GENTIAN VIOLET 2%- gentian violet 2% solution
The Podiatree Company

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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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

Label

GENTIAN VIOLET 2%
gentian violet 2% solution

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

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

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

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

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

Labeler - The Podiatree Company (078656000)

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

Revised: 10/2014

Document Id: af575abb-90ba-4b87-b0fd-7ccb373b5c83

Set id: a972c857-1e3e-4a89-9fb2-da5a64d55bf7

Version: 1

Effective Time: 20141014

The Podiatree Company