Your browser does not support JavaScript! DE LA CRUZ GENTIAN VIOLET (GENTIAN VIOLET) TINCTURE [DLC LABORATORIES, INC.]
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DE LA CRUZ GENTIAN VIOLET (gentian violet) tincture
[DLC Laboratories, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

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
  • 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.

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

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

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
DE LA CRUZ GENTIAN VIOLET 
gentian violet tincture
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-1531
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GENTIAN VIOLET (GENTIAN VIOLET CATION) GENTIAN VIOLET1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL10 mL  in 100 mL
WATER 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:24286-1531-730 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E11/01/2012
Labeler - DLC Laboratories, Inc. (093351930)
Establishment
NameAddressID/FEIBusiness Operations
DLC Laboratories, Inc.093351930MANUFACTURE(24286-1531), LABEL(24286-1531)

Revised: 12/2012
Document Id: 48e91fa5-4b1b-47c6-ae23-a32caf78465d
Set id: d7b4ca59-1bc3-4540-bc0a-2f4b7495a0a7
Version: 1
Effective Time: 20121220
 
DLC Laboratories, Inc.

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