FUNGAL NAIL PATCHES- tolnaftate, undecylenic acid patch

Fungal Nail Patches by

Drug Labeling and Warnings

Fungal Nail Patches by is a Otc medication manufactured, distributed, or labeled by Lianjiang Shanlilai E-commerce Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Fungal Nail Patches

ACTIVE INGREDIENT

TOLNAFTATE 1%
UNDECYLENIC ACID 25%

PURPOSE

Anti-fungal

INDICATIONS & USAGE

Repairs fungal nail damage and improves nail appearance.

WARNINGS

For external use only.

DO NOT USE

Do not use on any skin with inflammation,infectlon, or redness.

Do not use if preqnant or if there is an allergic reaction to this product

Avoid contact with eyes.

STOP USE

Stop use and ask a doctor if lrritation occurs or discomfort persists

KEEP OUT OF REACH OF CHILDREN

in case of accidental ingestion, seek medical advice immediatelyor contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Clean and prepare the affected nail.
Apply the fungal nail patch. Firmly secure the patch tothe sides of the toes or fingers, folding the remainingadhesive part to fully cover the toesffingertips.

Leave the patch on for 6 -8 hours. Use the patchesconsistently before bed for 3 -é months.

Maintain good foot hygiene.

STORAGE AND HANDLING

Store at room temperature and avoid excessive heat and direct sunlight.

INACTIVE INGREDIENT

Polyester Spandex
Acrylate Copolymer
Tackifying Resin
Glycerin
Water
Silicone Oil Paper

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FUNGAL NAIL PATCHES 
tolnaftate, undecylenic acid patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85038-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	25 g  in 100
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100

Inactive Ingredients
Ingredient Name	Strength
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85038-005-01	20 in 1 PACKAGE	12/19/2024
1		1 in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	12/19/2024

Labeler - Lianjiang Shanlilai E-commerce Co., Ltd. (638192827)

Establishment
Name	Address	ID/FEI	Business Operations
Lianjiang Shanlilai E-commerce Co., Ltd.		638192827	manufacture(85038-005)