SPL v1
SPL
SPL Set ID 26cfedcd-66e8-f95b-e063-6394a90a1ee3
Route
TOPICAL
Published
Effective Date 2024-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (0.01 mg)
Inactive Ingredients
Methylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-01
Description

Tolnaftate 1%

Medication Information

Warnings and Precautions

1. Do not use on children under 2 years of age unless directed by a doctor.

2. For external use only.

3. Avoid contact with the eye.

* If irritation occurs or there is no improvement within two weeks discontinue use and consult a doctor.

Indications and Usage

For effective treatment of most athlete's foot (dermatophytosis). Relieves: Itching, burning, scaling, irritation, soreness.

Dosage and Administration

Fill foot basin with warm water and add 1 oz of solution (1.5 tbsp) for every one gallon of water. Mix until water is diluted with the solution. Soak your feet for 5-10 minutes.

Description

Tolnaftate 1%

Section 50565-1

WARNINGS - Keep children out of reach.

Section 51727-6

Ethanol, Polysorbate 20, Polyethylene Glycol 300, Methylparaben.

Section 51945-4

Section 55105-1

Antifungal. Prevents athlete's foot with use.

Section 55106-9

Tolnaftate 1%

Structured Label Content

Indications and Usage (34067-9)

For effective treatment of most athlete's foot (dermatophytosis). Relieves: Itching, burning, scaling, irritation, soreness.

Dosage and Administration (34068-7)

Fill foot basin with warm water and add 1 oz of solution (1.5 tbsp) for every one gallon of water. Mix until water is diluted with the solution. Soak your feet for 5-10 minutes.

Warnings and Precautions (34071-1)

1. Do not use on children under 2 years of age unless directed by a doctor.

2. For external use only.

3. Avoid contact with the eye.

* If irritation occurs or there is no improvement within two weeks discontinue use and consult a doctor.

Section 50565-1 (50565-1)

WARNINGS - Keep children out of reach.

Section 51727-6 (51727-6)

Ethanol, Polysorbate 20, Polyethylene Glycol 300, Methylparaben.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antifungal. Prevents athlete's foot with use.

Section 55106-9 (55106-9)

Tolnaftate 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:24.829336 · Updated: 2026-03-14T23:05:07.358425