Active Ingredient
Undecylenic Acid 25%
Ourui One Fungal Nail Treatment Liquid
FDA Label NDC 87786-074
13 label sections · Submitted to the FDA by Wenzhou Yuyuan Pharmaceutical Co., Ltd. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wenzhou Yuyuan Pharmaceutical Co., Ltd. for the product Ourui One Fungal Nail Treatment (NDC 87786-074). 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 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
Warnings
For external use only.
Do Not Use
Do not use on children under 2 years of age unless directed by a doctor
When Using
Avoid contact with eyes.If contact occurs, rinse thoroughly with water
Stop Use
Stop use and ask a doctor if irritation, redness, or symptoms worsen or persist
Ask Doctor
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.
Directions
Prep: Wash the affected area with soap and water. Soak the nail to soften it
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
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 (59°–86°F /15°–30°C)
Keep away from direct sunlight and excessive moisture
Close cap tightly after each use
Inactive Ingredients
Apricot Kernel Oil, Bergamot Oil,Camphor Oil, Jojoba Oil, Lavender Oil, Mineral Oil, Peppermint Oil, Tea Tree Oil, Tocopherol (Vitamin E)
Principal Display Panel
25 (0974f91f914e1741c202ac656e087d5e)
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