FDA Label for Tolcylen Antifungal Solution

View Indications, Usage & Precautions

Tolcylen Antifungal Solution Product Label

The following document was submitted to the FDA by the labeler of this product Marlinz Pharma, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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