Label: GENTIAN VIOLET 1% liquid

  • 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 December 23, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug facts

  • Active Ingredient

    Gentian Violet 1%

  • Purpose

    Antiseptic

  • Indications

    First aid to help protect against infection in minor cuts, scrapes, and burns.

  • Warnings

    For external use only.

    Do not apply to an ulcerative lesion as this may cause tatooing of the skin. Do not use in the eyes or over large areas of the body.

  • Ask a doctor before use if

    redness, irritation, swelling or pain persists or increases or if infection ocurs.

  • 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

    Ethyl Alcohol 10% and Purified Water.

  • DLC 30 mL Label

    DLCGV.jpgSLC Spanish

  • GNP Label

    GNPGNP

  • DLC Label Arabic

    DLC GV Arabic Front.jpgDLC GV Arabic Inside.jpg

  • DLC 59 mL Label

    DLC GV 1 2floz.jpg

  • INGREDIENTS AND APPEARANCE
    GENTIAN VIOLET 1% 
    gentian violet 1% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY) GENTIAN VIOLET10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-9114-9259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/13/2017
    2NDC:0395-9114-9130 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 not finalpart333A01/01/2008
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884manufacture(0395-9114) , analysis(0395-9114) , pack(0395-9114) , label(0395-9114)
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