PURESKIN FUNGAL NAIL RENEWAL

Manufacturer
Stellans Inc.
Effective date
2023-08-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:26:35

Label at a glance#

ProductPURESKIN FUNGAL NAIL RENEWAL
Active ingredientUNDECYLENIC ACID
Label structure13 sections

Dosage and administration

1. Apply the product twice a day, in the morning and at night. 2. For initial use, soak the affected nail in warm water to soften it. Gently file the nail to make it thinner and remove dirt, being cautious not to harm the nail bed. Apply the product after this step. 3. After the first application, repeat every 2-3 days. File the surface of the affected nail and continue regular usage. In case of ingestion, seek me...

Storage and handling

●Keep away from direct sunlight or heat ●Store in room temperature

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 10%

Purpose

OTC - PURPOSE SECTION

Nail Fungus Treatment

Use

INDICATIONS & USAGE SECTION

Fungal nails
Athlete's Foot
Tinea Manuum
Jock Itch
Ringworm caused by fungus and bacterial infection.

Warnings

WARNINGS SECTION

For external use only; do not ingest.
Avoid eye contact; maintain dry and clean skin.
Exercise caution when using on severely ulcerated skin.
This product is not a substitute for medication.

Do not use

OTC - DO NOT USE SECTION

On open skin wounds

When Using

OTC - WHEN USING SECTION

Stop Use And See A Doctor If
You become pregnant or are planning to get pregnant while using the product.
You are allergic to this product (such as itching, rash swelling of the lips, eyelids, and shortness of breath).

Ask Doctor

OTC - ASK DOCTOR SECTION

If you are allergic to this product. If symptoms persist for over 7 days or worsen, consult your physician. If you are pregnant or breast-feeding - You become pregnant or are planning to ...

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of ingestion, call Poison Control Center hotline immediately or seek medical help.

Directions

DOSAGE & ADMINISTRATION SECTION

1. Apply the product twice a day, in the morning and at night.
2. For initial use, soak the affected nail in warm water to soften it. Gently file the nail to make it thinner and remove dirt, being cautious not to harm the nail bed. Apply the product after this step.
3. After the first application, repeat every 2-3 days. File the surface of the affected nail and continue regular usage.
In case of ingestion, seek medical assistance or contact a poison control center immediately.

Other information

STORAGE AND HANDLING SECTION

●Keep away from direct sunlight or heat
●Store in room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Acetic Acid, Sophora Flavescens, Propylene Glycol, Phenoxyethanol, Fructus Cnidii, Ethanol, Crocus Sativus L

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1212

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83565-00383565-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
21acf19d-d050-97ca-e063-6294a90a5e4104349547-aeed-3f60-e063-6294a90a8b3e2024-09-09WarningsExact identifier
spl set id: 04349547-aeed-3f60-e063-6294a90a8b3e

Reported adverse events (FAERS/openFDA)#

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