Gentian Violet 2%

Manufacturer
The Podiatree Company | EMS Contract Packaging
Effective date
2014-10-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:34:41

Label at a glance#

ProductGentian Violet 2%
Active ingredientGENTIAN VIOLET
Label structure12 sections

Dosage and administration

Clean the affected area. Apply a small amount using a cotton-tipped applicator one to three times daily. Do not bandage.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Gentian Violet 2%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Purpose

INDICATIONS & USAGE SECTION

First aid antiseptic to help protect against skin infection in minor cuts, scrapes or burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

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

OTC - STOP USE SECTION

if skin irritation or sensitivity develops or increases or if the condition persists or gets worse.

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the affected area. Apply a small amount using a cotton-tipped applicator one to three times daily. Do not bandage.

Other Information

OTHER SAFETY INFORMATION

Store at controlled room temperature. Will stain skin and clothing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

SD alcohol (10%), water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54633-014-02ML - Milliliter54633-0144884732a-fc88-4e16-af9f-31eb44bf42db12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GENTIAN VIOLETACTIVE INGREDIENTJ4Z741D6O51
GENTIAN VIOLET CATIONACTIVE MOIETY3GVJ31T6YY1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54633-01454633-014-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
GENTIAN VIOLETJ4Z741D6O5ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentian Violet 2%GENTIAN VIOLET 2%The Podiatree Company60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b82026-01-08WarningsExact identifier
ndc (package): 54633-014-02
ndc (product): 54633-014
ndc11 (package): 54633001402
af575abb-90ba-4b87-b0fd-7ccb373b5c83a972c857-1e3e-4a89-9fb2-da5a64d55bf72014-10-14WarningsExact identifier
spl id: af575abb-90ba-4b87-b0fd-7ccb373b5c83
spl set id: a972c857-1e3e-4a89-9fb2-da5a64d55bf7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.