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| Product NDC Code | 83837-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Athletes foot |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION/ DROPS | ||||
| RxCUI drug identifier | 313423 | ||||
| Application Number | M005 | ||||
| Labeler Name | Imperial Feet B.V. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Tolnaftate 1%
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 the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. 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. If condition persists longer, consult a doctor. Keep out of reach of children Supervise children in the use of this product
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient Inactive Ingredients Almond Oil, Alpha-Bisabolene, Calendula Officinalis Flower, Chamomile, Chlorphenesin, Glycerin, Methyl-Gluceth-20, Phenoxyethanol, Piroctone Olamine, Polysorbate 20, Polyethylene Glycol 400, Polyoxyl 40 Hydrogenated Castor Oil, Squalene, 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.Use Cures most Athlete's Foot
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 CALENDULA OFFICINALIS FLOWER CHLORPHENESIN GLYCERIN PIROCTONE OLAMINE ALMOND OIL POLYOXYL 40 HYDROGENATED CASTOR OIL WATER SQUALENE METHYL GLUCETH-20 .ALPHA.-BISABOLOL, (+)- PHENOXYETHANOL POLYSORBATE 20 TOLNAFTATE TOLNAFTATE CHAMOMILE FLOWER OIL POLYETHYLENE GLYCOL 400
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 / Product Label PDP
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Stop Use If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.
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 Supervise children in the use of this product
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store between 20 C and 30 C (68 F and 86 F)
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 . Do not use on children under 2 years of age unless directed by a doctor. . For external use only. . Avoid contact with the eyes. . If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor. Ask a doctor If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor. Stop Use If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult 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