Tolnaftate

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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
Tolnaftate is a OTC antifungal that is FDA approved for the treatment of athletes foot (tinea pedis), ringworm (tinea corporis).   Common adverse reactions include irritation.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

### Indications
- athletes foot (tinea pedis)
- ringworm (tinea corporis)
- for effective relief of itching, burning, cracking

### Directions
- wash affected area and dry thoroughly
- apply a thin layer over affected area twice daily (morning and night)
- supervise children in the use of this product
- for athletes foot: pay special attention to spaces between the toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
- use daily for 4 weeks. If condition lasts longer, ask a doctor.
- to prevent athletes foot, apply once or twice daily (morning and/or night)
- this product is not effective on the scalp or nails

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tolnaftate in adult patients.

### NonGuideline-Supported Use
- Onychomycosis due to dermatophyte

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Tolnaftate in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tolnaftate in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Tolnaftate in pediatric patients.

# Contraindications
There is limited information regarding Tolnaftate Contraindications in the drug label.

# Warnings
- For external use only
- avoid contact with the eyes
- irritation occurs
- there is no improvement within 4 weeks
- children under 2 years of age unless directed by a doctor
- If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

# Adverse Reactions

## Clinical Trials Experience
- irritation

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of Tolnaftate in the drug label.

# Drug Interactions
There is limited information regarding Tolnaftate Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA):
- Pregnancy Category
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tolnaftate in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Tolnaftate during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Tolnaftate with respect to nursing mothers.

### Pediatric Use
There is no FDA guidance on the use of Tolnaftate with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Tolnaftate with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Tolnaftate with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Tolnaftate with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Tolnaftate in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Tolnaftate in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Tolnaftate in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Tolnaftate in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Topical cream

### Monitoring
There is limited information regarding Monitoring of Tolnaftate in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Tolnaftate in the drug label.

# Overdosage
There is limited information regarding Overdose of Tolnaftate in the drug label.

# Pharmacology

## Mechanism of Action
There is limited information regarding Tolnaftate Mechanism of Action in the drug label.

## Structure
There is limited information regarding Tolnaftate Structure in the drug label.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Tolnaftate in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Tolnaftate in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Tolnaftate in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Tolnaftate in the drug label.

# How Supplied
There is limited information regarding Tolnaftate How Supplied in the drug label.

## Storage
- store at 68-77F (20-25C)

# Images

## Drug Images

## Package and Label Display Panel

### PRINCIPAL DISPLAY PANEL
Cures Most Athletes Foot
Relieves Itching & Burning
Compare to Tinactin active ingredient
Tolnaftate Cream USP, 1%
Antifungal

### Ingredients and Appearance

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Tolnaftate in the drug label.

# Precautions with Alcohol
- Alcohol-Tolnaftate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- Tinactin

# Look-Alike Drug Names
There is limited information regarding Tolnaftate Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price