Tolnaftate

Tolnaftate
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: Rabin Bista, M.B.B.S. [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

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

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• athlete’s foot (tinea pedis)
• ringworm (tinea corporis)

helps prevent most athlete’s foot with daily use

• 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 athlete’s 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 athlete’s 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.

Non–Guideline-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.

Non–Guideline-Supported Use

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

Contraindications

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

Warnings

• For external use only

When using this product

• avoid contact with the eyes

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks

Do not use

• children under 2 years of age unless directed by a doctor

Keep out of reach of children

• 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°-77°F (20°-25°C)

Images

Drug Images

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Package and Label Display Panel

PRINCIPAL DISPLAY PANEL

Cures Most Athlete’s Foot

Relieves Itching & Burning

Compare to Tinactin® active ingredient

Tolnaftate Cream USP, 1%

Antifungal

This image is provided by the National Library of Medicine.

Ingredients and Appearance

This image is provided by the National Library of Medicine.

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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

References

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