Active Ingredients
Undecylenic Acid 25%
Nail Repair Pen Liquid
FDA Label NDC 85636-021
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 Earth Surface Trading Co., Ltd. for the product Nail Repair Pen (NDC 85636-021). 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 ingredients, purpose, uses, warnings, stop use and ask a doctor if, do not use, keep out of reach of children., inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-fungal
Uses
Uses for relief and treatment of pain,soreness, and inflammation from nail fungus.
Symptoms: ■ discolored nails ■ brittle nails ■ distorted nails
Warnings
For external use only, Some individuals may be sensitive to essential oils.
Begin with a small drop to determine if product causes any irritation. Discontinue use if any irritation occurs.
Stop use and consult a doctor if condition worsens, Not for use on children under the age of 2 without physician direction.
Stop Use And Ask A Doctor If
rash occur
Do Not Use
on damaged or broken skik
Keep Out Of Reach Of Children.
If swallwed, get medical help or contact a Poison Control Center right away.
Inactive Ingredients
Water, Lonicera Japonica Flower Extract, Angelica Sinensis Root Extract, Glycerin, Allantoin, Garlic Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf Extract
Dosage & Administration
shake well before use.Wash and thoroughly dry the affectedarea. Apply 1-2 drops and gently rubinto affected area three times per day.
Package Label.Principal Display Panel
01 (Scree65)
* Please review the disclaimer below.
