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| Product NDC Code | 70084-510 | ||||
|---|---|---|---|---|---|
| Drug Name | Athletes foot |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 103951 | ||||
| Application Number | part333C | ||||
| Labeler Name | Quantum, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Tolnaftate 1.0%
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 Wash affected area and dry thoroughly. Apply a thin layer over affected area twice daily (morning and night). Pay special attention to spaces between the toes, wear well fitting 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 Achillea Millefolium (Yarrow) Extract, Allantoin, Anthemis Nobilis (Chamomile) Extract, Bentonite, Citric Acid, Echinacea Purpurea Extract, Equisetum Arvense (Horsetail) Extract, Glycereth-7 Cocoate, Glycerin, Glycyrrhiza Glabra (Licorice Root) Extract, Hamamelis Virginiana (Witch Hazel) Extract, Hibiscus Syriacus (Althaea) Extract, Kaolin, Laminaria Digitata (Sea Kelp) Extract, Magnesium Aluminum Silicate, Melaleuca Alternifolia (Tea Tree) Oil, Melissa Officinalis (Balm Mint) Extract, Menthol, Methyl Paraben, Mixed Tocopherols (Vitamin E), Origanum Vulgare (Oregano) Oil, Panthenol, Propyl Paraben, Purified Water, Rosmarinus Officinalis (Rosemary) Extract, Salvia Officinalis (Sage) Extract, Stearic Acid, Thymus Vulgaris (Thyme) Extract, Tussilago Farfara (Coltsfoot) Extract, Zinc Oxide.
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 Cures and prevents most Athlete's Foot. Relieves itching and burning.
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.Athletes Foot Tolnaftate Tolnaftate Tolnaftate Echinacea Purpurea TEA TREE OIL Menthol, Unspecified Form TOCOPHEROL Water Allantoin CHAMOMILE Bentonite Citric Acid Monohydrate EQUISETUM ARVENSE TOP PEG-7 GLYCERYL COCOATE Glycerin GLYCYRRHIZA GLABRA HIBISCUS SYRIACUS BARK HAMAMELIS VIRGINIANA TOP Kaolin LAMINARIA DIGITATA Magnesium Aluminum Silicate MELISSA OFFICINALIS Methylparaben OREGANO LEAF OIL Panthenol Propylparaben Rosemary Sage Stearic Acid Thyme TUSSILAGO FARFARA FLOWER Zinc Oxide
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.PRINCIPAL DISPLAY PANEL - 21 g Tube Carton Quantum ® HEALTH Athlete's Foot Quick Drying Antifungal Formula WITH A UNIQUE BLEND OF HERBS, ESSENTIAL OILS, TOPICAL NUTRIENTS STOPS ITCHING & BURNING ELIMINATES ODOR USE DAILY FOR PREVENTION CURES & PREVENTS MOST ATHLETE'S FOOT Ointment D E R M A Net Wt 21g / .75 OZ PRINCIPAL DISPLAY PANEL - 21 g Tube Carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
DISTRIBUTED BY: QUANTUM, INC. PO BOX 2791, EUGENE, OR 97402
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. Do not use on children under two years old unless under supervision of a doctor. If swallowed, seek medical help or contact the poison control center.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at room temperature.
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. Avoid contact with eyes. Stop and ask doctor if irritation occurs or there is no improvement within four weeks. Keep out of reach of children. Do not use on children under two years old unless under supervision of a doctor. If swallowed, seek medical help or contact the poison control center.
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