FungiFoam ANTIFUNGAL

FungiFoam ANTIFUNGAL

Drug Labeling and Warnings

Drug Details

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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 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

box

label

Tubelabel

Tubebox

FUNGIFOAM 
tolnaftate aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49406-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETEARETH-25 (UNII: 8FA93U5T67)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
JOJOBA OIL (UNII: 724GKU717M)  
TROLAMINE (UNII: 9O3K93S3TK)  
UREA (UNII: 8W8T17847W)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49406-004-751 in 1 BOX10/31/2012
175 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 49406-004-301 in 1 BOX07/13/2017
230 mL in 1 TUBE; Type 0: Not a Combination Product
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/FEIBusiness Operations
Paket Corporation007774730manufacture(49406-004)

Revised: 4/2018
 
The Tetra Corporation


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