84558-021

Manufacturer
GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd
Effective date
2026-06-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-07-17 21:35:41

Label at a glance#

Productantifungal pen
Active ingredientTOLNAFTATE
Label structure12 sections

Dosage and administration

Before first use, twist the end of the pen until liquid appears on the applicator tip. Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice or three times daily, morning and night, or as directed by a doctor. This product is not effective on the scalp or nails.lf the condition persists longer, please consult a doctor.

Storage and handling

Storage: Store in a dry and dark place at room temperature(5-25°C).

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Use

INDICATIONS & USAGE SECTION

For the effective treatment of discoloration, thickening, splitting, crumbling and brittleness.
Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
Helps prevent most athlete's foot with daily use.
Provides effective relief of itching, scaling, cracking, burning, redness, soreness, irritation,
discomfort.

Warnings

WARNINGS SECTION

For external use only.
Avoid contact with the eyes and mucous membranest.

ln the event of oversensitivity, stop using dermavia+Fungal Nail Treatment liquid.
Consult your doctor if there is no improvement within two weeks.
Consult your doctor before using if you are pregnant or are breastfeeding.
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use

OTC - DO NOT USE SECTION

on open wounds or damaged skin

OTC - WHEN USING SECTION

avoid contact with eyes
do not apply to irritated or broken skin
use only as directed

OTC - STOP USE SECTION

If irritation occurs, stop using it immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, get medical help or contact a Poison
Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Before first use, twist the end of the pen until liquid appears on the applicator tip.
Clean the affected area and dry thoroughly.
Apply a thin layer of the product over affected area twice or three times daily, morning and
night, or as directed by a doctor.
This product is not effective on the scalp or nails.lf the condition persists longer, please
consult a doctor.

Other information

STORAGE AND HANDLING SECTION

Storage: Store in a dry and dark place at room temperature(5-25°C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Argania Spinosa Kernel Oil, Melaleuca Alternifolia Leaf Oil,
Origanum Vulgare Oil, Prunus Amygdalus Dulcis Oil,Simmondsia Chinensis Seed Oil,
Tocopherol, Vitis Vinifera Seed Oil.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84558-02184558-021-01, 84558-021-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
54f6b60c-e2d9-83d9-e063-6294a90a6cdb54f6ba63-5d2f-e034-e063-6394a90a411d2026-06-23WarningsExact identifier
spl id: 54f6b60c-e2d9-83d9-e063-6294a90a6cdb
spl set id: 54f6ba63-5d2f-e034-e063-6394a90a411d