Gentian Violet 1%

Manufacturer: Humco Holding Group, Inc.
Effective date: 2021-12-23
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 23:45:53

Label at a glance#

ProductGentian Violet 1%

Active ingredientGENTIAN VIOLET

Label structure14 sections

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Gentian Violet 1%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Indications

INDICATIONS & USAGE SECTION

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

Indications

RECENT MAJOR CHANGES SECTION

First aid to help protect against infection in minor cuts, scrapes, and burns. (12/2021)

Warnings

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

will stain skin or clothing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ethyl Alcohol 10% and Purified Water.

DLC 30 mL Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DLCGV.jpgSLC Spanish

GNP Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GNPGNP

DLC Label Arabic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DLC GV Arabic Front.jpgDLC GV Arabic Inside.jpg

DLC 59 mL Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DLC GV 1 2floz.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310481	gentian violet 1 % Topical Solution	PSN	5
310481	gentian violet 10 MG/ML Topical Solution	SCD	5
310481	gentian violet 1 % Topical Solution	SY	5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0395-9114-91	2022-07-29	C162847	48780-1	e4f33bdf-ae13-d8a0-e053-dadaa90a6e4e	Private Label Gentian Violet 1%
0395-9114-92	2022-07-29	C162847	48780-1	e4f33bdf-ae13-d8a0-e053-dadaa90a6e4e	Private Label Gentian Violet 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0395-9114-91	Gentian Violet 1%	30 mL in 1 BOTTLE, PLASTIC	LIQUID	30		5
0395-9114-92	Gentian Violet 1%	59 mL in 1 BOTTLE, PLASTIC	LIQUID	59		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0395-9114	GENTIAN VIOLET 1% LIQUID [HUMCO HOLDING GROUP, INC.]	5	Legacy NDC, 2 package rows	20211224_60547538-9b52-8e90-e053-2991aa0ac732.zip

Products#

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

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

Gentian Violet 1%
ALCOHOL
WATER
GENTIAN VIOLET
GENTIAN VIOLET CATION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0395-9114	0395-9114-92, 0395-9114-91

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
Name	UNII	Kind
ALCOHOL	3K9958V90M	IACT
WATER	059QF0KO0R	IACT
GENTIAN VIOLET	J4Z741D6O5	ACTIB

Source Document#

Source XML

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d3d1edfc-fcd1-1889-e053-2a95a90a5d59			60547538-9b52-8e90-e053-2991aa0ac732	2021-12-23	Warnings	Exact identifier spl id: d3d1edfc-fcd1-1889-e053-2a95a90a5d59 spl set id: 60547538-9b52-8e90-e053-2991aa0ac732

Reported adverse events (FAERS/openFDA)#

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