Drug facts

Active Ingredient

Gentian Violet 1%

Purpose

Antiseptic

Indications

First aid to help protect against infection in minor cuts, scrapes, and burns.

Warnings

For external use only.

Do not apply to an ulcerative lesion as this may cause tatooing of the skin. Do not use in the eyes or over large areas of the body.

Ask a doctor before use if

redness, irritation, swelling or pain persists or increases or if infection ocurs.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Directions

Clean the affected area and apply directly to the wound or use cotton applicator once or twice daily. Do not bandage.

Other information

will stain skin or clothing.

Inactive ingredients

Ethyl Alcohol 10% and Purified Water.

DLC 30 mL Label

SLC Spanish

GNP Label

GNP GNP

DLC Label Arabic

DLC GV Arabic Front.jpg DLC GV Arabic Inside.jpg

DLC 59 mL Label

DLC GV 1 2floz.jpg

GENTIAN VIOLET 1%
gentian violet 1% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82645-917
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	10 mg in 1 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82645-917-92	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2017
2	NDC:82645-917-91	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M003	01/01/2008

Labeler - Pharma Nobis, LLC (118564114)

Registrant - Pharma Nobis, LLC (118564114)

Name	Address	ID/FEI	Business Operations
Establishment
Pharma Nobis, LLC		118564114	manufacture(82645-917) , analysis(82645-917) , pack(82645-917) , label(82645-917)

Private Label Gentian Violet 1%