Fungifoam Aerosol, Foam
FDA Label NDC 49406-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Tetra Corporation for the product Fungifoam (NDC 49406-004). 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, uses:, warnings, keep out of reach of children., if pregnant or breast-feeding, directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Box (Box)

Box (Box)

Label (Label)

Label (Label)

Tubelabel (Tubelabel)

Tubelabel (Tubelabel)

Tubebox (Tubebox)

Tubebox (Tubebox)

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