Label: DE LA CRUZ GENTIAN VIOLET- gentian violet tincture 

  • Label RSS
  • NDC Code(s): 24286-1531-7
  • Packager: DLC Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Gentian violet 1%

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  • Purpose

    Antiseptic

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  • Uses

    First aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
    • insect bites
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  • 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
    • do not apply in large quantities or over large areas of the body
    • do not apply over raw surfaces or blistered areas
    • 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.

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  • 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
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  • Other information

    • medication will stain skin and clothing
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  • Inactive ingredients

    alcohol, purified water

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  • Questions

    1-800-858-3889

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  • SPL UNCLASSIFIED SECTION

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

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  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

    De La Cruz®

    GENTIAN VIOLET
    1% Sol. - Alcohol 9%

    FOR EXTERNAL USE ONLY

    FIRST AID ANTISEPTIC

    1 FL OZ (30 mL)

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    DE LA CRUZ GENTIAN VIOLET 
    gentian violet tincture
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:24286-1531
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GENTIAN VIOLET (GENTIAN VIOLET CATION) GENTIAN VIOLET 1 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL 10 mL  in 100 mL
    WATER  
    Product Characteristics
    Color PURPLE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24286-1531-7 30 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part333E 11/01/2012
    Labeler - DLC Laboratories, Inc. (093351930)
    Establishment
    Name Address ID/FEI Business Operations
    DLC Laboratories, Inc. 093351930 MANUFACTURE(24286-1531), LABEL(24286-1531)
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