Active Ingredient
Undecylenic acid 25%
Avenaster Fungal Nail Care Duo Set (night) Liquid
FDA Label NDC 85248-214
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 (night) (NDC 85248-214). 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,Treats most Athlete’s Foot (Tinea Pedis) and Ringworm.
Relieves itching, scaling, cracking, burning, redness, soreness, and irritation and discomfort.
Helps prevent most athlete's foot (dermatophytosis) with daily use.
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 before application.
2.Apply a thin layer of the Night Formula to: • The nail surface • Under the nail edge • Around the nail area.
3.Allow the product to dry completely before covering.
4.Use once daily before bedtime.
5.After each use, remove one sticker from the progress tracker. Stay consistent — daily use is key to visible improvement. Continued use for up to 3 months is recommended.
Other Information
Store at room temperature 15℃~30℃(59℉~86℉). Close cap tightly after each use.
Keep away from direct sunlight and excessive moisture.
Inactive Ingredients
Panthenol, Polyethylene Glycol, Alcohol, Tea Tree Oil, Propylene Glycol, Lavandula Angustifolia (Lavender) Oil
Principal Display Panel
25 (38cde480ac3445a6e246ec948e2439da)
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