Otc - Active Ingredient
UNDECYLENIC ACID 25%
Bldaxn Nail Repair Pen Liquid
FDA Label NDC 76986-022
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Quadrant Ecological Technology Co., Ltd. for the product Bldaxn Nail Repair Pen (NDC 76986-022). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Renew Nails
Indications & Usage
Treats fungal infections offingernails, toenails, and surrounding skin.Effective against athlete's foot, ringworm, and nail fungus. Helps improve nail discoloration, thickness, and cracking.
Warnings
For external use only
Otc - Do Not Use
Ifyou experience any signs of sensitivity or irritation, discontinue use and consult a doctor.
Otc - When Using
When using this product Avoid contact with eyes.
Ask a doctor before you use lfyou have diabetes or poor blood circulation.
Otc - Stop Use
Stop use and ask a doctor If discomfort persists
Otc - Keep Out Of Reach Of Children
If the product gets into your eyes, flush with water for 15 minutes
Ifswallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
1. Clean and dry the affected nail and surrounding area.
2. Twist the base of the pen clockwise until the brush tip is saturated
3. Apply a thin layer to the entire nail. Allow it to dry for 2-3 minutes.
4. Apply twice daily (morning and night) until a healthy nail has fully grown out.
For Athlete's Foot:
Pay special attention to the spaces between your toes.
Wear well-fitting, ventilated shoes, and change shoes and socks at leastonce daily.
For athlete's foot and jock itch, use daily for 4 weeks
Inactive Ingredient
ALCOHOL
WATER
UREA
PROPYLENE GLYCOL
SALICYLIC ACID
MENTHOL
HYDROXYPROPYLCELLULOSE
ZANTHOXYLUM BUNGEANUM FRUIT EXTRACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
DISODIUM EDTA
GLYCOLIC ACID
Package Label.Principal Display Panel
Label (Label)
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