85248-030

85248-030
SPL v1
SPL
SPL Set ID 49964c81-1c86-e1f5-e063-6394a90a7d08
Route
TOPICAL
Published
Effective Date 2026-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Pseudolarix Amabilis Bark Salicylic Acid Euphorbia Hirta Whole Benzoic Acid Alcohol Phenylephrine Hydrochloride Phellodendron Amurense Bark Sophora Flavescens Root Lactobacillus Acidophilus

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-30

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

Use

.Effectivein treating athlete's foot (tineapedis) .Helps prevent athlete's foot with regular use .For effective relief of itching, cracking, burning, scaling and discomfort

Stop Use

·Irritation occurs

·There is no improvement within 4 weeks.

Warnings

For external use only

do not use while smoking or near heat or flame.

Ask Doctor

·Irritation occurs

·There is no improvement within 4 weeks.

Directions

·Wash the affected area and dry thoroughly

·Shake can well and spray a thin layer over affected area twice daily (morning and night)

·Supervise children in the use of this product

·pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily

·Use daily for 4 weeks; if condition persists longer, ask a doctor

·To prevent athlete's foot, apply once or twice daily (morning and/or night, or as directed by a doctor)

·This product is not effective on the scalp or nails.

Do Not Use

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

When Using

this product avoid contact with the eyes

.Use only as directed. Intentional misuse by deliberately concentrating and inhaling

the contents can be harmful or fatal.

.Do not puncture or incinerate. Contents under pressure, Do not store at temperatures above 120°F

Active Ingredient

Tolnaftate 1%

Other Information

Store between 20-25°C (68-77°F)

Inactive Ingredients

alcohol,benzoic acid,euphorbia hirta whole,phellodendron amurense bark,phenylephrine hydrochloride,pseudolarix amabilis bark,salicylic acid,sophora flavescens root,Probiotic.





Principal Display Panel

Keep Oot of Reach of Children

If swallowed get medical help or contact a poison control center right away.


Structured Label Content

Use

.Effectivein treating athlete's foot (tineapedis) .Helps prevent athlete's foot with regular use .For effective relief of itching, cracking, burning, scaling and discomfort

Purpose

Antifungal

Stop Use

·Irritation occurs

·There is no improvement within 4 weeks.

Warnings

For external use only

do not use while smoking or near heat or flame.

Ask Doctor

·Irritation occurs

·There is no improvement within 4 weeks.

Directions

·Wash the affected area and dry thoroughly

·Shake can well and spray a thin layer over affected area twice daily (morning and night)

·Supervise children in the use of this product

·pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily

·Use daily for 4 weeks; if condition persists longer, ask a doctor

·To prevent athlete's foot, apply once or twice daily (morning and/or night, or as directed by a doctor)

·This product is not effective on the scalp or nails.

Do Not Use (Do not use)

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

When Using

this product avoid contact with the eyes

.Use only as directed. Intentional misuse by deliberately concentrating and inhaling

the contents can be harmful or fatal.

.Do not puncture or incinerate. Contents under pressure, Do not store at temperatures above 120°F

Active Ingredient

Tolnaftate 1%

Other Information (Other information)

Store between 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

alcohol,benzoic acid,euphorbia hirta whole,phellodendron amurense bark,phenylephrine hydrochloride,pseudolarix amabilis bark,salicylic acid,sophora flavescens root,Probiotic.





Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

If swallowed get medical help or contact a poison control center right away.


Advanced Ingredient Data


Raw Label Data

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