85248-095update

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD
Effective date
2026-06-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-07-17 21:35:37

Label at a glance#

ProductFIobow FUNGAL NAIL TREATMENT
Active ingredientTOLNAFTATE
Label structure13 sections

Dosage and administration

Directions For athlete's foot and ringworm: use daily for 4 weeks. Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. This product is not effective for the treatment of ringworm of the scalp or nails. For athlete's foot: pay special attention to spaces between the...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Use

INDICATIONS & USAGE SECTION

Cures most Athlete's Foot (Tinea Pedis)and Ringworm (Tinea Corporis). Relieves itching, scaling, cracking, burning,redness, soreness, irritation and discomfort. Helps prevent most athlete's foot (dermatophytosis) with daily use.



Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

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

When Using

OTC - WHEN USING SECTION

avoid contact with eyes.

Stop Use

OTC - STOP USE SECTION

irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).

Ask Doctor

OTC - ASK DOCTOR SECTION

irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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

Directions

DOSAGE & ADMINISTRATION SECTION

Directions For athlete's foot and ringworm: use daily for 4 weeks. Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. This product is not effective for the treatment of ringworm of the scalp or nails.
For athlete's foot: pay special attention to spaces between the toes, wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. To prevent athlete's foot, apply once or twice daily(morning and/or night). Apply to skin around the nail and cuticle.

Other information

OTC - STOP USE SECTION

Store at room temperature 15º-30℃ (59-86℉)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Euphorbia hirta (whole), Glycerin, Hydracrylic Acid,Pseudolarix amabilis (bark),Resorcinol.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-136979843980357GTIN-13: 6979843980357
EAN-13: 6979843980357
GTIN storage (14 digits): 06979843980357
37c803e5e40ec812d44c2e4f17338412.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85248-09585248-095-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-02-07full-release2026-06-01 01:37:30

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FIobow FUNGAL NAIL TREATMENTTOLNAFTATE 1% FUNGAL NAIL TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a49db2b-e45a-57c5-e063-6294a90a065c2026-06-23WarningsExact identifier
ndc (package): 85248-095-01
ndc (product): 85248-095
ndc11 (package): 85248009501
spl id: 54f61cc1-1152-7359-e063-6394a90aedd1
spl set id: 4a49db2b-e45a-57c5-e063-6294a90a065c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.