GENTIAN VIOLET 2% solution

Gentian Violet 2% by

Drug Labeling and Warnings

Gentian Violet 2% by is a Otc medication manufactured, distributed, or labeled by The Podiatree Company, EMS Contract Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Gentian Violet 2%

Purpose

Antiseptic

Purpose

First aid antiseptic to help protect against skin infection in minor cuts, scrapes or burns

Warnings

For external use only

Do not use

in eyes; with bandages; on large areas of the body; longer than one week unless directed by a doctor; stop use and consult a doctor if condition persists; in case of deep puncture wounds, animal bites or serious burns, consult a doctor; if known to be sensitive to any ingredients in the product; do not apply to ulcerative lesions as this may result in tattooing of the skin.

Stop use and ask a doctor or pharmacist

if skin irritation or sensitivity develops or increases or if the condition persists or gets worse.

KEEP OUT OF REACH OF CHILDREN.

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

Directions

Clean the affected area. Apply a small amount using a cotton-tipped applicator one to three times daily. Do not bandage.

Other Information

Store at controlled room temperature. Will stain skin and clothing.

Inactive Ingredients

SD alcohol (10%), water

Questions or Suggestions?

1.855.763.8733 or visit us at www.thepodiatreecompany.com

PRINCIPAL DISPLAY PANEL

Label

INGREDIENTS AND APPEARANCE

GENTIAN VIOLET 2% 
gentian violet 2% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54633-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY)	GENTIAN VIOLET	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54633-014-02	59.14 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/14/2014

Labeler - The Podiatree Company (078656000)

Establishment
Name	Address	ID/FEI	Business Operations
EMS Contract Packaging		048602791	manufacture(54633-014)