Label: PUREGEL HAND SANITIZER- alcohol gel

  • NDC Code(s): 74830-546-01
  • Packager: Economy Polymers and Chemicals
  • 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 5, 2023

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

View All Sections
  • DRUG FACTS

  • Active ingredient

    Ethyl Alcohol 70% v/v

    Purpose

    Antiseptic

  • Uses

    • Hand sanitizer to help reduce bacteria on the skin that could cause disease 
    • Reccomended for repeated use
  • Warnings

    Keep away from fire and flame.

    For external use only

    When using this product

    do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    if irritation or rash appears and lasts.

    Keep out of reach of children.

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

  • Directions

    • Place enough product in your palm to thoroughly cover your hands
    • Rub hands together briskly until dry
    • Children under 6 years of age should be supervised when using this product.
  • Inactive ingredients

    USP water, Propan-2-ol, Glycerin, Fragrance, acrylates c10-30 alkyl acrylate crosspolymer, aminomethyl propanol

  • Other Information

    • Store below 110°F (43° C)
    • May discolor certain fabrics or surfaces
  • Package Labeling:

    Label4

  • INGREDIENTS AND APPEARANCE
    PUREGEL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74830-546
    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
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74830-546-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/31/2020
    Labeler - Economy Polymers and Chemicals (008087603)
    Registrant - Economy Polymers and Chemicals (008087603)
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!