DE LA CRUZ GENTIAN VIOLET- gentian violet tincture 
DLC Laboratories, Inc.

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.

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DE LA CRUZ® GENTIAN VIOLET 1%

Drug Facts

Active ingredient

Gentian violet 1%

Purpose

Antiseptic

Uses

First aid to help prevent infection in minor:

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

Other information

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 Type HUMAN OTC DRUG Item Code (Source) NDC:24286-1531
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY) GENTIAN VIOLET 1 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL (UNII: 3K9958V90M) 10 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
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)

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.