FUNGAL NAIL RENEWAL

Manufacturer
Shenzhen Xiaomai Manufacturing Co., Ltd.
Effective date
2024-08-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:56:22

Label at a glance#

ProductFUNGAL NAIL RENEWAL
Active ingredientUNDECYLENIC ACID, TOLNAFTATE
Label structure13 sections

Dosage and administration

Apply the product twice a day, in the morning and at night.For initial use, soak the affected nail in warm water to soften itGently file the nail to make it thinner and remove dirt, beingcautious not to ham the nail bed. Apply the product after this step.After the first application, repeat every 2-3 days. File the surfaceof the affected nail and continue regular usage.*In case ofingestion, seek medical assistance ...

Storage and handling

Please store in a cool, dry place away from direct sunlight.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25%

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Fungal nails, Athlete's Foot, Tinea Manuum, Jock ltch, Ringwormcaused by fungus and bacterial infection.For all caused by nail fungus, nail discoloration, nail thickening,nail splitting, nail crumbling.

Use

INDICATIONS & USAGE SECTION

For nails

Warnings

WARNINGS SECTION

-For external use only
-Keep away from fire and flame

Do not use

OTC - DO NOT USE SECTION

This product is not a substitute for medication.

When Using

OTC - WHEN USING SECTION

For external use only, do not ingest.
Avoid eye contact; maintain dry and clean skin.
Exercise caution when using on severely ulcerated skin.
Keep out of reach of children.

Stop Use

OTC - STOP USE SECTION

Keep Out Of Reach Of Chlidren:if swallowed,get medical help or
contact a Poison Control Center right away."

Ask Doctor

OTC - ASK DOCTOR SECTION

When Pregnant or breast-feeding.

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Oot Of Reach Of Children

Directions

DOSAGE & ADMINISTRATION SECTION

Apply the product twice a day, in the morning and at night.For initial use, soak the affected nail in warm water to soften itGently file the nail to make it thinner and remove dirt, beingcautious not to ham the nail bed. Apply the product after this step.After the first application, repeat every 2-3 days. File the surfaceof the affected nail and continue regular usage.*In case ofingestion, seek medical assistance or contact apoison control center immediately.

Other information

STORAGE AND HANDLING SECTION

Please store in a cool, dry place away from direct sunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Undecylenic Acid,Tolnaftate, Ethyl Lactate, Aqua, Lactic Acid,Resacetophenone, Acetic Acid, Sophora Flavescens Extract,Stellera Chamaejasme Leaf/Stem Extract, Crocus Sativus StyleExtract, Eucalyptol, Olea Europaea (Olive) Fruit Oil, LavandulaAngustifolia (Lavender) Oil, Aloe Barbadensis Leaf Extract,CarthamusTinctorius (Saffower) Seed Oil, HydrogenatedPolyisobutene, Melaleuca Alternifolia (Tea Tree) Leaf Oil, OryzaSativa (Rice) Bran Oil, Prunus Amygdalus Dulcis (Sweet Almond)Oil, Sesamum Indicum (Sesame) Seed Oil, Simmondsia Chinensis(Jojoba) Seed Oil, Tocopheryl Acetate.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LBEALLBEAL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83872-438FUNGAL NAIL RENEWAL (RENEWAL) LIQUID [SHENZHEN XIAOMAI MANUFACTURING CO., LTD.]1Unmatched20240821_2019333d-70a4-c457-e063-6294a90aa73d.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83872-43883872-438-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

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
364372f8-d724-e019-e063-6394a90a99482019333d-70a4-c457-e063-6294a90aa73d2025-05-29WarningsExact identifier
spl set id: 2019333d-70a4-c457-e063-6294a90aa73d

Reported adverse events (FAERS/openFDA)#

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