Otc - Active Ingredient
Undecylenic Acid 25%
Antifungal Toenail Fungus Pen Liquid
FDA Label NDC 84763-009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yunqi Cosmetics (shenzhen) Co., Ltd for the product Antifungal Toenail Fungus Pen (NDC 84763-009). 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
Antifungal
Indications & Usage
Mainly used to control and reduce fungalissues on the nails and improve nailproblems caused by fungal invasion.
Warnings
For external use only.
Otc - Do Not Use
Do not use on children under 2 years ofage unless directed by a doctor.
Otc - When Using
When using this product avoid contactwith eyes.
Otc - Stop Use
Stop use and ask a doctorif experience persistent nail bed redness,irritation, or discomfort.
Pregnant women, people with sensitive skin, or children should consult a professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
After cleaning and drying the nails, removethe cap, and rotate the bottom of the penwith the brush facing downward until theproduct flows out. Apply evenly to thesurface and edges of the nails. lt isrecommended to use twice daily, in themorning and evening
Inactive Ingredient
Hydrogenated Sweet Almond Oil, lsononyIsononanoate,Camellia vaponica Seed 0ilAloe Yohiyu Matsu Ekisu, HydrogenatedVojoba Oil, Melaleuca Alternifolia(TeaTree)Leaf Oil, Eugenia Caryophyllus(Clove)Bud 0il, Lavandula Angustifolia(Lavender)0il,Adeps Bovis, MenthaArvensis Leaf Oil, Propolis ExtractTocopherol, Olea Europaea(0live)Fruit 0il.Prunus Amygdalus Dulcis(Sweet Almond)Oil, Linum Usitatissimum(Linseed)SeedOil, Borago Officinalis Seed Oil,Turpentine, Thymus Vulgaris(Thyme)0il
Package Label.Principal Display Panel
Label (Label)
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