Label: HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 September 15, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease.

  • Warnings

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

  • Do not use

    • on open skin wounds
    • do not inhale or ingest
    • do not use on infants
  • WHEN USING

    When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water

    ?Avoid contact with open skin ? Do not inhale or ingest

  • STOP USE

    Stop use and ask a doctor if skin irritation or redness develops.

  • 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

    Wet hands thoroughly with product and allow to dry without wiping
    Children under 6 years of age use only under adult supervision
    Not recommended for infants

  • Other information

    • Store below 110F (43C)
    • May discolor fabrics
  • Inactive ingredients

    Water (Aqua), Glycerin, Butylene Glyool, Carbomer, Aminomethyl
    Propanol, Aloe Barbadensis Leaf Extract, Xanthan Gum

  • 70 % Alcohol Gel- 1 gallon

    Hand Sanitizer

  • 70 % Alcohol Gel-55 gallon

    Hand Sanitizer

  • 70 % Alcohol Gel- 275 gallon

    Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79117-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    HYDROXYPROPYL CELLULOSE (TYPE M) (UNII: U3JF91U133)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79117-070-013875 mL in 1 JUG; Type 0: Not a Combination Product09/15/2020
    2NDC:79117-070-55208197 mL in 1 DRUM; Type 0: Not a Combination Product09/15/2020
    3NDC:79117-070-991040875 mL in 1 DRUM; Type 0: Not a Combination Product09/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/15/2020
    Labeler - Emerge Technologies, Inc. (143443492)
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