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| Product NDC Code | 82739-022 | ||||
|---|---|---|---|---|---|
| Drug Name | Izkut fungal nail patches |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 2677690 | ||||
| Application Number | M005 | ||||
| Labeler Name | Shenzhen Situya Trading Co., Ltd. | ||||
| 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 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 ■ Clean and thoroughly dry the affected area before application. ■ Peel off the patch's protective film, starting with the outer side and then the inner side. ■ Place the sticky side of the patch directly onto the infected area on the nail and remove the release paper. ■ Gently wrap the sides of the toe or finger to ensure a snug fit. ■ Fold the remaining adhesive part to cover the toe/fingertip. ■ Leave the patch on for 6–8 hours (It is recommended to use overnight for 3–6 months).
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Glycerin, 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.Use Repairs fungal nail damage and improves nail appearance
Purpose
Information about the drug product’s indications for use.Purpose Anti-Fungal
Spl product data elements
Usually a list of ingredients in a drug product.IZKUT Fungal Nail Patches Fungal Nail Patches WATER TOLNAFTATE TOLNAFTATE GLYCERIN
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 1
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask Doctor ■ if you have diabetes or poor blood circulation
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 ■ Do not use if you are allergic to any of the ingredients ■ Do not use if you are pregnant or breastfeeding
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 Oot Of Reach Of Children ■ In case of contact with eyes, flush with water for at least 15 minutes. ■ If swallowed, seek medical assistance immediately or contact a Poison Control Center.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions IZKUT LLC 5830 E 2ND ST, STE 7000 #5472 CASPER, WY 82609 Call: 1-307-247-9088 Email: [email protected] Website: www.izkutllc.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 ■ if irritation occurs and discomfort persists
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 ■ Avoid direct contact with eyes, mouth, mucous membrane, wounds
Storage and handling
Information about safe storage and handling of the drug product.Other information ■ Store at room temperature and keep away from direct sunlight. ■ Skin discoloration may occur during or after use.
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