Initial Drug Listing - Athlete's Foot Soap Bar

Initial Drug Listing - Athlete's Foot Soap Bar
SPL v2
SPL
SPL Set ID 3b2cedb2-18f4-f571-e063-6394a90a6418
Route
TOPICAL
Published
Effective Date 2025-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Sodium Dodecylbenzenesulfonate Propylene Glycol Olea Europaea (olive) Fruit Oil Sorbitol Water Melaleuca Alternifolia (tea Tree) Leaf Oil Myristic Acid Sodium Myristate Cocos Nucifera (coconut) Oil Sodium Hydroxide Hamamelis Virginiana Bark Glycerin Lauric Acid Elaeis Guineensis (palm) Oil Sulfur Stearic Acid Sodium Glutamate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-18

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 irritations.

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

if swallowed, get medical help or contact a Posion Control Center right away.

Section 50566-9

Stop use and ask doctor if irritation occurs, 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

Aqua (Water), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sorbitol, Elaeis Guineensis (Palm) Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Propylene Glycol, Glycerin, Stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzene Sulfonate, Sulfur Thermal Water, Hamamelis Virginiana (Witch Hazel) Extract, Ceramide

Section 51945-4

Section 53413-1

visit us at www.hermonhealth.com

Section 55105-1

Antifungal

Section 55106-9

Tolnaftate 1%

Section 60561-8

Store at room temperature. Protect from excessive heat (above 104ºF /40ºC)


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 irritations.

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)

if swallowed, get medical help or contact a Posion Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask doctor if irritation occurs, 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)

Aqua (Water), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sorbitol, Elaeis Guineensis (Palm) Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Propylene Glycol, Glycerin, Stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzene Sulfonate, Sulfur Thermal Water, Hamamelis Virginiana (Witch Hazel) Extract, Ceramide

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%

Section 60561-8 (60561-8)

Store at room temperature. Protect from excessive heat (above 104ºF /40ºC)


Advanced Ingredient Data


Raw Label Data

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