Label: GUSTAR HAND SANITIZER (ETHANOL)- 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 May 25, 2020

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  • ACTIVE INGREDIENT

    Ethyl alcohol 62%

  • INACTIVE INGREDIENTS

    Water, Glycerin, Carbomer, Triethanolamine, Polysorbate 80

  • PURPOSE

    Antiseptic

  • WARNINGS

    ■ For external use only.
    ■ Flammable. ■ Keep away from heat and Flame.

    When using this product
    ■ Keep out of eyes, ears and mouth.
    ■ If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor
    ■ If irritation and rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Uses

    Hand sanitizer to help reduce bacteria on the skin. Only when water and soap is not available.

  • Directions

    ■ Wet hands thoroughly with product and rub hands together until dry.
    ■ Supervise children under 6 years of age when using.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of pouch

  • INGREDIENTS AND APPEARANCE
    GUSTAR HAND SANITIZER (ETHANOL) 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73819-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73819-0002-125 mL in 1 POUCH; Type 0: Not a Combination Product03/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/21/2020
    Labeler - GuStar Co Ltd (694234583)
    Registrant - GuStar Co Ltd (694234583)
    Establishment
    NameAddressID/FEIBusiness Operations
    DASOL CO.,LTD.557839013manufacture(73819-0002)
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