FUNGAL NAIL RENEWAL- oil liquid

Fungal nail renewal by

Drug Labeling and Warnings

Fungal nail renewal by is a Otc medication manufactured, distributed, or labeled by Shenzhen Xiaomai Manufacturing Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Tolnaftate1%

Undecylenic Acid 25%

Purpose

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

For nails

Warnings

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

Do not use

This product is not a substitute for medication.

When Using

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

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

Ask Doctor

When Pregnant or breast-feeding.

Keep Oot Of Reach Of Children

Keep Oot Of Reach Of Children

Directions

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

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

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FUNGAL NAIL RENEWAL 
oil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83872-329
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 30 mL
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	8 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
HYDROGENATED POLYISOBUTENE 8 (UNII: 7YR4ZFS62E)
ETHYL LACTATE (UNII: F3P750VW8I)
LACTIC ACID (UNII: 33X04XA5AT)
RESACETOPHENONE (UNII: UC3V356VZC)
WATER (UNII: 059QF0KO0R)
ACETIC ACID (UNII: Q40Q9N063P)
STELLERA CHAMAEJASME WHOLE (UNII: 80N0P0DD9J)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83872-329-01	30 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	07/17/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	07/17/2024

Labeler - Shenzhen Xiaomai Manufacturing Co., Ltd. (712999147)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Xiaomai Manufacturing Co., Ltd.		712999147	manufacture(83872-329)