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| Product NDC Code | 52000-418 | ||||
|---|---|---|---|---|---|
| Drug Name | Antifungal foot |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | AEROSOL, SPRAY | ||||
| RxCUI drug identifier | 313421 | ||||
| Application Number | M005 | ||||
| Labeler Name | Universal Distribution Center LLC | ||||
| 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 affected area and dry thoroughly • shake can well and spray a thin layer over affected area twice daily (morning and night) • supervise children in the use of this product • for athlete's foot: pay special attention to space between the toes; wear well-fitted, ventilated shoes and change shoes and socks at least once a day. • use daily for 4 weeks; if condition persists longer, consult a doctor • to prevent athlete's foot, apply once or twice daily (morning and night) • in case of clogging, clean nozzle with a pin
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients butane, propane, alcohol, butylated hydroxytoluene, Zea Mays Starch.
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 (tinea pedis) and ringworm (tinea corporis) • if used daily, can prevent recurrence of athlete's foot • relieves symptoms of athlete's foot, including, burning and cracking
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.ANTIFUNGAL FOOT Tolnaftate TOLNAFTATE TOLNAFTATE BUTANE PROPANE ALCOHOL BUTYLATED HYDROXYTOLUENE STARCH, CORN
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.Packaging ANTFSpray-3
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
FOR ATHLETE'S FOOT Cures & Prevents Most Athlete's Foot Relieves Itching & Burning Fights Odor All Day * Compare to the Active Ingredient in Tinactin® CAUTION CONTENTS UNDER PRESSURE Read precautions on back panel. Distributed by: UNIVERSAL DISTRIBUTION CENTER, LLC Edison, NJ 08817 NO CFCs CONTAINS NO CFCs WHICH DEPLETE THE OZONE LAYER Made in China
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 immediately. Do not use on children under 2 years of age unless directed by a doctor.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions/Comments? 1-855-345-5575
Storage and handling
Information about safe storage and handling of the drug product.Other Information store between 68° to 77°F (20° to 25°C)
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. Flammable. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F (49°C). When using this product • avoid contact eyes & face • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal. Stop use and ask a doctor if • irritation occurs • there is no improvement after 4 weeks Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. 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