85966-005 Nail Fungus Treatment Pen

85966-005 Nail Fungus Treatment Pen
SPL v2
SPL
SPL Set ID 3fe842e1-b3db-c003-e063-6394a90a46b8
Route
TOPICAL
Published
Effective Date 2025-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (25 g) Tolnaftate (1 g)
Inactive Ingredients
Oregano Leaf Oil Lavandula Angustifolia Flowering Top Bisabolol Panthenol Cinnamon Bark Oil Phenoxyethanol Isopropyl Myristate Melaleuca Alternifolia (tea Tree) Leaf Oil Tocopherol Caprylic/capric/succinic Triglyceride Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-29

Description

UNDECYLENIC ACID 25% TOLNAFTATE 1%


Medication Information

Warnings and Precautions

For external use only, Store in a cool place and avoid sunshine and heat.

Indications and Usage



. For the effective treatment of discoloration, thickening, splitting, crumbling and

brittleness.

.Provides effective relief from itching, scaling, burning, redness, soreness, andirritation while curing most athlete's foot (tinea pedis) and jock itch (tinea cruris).

Proven effective in the prevention of most athlete's foot (tinea pedis) with daily use

Dosage and Administration



Clean and dry the affected nail and surrounding area.

Twist the base of the pen clockwise until the brush tip is saturated.

Apply a thin layer to the entire nail. Let it dry for 2-3 minutes.

Apply twice daily (morning and night) until a healthy nail has fully grown out.

For athletes foot: Pay special attention to spaces between the toes,wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.

For athlete's foot and jock itch, use daily for 4 weeks..This product is not effective on the scalp or nails. lf condition persistslonger, consult a doctor.

Description

UNDECYLENIC ACID 25% TOLNAFTATE 1%

Section 50565-1

Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if . irritation occurs or if there is no improvement within 4 weeks.

Section 50567-7

When using this product · avoid contact with the eyes or damaged skin.

Section 50570-1

Do not use · on children under 2 years of age unless directed by a doctor.

Section 51727-6

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL

OREGANO OIL

CEYLON CINNAMON BARK OIL

LAVANDULA ANGUSTIFOLIA (LAVENDER) EXTRACT

CAPRYLIC/CAPRIC DIGLYCEROL SUCCINATE

ISOPROPYL MYRISTATE

TOCOPHEROL

BISABOLOL

PANTHENOL

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

Section 51945-4

Section 55105-1

Antifungal

Section 55106-9

UNDECYLENIC ACID 25%

TOLNAFTATE 1%


Structured Label Content

Indications and Usage (34067-9)



. For the effective treatment of discoloration, thickening, splitting, crumbling and

brittleness.

.Provides effective relief from itching, scaling, burning, redness, soreness, andirritation while curing most athlete's foot (tinea pedis) and jock itch (tinea cruris).

Proven effective in the prevention of most athlete's foot (tinea pedis) with daily use

Dosage and Administration (34068-7)



Clean and dry the affected nail and surrounding area.

Twist the base of the pen clockwise until the brush tip is saturated.

Apply a thin layer to the entire nail. Let it dry for 2-3 minutes.

Apply twice daily (morning and night) until a healthy nail has fully grown out.

For athletes foot: Pay special attention to spaces between the toes,wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.

For athlete's foot and jock itch, use daily for 4 weeks..This product is not effective on the scalp or nails. lf condition persistslonger, consult a doctor.

Warnings and Precautions (34071-1)

For external use only, Store in a cool place and avoid sunshine and heat.

Section 50565-1 (50565-1)

Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if . irritation occurs or if there is no improvement within 4 weeks.

Section 50567-7 (50567-7)

When using this product · avoid contact with the eyes or damaged skin.

Section 50570-1 (50570-1)

Do not use · on children under 2 years of age unless directed by a doctor.

Section 51727-6 (51727-6)

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL

OREGANO OIL

CEYLON CINNAMON BARK OIL

LAVANDULA ANGUSTIFOLIA (LAVENDER) EXTRACT

CAPRYLIC/CAPRIC DIGLYCEROL SUCCINATE

ISOPROPYL MYRISTATE

TOCOPHEROL

BISABOLOL

PANTHENOL

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

UNDECYLENIC ACID 25%

TOLNAFTATE 1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)