Fungal Nail Patches

SPL v1

SPL

SPL Set ID 299a63ad-f321-117c-e063-6394a90a3a22

Route

TOPICAL

Published

Effective Date 2024-12-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Undecylenic Acid (25 g) Tolnaftate (1 g)

Inactive Ingredients

Acrylic Acid/sodium Acrylate Copolymer (1:1; 600 Mpa.s At 0.2%) Glycerin Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-12-19

Description

Fungal Nail Patches

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Repairs fungal nail damage and improves nail appearance.

Dosage and Administration

Clean and prepare the affected nail.

Apply the fungal nail patch. Firmly secure the patch tothe sides of the toes or fingers, folding the remainingadhesive part to fully cover the toesffingertips.

Leave the patch on for 6 -8 hours. Use the patchesconsistently before bed for 3 -é months.

Maintain good foot hygiene.

Description

Fungal Nail Patches

Section 42229-5

Fungal Nail Patches

Section 44425-7

Store at room temperature and avoid excessive heat and direct sunlight.

Section 50565-1

in case of accidental ingestion, seek medical advice immediatelyor contact a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if lrritation occurs or discomfort persists

Section 50570-1

Do not use on any skin with inflammation,infectlon, or redness.

Do not use if preqnant or if there is an allergic reaction to this product

Avoid contact with eyes.

Section 51727-6

Polyester Spandex

Acrylate Copolymer

Tackifying Resin

Glycerin

Water

Silicone Oil Paper

Section 51945-4

Section 55105-1

Anti-fungal

Section 55106-9

TOLNAFTATE 1%

UNDECYLENIC ACID 25%

Structured Label Content

Indications and Usage (34067-9)

Repairs fungal nail damage and improves nail appearance.

Dosage and Administration (34068-7)

Clean and prepare the affected nail.

Apply the fungal nail patch. Firmly secure the patch tothe sides of the toes or fingers, folding the remainingadhesive part to fully cover the toesffingertips.

Leave the patch on for 6 -8 hours. Use the patchesconsistently before bed for 3 -é months.

Maintain good foot hygiene.

Warnings and Precautions (34071-1)

For external use only.

Section 42229-5 (42229-5)

Fungal Nail Patches

Section 44425-7 (44425-7)

Store at room temperature and avoid excessive heat and direct sunlight.

Section 50565-1 (50565-1)

in case of accidental ingestion, seek medical advice immediatelyor contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if lrritation occurs or discomfort persists

Section 50570-1 (50570-1)

Do not use on any skin with inflammation,infectlon, or redness.

Do not use if preqnant or if there is an allergic reaction to this product

Avoid contact with eyes.

Section 51727-6 (51727-6)

Polyester Spandex

Acrylate Copolymer

Tackifying Resin

Glycerin

Water

Silicone Oil Paper

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anti-fungal

Section 55106-9 (55106-9)

TOLNAFTATE 1%

UNDECYLENIC ACID 25%

Advanced Ingredient Data

[{"name": "ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%)", "unii": "M4PPW69Y4H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "UNDECYLENIC ACID", "unii": "K3D86KJ24N", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "TOLNAFTATE", "unii": "06KB629TKV", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Repairs fungal nail damage and improves nail appearance.", "34068-7": "Clean and prepare the affected nail. Apply the fungal nail patch. Firmly secure the patch tothe sides of the toes or fingers, folding the remainingadhesive part to fully cover the toesffingertips. Leave the patch on for 6 -8 hours. Use the patchesconsistently before bed for 3 -é months. Maintain good foot hygiene.", "34071-1": "For external use only.", "42229-5": "Fungal Nail Patches", "44425-7": "Store at room temperature and avoid excessive heat and direct sunlight.", "50565-1": "in case of accidental ingestion, seek medical advice immediatelyor contact a Poison Control Center right away", "50566-9": "Stop use and ask a doctor if lrritation occurs or discomfort persists", "50570-1": "Do not use on any skin with inflammation,infectlon, or redness. Do not use if preqnant or if there is an allergic reaction to this product Avoid contact with eyes.", "51727-6": "Polyester Spandex Acrylate Copolymer Tackifying Resin Glycerin Water Silicone Oil Paper", "55105-1": "Anti-fungal", "55106-9": "TOLNAFTATE 1% UNDECYLENIC ACID 25%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:56.532246 · Updated: 2026-03-14T23:06:06.305155