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| Product NDC Code | 54633-017 | ||||
|---|---|---|---|---|---|
| Drug Name | Fortinia of |
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| Type | Brand | ||||
| Pharm Class | Azole Antifungal [EPC], Azoles [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 309370 | ||||
| Application Number | part333C | ||||
| Labeler Name | The Podiatree Company | ||||
| 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 Clotrimazole 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 • apply one drop to the affected area twice daily (morning and night) or as directed by your doctor • using a disposable cotton swab, spread a thin layer over the affected area • discard cotton swab • supervise children in the use of this product • for athlete’s foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily • for athlete’s foot and ringworm infections, use daily for 4 weeks • this product is not effective on scalp or nails
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Ethyl Alcohol (79%), Propylene Glycol
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 • cures most athlete’s foot infections and ringworm infections • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
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.Fortinia OF clotrimazole 1% PROPYLENE GLYCOL ALCOHOL CLOTRIMAZOLE CLOTRIMAZOLE
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 label
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. When using this product, avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
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. In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store at controlled room temperature.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Suggestions? 1.855.763.8733 or visit us at www.thepodiatreecompany.com
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 or pharmacist if • irritation occurs • there is no improvement within 4 weeks
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 near heat or ame, or while smoking. Cap tightly and store at room temperature away from heat.
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