85261-601 - 激活

85261-601 - 激活
SPL v3
SPL
SPL Set ID 2da7a20e-021e-2111-e063-6294a90ad441
Route
TOPICAL
Published
Effective Date 2025-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Melaleuca Alternifolia (tea Tree) Leaf Oil Water Lauric Acid Propylene Glycol Stearate Butyrospermum Parkii (shea) Butter Sodium Hydroxide Cocos Nucifera (coconut) Oil Stearic Acid Sorbitol Aloe Barbadensis Leaf Juice Fragrance Lavender Orc1800979 Glycerin Sodium Palmitate Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-20
Description

Tolnaftate 1%

Medication Information

Warnings and Precautions

For External use only.

Indications and Usage

Helps relieve and prevent itching, burning, cracking, and scaling associated with fungal infections such as athlete's foot, jock itch, ringworm, and other skin irriations.

Dosage and Administration

Wash affected area & dry thoroughly. Apply a thin layer over affected area twice daily (morning and night). Supervise children in the use of this product. Use daily for 2 weeks.

Description

Tolnaftate 1%

Section 50565-1

keep out of reach of Children. If swallowed, get medical help of contac a Poison Control Center right away.

Section 50566-9

Stop use and ask doctor if irritation occurs or there is no improvement within 2 weeks.

Section 50567-7

When using this product avoid contact with eyes, if contact occurs, rinse thoroughly with water.

Section 50570-1

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

Section 51727-6

Stearic Acid, Lauric Acid, Water, Cocos Nucifera (Coconut) Oil, Glycerin, Sorbitol, Sucrose, Aloe Barbadensis Leaf Juice, Sodium Palmitate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Butyrospermum Parkii (Shea) Butter, Sodium Hydroxide, Propylene Glycol Stearate, Fragrance Lavender

Section 51945-4

Section 55105-1

Antifungal

Section 55106-9

Tolnaftate 1%

Section 60561-8

Store at room temperature. Protect from excessive heat (above 104°F/ 40°C)

Structured Label Content

Indications and Usage (34067-9)

Helps relieve and prevent itching, burning, cracking, and scaling associated with fungal infections such as athlete's foot, jock itch, ringworm, and other skin irriations.

Dosage and Administration (34068-7)

Wash affected area & dry thoroughly. Apply a thin layer over affected area twice daily (morning and night). Supervise children in the use of this product. Use daily for 2 weeks.

Warnings and Precautions (34071-1)

For External use only.

Section 50565-1 (50565-1)

keep out of reach of Children. If swallowed, get medical help of contac a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask doctor if irritation occurs or there is no improvement within 2 weeks.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes, if contact occurs, rinse thoroughly with water.

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Stearic Acid, Lauric Acid, Water, Cocos Nucifera (Coconut) Oil, Glycerin, Sorbitol, Sucrose, Aloe Barbadensis Leaf Juice, Sodium Palmitate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Butyrospermum Parkii (Shea) Butter, Sodium Hydroxide, Propylene Glycol Stearate, Fragrance Lavender

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Tolnaftate 1%

Section 60561-8 (60561-8)

Store at room temperature. Protect from excessive heat (above 104°F/ 40°C)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:13.730405 · Updated: 2026-03-14T23:12:24.385926