Label: HUMCO GENTIAN VIOLET 2%- gentian violet 2% liquid

  • NDC Code(s): 0395-1005-92
  • Packager: Humco Holding Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Gentian Violet 2%

  • Purpose

    Antiseptic

  • Uses

    For external treatment of abrasions, minor cuts, surface injuries, and superficial infections of the skin.

  • Warnings

    For external use only.

    Do not apply to an ulcerative lesion as this may cause tattoing of the skin.

    Do not use in the eyes.

  • Ask a doctor before use if

    Redness, irritation, swelling or pain persists or increases of if infection occurs.

  • Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

  • Directions

    Clean the affected area and apply directly to the wound or use cotton applicator once or twice daily. Do not bandage.

  • Other information

    Will stain skin or clothing.

  • Inactive ingredients

    Alcohol and Purified water

  • Questions or Comments?

    1-800-662-3435

  • Principal Display Panel

    GV5.jpggv

  • INGREDIENTS AND APPEARANCE
    HUMCO GENTIAN VIOLET 2% 
    gentian violet 2% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-1005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY) GENTIAN VIOLET20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-1005-9259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00301/01/2008
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(0395-1005) , analysis(0395-1005) , pack(0395-1005) , label(0395-1005)
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