84763-009 Antifungal Toenail Fungus Pen

84763-009 Antifungal Toenail Fungus Pen
SPL v1
SPL
SPL Set ID 48b5fbd9-bdf5-21ac-e063-6394a90aa6b6
Route
TOPICAL
Published
Effective Date 2026-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (0.25 g)
Inactive Ingredients
Eugenia Caryophyllus (clove) Bud Oil Propolis Wax Borago Officinalis Seed Oil Thymus Vulgaris (thyme) Oil Adeps Bovis Lavandula Angustifolia (lavender) Oil Mentha Arvensis Leaf Oil Aloe Isononyl Isononanoate Turpentine Hydrogenated Jojoba Oil Melaleuca Alternifolia (tea Tree) Leaf Oil Camellia Japonica Seed Oil Olea Europaea (olive) Fruit Oil Linum Usitatissimum (linseed) Seed Oil Tocopherol Prunus Amygdalus Dulcis (sweet Almond) Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-19

Description

Undecylenic Acid 25%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Mainly used to control and reduce fungalissues on the nails and improve nailproblems caused by fungal invasion.

Dosage and 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

Description

Undecylenic Acid 25%

Section 50565-1

Keep out of reach of children.

Section 50566-9



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.

Section 50567-7

When using this product avoid contactwith eyes.

Section 50570-1

Do not use on children under 2 years ofage unless directed by a doctor.

Section 51727-6

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

Section 51945-4

Section 55105-1

Antifungal

Section 55106-9

Undecylenic Acid 25%


Structured Label Content

Indications and Usage (34067-9)

Mainly used to control and reduce fungalissues on the nails and improve nailproblems caused by fungal invasion.

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)



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.

Section 50567-7 (50567-7)

When using this product avoid contactwith eyes.

Section 50570-1 (50570-1)

Do not use on children under 2 years ofage unless directed by a doctor.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Undecylenic Acid 25%


Advanced Ingredient Data


Raw Label Data

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