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Product NDC Code | 67091-276 | ||||
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Drug Name | Winco foods tolnaftate |
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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 | Winco Foods, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each gram) Purpose Tolnaftate 1%--------------------------------------------------------------------------------- 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.DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704 MADE IN KOREA
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients buylated hydroxytoluene, ceteth-20, cetyl alcohol, methylparaben, mineral oil, propylene glycol, propylparaben, sorbitan monostearate, stearyl alcohol, 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.Directions wash affected area and dry thoroguhly apply 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 spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily use daily for 4 weeks; if condition persists longer, ask a doctor to prevent athlete's foot, apply once or twice daily (morning and/or night) this product is not effective on the scalp or nails
Purpose
Information about the drug product’s indications for use.Uses Proven clinically effective in the treatment of athlete's foot (tinea pedis) and rignworm (tinea corporis) Helps prevent most athlete's foot with daily use For effective relief of itching, burning and cracking
Spl product data elements
Usually a list of ingredients in a drug product.Winco Foods Tolnaftate Tolnaftate CETETH-20 CETYL ALCOHOL METHYLPARABEN MINERAL OIL PROPYLENE GLYCOL PROPYLPARABEN SORBITAN MONOSTEARATE STEARYL ALCOHOL 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.24193
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.
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° to 25C° (68° to 77F°) Lot No & Exp. Date: see box or see crimp of tube
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 there is no improvement within 4 weeks
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.
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 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