
    2NDC:80004-002-02473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2020
    3NDC:80004-002-031893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2020
    4NDC:80004-002-043785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2020
    5NDC:80004-002-051200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/31/2020
    Labeler - Grove Inc. (117503705)
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