FDA Label for Fungifoam

View Indications, Usage & Precautions

Fungifoam Product Label

The following document was submitted to the FDA by the labeler of this product The Tetra Corporation. 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 percent


Purpose



Antifungal


Uses:



For effective treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis).
Relieves:

  • itching
  • scaling
  • cracking
  • redness
  • soreness
  • burning
  • irritation
  • Prevents the recurrence of most athlete's foot with daily use.


Warnings



For external use only.

When using this product avoid contact with the eyes.

Stop use and ask a doctor if:

  • When using for treatment of athlete's foot or ringworm: If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
  • When using for prevention of athlete's foot: If irritation occurs, discontinue use and consult a doctor.
  • Do not use on children under 2 years of age unless directed by a doctor.


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 professional before use.


Directions:



For treatment of athlete's foot, and ring-worm:

  • Clean the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor.
  • Supervise children in the use of this product
  • For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • For athlete's foot and ringworm, use daily for 4 weeks.
  • If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.
  • To prevent athlete's foot:

    • Wash the feet and dry thoroughly.
    • Apply a thin layer of the product to the feet once or twice daily (morning and/or night)
    • Supervise children in the use of this product.
    • Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.

Other Information:



Store at room temperature, 25 degrees Celsius (77 degrees Fahrenheit).


Inactive Ingredients:



BHT, C12-15 Alkyl Benzoate, Cellulose Gum, Ceteareth-20 and Ceteareth-25, Cetearyl Alcohol, Ehtyl-hexyglycerin, Ethoxydiglycol, Hydroxyethyl Cellulose, Stearic Acid, Phenoxyethanol, Polysorbate 60, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Triethanolamine, Urea and Water


Package Label




* Please review the disclaimer below.