Gentian violet

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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.

### NonGuideline-Supported Use
- There is limited information regarding Off-Label NonGuideline-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.

### NonGuideline-Supported Use
- There is limited information regarding Off-Label NonGuideline-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

## 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

## Package and Label Display Panel

# 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