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 July 30, 2020

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

View All Sections
  • Drug Facts

  • Active ingredient

    Ethyl alcohol 70% v/v

    Purpose

    Antiseptic

  • Uses

    • For handwashing to decrease bacteria on the skin
    • Recommended for repeated use.
  • Warnings

    Flammable, keep away from fire or flame

    For external use only.

    Do not use

    in the eyes.

    Stop use and ask a doctor if 

    • irritation and redness develop 
    • condition persists for more than 72 hours

    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.
  • Other information

    Store at 15° to 25°C (59° to 77°F)

  • Inactive ingredients

    Carbomer, propylene glycol, purified water, titanium dioxide

  • QUESTIONS

    TO REPOT ADVERSE EVENT, CONTACT +1(727)441-3222

  • Package Labeling:

    BottleBox

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78894-000
    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
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78894-000-061 in 1 BOX05/10/2020
    1200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/10/2020
    Labeler - DVRYL International Limited (664206198)
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!