Label: GERMSTARONE UNSCENTED- ethyl alcohol solution

  • NDC Code(s): 57915-021-01, 57915-021-02, 57915-021-03, 57915-021-04
  • Packager: Soaptronic, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • ACTIVE INGREDIENT

    Active ingredient              

    Ethyl alcohol 63% (W/W)

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    Kills 99.99% of all disease causing germs on contact, and protects and restores moisture.

  • WARNINGS

    Warnings
    For external use only. Keep out of eyes. In case of eye contact immediately flush eyes with water. If irritation persists, get medical attention. If swallowed, contact physician. Flammable, keep away from heat or flames. Germstar Wipes are safe for most surfaces, however can be harmful to some. Test wipe on a non-conspicuous area if unsure.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply Germstar all over the surface of your hands and rub into skin until dry. Supervise children in the use of this product.

  • SPL UNCLASSIFIED SECTION

    Other information

    Germstar is non allergenic. Store at 20° to 25°C (68° to 77°F). May be harmful to some surfaces/materials.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Isopropanol, Emollient Complex.

  • QUESTIONS

    Questions?

    Call Germstar at 1-800.327.2606

  • PRINCIPAL DISPLAY PANEL

    Germstar ONE unscented

  • INGREDIENTS AND APPEARANCE
    GERMSTARONE UNSCENTED 
    ethyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57915-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL630 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57915-021-01946 g in 1 BAG; Type 0: Not a Combination Product04/30/2020
    2NDC:57915-021-02474 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/30/2020
    3NDC:57915-021-03236 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/30/2020
    4NDC:57915-021-0459 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00304/30/2020
    Labeler - Soaptronic, LLC (082741674)
    Registrant - Soaptronic, LLC (082741674)
    Establishment
    NameAddressID/FEIBusiness Operations
    Soaptronic, LLC082741674manufacture(57915-021)
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