Label: DE LA CRUZ GENTIAN VIOLET- gentian violet tincture

  • NDC Code(s): 24286-1531-7, 24286-1531-8
  • Packager: DLC Laboratories, Inc.
  • 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 May 16, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Gentian violet 1%

  • Purpose

    Antiseptic

  • Uses

    First aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
    • insect bites
  • Warnings

    For external use only

    Consult a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not use in or near the eyes or over large areas of the body
    • do not apply to an ulcerative lesion as this may result in tattooing of the skin

    Stop use and consult a doctor if

    • redness, irritation, swelling or pain persists or increases, or if infection or rash occurs
    • symptoms persist for more than 7 days, or clear up and occur again within a few days

    KEEP OUT OF THE REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • clean the affected area
    • apply a small amount of this product to the area using the enclosed applicator or a cotton-tipped applicator 1 to 2 times daily
    • do not bandage
  • Other information

    • medication will stain skin and clothing
  • Inactive ingredients

    alcohol, purified water

  • Questions

    1-800-858-3889

  • SPL UNCLASSIFIED SECTION

    Manufactured by
    DE LA CRUZ PRODUCTS
    A DIVISION OF DLC LABORATORIES, INC.
    PARAMOUNT, CA 90723 USA

  • PRINCIPAL DISPLAY PANEL

    DLC GV 5-16-23DLC GV 1 2floz.jpgDLCGV.jpgSpanish

    Arabic front

    Arabic inside

  • INGREDIENTS AND APPEARANCE
    DE LA CRUZ GENTIAN VIOLET 
    gentian violet tincture
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-1531
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY) GENTIAN VIOLET1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M) 10 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24286-1531-730 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product12/13/2017
    2NDC:24286-1531-859 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/01/2012
    Labeler - DLC Laboratories, Inc. (093351930)
    Registrant - Pharma Nobis, LLC (118564114)
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