Active Ingredient
Urea 20%
Avenaster Fungal Nail Care Duo Set (day) Liquid
FDA Label NDC 85248-215
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 Avenaster Fungal Nail Care Duo Set (day) (NDC 85248-215). 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
Softens thickened, hardened and brittle cuticles; dissolves dead old keratin.
Use
Softens thickened keratin, dissolves dead cuticles, moisturizes and repairs, helps improve thickened toenails, brittle nails, and dry, peeling skin around the nails caused by tinea pedis, and enhances the penetration of subsequent antibacterial ingredients.
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
When using this product, avoid contact with eyes.
Stop Use
Stop use and ask a doctor if irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).
Ask Doctor
Stop use and ask a doctor if irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
1.Clean and dry the affected area with soap and water.
2.Apply a thin layer of the Day Formula evenly to the nail surface.
3.Allow the product to absorb fully.
4.For thick nails, gently file the surface every 2‑3 days if needed. Do not over‑file or apply excessive pressure.
5.Use once daily after waking. Continue daily use to help soften thick nails and improve absorption
Other Information
Store at room temperature 15°C~30°C(59°F~86°F). Close cap tightly after each use.
Keep away from direct sunlight and excessive moisture.
Inactive Ingredients
Purified Water, Glycerin, Propylene Glycol, Lactic Acid, Polyethylene Glycol, Tea Tree Oil
Principal Display Panel
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