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| Product NDC Code | 67091-190 | ||||
|---|---|---|---|---|---|
| Drug Name | Winco antifungal |
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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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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient 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 China
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient cetostearyl alcohol, ethylparaben, glycerin, glyceryl monostearate, petrolatum, propylene glycol, purified water, sodium sulfite, steareth-20, stearic acid
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 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 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 longer, consult 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 most athlete's foot (tinea pedis) and ringworm (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 Antifungal Tolnaftate TOLNAFTATE TOLNAFTATE GLYCERIN PETROLATUM SODIUM SULFITE STEARETH-20 CETOSTEARYL ALCOHOL ETHYLPARABEN GLYCERYL MONOSTEARATE PROPYLENE GLYCOL WATER STEARIC ACID
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
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 on children under 2 years of age except under the advice and supervision of 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 (1-800-222-1222) 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 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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at room temperature 20-25°C (68-77°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 For external use only
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