TAGOQHIA EXTRA STRENGTH NAIL REPAIR PEN- tolnaftate, undecylenic acid liquid

Drug Labeling and Warnings

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 product.

WHEN USING

Avoid contact with eyes. If in eyes, rinse thoroughly with water.

STOP USE

Irritation occurs or discomfort persists.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

1.Turn the top switch to the left, then press the top button to release the medication onto the brush head.

2.Apply an appropriate amount of the solution to the areas requiring treatment, ensuring complete coverage of all affected parts.

3.Use 1-2 times daily for 3-4 weeks, depending on the condition being treated.

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

TAGOQHIA EXTRA STRENGTH NAIL REPAIR PEN 
tolnaftate, undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85304-031
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 mL
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
LAUROCAPRAM (UNII: 1F3X9DRV9X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHICONE (UNII: 92RU3N3Y1O)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALCOHOL (UNII: 3K9958V90M)
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85304-031-01	3 in 1 PACKAGE	04/08/2026
1		15 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	M005	04/08/2026

Labeler - Guangzhou Borderless Technology Co., Ltd. (452282332)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Borderless Technology Co., Ltd.		452282332	manufacture(85304-031)