Label: GENESIS ADVANCED 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 31, 2020

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

View All Sections
  • Drug Fact

  • Active ingredient

    Ethyl Alcohol 70% v/v

    Purpose

    Antiseptic

  • Use[s]

    Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

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

    Do not use

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

    When using this product

    keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. 

    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.

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

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

    Water, propylene glycol, carbomer, triethanolamine.

  • Package Labeling:236mL

    Bottle

  • Package Labeling:500mL

    Bottle2

  • Package Labeling:3785mL

    Bottle3

  • INGREDIENTS AND APPEARANCE
    GENESIS ADVANCED HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79345-000
    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
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79345-000-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    2NDC:79345-000-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    3NDC:79345-000-373785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/15/2020
    Labeler - Genesis Supply, LLC (117519105)
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!