Active Ingredient
Undecylenic Acid 8%
Pureskin Fungal Nail Renewal Patches
FDA Label NDC 84746-006
9 label sections · Submitted to the FDA by Shandong Yuyaotang Pharmaceutical Co., Ltd · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shandong Yuyaotang Pharmaceutical Co., Ltd for the product Pureskin Fungal Nail Renewal Patches (NDC 84746-006). 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, directions, other information, inactive ingredients, questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Use
For repairing nails affected by fungal infections
Warnings
1. Keep out of children's reach. Avoid contact with eyes, mouth, mucous membranes, wounds, or inflamed skin.
2. External use only.
3. Do not use if allergic to any ingredient.
4. Do not use in children.
5. Do not use if pouch is torn or broken.
6. Discontinue use if skin becomes red, swollen, or itchy, and consult a healthcare professional.
Directions
Begin by removing any nail polish. Cleanse nails and surrounding skin, ensuring thorough drying to enhance adhesion.
a. Peel off protective films and sequentially.
b. Apply the patch to the affected nail area, removing release paper.
c. Firmly cover the sides of the toe or finger.
d. Fold the remaining adhesive to envelop the toe/fingertip.
e. Maintain the patch for 6-8 hours (overnight use recommended for 3-6 months).
Use daily for optimal results. It is recommended to roughen the nail surface before application for better adhesion.
Other Information
Store at room temperature. Keep away from moisture and sunlight.
Do not use if seal is broken or missing.
Inactive Ingredients
Polyester, Spandex, Acrylate Copolymer, Tackifying Resin, Glycerin, Water, Acrylic Copolymer, Silicone Oil, Paper
Questions
[email protected]
www.pureskinsupport.com
Principal Display Panel
1 (Laebl)
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