GENTIAN VIOLET 1% liquid

Gentian Violet 1% by

Drug Labeling and Warnings

Gentian Violet 1% by is a Otc medication manufactured, distributed, or labeled by Humco Holding Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug facts

Active Ingredient

Gentian Violet 1%

Purpose

Antiseptic

Uses

For external treatment of abrasions, minor cuts, surface injuries, ad superficial infections of the skin.

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.

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 and purified water.

DLC Label

GNP Label

DLC Label Arabic

INGREDIENTS AND APPEARANCE

GENTIAN VIOLET 1% 
gentian violet 1% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0395-9114
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	10 mg  in 1 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: 0395-9114-92	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2017
2	NDC: 0395-9114-91	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2008

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	manufacture(0395-9114) , analysis(0395-9114) , pack(0395-9114) , label(0395-9114)