Label: GENTIAN VIOLET 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 June 29, 2022

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  • ACTIVE INGREDIENT

    Gentian Violet …………………….…………….……………. 0.1%

  • PURPOSE

    First Aid Antiseptic

  • INDICATIONS & USAGE

    For external treatment of abrasions and minor cuts.

  • WARNINGS

    For external use only.

    Do not apply to an ulcerative lesion as this may result in tattooing of the skin. Do not use in the eyes.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

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

  • INACTIVE INGREDIENT

    Isopropyl Alcohol, Aqua.

  • PRINCIPAL DISPLAY PANEL

    1 oz

  • INGREDIENTS AND APPEARANCE
    GENTIAN VIOLET 
    gentian violet liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73386-140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY) GENTIAN VIOLET0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73386-140-7128 g in 1 BOTTLE; Type 0: Not a Combination Product09/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/02/2021
    Labeler - SANVALL ENTERPRISES, INC (966905507)
    Registrant - CHEMCO CORPORATION (032495954)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHEMCO CORPORATION032495954manufacture(73386-140)
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