85398-020-03 Label

85398-020-03 Label
SPL v3
SPL
SPL Set ID 42c769de-f1e1-b3a1-e063-6394a90ab2a1
Route
TOPICAL
Published
Effective Date 2026-02-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Sodium Palmitate Sucrose Cocos Nucifera (coconut) Oil Lauric Acid Stearic Acid Glycerin Propylene Glycol Sodium Hydroxide Aqua Sorbitol Melaleuca Alternifolia (tea Tree) Leaf Oil Aloe Barbadensis Leaf Juice Butyrospermum Parkii (shea) Butter

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2025-11-25 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 orcontact a 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

avoide contact with eyes, lf contact occurs, rinse thoroughly with water.

Section 50570-1

on children under 2 years of age unless directed by a doctor.

Section 51727-6

(Original)

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 Leaf Juice, Cocos Nucifera (Coconut) Oil



(Lavender)

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 Leaf Juice, 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%

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 orcontact a 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)

avoide contact with eyes, lf contact occurs, rinse thoroughly with water.

Section 50570-1 (50570-1)

on children under 2 years of age unless directed by a doctor.

Section 51727-6 (51727-6)

(Original)

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 Leaf Juice, Cocos Nucifera (Coconut) Oil



(Lavender)

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 Leaf Juice, 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%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:16.636940 · Updated: 2026-03-14T23:12:28.058882