NDC 49406-004 Fungifoam

Tolnaftate

NDC Product Code 49406-004

NDC 49406-004-30

Package Description: 1 TUBE in 1 BOX > 30 mL in 1 TUBE

NDC 49406-004-75

Package Description: 1 BOTTLE in 1 BOX > 75 mL in 1 BOTTLE

NDC Product Information

Fungifoam with NDC 49406-004 is a a human over the counter drug product labeled by The Tetra Corporation. The generic name of Fungifoam is tolnaftate. The product's dosage form is aerosol, foam and is administered via topical form.

Labeler Name: The Tetra Corporation

Dosage Form: Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Fungifoam Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • TOLNAFTATE 10 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: The Tetra Corporation
Labeler Code: 49406
FDA Application Number: part333C What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-13-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Tolnaftate

Tolnaftate is pronounced as (tole naf' tate)

Why is tolnaftate medication prescribed?
Tolnaftate stops the growth of fungi that cause skin infections, including athlete's foot, jock itch, and ringworm.This medication is sometimes prescribed for other uses;...
[Read More]

* Please review the disclaimer below.

Fungifoam Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Tolnaftate 1 percent

Purpose

Antifungal

Uses:

  • For effective treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis).
  • Relieves:
  • ItchingscalingcrackingrednesssorenessburningirritationPrevents 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 productFor 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

* Please review the disclaimer below.