87083-001

87083-001
SPL v1
SPL
SPL Set ID 41bad254-b674-9521-e063-6294a90ab634
Route
topical
Published
Effective Date 2025-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
tolnaftate (1 g)
Inactive Ingredients
caramel polyoxyl 40 hydrogenated castor oil polysorbate 20 alcohol water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-10-22

Purpose

Antifungal

Description

Tolnaftate 1%


Medication Information

Warnings

For external use only.

Purpose

Antifungal

Directions

For athlete's foot and ring worm: use daily for 4 weeks.

Clean the affected area and dry thoroughly.

Apply a thin layer of the product over affected area twice daily(morning and night) or as directed by a doctor. Supervise child ren in the use of this product.

This product is not effective for the treatment of ring worm of the scalp or nails.

Other Information

Store at room temperature 15-30℃(59-86℉)

Inactive Ingredients

Water, Ethanol, PEG-40 hydrogenated castor oil, Caramel color, Polysorbate -20.

Description

Tolnaftate 1%

Principal Display Panel

Use

Cures most Athlete's Foot (Tinea Pedis) and Ringworm (Tinea Corporis).

Relieves itching, scaling, cracking, burning.

redness, soreness, and Irritation and discomfort.

Helps prevent most athlete's foot (dermatophytosis) with daily use.

Stop Use

Irritation occurs, there is no Improvement with in 4 weeks (for athlete's foot and ringworm).

Ask Doctor

Irritation occurs, there is no Improvement with in 4 weeks (for athlete's foot and ringworm).

Do Not Use

on Children under 2 years of age unless directed by a doctor.

When Using

When using this product avoid contact with eyes.

Active Ingredient



Tolnaftate 1%

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

For external use only.

Purpose

Antifungal

Directions

For athlete's foot and ring worm: use daily for 4 weeks.

Clean the affected area and dry thoroughly.

Apply a thin layer of the product over affected area twice daily(morning and night) or as directed by a doctor. Supervise child ren in the use of this product.

This product is not effective for the treatment of ring worm of the scalp or nails.

Other Information (Other information)

Store at room temperature 15-30℃(59-86℉)

Inactive Ingredients (Inactive ingredients)

Water, Ethanol, PEG-40 hydrogenated castor oil, Caramel color, Polysorbate -20.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Use

Cures most Athlete's Foot (Tinea Pedis) and Ringworm (Tinea Corporis).

Relieves itching, scaling, cracking, burning.

redness, soreness, and Irritation and discomfort.

Helps prevent most athlete's foot (dermatophytosis) with daily use.

Stop Use

Irritation occurs, there is no Improvement with in 4 weeks (for athlete's foot and ringworm).

Ask Doctor

Irritation occurs, there is no Improvement with in 4 weeks (for athlete's foot and ringworm).

Do Not Use (Do not use)

on Children under 2 years of age unless directed by a doctor.

When Using

When using this product avoid contact with eyes.

Active Ingredient



Tolnaftate 1%

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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