Active Ingredient
Undecylenic Acid 25%
Pharmbanner Fungal Nail Renewal Liquid
FDA Label NDC 83818-019
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Xinxin Yunhai Technology Co., Ltd. for the product Pharmbanner Fungal Nail Renewal (NDC 83818-019). 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
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
if irritation, redness, or symptoms worsen or persist
Ask 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)
Questions
Email us: [email protected]
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