Label: AMERICAN HAND SANITIZER- 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 13, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 80% v/v

  • Purpose

    Antiseptic

  • Use

    For hand sanitizer to decrease bacteria and viruses on the skin.

    Recommended for repeated use.

  • 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 avoid contact with eyes. In case of contact with flush eyes with water.

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops or if condition persists for more than 72 hours.

  • 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

    • Read the entire label before using this product.
    • Pump a small amout of liquid into palm of hand.
    • Rub thoroughly over all surfaces on both hands for 15 seconds
  • Other information

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

    glycerin, hydrogen peroxide, water

  • Package Label - Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    AMERICAN HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79421-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79421-003-01150 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/2020
    2NDC:79421-003-023785 mL in 1 JUG; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - American Hand Sanitizer LLC (117295138)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Hand Sanitizer LLC117295138manufacture(79421-003)
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