Dermatool Antifungal

Dermatool Antifungal
SPL v1
SPL
SPL Set ID 2d2c0e12-123d-75bd-e063-6394a90ae546
Route
TOPICAL
Published
Effective Date 2023-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Hydrogenated Polybutene (1300 Mw) Almond Oil .alpha.-tocopherol Acetate Aloe Vera Leaf Butylated Hydroxytoluene Rice Bran Oil Safflower Oil Lavender Oil Jojoba Oil Melaleuca Alternifolia (tea Tree) Leaf Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-06

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 eyes.

Stop use and ask a doctor if: irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).

Indications and Usage

Cures 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) with daily use.

Dosage and Administration

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 product is not effective for the treatment of ringworm 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.

Description

Tolnaftate 1%

Section 50565-1

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

Section 51727-6

Carthamus Tinctorius (Safflower) Seed Oil, Hydrogenated Polyisobutene, Oryza Sativa (Rice) Bran Oil, Sesamum Indicum (Sesame) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Simmondsia Chinensis (Jojoba) Seed Oil, BHT.

Section 51945-4

Section 55105-1

Antifungal

Section 55106-9

Tolnaftate 1%


Structured Label Content

Indications and Usage (34067-9)

Cures 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) with daily use.

Dosage and Administration (34068-7)

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 product is not effective for the treatment of ringworm 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.

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 eyes.

Stop use and ask a doctor if: irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Carthamus Tinctorius (Safflower) Seed Oil, Hydrogenated Polyisobutene, Oryza Sativa (Rice) Bran Oil, Sesamum Indicum (Sesame) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Simmondsia Chinensis (Jojoba) Seed Oil, BHT.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Tolnaftate 1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)