85966-006 Fungal Nail Patches

85966-006 Fungal Nail Patches
SPL v1
SPL
SPL Set ID 3fe861cc-c972-a328-e063-6294a90afc8f
Route
TOPICAL
Published
Effective Date 2025-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (0.01 g)
Inactive Ingredients
Glycerin 4-terpineol Lactic Acid Urea Water

Identifiers & Packaging

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

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 nall fungus, discoloration, thickening, splitting, crumbling and brittleness.

Restore and improve the appearance of nails that have been affected by fungus.

Dosage and Administration

1.Clean and dry the affected nail and surrounding area.

2.Remove the patch from its protective film.

3.Place it directly onto the infected nail, ensuring full coverage.

4. Gently press down on the edges of the patch to make sure it is firmly adhered to the nail and skin, with no airbubbles.

5. Keep the patch on for 24 hours. Replace it once a day, preferably after showering.

Description

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.It's normal to feel a slight, temporary sensation of irritation, tingling, or burning. lf symptoms persist or worsen,discontinue use.

Section 50570-1

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

Section 51727-6

WATER

UREA

LACTIC ACID

GLYCERIN

TERPINEN-4-OL

Section 51945-4

Section 55105-1

Antifungal

Section 55106-9

TOLNAFTATE 1%

Structured Label Content

Indications and Usage (34067-9)

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

Restore and improve the appearance of nails that have been affected by fungus.

Dosage and Administration (34068-7)

1.Clean and dry the affected nail and surrounding area.

2.Remove the patch from its protective film.

3.Place it directly onto the infected nail, ensuring full coverage.

4. Gently press down on the edges of the patch to make sure it is firmly adhered to the nail and skin, with no airbubbles.

5. Keep the patch on for 24 hours. Replace it once a day, preferably after showering.

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.It's normal to feel a slight, temporary sensation of irritation, tingling, or burning. lf symptoms persist or worsen,discontinue use.

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)

WATER

UREA

LACTIC ACID

GLYCERIN

TERPINEN-4-OL

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

TOLNAFTATE 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:07.609346 · Updated: 2026-03-14T23:10:19.800513