FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]

FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]
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NDC 49406-004-30, 49406-004-75
Set ID 2449e8e5-9d7e-4119-9e7a-378efe55f875
Category HUMAN OTC DRUG LABEL
Packager The Tetra Corporation
Generic Name
Product Class
Product Number
Application Number PART333C
  • 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)

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