SPL v2
SPL
SPL Set ID 33994035-b429-4ead-8885-98e38b25059a
Route
TOPICAL
Published
Effective Date 2026-01-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Sodium Palmate Sodium Cocoate Water Glycerin Melaleuca Alternifolia Leaf Eucalyptus Oil Sodium Chloride Sodium Gluconate Tetrasodium Glutamate Diacetate Activated Charcoal

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-28

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

Uses

● Proven clinically effective in the treatment of most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris).

● For effective relief of itching, burning and cracking skin.

Section 50565-1

Warnings

For external use only



When using this productavoid contact with the eye

Stop use and ask a doctor ifirritation occurs or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.

Do Not use onchildren under 2 under of age except under the advice and supervision of a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

● Wash affected area well and let product sit 1-2 minutes before rinsing.

● Make sure to dry affected area thoroughly.

● Supervise children in the use of this product.

● For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.

● Use 1-2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor.

● This product is not effective on the scalp or nails.

Product Label

Active Ingredient

Tolnaftate 1%

Inactive Ingredients

Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Sodium Gluconate, Eucalyptus Globulus Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Palm Acid, Sodium Chloride, Palm Kernel Acid, Charcoal Powder


Structured Label Content

Uses

● Proven clinically effective in the treatment of most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris).

● For effective relief of itching, burning and cracking skin.

Section 50565-1 (50565-1)

Purpose

Antifungal

Warnings

For external use only



When using this productavoid contact with the eye

Stop use and ask a doctor ifirritation occurs or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.

Do Not use onchildren under 2 under of age except under the advice and supervision of a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

● Wash affected area well and let product sit 1-2 minutes before rinsing.

● Make sure to dry affected area thoroughly.

● Supervise children in the use of this product.

● For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.

● Use 1-2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor.

● This product is not effective on the scalp or nails.

Product Label (Product label)

Active Ingredient

Tolnaftate 1%

Inactive Ingredients (Inactive ingredients)

Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Sodium Gluconate, Eucalyptus Globulus Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Palm Acid, Sodium Chloride, Palm Kernel Acid, Charcoal Powder


Advanced Ingredient Data


Raw Label Data

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