Tolcylen Antifungal Solution
FDA Label NDC 70945-100

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marlinz Pharma, Llc for the product Tolcylen Antifungal Solution (NDC 70945-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, warnings, uses, directions, inactive ingredeints, outer carton - principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Warnings

Keep out of reach of children

Do not use on children under 2 years of age ■ For external use only ■ Avoid contact with the eyes. If eye contact occurs, wash thoroughly with
water ■ Stop use and consult a physician if irritation occurs or if there is no improvement within four (4) weeks ■ Keep out of reach of children ■ If swallowed,
get medical help or contact a poison control center right away ■ If pregnant or breast-feeding, ask a health-care professional before use.

Uses

Cures most Athlete’s Foot (Tinea Pedis) ■ Relieves itching, cracking, burning and scaling, which accompanies this condition ■
Prevents recurrence of Athlete’s Foot

Directions

Wash the affected area with soap and water.
■ Dry thoroughly, then apply a thin layer over the affected area.
■ Use twice daily (morning and night) or as directed by a physician.
■ Pay special attention to the spaces between the toes and the areas around the edges and under the front of the nails.
■ Wear well-fitted ventilated shoes and change socks at least once daily.
■ Use daily for four (4) weeks. If condition persists longer, consult a physician.
■ Wash hands after each use. Store and use at room temperature.

Inactive Ingredeints

Inactive Ingredients: Ethyl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Propylene Glycol, Water
Cosmetic Ingredients: Urea, Lactic Acid, Jojoba Oil, Undecylenic Acid, Dimethyl Isosorbide, Vitamin E

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