Label: ANTIBACTERIAL 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 January 1, 2019

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

View All Sections
  • Active ingredient Purpose

    Ethyl Alcohol 62% ........................................Antiseptic

    Purpose

    Antiseptic Hand Sanitizer

  • Use

    Decrease bacteria on hands

  • Warnings

    External Use Only.

    Flammable: Keep away from flame or high heat

    Keep out of reach of children

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

  • Directions

    Rub hands thoroughly with product and allow to dry.

  • Inactive Ingredient

    Aminomethyl Propanol, Carbomer, Isopropyl Alcohol, Water

  • Stop and Ask a doctor if

    Irritation or redness develop.

  • HOW SUPPLIED

    Product: 71246-50309

    NDC: 71246-5030-1 59 mL in a BOTTLE

  • HAND SANITIZER (ALCOHOL) GEL

    Label Image
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER  
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71246-5030
    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
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71246-5030-159 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A01/01/2019
    Labeler - JFL ENTERPRISES, INC (010967011)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bath Concept Cosmetics (Dongguan) Co., Ltd529623933manufacture(71246-5030)
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!