SPL v1
SPL
SPL Set ID 499c0bab-e7c6-9f20-e063-6294a90aae8b
Route
TOPICAL
Published
Effective Date 2026-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (0.15 mg)
Inactive Ingredients
Eucalyptol Squalene Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2026-01-30 Until 2027-02-05

Description

Tolnaftate 1%


Medication Information

Warnings and Precautions

For external use only. Do not use on children under 2 years of age unless directed by a doctor. When using this product, avoid contact with the eyes. Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

1. 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. Gently file the nail to make it thinner and remove debris, being cautious not to harm the nail bed. For best results, file nails every 2-3 days. 2. Supervise children in the use of this product. 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). For toe fungus, apply to skin around the nail and cuticle. Visible improvement may be seen in as little as 7 days. Continue regular use to help prevent fungus regrowth.

Dosage and Administration

Twice each day,1ml each time. 15 days supply

Description

Tolnaftate 1%

Section 50565-1

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

Section 50566-9

Chest pain, rapid heart beat, faintness, or dizziness occurs sudden, unexplained weight gain occurs,your hands or feet swell.

Section 50567-7

1. 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. Gently file the nail to make it thinner and remove debris, being cautious not to harm the nail bed. For best results, file nails every 2-3 days. 2. Supervise children in the use of this product. 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). For toe fungus, apply to skin around the nail and cuticle. Visible improvement may be seen in as little as 7 days. Continue reqular use to help prevent fungus regrowth.

Section 50570-1

For external use only. Do not use on children under 2 years of age unless directed by a doctor. When using this product, avoid con tact with the eyes. Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Aloe Vera Extract, Helianthus Annuus (Sunflower) Seed Oil, Prunus Armeniaca (Apricot) Kernel Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Eugenia Caryophyllus (Clove) Bud Oil, Lavandula Angustifolia (Lavender) Oil, Hakka Yu, Tocopherol, Origanum Vulgare Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Eucalyptol, Tocopheryl Acetate, Squalene, Propolis Extract, Citrus Bergamia (Bergamot) Fruit Oil.

Section 51945-4

Section 55105-1

Antifungal

Section 55106-9

Tolnaftate 1%


Structured Label Content

Indications and Usage (34067-9)

1. 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. Gently file the nail to make it thinner and remove debris, being cautious not to harm the nail bed. For best results, file nails every 2-3 days. 2. Supervise children in the use of this product. 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). For toe fungus, apply to skin around the nail and cuticle. Visible improvement may be seen in as little as 7 days. Continue regular use to help prevent fungus regrowth.

Dosage and Administration (34068-7)

Twice each day,1ml each time. 15 days supply

Warnings and Precautions (34071-1)

For external use only. Do not use on children under 2 years of age unless directed by a doctor. When using this product, avoid contact with the eyes. Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Chest pain, rapid heart beat, faintness, or dizziness occurs sudden, unexplained weight gain occurs,your hands or feet swell.

Section 50567-7 (50567-7)

1. 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. Gently file the nail to make it thinner and remove debris, being cautious not to harm the nail bed. For best results, file nails every 2-3 days. 2. Supervise children in the use of this product. 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). For toe fungus, apply to skin around the nail and cuticle. Visible improvement may be seen in as little as 7 days. Continue reqular use to help prevent fungus regrowth.

Section 50570-1 (50570-1)

For external use only. Do not use on children under 2 years of age unless directed by a doctor. When using this product, avoid con tact with the eyes. Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Aloe Vera Extract, Helianthus Annuus (Sunflower) Seed Oil, Prunus Armeniaca (Apricot) Kernel Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Eugenia Caryophyllus (Clove) Bud Oil, Lavandula Angustifolia (Lavender) Oil, Hakka Yu, Tocopherol, Origanum Vulgare Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Eucalyptol, Tocopheryl Acetate, Squalene, Propolis Extract, Citrus Bergamia (Bergamot) Fruit Oil.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Tolnaftate 1%


Advanced Ingredient Data


Raw Label Data

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