Label: HAND SANITIZER- ethyl alcohol 70% gel

  • 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 June 26, 2020

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  • Active Ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    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 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 immediately.

  • ­­­­­­­­­­­­­­­­­­­­­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 (59-86F)

    Avoid freezing and excessive heat above 40C (104F)

  • Inactive Ingredients

    Carbopol, Glycerin, Triethanolamine

  • Gel Hand Sanitizer

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  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol 70% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78635-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL175 mL  in 250 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    TRIETHANOLAMINE ISOSTEARATE (UNII: T8OTU5ECY5)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78635-100-08250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    2NDC:78635-100-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    3NDC:78635-100-044000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - Premium Printing Inc. (035632750)
    Registrant - Premium Printing Inc. (035632750)
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