SPL v1
SPL
SPL Set ID 451c9658-d465-f349-e063-6294a90ae075
Route
TOPICAL
Published
Effective Date 2025-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Artemisia Vulgaris Oil Acetic Acid Tea Tree Oil Chlorhexidine Diacetate Salicylic Acid Mentha Arvensis Top Aloe

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-05

Description

Active Ingredient:Tolnaftate 1%


Medication Information

Warnings and Precautions

WarningsFor external use only. Avoid contactwith the eyes.

Do not use on children under 2.Useonly under medical advice.

Stop use and ask a doctor ifirritation occurs, there is noimprovement within 4 weeks

Indications and Usage

Preparation: Begin by washingthe affected area with soap, thensoak the nail in warm water tosoften it.

Nail Care: For fungal nails, gentlyremove debris and file downthickened areas until smooth. Anail file may be used every 2-3days to lightly buff the surface.

Application: Apply a thin layer ofthe solution to the affected nail.including the skin beneath andaround the cuticle.

Dosage and Administration

Frequency: Repeat this process2-3 times a day. For best resultscontinue use for a continuousperiod of 4 weeks

Description

Active Ingredient:Tolnaftate 1%

Section 50565-1

Keep out of reach of children.lfswallowed, call poison control orget medical help immediately.

Section 51727-6

ARTEMISIA VULGARIS OIL

ACETIC ACID

CHLORHEXIDINE DIACETATESALICYLIC ACID

MENTHA ARVENSIS TOP

ALOE

TEA TREE OIL

Section 51945-4

Section 55105-1

Stops ltching and Burning

Deep Repair Nail Fungus

Section 55106-9

Active Ingredient:Tolnaftate 1%


Structured Label Content

Indications and Usage (34067-9)

Preparation: Begin by washingthe affected area with soap, thensoak the nail in warm water tosoften it.

Nail Care: For fungal nails, gentlyremove debris and file downthickened areas until smooth. Anail file may be used every 2-3days to lightly buff the surface.

Application: Apply a thin layer ofthe solution to the affected nail.including the skin beneath andaround the cuticle.

Dosage and Administration (34068-7)

Frequency: Repeat this process2-3 times a day. For best resultscontinue use for a continuousperiod of 4 weeks

Warnings and Precautions (34071-1)

WarningsFor external use only. Avoid contactwith the eyes.

Do not use on children under 2.Useonly under medical advice.

Stop use and ask a doctor ifirritation occurs, there is noimprovement within 4 weeks

Section 50565-1 (50565-1)

Keep out of reach of children.lfswallowed, call poison control orget medical help immediately.

Section 51727-6 (51727-6)

ARTEMISIA VULGARIS OIL

ACETIC ACID

CHLORHEXIDINE DIACETATESALICYLIC ACID

MENTHA ARVENSIS TOP

ALOE

TEA TREE OIL

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Stops ltching and Burning

Deep Repair Nail Fungus

Section 55106-9 (55106-9)

Active Ingredient:Tolnaftate 1%


Advanced Ingredient Data


Raw Label Data

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