Label: ANTIMICROBIAL HAND SANITIZER- alcohol 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 August 20, 2020

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  • Drug Facts

  • Active ingredient

    Alcohol 70% v/v

    Purpose

    Antimicrobial

  • Use[s]

    Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

  • Warnings

    Flammable. Keep away from fire or flame.

    For External use only.

    Do not use

    • on children less than 2 months of age
    • on open skin wounds

    When using this product

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

    Stop use and ask a doctor

    if irritation or rash appears and lasts.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough product in your palm to thoroughly cover your hands.
    • Rub hands together briskly together until dry.
    • Children under 6 years of age should be supervised when using this product.
  • Inactive ingredients

    Water (Aqua), Isopropyl Alcohol, PEG-12 Dimethicone, Caprylyl Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate.

  • Other information

    • Store between 54-84°F (15-30°C)
    • May discolor certain fabrics or surfaces
  • 80182-001-12

    Bottle

  • 80182-001-16

    Bottle2

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76939-555
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76939-555-12350 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    2NDC:76939-555-16475 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/15/2020
    Labeler - NVIP LLC (117497228)
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