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 May 11, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antimicrobial

  • Purpose

    Antimicrobial, Hand Sanitizer

  • Use

    Hand sanitizer to help reduce bacteria on the skin.

  • Warnings

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

  • WHEN USING

    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.

  • STOP USE

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply directly on hands and rub in thoroughly
    • Children under 6 years of age should be supervised when using.
  • Other information

    • Store below 110°F (43°C)
  • Inactive ingredients

    Acrylates Copolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Glycerin, Water

  • Package Label - Principal Display Panel

    236 mL NDC: 77664-920-01

    Hand Sanitizer Gel 8 fl oz

    3785 mL NDC: 77664-920-02

    Hand Sanitizer Gel 128 fl oz

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77664-920
    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) 1.45 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77664-920-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:77664-920-023785 mL in 1 BOTTLE; 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 - Beauty Elite Group (169882383)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!