Label: GENTIAN VIOLET 2% solution

  • 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 19, 2017

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  • Active Ingredient

    Gentian Violet 2%

  • Purpose

    Antiseptic

  • Purpose

    First aid antiseptic to help protect against skin infection in minor cuts, scrapes or burns

  • Warnings

    For external use only

  • Do not use

    in eyes; with bandages; on large areas of the body; longer than one week unless directed by a doctor; stop use and consult a doctor if condition persists; in case of deep puncture wounds, animal bites or serious burns, consult a doctor; if known to be sensitive to any ingredients in the product; do not apply to ulcerative lesions as this may result in tattooing of the skin.

  • Stop use and ask a doctor or pharmacist

    if skin irritation or sensitivity develops or increases or if the condition persists or gets worse.

  • KEEP OUT OF REACH OF CHILDREN.

    In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

  • Directions

    Clean the affected area. Apply a small amount using a cotton-tipped applicator one to three times daily. Do not bandage.

  • Other Information

    Store at controlled room temperature. Will stain skin and clothing.

  • Inactive Ingredients

    SD alcohol (10%), water

  • Questions or Suggestions?

    1.855.763.8733 or visit us at www.thepodiatreecompany.com

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    GENTIAN VIOLET 2% 
    gentian violet 2% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54633-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY) GENTIAN VIOLET2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54633-014-0259.14 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/14/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/14/2014
    Labeler - The Podiatree Company (078656000)
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