Update-85569-010-01

Update-85569-010-01
SPL v2
SPL
SPL Set ID 3d4bbc65-955f-8fd8-e063-6294a90adc44
Route
TOPICAL
Published
Effective Date 2025-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (25 g) Tolnaftate (1 g)
Inactive Ingredients
Isopropyl Myristate Tea Tree Oil Water Glycerin Carboxymethylcellulose Sodium Urea Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-10
Description

25% Undecylenic Acid 1% Tolnaftate

Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • Helps Inhibit the growth of fungus.
  • Improves the appearance of nails affected by fungus, including discoloration, thickening, splitting, crumbing, and brittleness.

Dosage and Administration

Directions (Treatment)

  • Wash affected area and dry thoroughly.
  • Apply a thin layer of the product over the affected area (around the nails and underneath nail tips) twice daily or directed by a doctor.
  • Supervise children in the use of this product.

Directions (Patch)

  • Clean & prepare the affected nail.
  • Apply the antifungal solution to the affected nail.
  • Apply the fungus nail patch. Firmly secure the patch to the sides of the toes or fingers, folding the remaining adhesive part to fully cover the toes/fingertips.
  • Leave the patch on for 6-8 hours. Frequency: Use the patches consistently before bed.
  • Maintain good foot hygiene.
Description

25% Undecylenic Acid 1% Tolnaftate

Section 50565-1

In case of accidental ingestion, seek medical advice immediately or contact a poison control center right away.

Section 50566-9

Stop use and ask a doctor if

  • irritation occurs
  • this is no improvement within 4 weeks.

Section 50567-7

when using this product:

avoid contact with eyes. Do not exceed the recommended daily dosge unless directed by a doctor.

Section 50570-1
  • on children under 2 years of age unless directed by a doctor.
  • on diaper rash

Section 51727-6

(Treatment) Isopropyl Myristate, Tea Tree Oil

(Patch) Water, Glycerin, Sodium Carboxymethyl Cellulose, Butylene Glycol, Urea

Section 51945-4

Section 53413-1

Email: [email protected]

Section 53414-9

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

Section 55105-1

Anti-fungal

Section 55106-9

25% Undecylenic Acid

1% Tolnaftate

Section 60561-8

Store at 20-25°C (68-77°F)

Structured Label Content

Indications and Usage (34067-9)
  • Helps Inhibit the growth of fungus.
  • Improves the appearance of nails affected by fungus, including discoloration, thickening, splitting, crumbing, and brittleness.

Dosage and Administration (34068-7)

Directions (Treatment)

  • Wash affected area and dry thoroughly.
  • Apply a thin layer of the product over the affected area (around the nails and underneath nail tips) twice daily or directed by a doctor.
  • Supervise children in the use of this product.

Directions (Patch)

  • Clean & prepare the affected nail.
  • Apply the antifungal solution to the affected nail.
  • Apply the fungus nail patch. Firmly secure the patch to the sides of the toes or fingers, folding the remaining adhesive part to fully cover the toes/fingertips.
  • Leave the patch on for 6-8 hours. Frequency: Use the patches consistently before bed.
  • Maintain good foot hygiene.
Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

In case of accidental ingestion, seek medical advice immediately or contact a poison control center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • irritation occurs
  • this is no improvement within 4 weeks.

Section 50567-7 (50567-7)

when using this product:

avoid contact with eyes. Do not exceed the recommended daily dosge unless directed by a doctor.

Section 50570-1 (50570-1)
  • on children under 2 years of age unless directed by a doctor.
  • on diaper rash

Section 51727-6 (51727-6)

(Treatment) Isopropyl Myristate, Tea Tree Oil

(Patch) Water, Glycerin, Sodium Carboxymethyl Cellulose, Butylene Glycol, Urea

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Email: [email protected]

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)

25% Undecylenic Acid

1% Tolnaftate

Section 60561-8 (60561-8)

Store at 20-25°C (68-77°F)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:58.314658 · Updated: 2026-03-14T23:14:02.652954