GENTIAN VIOLET TOPICAL SOLUTION- gentian violet liquid

Gentian Violet Topical Solution by

Drug Labeling and Warnings

Gentian Violet Topical Solution by is a Otc medication manufactured, distributed, or labeled by Laboratorios Jaloma, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Gentian Violet 1%

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

Topical antiseptic as first aid to help

prevent infection in minor cuts, scrapes

and burns.

WARNINGS

Warnings

For external use only

Do not use in the eyes or apply over

large areas of the body.

ASK DOCTOR/PHARMACIST

Consult a doctor in case of deep or

puncture wounds, animal bites or

serious burns.

STOP USE

Stop use and consult a doctor if the

condition persists or gets worse.

DO NOT USE

Do not use longer than 1 week unless

directed by a  doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

In case of accidental ingestion get

medical help or contact a Poison

Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Clean the affected area and apply a

small amount of this product on the

area 1 to 3 times daily.  May be

covered with a sterile bandage.

INACTIVE INGREDIENT

Inactive Ingredients

glycerin, water

PRINCIPAL DISPLAY PANEL

Jaloma

VIOLETA DE GENCIANA

SOLUCION TOPICA

1%

ANTISEPTICO

GENTIAN VIOLET

TOPICAL SOLUTION

1%

ANTISEPTIC

NET 0.84 FL. OZ. (25 ml)

WITH APPLICATOR

INGREDIENTS AND APPEARANCE

GENTIAN VIOLET TOPICAL SOLUTION 
gentian violet liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65055-401
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	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65055-401-01	25 mL in 1 BOTTLE, PLASTIC
2	NDC: 65055-401-02	40 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	09/27/2013

Labeler - Laboratorios Jaloma, S.A. de C.V. (811122357)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratorios Jaloma, S.A. de C.V.		811122357	manufacture(65055-401)