85398-029 Initial-149

85398-029 Initial-149
SPL v1
SPL
SPL Set ID 48b5d7b3-a134-ecdd-e063-6294a90a3213
Route
TOPICAL
Published
Effective Date 2026-02-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (4.52 g)
Inactive Ingredients
Glycerin Cocos Nucifera (coconut) Oil Sodium Palmitate Sucrose Butyrospermum Parkii (shea) Butter Aqua Sodium Hydroxide Aloe Barbadensis Leaf Juice Propylene Glycol Lauric Acid Melaleuca Alternifolia (tea Tree) Leaf Oil Stearic Acid Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-02-02

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 beforerinsing.
  • Make sure to dry affected area thoroughly.
  • Supervisechildren 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 timesdaily. 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 50565-1

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

Section 50567-7

When using this product Avoid contactwith the eye.

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.

Do not use on children under 2 of age except under the advice and supervision of a doctor.

Section 51727-6

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

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 59-86F (15°-30°C).


Structured Label Content

Indications and Usage (34067-9)
  • Wash affected area well and let product sit 2-3 minutes beforerinsing.
  • Make sure to dry affected area thoroughly.
  • Supervisechildren 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 timesdaily. 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 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product Avoid contactwith the eye.

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.

Do not use on children under 2 of age except under the advice and supervision of a doctor.

Section 51727-6 (51727-6)

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

Section 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

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