FUNGIFOAM - tolnaftate aerosol, foam 
The Tetra Corporation

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.

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FungiFoam(R) 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

NDC #49406-004-75

FungiFoam(R)
ANTIFUNAL

TOLNAFTATE 1 PERCENT ANTIFUNGAL FOAM

Proven clinically effective:

  • in the treatment of most Athlete's Foot and Ringworm.
  • to prevent most Athlete's Foot with daily use.
Relieves Itching, Scaling, Cracking, Redness, Soreness, Burning and Irritation

From the makers of Formula 3(R)

DISPENSED ONLY BY PHYSICIANS

2.5 fl oz (75ml)

Patent Pending

3 Easy Steps For Treatment and Prevention

Proven clinically effective in the treatment of athlete's foot, and with daily use, helps keep it from coming back.

1 Wash thoroughly and towel off until completely dry.

2 A pearl-sized amount of FungiFoam(R) is enough to treat one foot. Use sparingly - a little goes a long way. To Treat - Use Twice a Day. For Prevention - Use Once a Day

3 Wear clean, dry socks and dry shoes. Change daily.

FungiFoam(R) is backed by The Tetra Corporation's Unconditional Patient-Direct, Money-Back Guarantee.

Questions or Comments?
1-800-826-0479
9:00 AM to 6:00 PM EST.

Made in a USA, FDA Registered Laboratory

THE TETRA CORPORATION
Eaton Rapids, MI 48827

Ask your doctor about Formula3(R)

box

label

FUNGIFOAM 
tolnaftate aerosol, foam
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DescriptionMarketing Start DateMarketing End Date
1NDC:49406-004-751 in 1 BOX
175 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/31/2012
Labeler - The Tetra Corporation (829958409)
Registrant - Elba, Inc. (108428483)
Establishment
NameAddressID/FEIBusiness Operations
Elba, Inc.108428483manufacture(49406-004)

Revised: 10/2012
 
The Tetra Corporation