76986-026 Bldaxn Fungus Nail Pen

76986-026 Bldaxn Fungus Nail Pen
SPL v1
SPL
SPL Set ID 49e291e1-be83-8926-e063-6394a90a13c2
Route
TOPICAL
Published
Effective Date 2026-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (0.01 g) Undecylenic Acid (0.25 g)
Inactive Ingredients
Salicylic Acid Hydroxypropylcellulose Menthol Alcohol Water Melaleuca Alternifolia (tea Tree) Leaf Oil Urea Zanthoxylum Bungeanum Fruit Propylene Glycol Edetate Disodium Glycolic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-02-03

Description

UNDECYLENIC ACID 25% TOLNAFTATE 1%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Treats fungal infections of fingernails, toenails, and surrounding skin.Effective against athlete's foot, ringworm, and nail fungus. Helps improve nail discoloration, thickness, and cracking.

Dosage and 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.

Description

UNDECYLENIC ACID 25% TOLNAFTATE 1%

Section 50565-1

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.

Section 50566-9

Stop use and ask a doctor If discomfort persists.

Section 50567-7

When using this product Avoid contact with eyes.

Section 50570-1

If you experience any signs of sensitivity or irritation, discontinue use and consult a doctor.

Section 51727-6

ALCOHOL

WATER

UREA

PROPYLENE GLYCOL

SALICYLIC ACID

MENTHOL

HYDROXYPROPYLCELLULOSE

ZANTHOXYLUM BUNGEANUM FRUIT EXTRACT

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL

DISODIUM EDTA

GLYCOLIC ACID

Section 51945-4

Section 55105-1

Renew Nails

Section 55106-9

UNDECYLENIC ACID 25%

TOLNAFTATE 1%


Structured Label Content

Indications and Usage (34067-9)

Treats fungal infections of fingernails, toenails, and surrounding skin.Effective against athlete's foot, ringworm, and nail fungus. Helps improve nail discoloration, thickness, and cracking.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

Stop use and ask a doctor If discomfort persists.

Section 50567-7 (50567-7)

When using this product Avoid contact with eyes.

Section 50570-1 (50570-1)

If you experience any signs of sensitivity or irritation, discontinue use and consult a doctor.

Section 51727-6 (51727-6)

ALCOHOL

WATER

UREA

PROPYLENE GLYCOL

SALICYLIC ACID

MENTHOL

HYDROXYPROPYLCELLULOSE

ZANTHOXYLUM BUNGEANUM FRUIT EXTRACT

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL

DISODIUM EDTA

GLYCOLIC ACID

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Renew Nails

Section 55106-9 (55106-9)

UNDECYLENIC ACID 25%

TOLNAFTATE 1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)