Active Ingredient
Undecylenic Acid 25%
Lyssera Fungal Nail Renewal Liquid
FDA Label NDC 85248-174
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Lyssera Fungal Nail Renewal (NDC 85248-174). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Package Label.Principal Display Panel
25 (0edda447c8ea1ed8bb98b9b949c797c3)
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