85966-001 Extra Strength Nail Fungus Treatment

Drug Facts

Composition & Product

Active Ingredients

Tolnaftate (1 g) Undecylenic Acid (25 g)

Inactive Ingredients

Aqua Biotin Lavender Oil Urea Menthol Ethoxydiglycol Oregano Leaf Oil Salicylic Acid .alpha.-tocopherol Acetate Tea Tree Oil Propylene Glycol Glycerin Alcohol Aloe Barbadensis Leaf Powder

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-07-25

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 nail fungus, discoloration, thickening, splitting, crumbling and brittleness

Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).

For effective relief of itching, scaling, burning, redness, soreness, and irritation.

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

Dosage and Administration

1. Regularly trim the affected nails and gently file the surface (once a month or as needed).

2. Shake well before use. Wash the affected nails and surrounding skin with soap and water and dry thoroughly.

3. Using a sterile disposable cotton swab or dropper, apply a thin layer of the product over affectedarea twice daily (morning and night). Use a new swab each time to avoid cross-contamination.

4. Allow the product to air-dry completely before putting on socks or shoes to ensure full absorption.

5. For best results, apply daily until a healthy new nail has fully grown out. This product is noteffective on the scalp or nails.

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

UREA

ETHOXYDIGLYCOL

PROPYLENE GLYCOL

ALCOHOL DENAT.

TEA TREE OIL

OREGANO OIL

LAVENDER OIL

MENTHOL

ALOE BARBADENSIS LEAF EXTRACT

SALICYLIC ACID

BIOTIN/VITAMIN H

TOCOPHEROL ACETATE / VITAMIN E

AQUA

GLYCERIN

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 nail fungus, discoloration, thickening, splitting, crumbling and brittleness

Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).

For effective relief of itching, scaling, burning, redness, soreness, and irritation.

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

Dosage and Administration (34068-7)

1. Regularly trim the affected nails and gently file the surface (once a month or as needed).

2. Shake well before use. Wash the affected nails and surrounding skin with soap and water and dry thoroughly.

3. Using a sterile disposable cotton swab or dropper, apply a thin layer of the product over affectedarea twice daily (morning and night). Use a new swab each time to avoid cross-contamination.

4. Allow the product to air-dry completely before putting on socks or shoes to ensure full absorption.

5. For best results, apply daily until a healthy new nail has fully grown out. This product is noteffective on the scalp or nails.

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)

UREA

ETHOXYDIGLYCOL

PROPYLENE GLYCOL

ALCOHOL DENAT.

TEA TREE OIL

OREGANO OIL

LAVENDER OIL

MENTHOL

ALOE BARBADENSIS LEAF EXTRACT

SALICYLIC ACID

BIOTIN/VITAMIN H

TOCOPHEROL ACETATE / VITAMIN E

AQUA

GLYCERIN

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

UNDECYLENIC ACID 25%

TOLNAFTATE 1%

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "For the effective treatment of nail fungus, discoloration, thickening, splitting, crumbling and brittleness Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). For effective relief of itching, scaling, burning, redness, soreness, and irritation. Proven effective in the prevention of most athlete's foot (tinea pedis) with daily use.", "34068-7": "1. Regularly trim the affected nails and gently file the surface (once a month or as needed). 2. Shake well before use. Wash the affected nails and surrounding skin with soap and water and dry thoroughly. 3. Using a sterile disposable cotton swab or dropper, apply a thin layer of the product over affectedarea twice daily (morning and night). Use a new swab each time to avoid cross-contamination. 4. Allow the product to air-dry completely before putting on socks or shoes to ensure full absorption. 5. For best results, apply daily until a healthy new nail has fully grown out. This product is noteffective on the scalp or nails.", "34071-1": "For external use only, Store in a cool place and avoid sunshine and heat.", "50565-1": "Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if . irritation occurs or if there is no improvement within 4 weeks.", "50567-7": "When using this product · avoid contact with the eyes or damaged skin.", "50570-1": "Do not use on children under 2 years of age unless directed by a doctor", "51727-6": "UREA ETHOXYDIGLYCOL PROPYLENE GLYCOL ALCOHOL DENAT. TEA TREE OIL OREGANO OIL LAVENDER OIL MENTHOL ALOE BARBADENSIS LEAF EXTRACT SALICYLIC ACID BIOTIN/VITAMIN H TOCOPHEROL ACETATE / VITAMIN E AQUA GLYCERIN", "55105-1": "Antifungal", "55106-9": "UNDECYLENIC ACID 25% TOLNAFTATE 1%"}