Gentian violet

Gentian violet
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Gentian violet is an antifungal agent that is FDA approved for the treatment of candidal vulvovaginitis and as an antiseptic to protect against skin infection in minor cuts, scrapes or burns. Common adverse reactions include discoloration of skin.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

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

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

• There is limited information regarding Off-Label Guideline-Supported Use of Gentian violet in adult patients.

Non–Guideline-Supported Use

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Gentian violet in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

• There is limited information regarding Off-Label Guideline-Supported Use of Gentian violet in pediatric patients.

Non–Guideline-Supported Use

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Gentian violet in pediatric patients.

Contraindications

There is limited information regarding Gentian violet Contraindications in the drug label.

Warnings

• For external use only

DO NOT USE

• 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

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

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Gentian violet in the drug label.

Postmarketing Experience

• There is limited information regarding Postmarketing Experience of Gentian violet in the drug label.

Drug Interactions

• There is limited information regarding Drug interactions of Gentian violet in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Gentian violet in women who are pregnant.
Pregnancy Category (AUS):

• There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Gentian violet in women who are pregnant.

Labor and Delivery

• There is no FDA guidance on use of Gentian violet during labor and delivery.

Nursing Mothers

• There is no FDA guidance on the use of Gentian violet with respect to nursing mothers.

Pediatric Use

• There is no FDA guidance on the use of Gentian violet with respect to pediatric patients.

Geriatic Use

• There is no FDA guidance on the use of Gentian violet with respect to geriatric patients.

Gender

• There is no FDA guidance on the use of Gentian violet with respect to specific gender populations.

Race

• There is no FDA guidance on the use of Gentian violet with respect to specific racial populations.

Renal Impairment

• There is no FDA guidance on the use of Gentian violet in patients with renal impairment.

Hepatic Impairment

• There is no FDA guidance on the use of Gentian violet in patients with hepatic impairment.

Females of Reproductive Potential and Males

• There is no FDA guidance on the use of Gentian violet in women of reproductive potentials and males.

Immunocompromised Patients

• There is no FDA guidance one the use of Gentian violet in patients who are immunocompromised.

Administration and Monitoring

Administration

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

Monitoring

• There is limited information regarding Monitoring of Gentian violet in the drug label.

IV Compatibility

• There is limited information regarding IV Compatibility of Gentian violet in the drug label.

Overdosage

• There is limited information regarding Chronic Overdose of Gentian violet in the drug label.

Pharmacology

This image is provided by the National Library of Medicine.

Mechanism of Action

• There is limited information regarding Mechanism of action of Gentian violet in the drug label.

Structure

There is limited information regarding Gentian violet Structure in the drug label.

Pharmacodynamics

• There is limited information regarding Pharmacodynamics of Gentian violet in the drug label.

Pharmacokinetics

• There is limited information regarding Pharmacokinetics of Gentian violet in the drug label.

Nonclinical Toxicology

• There is limited information regarding Nonclinical Toxicology of Gentian violet in the drug label.

Clinical Studies

• There is limited information regarding Clinical Studies of Gentian violet in the drug label.

How Supplied

There is limited information regarding Gentian violet How Supplied in the drug label.

Storage

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

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

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Patient Counseling Information

KEEP OUT OF REACH OF CHILDREN.

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

Precautions with Alcohol

• Alcohol-Gentian violet interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• GENTIAN VIOLET®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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