LYSSERA FUNGAL NAIL RENEWAL- undecylenic acid 25% antifunga liquid

LYSSERA Fungal Nail Renewal by

Drug Labeling and Warnings

LYSSERA Fungal Nail Renewal by is a Otc medication manufactured, distributed, or labeled by Jiangxi Yudexi Pharmaceutical Co., LTD, Jiangxi Zhongletang Pharmaceuticals Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

​Undecylenic Acid 25%

Purpose

Antifungal

Use

Helps prevent fungal infections, including tinea pedis (toenail onychomycosis).
Relieves itching, burning, and cracking.
Cures athlete's foot.

Warnings

1.For external use only.
2.Avoid contact with eyes
3.Stop use and consult a doctor if irritation occurs or condition worsens
4.Keep out of reach of children
5.If swallowed, get medical help or contact a Poison Control Center immediately

Do not use

on irritated, inflamed, or broken skin
if you are allergic to any of the ingredients in this product
on children under 2 years of age unless directed by a doctor

When Using

·avoid contact with eyes.

Stop Use

Stop use and consult a doctor if irritation occurs or condition worsens

Ask Doctor

If swallowed, get medical help or contact a Poison Control Center immediately

Keep Oot Of Reach Of Children

Keep out of reach of children

Directions

1.Prep: Wash the affected area with soap and water. Soak the nail to soften it.
2.For toenail fungus:
Gently file thickened areas of the nail every 2-3 days (avoid damaging nail bed).
Apply a thin layer over the entire nail surface, under the nail edge, and around the cuticle.
Use twice daily: morning and evening for at least 6 weeks.
For best results, continue use for 3-6 months or as directed by a doctor.
3.For athlete's foot:
Apply to affected areas and between toes.
Allow product to dry fully before putting on socks or shoes.

Other information

Store at room temperature 15-30°C (59-86°F).
Keep away from direct sunlight and moisture.

Inactive ingredients

Mineral Oil, Apricot Kernel Oil, Tea Tree Oil, Tocopherol (Vitamin E), Peppermint Oil, Camphor

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LYSSERA FUNGAL NAIL RENEWAL 
undecylenic acid 25% antifunga liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85248-174
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

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PEPPERMINT OIL (UNII: AV092KU4JH)
TOCOPHEROL (UNII: R0ZB2556P8)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
TEA TREE OIL (UNII: VIF565UC2G)
APRICOT KERNEL OIL (UNII: 54JB35T06A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85248-174-01	4 in 1 BOX	03/26/2026
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	03/26/2026

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

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Zhongletang Pharmaceuticals Co.,Ltd.		411295811	manufacture(85248-174)