85248-115 Renew2

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD
Effective date
2026-07-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-07-25 05:10:06

Label at a glance#

ProductDERMFREE HELPS WITH NAGELPILZ
Active ingredientTOLNAFTATE
Label structure12 sections

Dosage and administration

For athlete's foot and ringworm:use daily for 4 weeks.Clean the affected area and dry thoroughly.Keep away from fire and flames.For external use on nails and the immediately adjacent skin only.Use once daily, preferably before bedtime. Unscrew the bottle cap and use the brush to apply the medicine directly to the nail.The medication will then penetrate deeply into the nail.If the nail area is infected, spray the m...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Use

INDICATIONS & USAGE SECTION

Antifungal treatment for fingernails,toenails, and surrounding skin.Effective against fungal nails and athlete's foot caused by fungi.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

if you experience any signs of sensitivity or irritation

When Using

OTC - WHEN USING SECTION

Not for use in the eyes, mouth,or vaginal area.

Stop Use

OTC - STOP USE SECTION

If the area of application shows increased irritation
If there is Consult a doctor if symptoms worsen.If pregnant or breastfeeding

Ask Doctor

OTC - ASK DOCTOR SECTION

If the area of application shows increased irritation
If there is Consult a doctor if symptoms worsen.If pregnant or breastfeeding

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidental ingestion occurs,seek medical assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

For athlete's foot and ringworm:use daily for 4 weeks.Clean the affected area and dry thoroughly.Keep away from fire and flames.For external use on nails and the immediately adjacent skin only.Use once daily, preferably before bedtime.
Unscrew the bottle cap and use the brush to apply the medicine directly to the nail.The medication will then penetrate deeply into the nail.If the nail area is infected, spray the medication onto the affected area.SHAKE WELL BEFORE USE.Store at 5'c to 30°0(41'F to 86°F) in a cool dry place. Keep tightly closed and away from sunlight

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

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85248-11585248-115-01, 85248-115-02, 85248-115-03

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
22026-04-29full-release2026-06-01 01:55:35
12026-02-08monthly-update2026-06-03 17:56:20

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
DERMFREE HELPS WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZJiangxi Yudexi Pharmaceutical Co., LTD4a4d9361-3633-59b2-e063-6294a90aa3ea2026-07-21WarningsExact identifier
ndc (package): 85248-115-01
ndc (package): 85248-115-02
ndc (package): 85248-115-03
ndc (product): 85248-115
ndc11 (package): 85248011501
ndc11 (package): 85248011503
ndc11 (package): 85248011502
spl id: 572bbfe3-89eb-38c5-e063-6294a90a9b9b
spl set id: 4a4d9361-3633-59b2-e063-6294a90aa3ea

Reported adverse events (FAERS/openFDA)#

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