Label: HAND SANITIZER- isopropyl alcohol solution

  • 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 February 1, 2022

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  • Active Ingredient(s)

    Isopropyl Alcohol 70%

  • Purpose

    Antimicrobial

  • Use

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

  • 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.
  • 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. Do not ingest. In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    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.

  • Other information

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

    Deionized Water, Glycerin, Lauryl Lactate, Myristyl Lactate, Cetyl Lactate, Hydroxypropyl Cellulose, Limonene

  • Package Label - Principal Display Panel

    60 ml NDC: 80932-001-06

    2 fl oz

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    isopropyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80932-001
    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
    MYRISTYL LACTATE (UNII: 1D822OC34X)  
    CETYL LACTATE (UNII: A7EVH2RK4O)  
    LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80932-001-0660 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/29/2020
    Labeler - ROOTS BEAUTY INNOVATIONS LLC (111051318)
    Establishment
    NameAddressID/FEIBusiness Operations
    ROOTS BEAUTY INNOVATIONS LLC111051318manufacture(80932-001)
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