Label: INSTANT HAND SANITIZER- 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 23, 2017

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

View All Sections
  • Active Ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    Decreases bacteria on hands

  • Warnings

    For external use only

    Flammable. Keep away from fire or flame

    Stop use and ask a doctor

    if rash or irritation develops and lasts

    Keep out of reach of children

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

  • Directions

    Apply onto hands and rub until dry

  • Inactive Ingredients

    Water, Aloe barbadensis Leaf Juice, Glycerin, Propylene Glycol, Triethanolamine, Carbomer

  • labeling

    label

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-601-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product01/05/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/05/2015
    Labeler - Harmon Stores Inc (804085293)
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!