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Product NDC Code | 49406-004 | ||||||
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Drug Name | Fungifoam |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | AEROSOL, FOAM | ||||||
RxCUI drug identifier | 1356533, 1356538 |
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Application Number | M005 | ||||||
Labeler Name | The Tetra Corporation | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Tolnaftate 1 percent
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Purpose
Information about the drug product’s indications for use.Purpose Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.FungiFoam TOLNAFTATE 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 TOLNAFTATE TOLNAFTATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Product label image description image description image description image description
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information: Store at room temperature, 25 degrees Celsius (77 degrees Fahrenheit).
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API