Nail Antifungal Treatment

Nail Antifungal Treatment
SPL v3
SPL
SPL Set ID 2ea24785-c648-4104-e063-6294a90ab12f
Route
TOPICAL
Published
Effective Date 2025-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (5 mg) Tolnaftate (1 mg)
Inactive Ingredients
Water Glycerin Pseudolarix Amabilis Bark Hydracrylic Acid Euphorbia Hirta Whole Resorcinol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-21

Description

Anti fungal


Medication Information

Warnings and Precautions

WARNINGS

For external use only.

Indications and Usage

Uses:

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

Dosage and Administration

DIRECTIONS:

1. Apply the product twice a day, in the morning and at night.

2. For initial use, soak the affected nail in warm water to soften it. Gently file thenail to make it thinner and remove dirt, being cautious not to harm the nail bed.For best results file nails every 2-3 days.

3. Use the brush applicator to applythe solution on the affected areas.

4.Visible results will be seen in as little as 2week, continue regular usage toprevent fungus regrowth.

Description

Anti fungal

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 50566-9

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

within 4 weeks.

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

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.

Section 50570-1

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

Section 51727-6

Inactive ingredients:

water,euphorbia hirta whole,glycerin, hydracrylic acid,pseudolarix amabilis bark,resorcinol

Section 51945-4

Section 55105-1

Anti fungal

Section 55106-9

Tolnaftate(1%)........................Anti fungal

Salicylic acid(5%) ........................Anti fungal

Section 60561-8

OTHER INFORMATION

Store at room temperature 15-30°C (59°-86°F)


Structured Label Content

Indications and Usage (34067-9)

Uses:

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

Dosage and Administration (34068-7)

DIRECTIONS:

1. Apply the product twice a day, in the morning and at night.

2. For initial use, soak the affected nail in warm water to soften it. Gently file thenail to make it thinner and remove dirt, being cautious not to harm the nail bed.For best results file nails every 2-3 days.

3. Use the brush applicator to applythe solution on the affected areas.

4.Visible results will be seen in as little as 2week, continue regular usage toprevent fungus regrowth.

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 50566-9 (50566-9)

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

within 4 weeks.

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

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.

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:

water,euphorbia hirta whole,glycerin, hydracrylic acid,pseudolarix amabilis bark,resorcinol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anti fungal

Section 55106-9 (55106-9)

Tolnaftate(1%)........................Anti fungal

Salicylic acid(5%) ........................Anti fungal

Section 60561-8 (60561-8)

OTHER INFORMATION

Store at room temperature 15-30°C (59°-86°F)


Advanced Ingredient Data


Raw Label Data

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