YAMANGU FUNGAL NAIL REPAIR PEN- undecylenic acid 25% tolnaftate 1% fungal nail repair pen liquid

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

Undecylenic acid 25% Tolnaftate 1%

Purpose

Antifungal

Use

Treats most Athlete's Foot(Tinea Pedis) and Ringworm.
Relieves itching,scaling, cracking, burning, redness, soreness, and irritation and discomfort. Helps prevent most athlete's foot (dermatophytosis) with daily use.

Warnings

For external use only.

Do not use

on children under 2 years of age unless directed by a doctor.

When Using

avoid contact with eyes.

Stop Use

irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).

Ask Doctor

irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For athlete's foot and ringworm:use daily for 4 weeks.
Clean the affected area and dry thoroughly.
Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
Supervise children in the use of this product.
For athlete's foot: pay special attention to spaces between the toes, wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
To prevent athlete's foot, apply once or twice daily (morning and/or night).
Apply to skin around the nail and cuticle.

Other information

Store at room temperature 15-30℃ (59-86℉)

Inactive ingredients

Tea tree oil，glycerin，polyethylene glycol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

YAMANGU FUNGAL NAIL REPAIR PEN 
undecylenic acid 25% tolnaftate 1% fungal nail repair pen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85248-196
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
GLYCERIN (UNII: PDC6A3C0OX)
TEA TREE OIL (UNII: VIF565UC2G)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85248-196-01	6 in 1 BOX	04/23/2026
1		3 mL in 1 TUBE; 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	04/23/2026

Labeler - Jiangxi Yudexi Pharmaceutical Co., LTD (455662836)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Zhongletang Pharmaceuticals Co.,Ltd.		411295811	manufacture(85248-196)