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FungiFoam

Dosage form: aerosol, foam
Ingredients: TOLNAFTATE 10mg in 1mL
Labeler: The Tetra Corporation
NDC Code: 49406-004

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

FungiFoam ANTIFUNGAL

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

FUNGIFOAM 
tolnaftate aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49406-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
ALKYL (C12-15) BENZOATE 
CARBOXYMETHYLCELLULOSE SODIUM 
POLYOXYL 20 CETOSTEARYL ETHER 
CETEARETH-25 
CETOSTEARYL ALCOHOL 
ETHYLHEXYLGLYCERIN 
DIETHYLENE GLYCOL MONOETHYL ETHER 
STEARIC ACID 
PHENOXYETHANOL 
POLYSORBATE 60 
PROPYLENE GLYCOL 
JOJOBA OIL 
TROLAMINE 
UREA 
WATER 
Packaging
#Item CodePackage Description
1NDC:49406-004-751 BOTTLE in 1 BOX
175 mL in 1 BOTTLE
2NDC:49406-004-301 TUBE in 1 BOX
230 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/31/2012
Labeler - The Tetra Corporation (829958409)
Registrant - The Tetra Corporation (829958409)
Establishment
NameAddressID/FEIOperations
Advanced Cosmetic Research Laboratories, Inc.874810872manufacture(49406-004)

Revised: 12/2017
 
The Tetra Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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