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| Product NDC Code | 81929-006 | ||||
|---|---|---|---|---|---|
| Drug Name | Derman antifungal |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | AEROSOL | ||||
| RxCUI drug identifier | 313421 | ||||
| Application Number | M005 | ||||
| Labeler Name | Taisho Pharmaceutical California Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Tolnaftate 1% Purpose Antifungal
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 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 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, consult a doctor to prevent athlete's foot: wash the feet and dry thoroughly; spray a thin layer of the product to the feet once or twice daily (morning and/or night) this product is not effective on the scalp or nails if nozzle clogs, clean with a pin
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients BHT, isobutane, PPG-12-buteth-16, SD alcohol 40-B
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 Clinically proven to prevent most athlete’s foot. prevent the recurrence of athlete's foot with daily use for effective relief of itching, cracking 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.Derman Antifungal TOLNAFTATE BUTYLATED HYDROXYTOLUENE ISOBUTANE PPG-12-BUTETH-16 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.Package Labeling: bottle
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
Other information store between 20° and 30°C (68° and 86°F)
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.Do not use on children under 2 years of age unless directed by 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. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if irritation occurs no improvement within four weeks for athlete's foot and ringworm
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with the eyes or mouth use only as directed
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: Contents under pressure. Avoid spraying in eyes. Do not use or store near heat or open flame. Do not puncture or incinerate container. Do not store at temperature above 120ºF. Keep out of the reach of children. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. When using this product avoid contact with the eyes or mouth use only as directed Stop use and ask a doctor if irritation occurs no improvement within four weeks for athlete's foot and ringworm 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.
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