TOENAIL FUNGUS TREATMENT EXTRA STRENGTH PEN- tolnaftate, undecylenic acid liquid

Toenail Fungus Treatment Extra Strength Pen by

Drug Labeling and Warnings

Toenail Fungus Treatment Extra Strength Pen 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

Toenail Fungus Treatment Extra Strength Pen

ACTIVE INGREDIENT

TOLNAFTATE 1%
UNDECYLENIC ACID 25%

PURPOSE

Anti-fungal

INDICATIONS & USAGE

For the effective treatment of nail fungus,discoloration,thick-ening,splitting,crumbling and brittleness.

WARNINGS

For external use only.

DO NOT USE

children under 2 years of age.
pregnant or if there is any allergic reaction to this produce.

WHEN USING

Avoid contact with eyes. in case of contact, rinse thoroughly
with water.

STOP USE

lrritation occurs or discomfort persists.

KEEP OUT OF REACH OF CHILDREN

In case of accidental ingestion, seek medical advice
immediately or contact a Poison Control center right away.

DOSAGE & ADMINISTRATION

Wash and dry your nails before use, Remove the capcovering the brush of the pen.
Twist the end of the pen clockwise to dispense the liquidonto the brush.
Apply the liquid 3 times over the areas that need to berepalred, and make sure to cover all affected parts.
Use 2-3 times daily for 2-4 week s, depending on thecondition of the area that needs repair.

STORAGE AND HANDLING

Store between 15° to 30 °C (59 °to 86 °F)Avoid freezing andexcessive heat above 40C°(104F).

INACTIVE INGREDIENT

ALCOHOL
DIMETHICONE
CETOSTEARYL ALCOHOL
TEA TREE OIL
PROPYLENE GLYCOL
TOCOPHEROL
SAFFLOWER OIL
WATER

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOENAIL FUNGUS TREATMENT EXTRA STRENGTH PEN 
tolnaftate, undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85038-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
SAFFLOWER OIL (UNII: 65UEH262IS)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
TEA TREE OIL (UNII: VIF565UC2G)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85038-001-01	3 in 1 PACKAGE	12/11/2024
1		5 mL in 1 BOTTLE; 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	12/11/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Lianjiang Shanlilai E-commerce Co., Ltd.		638192827	manufacture(85038-001)