85398-019 Update

85398-019 Update
SPL v2
SPL
SPL Set ID 41e37014-549c-e592-e063-6294a90ac6ab
Route
TOPICAL
Published
Effective Date 2025-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Sodium Palmitate Cocos Nucifera (coconut) Fruit Juice Melaleuca Alternifolia (tea Tree) Leaf Oil Aloe Barbadensis Leaf Juice Diospyros Kaki Fruit Sorbitol Propylene Glycol Cocos Nucifera (coconut) Oil Cucurbita Pepo (pumpkin) Seed Oil Stearic Acid Water Sodium Hydroxide Sodium Palmate Sucrose Glycerin Butyrospermum Parkii (shea) Butter Lauric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2025-11-07 Until 2026-01-01
Description

Tolnaftate 1%

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage
  • Wash affected area well and let product sit 2–3 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.
Dosage and Administration
  • For effective 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.
Description

Tolnaftate 1%

Section 44425-7

Store at room temperature 59°–86°F (15°–30°C).

Section 50565-1

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

Section 50566-9

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

Section 50567-7

When using this product avoide contact with eyesIf 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

Sucrose, Stearic Acid, Propylene Glycol, Sorbitol, Sodium Palmitate, Water, Glycerin, Butyrospermum Parkii (Shea) Butter, Lauric Acid, Sodium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis Leaf Juice, Diospyros Kaki Fruit Extract, Cocos Nucifera (Coconut) Fruit Extract, Cucurbita Pepo (Pumpkin) Seed Extract, Fragrance

Section 51945-4

Section 53413-1

visit us at www.hermonhealth.com

Section 55105-1

Antifungal

Section 55106-9

Tolnaftate 1%

Structured Label Content

Indications and Usage (34067-9)
  • Wash affected area well and let product sit 2–3 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.
Dosage and Administration (34068-7)
  • For effective 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.
Warnings and Precautions (34071-1)

For external use only.

Section 44425-7 (44425-7)

Store at room temperature 59°–86°F (15°–30°C).

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product avoide contact with eyesIf 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)

Sucrose, Stearic Acid, Propylene Glycol, Sorbitol, Sodium Palmitate, Water, Glycerin, Butyrospermum Parkii (Shea) Butter, Lauric Acid, Sodium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis Leaf Juice, Diospyros Kaki Fruit Extract, Cocos Nucifera (Coconut) Fruit Extract, Cucurbita Pepo (Pumpkin) Seed Extract, Fragrance

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

visit us at www.hermonhealth.com

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Tolnaftate 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:16.523578 · Updated: 2026-03-14T23:12:26.991151