Label: FUNGIFOAM- tolnaftate aerosol, foam

  • NDC Code(s): 49406-004-30, 49406-004-75
  • Packager: The Tetra Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated July 13, 2020

If you are a consumer or patient please visit this version.

  • 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

  • INGREDIENTS AND APPEARANCE
    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 BOX07/13/2020
    175 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49406-004-301 in 1 BOX07/13/2020
    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 finalpart333C07/13/2020
    Labeler - The Tetra Corporation (829958409)
    Registrant - The Tetra Corporation (829958409)
    Establishment
    NameAddressID/FEIBusiness Operations
    Paket Corporation007774730manufacture(49406-004)