Label: 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 July 13, 2020

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  • Active Ingredient

    Isopropyl Alcohol 70%, USP

  • Purpose

    Antimicrobial

  • Uses

    Use as a hand sanitizer in the absence of soap and water, to reduce bacteria on the skin which may cause illness.

    Recommended for repeated use.

  • Warnings

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

    When Using This Product: 

    • Do not use in or near the eyes, or inhale.
    • In case of contact, rinse eyes thoroughly with water.

    Stop use and contact your doctor if a rash or irritation appear and persist at the site of contact.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help immediately or contact a poison control center immediately.

  • Directions

    • Spray hand sanitizer onto hands or enough to thoroughly cover hands. Rub hands together briskly for 30 seconds or until dry.
    • Children under 6 years of age must be supervised when using the product
  • Other information

    • Do not store above 110°F (43°C). May discolor certain fabrics or substances.
  • Inactive ingredients

    aloe (aloe barbadensis) juice, carbomer 940NF, dl-alpha-tocopheryl acetate, triethanolamine glycerin.

  • Product Label

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  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79670-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79670-001-0160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    2NDC:79670-001-023 in 1 PACKAGE06/01/2020
    260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    3NDC:79670-001-036 in 1 PACKAGE06/01/2020
    360 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - 12016133 Canada Inc (204167266)
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