Label: HAND SANITIZER- alcohol spray

  • 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 29, 2020

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  • Active Ingredient

    Alcohol 80% v/v

  • Purpose

    Antiseptic

  • Uses

    • Hand sanitizer to help reduce bacteriaa on the skin
  • Warnings

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

    When using this product

    do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    if irritation or rash develops

  • 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 rub lightly until dry. Do not wipe off or rinse.
  • Other information

    • May discolor frabrics or surfaces.
    • Store below 105°F (40°C)
  • Inactive ingredients

    Denatonium Benzoate, Glycerin, Purified Water USP

  • Package Label

    package label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76095-018
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76095-018-16500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/25/2020
    Labeler - Midway Importing, Inc. (611851627)
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