SPL v2
SPL
SPL Set ID 26e4397e-a158-d468-e063-6394a90ac765
Route
TOPICAL
Published
Effective Date 2024-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
1,2-hexanediol Aluminum Glycinate Cellulose Gum Tartaric Acid Edetate Disodium Urea Glycerin Butylene Glycol Water Polysorbate 80 Sodium Polyacrylate (2500000 Mw) Fumaric Acid

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2026-01-01

Description

Directions - Remove any nail polish before use. Clean and thoroughly dry the affected area. - Peel off the protective film from the patch, starting with the outer edge and then the inner side. - Center the white area of the patch over the infected part of the nail. - Apply the adhesive side directly onto the nail. - Wrap the sides of the patch around the toe or finger to ensure a snug fit. - Fold the remaining adhesive part over the toe or fingertip. - Leave the patch on for 6-8 hours. For best results, use overnight for 3-6 months


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Repairs fungal nail damage and improves nail appearance

Dosage and Administration

Directions

- Remove any nail polish before use. Clean and thoroughly dry the affected area. - Peel off the protective film from the patch, starting with the outer edge and then the inner side. - Center the white area of the patch over the infected part of the nail. - Apply the adhesive side directly onto the nail. - Wrap the sides of the patch around the toe or finger to ensure a snug fit. - Fold the remaining adhesive part over the toe or fingertip. - Leave the patch on for 6-8 hours. For best results, use overnight for 3-6 months

Description

Directions - Remove any nail polish before use. Clean and thoroughly dry the affected area. - Peel off the protective film from the patch, starting with the outer edge and then the inner side. - Center the white area of the patch over the infected part of the nail. - Apply the adhesive side directly onto the nail. - Wrap the sides of the patch around the toe or finger to ensure a snug fit. - Fold the remaining adhesive part over the toe or fingertip. - Leave the patch on for 6-8 hours. For best results, use overnight for 3-6 months

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away

Section 50567-7

When using this product avoid contact with eyes. In case of contact, rinse thoroughly with water

Section 50569-3

Stop and ask a doctor if - irritation occurs - there is no improvement within 4 weeks

Section 50570-1

Do not use on children under 3 years of age unless directed by a doctor.

Section 51727-6

Inactive ingredients Glycerin, Tartaric Acid, Polysorbate 80, 1.2-Hexanediol, Disodium EDTA, Cellulose Gum, Sodium Polyacrylate, Aluminum Glycinate, Fumaric Acid, Butylene Glycol, Urea, Water

Section 51945-4

Drug Facts

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Anti-fungal

Section 55106-9

Active ingredients

Tolnaftate 1.0%

Section 60561-8

Other information Store at room temperature 15°-30°C (59°-86°F), away from excess heat and direct sun


Structured Label Content

Indications and Usage (34067-9)

Repairs fungal nail damage and improves nail appearance

Dosage and Administration (34068-7)

Directions

- Remove any nail polish before use. Clean and thoroughly dry the affected area. - Peel off the protective film from the patch, starting with the outer edge and then the inner side. - Center the white area of the patch over the infected part of the nail. - Apply the adhesive side directly onto the nail. - Wrap the sides of the patch around the toe or finger to ensure a snug fit. - Fold the remaining adhesive part over the toe or fingertip. - Leave the patch on for 6-8 hours. For best results, use overnight for 3-6 months

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. In case of contact, rinse thoroughly with water

Section 50569-3 (50569-3)

Stop and ask a doctor if - irritation occurs - there is no improvement within 4 weeks

Section 50570-1 (50570-1)

Do not use on children under 3 years of age unless directed by a doctor.

Section 51727-6 (51727-6)

Inactive ingredients Glycerin, Tartaric Acid, Polysorbate 80, 1.2-Hexanediol, Disodium EDTA, Cellulose Gum, Sodium Polyacrylate, Aluminum Glycinate, Fumaric Acid, Butylene Glycol, Urea, Water

Section 51945-4 (51945-4)

Drug Facts

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Anti-fungal

Section 55106-9 (55106-9)

Active ingredients

Tolnaftate 1.0%

Section 60561-8 (60561-8)

Other information Store at room temperature 15°-30°C (59°-86°F), away from excess heat and direct sun


Advanced Ingredient Data


Raw Label Data

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