Label: ABBEXA HAND SANITIZER- ethanol 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 April 2, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • Product Information

  • Active Ingredient

    Ethanol 75%

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use To sterilize and disinfect skin.

  • WARNINGS

    Warnings For external use only.

    FLAMMABLE liquid and vapour. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. Causes serious eye irritation. Keep container tightly closed.

    Avoid contact with eyes. If contact occurs, immediately rinse eyes with water. Stop use and consult a doctor if irritation and redness persists.

    Keep out of reach of children. If swallowed, seek medical assistance.

  • DOSAGE & ADMINISTRATION

    Directions Apply evenly to hands, then repeatedly rub hands until product has dried. No water required. Do not use on damaged, sensitive or irritated skin. In case of contact, rinse thoroughly with tepid water.

  • SPL UNCLASSIFIED SECTION

    Other Information Proven to be effective at decreasing bacteria. Suitable for repeated use on skin.

    This product contains ethanol, which can irritate mucous membranes and wounds, and should not be used by those who are allergic to alcohol.

  • STORAGE AND HANDLING

    Storage Do not store above 110°F (43 °C).

  • INACTIVE INGREDIENT

    Inactive Ingredients Carbomer, Glycerol, Rose Essence, Distilled Water, Triethanolamine.

  • SPL UNCLASSIFIED SECTION

    Rinse-Free

    Quick Drying

    Antibacterial

    Abbexa LTD, Cambridge, UK, CB4 0GJ

    T: +44 1223 755950
    Abbexa LLC, Houston, TX, USA, 77042
    T: +1 832 327 7413

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    ABBEXA HAND SANITIZER 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74029-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74029-100-01100 mL in 1 TUBE; Type 0: Not a Combination Product04/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/02/2020
    Labeler - ABBEXA LTD (219351130)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABBEXA LTD219351130manufacture(74029-100)
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, PubMed, Biochemical Data Summary

More Info on this Drug

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