PURESKIN FUNGAL NAIL RENEWAL by Stellans Inc. 83565-003 Completed

PURESKIN FUNGAL NAIL RENEWAL by

Drug Labeling and Warnings

PURESKIN FUNGAL NAIL RENEWAL by is a Otc medication manufactured, distributed, or labeled by Stellans Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURESKIN FUNGAL NAIL RENEWAL- fungal nail renewal liquid 
Stellans Inc.

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83565-003 Completed

Active Ingredient

Undecylenic Acid 10%

Purpose

Nail Fungus Treatment

Use

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

Warnings

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

On open skin wounds

When Using

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

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

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

Directions

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

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

Inactive ingredients

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

Questions

www.pureskinsupport.com info@pureskinsupport.com
951-265-8930

PRINCIPAL DISPLAY PANEL

PURESKIN FUNGAL NAIL RENEWAL 
fungal nail renewal liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83565-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
SOPHORA FLAVESCENS WHOLE (UNII: X8KX602M5L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CROCUS SATIVUS WHOLE (UNII: Z5C927G4XF)
CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)
ACETIC ACID (UNII: Q40Q9N063P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83565-003-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	08/30/2023	09/09/2024

Labeler - Stellans Inc. (111157321)

Establishment
Name	Address	ID/FEI	Business Operations
Stellans Inc.		111157321	label(83565-003) , manufacture(83565-003)

Revised: 9/2024

Document Id: 21acf19d-d050-97ca-e063-6294a90a5e41

34390-5

Set id: 04349547-aeed-3f60-e063-6294a90a8b3e

Version: 2

Effective Time: 20240909