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Fungifree fungal nail patches - Medication Information

Product NDC Code 83364-013
Drug Name

Fungifree fungal nail patches

Type Brand
Active Ingredients
Tolnaftate 1 g/100g
Route TOPICAL
Dosage Form PATCH
Labeler Name YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD
Packages
Package NDC Code Description
83364-013-01 21 patch in 1 patch (83364-013-01) / .7 g in 1 patch
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Tolnaftate 1.0%

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 - 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

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.
Repairs fungal nail damage and improves nail appearance 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

Purpose

Information about the drug product’s indications for use.
Anti-fungal

Spl product data elements

Usually a list of ingredients in a drug product.
FungiFree Fungal Nail Patches Tolnaftate 1,2-HEXANEDIOL ALUMINUM GLYCINATE CELLULOSE GUM TOLNAFTATE TOLNAFTATE TARTARIC ACID EDETATE DISODIUM UREA GLYCERIN BUTYLENE GLYCOL WATER POLYSORBATE 80 SODIUM POLYACRYLATE (2500000 MW) FUMARIC 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.
Drug Facts drug facts Active ingredients Tolnaftate 1.0% Anti-fungal Repairs fungal nail damage and improves nail appearance 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 For external use only

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.
Stop and ask a doctor if - irritation occurs - there is no improvement within 4 weeks

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

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 feeding
If 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 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