Label: HAND SANITIZER- ethyl 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 December 13, 2022

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

View All Sections
  • Drug Facts

  • Active ingredients

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children must be supervised in use of this product.

  • Use

    To help clean hands

  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

    Do not apply around eyes.

    When using this product, avoid contact with eyes. In case of contact flush eyes with water.

    Stop use and ask a doctor if redness or irritation develop & persist for more than 72 hrs.

  • Directions

    • Spread on both hands.

  • Inactive Ingredients

    Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water

  • Other Information

    • store at 20°C (68° to 77° F).  • may discolor fabrics.

  • Questions

    Call 1-855-755-5346

  • SPL UNCLASSIFIED SECTION

    Made in China for Innovation Line

    Culver City, CA 90230

    CITRUS SCENT

  • Packaging

    Sanitizer-1

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76138-114(NDC:70412-110)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76138-114-1330 mL in 1 BOTTLE; Type 0: Not a Combination Product01/02/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/02/2016
    Labeler - Innovation Specialties Inc (030837314)
    Establishment
    NameAddressID/FEIBusiness Operations
    Innovation Specialties Inc030837314relabel(76138-114) , repack(76138-114)
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!