GENTIAN VIOLET TOPICAL SOLUTION- gentian violet liquid 
Laboratorios Jaloma, S.A. de C.V.

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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Drug Facts

Active Ingredient

Gentian Violet 1%

Purpose

Antiseptic

Uses

Topical antiseptic as first aid to help

prevent infection in minor cuts, scrapes

and burns.

Warnings

For external use only

Do not use in the eyes or apply over

large areas of the body.


Consult a doctor in case of deep or

puncture wounds, animal bites or

serious burns.

Stop use and consult a doctor if the

condition persists or gets worse.

Do not use longer than 1 week unless

directed by a  doctor.

Keep out of the reach of children.

In case of accidental ingestion get

medical help or contact a Poison

Control Center right away.

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 Ingredients

glycerin, water

Image of Drug Facts

Jaloma

VIOLETA DE GENCIANA

SOLUCION TOPICA

1%

ANTISEPTICO

GENTIAN VIOLET

TOPICAL SOLUTION

1%

ANTISEPTIC

NET 0.84 FL. OZ. (25 ml)

WITH APPLICATOR

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GENTIAN VIOLET TOPICAL SOLUTION 
gentian violet liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65055-401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY) GENTIAN VIOLET1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65055-401-0125 mL in 1 BOTTLE, PLASTIC
2NDC:65055-401-0240 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/27/2013
Labeler - Laboratorios Jaloma, S.A. de C.V. (811122357)
Establishment
NameAddressID/FEIBusiness Operations
Laboratorios Jaloma, S.A. de C.V.811122357manufacture(65055-401)

Revised: 9/2013
Document Id: 3e1717af-cb87-4e61-8ef9-345e2a58d458
Set id: cda57f0f-4cf8-45bb-a675-a33b25e41ade
Version: 2
Effective Time: 20130927
 
Laboratorios Jaloma, S.A. de C.V.