ERWCNMIE TOENAIL FUNGUS TREATMENT PEN- tolnaftate, undecylenic acid liquid

ERWCNMIE Toenail Fungus Treatment Pen by

Drug Labeling and Warnings

ERWCNMIE Toenail Fungus Treatment Pen by is a Otc medication manufactured, distributed, or labeled by Shenzhen Joyuflsh Technology Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Tolnaftate 1%
UNDECYLENIC ACID 25%

PURPOSE

Anti-fungal and Nail Renewal

INDICATIONS & USAGE

For the effective treatment of nail fungus-including discoloration,.
thickening, 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. lf in eyes, rinse thoroughly with water.

STOP USE

lrritation occurs or discomfort persists.

KEEP OUT OF REACH OF CHILDREN

If accidental ingestion occurs, seek medical attention immediatelyand contact a Poison Control Center.

DOSAGE & ADMINISTRATION

1.Wash and dry your nails thoroughly before applying the product.Remove the cap that covers the brush.

2.Twist the end of the pen clockwise to dispense the liquid onto thebrush.
3.Apply the liquid three times to the areas requiring treatment,ensuring complete coverage of all affected parts.

4.Use 2 times daily for 2-4 weeks, depending on the condition beingtreated.

INACTIVE INGREDIENT

ALCOHOL
POLYETHYLENE GLYCOL
PROPYLENE GLYCOL
DIMETHICONE
C12-15 ALKYL LACTATE
ETHYLHEXYLGLYCERIN
GLYCERIN
LAUROCAPRAM
SOPHORA FLAVESCENS ROOT
TOCOPHEROL
PHENOXYETHANOL
WATER

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ERWCNMIE TOENAIL FUNGUS TREATMENT PEN 
tolnaftate, undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83766-108
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
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LAUROCAPRAM (UNII: 1F3X9DRV9X)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83766-108-01	3 in 1 PACKAGE	09/02/2025
1		5 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
2	NDC: 83766-108-02	6 in 1 PACKAGE	09/02/2025
2		5 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
3	NDC: 83766-108-03	9 in 1 PACKAGE	09/02/2025
3		5 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	09/02/2025

Labeler - Shenzhen Joyuflsh Technology Co.,Ltd. (603012375)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Joyuflsh Technology Co.,Ltd.		603012375	manufacture(83766-108)