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| Product NDC Code | 83364-011 | ||||
|---|---|---|---|---|---|
| Drug Name | Fungal nail patches |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| Labeler Name | YITONGBADA (SHENZHEN) INTERNATIONAL TRADE 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 ingredients Purpose Tolnaftate 1.0%...........................................................................................................Anti-fungal
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.For external use only
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Glycerin, Tartaric Acid, Polysorbate 80, 1.2-Hexanediol, Disodium EDTA, Cellulose Gum, Sodium Polyacrylate, Aluminum Glycinate, Fumaric Acid, Butylene Glycol, Urea, 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 - Remove any nail polish before use. Clean and thoroughly dry the affected area. - Peel off the protective film from the patch, starting with the outer edge and then the inner side. - Center the white area of the patch over the infected part of the nail. - Apply the adhesive side directly onto the nail. - Wrap the sides of the patch around the toe or finger to ensure a snug fit. - Fold the remaining adhesive part over the toe or fingertip. - Leave the patch on for 6-8 hours. For best results, use overnight for 3-6 months
Purpose
Information about the drug product’s indications for use.Uses Repairs fungal nail damage and improves nail appearance For external use only Do not use on children under 3 years of age unless directed by a doctor. When using this product avoid contact with eyes. In case of contact, rinse thoroughly with water Stop and ask a doctor if - irritation occurs - there is no improvement within 4 weeks If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away
Spl product data elements
Usually a list of ingredients in a drug product.Fungal Nail Patches Tolnaftate FUMARIC ACID WATER SODIUM POLYACRYLATE (2500000 MW) TARTARIC ACID GLYCERIN 1,2-HEXANEDIOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS UREA TOLNAFTATE TOLNAFTATE EDETATE DISODIUM BUTYLENE GLYCOL POLYSORBATE 80
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.Drug Facts Patch Drug Facts Active ingredients Purpose Tolnaftate 1.0%...........................................................................................................Anti-fungal Uses Repairs fungal nail damage and improves nail appearance For external use only Do not use on children under 3 years of age unless directed by a doctor. When using this product avoid contact with eyes. In case of contact, rinse thoroughly with water Stop and ask a doctor if - irritation occurs - there is no improvement within 4 weeks If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away Warnings Directions - Remove any nail polish before use. Clean and thoroughly dry the affected area. - Peel off the protective film from the patch, starting with the outer edge and then the inner side. - Center the white area of the patch over the infected part of the nail. - Apply the adhesive side directly onto the nail. - Wrap the sides of the patch around the toe or finger to ensure a snug fit. - Fold the remaining adhesive part over the toe or fingertip. - Leave the patch on for 6-8 hours. For best results, use overnight for 3-6 months Other information Store at room temperature 15°-30°C (59°-86°F), away from excess heat and direct sun Inactive ingredients Glycerin, Tartaric Acid, Polysorbate 80, 1.2-Hexanediol, Disodium EDTA, Cellulose Gum, Sodium Polyacrylate, Aluminum Glycinate, Fumaric Acid, Butylene Glycol, Urea, Water
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 3 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. In case of accidental ingestion, seek medical advice immediately 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 at room temperature 15°-30°C (59°-86°F), away from excess heat and direct sun
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 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 eyes. In case of contact, rinse thoroughly with water
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before 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
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