Active Ingredient
Undecylenic Acid 20%
Alphatip Nail Repair Pen Liquid
FDA Label NDC 85817-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Qiexiran Cosmetics Co., Ltd. for the product Alphatip Nail Repair Pen (NDC 85817-008). 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
Anti-Fungal
Use
For the treatment of most athlete’s foot (tinea pedis)
For the treatment of ringworm (tinea corporis)
Helps prevent recurrence of these fungal infections
Warnings
Do not use on children under 2 years of age unless directed by a doctor.
Stop use and ask a doctor if irritation occurs or condition persists.
If swallowed, get medical help or contact a Poison Control Center right away.
Do Not Use
On irritated skin and any area that is infected or reddened.
If pregnant or if there is any allergic reaction to this product.
When Using
Avoid contact with eyes.
Stop Use
If you have diabetes or poor blood circulation
Ask Doctor
If discomfort persists.
Keep Out Of Reach Of Children
If product gets into eyes, flush with water for 15 minutes
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Clean the affected area and dry thoroughly.
Apply a thin layer over affected area twice daily (morning and night).
Use daily for 4 weeks; if condition persists, consult a doctor.
Other Information
Skin discoloration may occur during or after use. Protect from excessive heat (above 40°C / 104°F)
Inactive Ingredients
Mineral Oil, Ethylene/Propylene/Styrene Copolymer, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Commiphora Myrrha Oil, Chrysanthellum Indicum Extract, Phytosteryl Oleate, Lavandula Angustifolia (Lavender) Oil.
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