85248-037

85248-037
SPL v1
SPL
SPL Set ID 49aba00d-9249-b403-e063-6394a90a787d
Route
TOPICAL
Published
Effective Date 2026-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Glycerin Resorcinol Hydracrylic Acid Euphorbia Hirta Whole Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-31

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

Use

Soothes most Athlete's Foot (Tinea Pedis)and Ringworm (Tinea Corporis).Relieves itching,scaling, cracking, burning, redness, sorenes, and irritation and discomfort. Helps prevent most athlete's foot(dermatophytosis) withdaily use.

Stop Use

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

Warnings

For external use only.

Ask Doctor

irritation occurs, there is no improvement with in 4 weeks (for athlete's foot and ringworm).This product cannot replace medication

Directions

For athlete's foot and ringworm: 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 children in the use of this product.This productis not effective for the prevention of ring worm of the scalp or nails. 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. To prevent athlete's foot, apply once or twice daily(morning and/or night).Apply to skin around the nail and cuticle.

Do Not Use

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

When Using

avoid contact with eyes.

Active Ingredient

Tolnaftate 1%

Other Information

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

Inactive Ingredients

water, euphorbia hirta whole, glycerin,hydracrylic acid,pseudolarix amabilis bark, resorcinol.

Principal Display Panel

Keep Oot of Reach of Children

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


Structured Label Content

Use

Soothes most Athlete's Foot (Tinea Pedis)and Ringworm (Tinea Corporis).Relieves itching,scaling, cracking, burning, redness, sorenes, and irritation and discomfort. Helps prevent most athlete's foot(dermatophytosis) withdaily use.

Purpose

Antifungal

Stop Use

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

Warnings

For external use only.

Ask Doctor

irritation occurs, there is no improvement with in 4 weeks (for athlete's foot and ringworm).This product cannot replace medication

Directions

For athlete's foot and ringworm: 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 children in the use of this product.This productis not effective for the prevention of ring worm of the scalp or nails. 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. To prevent athlete's foot, apply once or twice daily(morning and/or night).Apply to skin around the nail and cuticle.

Do Not Use (Do not use)

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

When Using

avoid contact with eyes.

Active Ingredient

Tolnaftate 1%

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

water, euphorbia hirta whole, glycerin,hydracrylic acid,pseudolarix amabilis bark, resorcinol.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

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


Advanced Ingredient Data


Raw Label Data

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