85248-221Update3

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD
Effective date
2026-07-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-07-22 05:10:09

Label at a glance#

ProductTINGOLE FUNGAL NAIL Patches
Active ingredientTOLNAFTATE
Label structure13 sections

Dosage and administration

Directions: Clean and thoroughly dry the affected area before application. ■ Peel off the patch's protective film, starting with the outer side and then the inner side. ■ Place the sticky side of the patch directly onto the infected area on the nail and remove the release paper. Gently wrap the sides of the toe or finger to ensure a snug fit. ■ Fold the remaining adhesive part to cover the toe/fingertip. Leave the...

Storage and handling

Store at room temperature and keep away from direct sunlight. Skin discoloration may occur during or after use.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate l%

Purpose

OTC - PURPOSE SECTION

Anti-Fungal

Use

INDICATIONS & USAGE SECTION

Repairs fungal nail damage and improves nail appearance

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

Avoid direct contact with eyes, mouth, mucous membrane, wounds
Do not use if you are allergic to any of the ingredients
Do not use if you are pregnant or breastfeeding

When Using

OTC - WHEN USING SECTION

Avoid direct contact with eyes, mouth, mucous membrane, wounds

Stop Use

OTC - STOP USE SECTION

if irritation occurs and discomfort persists

Ask Doctor

OTC - ASK DOCTOR SECTION

if you have diabetes or poor blood circulation

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of contact with eyes, flush with water for at least 15 minutes.
If swallowed, seek medical assistance immediately or contact a Poison Control Center.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Clean and thoroughly dry the affected area before application.
■ Peel off the patch's protective film, starting with the outer side and then the inner side.
■ Place the sticky side of the patch directly onto the infected area on the nail and remove the release paper. Gently wrap the sides of the toe or finger to ensure a snug fit.
■ Fold the remaining adhesive part to cover the toe/fingertip. Leave the patch on for 6-8 hours (It is recommended to use overnight for 3-6 months).

Other information

STORAGE AND HANDLING SECTION

Store at room temperature and keep away from direct sunlight.
Skin discoloration may occur during or after use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Polyester Spandex, Acrylate Copolymer, Tackifying Resin, Glycerin, Silicone Oil Paper

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

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
85248-22185248-221-01

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
32026-07-17daily-update2026-07-21 05:10:25
22026-05-26full-release2026-06-01 01:58:49
12026-05-22full-release2026-06-05 00:55:46

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
TINGOLE FUNGAL NAIL PatchesTOLNAFTATE 1% FUNGAL NAIL PATCHESJiangxi Yudexi Pharmaceutical Co., LTD5272c6fa-75f7-c698-e063-6394a90ac81e2026-07-20WarningsExact identifier
ndc (package): 85248-221-01
ndc (product): 85248-221
ndc11 (package): 85248022101
spl id: 57074d7f-b85d-ad16-e063-6394a90a64be
spl set id: 5272c6fa-75f7-c698-e063-6394a90ac81e

Reported adverse events (FAERS/openFDA)#

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