Active Ingredient
Undecylenic Acid 25%
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Xinxin Yunhai Technology Co., Ltd. for the product Meoly Fungal Nail Renewal (NDC 83818-026). 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.
Undecylenic Acid 25%
Toenail Fungus treatment
▪ Helps prevent fungal infections, including nail fungus and athlete's foot
▪ Helps reduce itching, burning, and discoloration
• Supports healthy nail and skin regeneration
▪ Helps cleanse and protect affected skin and nail surfaces
For external use only
• Do not use on children under 2 years of age unless directed by a doctor
■ Avoid contact with eyes. If contact occurs, rinse thoroughly with water
Purpose ....Antifungal
▪ Stop use and ask a doctor if irritation, redness, or symptoms worsen or persist
■ Keep out of reach of children
■ If swallowed, rinse mouth and seek medical attention or contact a Poison Control
Center right away.
Do not use on children under 2 years of age unless directed by a doctor
Avoid contact with eyes. If contact occurs, rinse thoroughly with water
if irritation, redness, or symptoms worsen or persist
irritation, redness, or symptoms worsen or persist
Keep out of reach of children
Wash the affected area with soap and water. Soak the nail to soften it
Store at room temperature (59°-86°F/15°-30°C)
▪ Keep away from direct sunlight and excessive moisture
Close cap tightly after each use
Apricot Kernel Oil, Bergamot Oil, Camphor Oil, Jojoba Oil, Lavender Oil, Mineral Oil, Peppermint Oil, Tea Tree Oil, Tocopherol (Vitamin E)
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