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| Product NDC Code | 83364-008 | ||||
|---|---|---|---|---|---|
| Drug Name | Fungifree nail repair solution |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| Application Number | M005 | ||||
| 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% ..…………………………………………………………………………….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 Cetyl alcohol, Glycerin, Monoolein, Salicylic acid, Stearyl alcohol, Urea, Acetic acid, mineral oil, etc.
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 -Soak your feet in hot water for 5 minutes, then dry your toes. -Use a nail cutter and file (not included) to trim nails that need repair so that the liquid can soak in better. -Gently turn the end of the pen to dispense treatment liquid onto the brush applicator. -Apply the liquid over the areas that need to be repaired, and make sure to cover all affected parts. -Use daily for 2-4 weeks, according to the condition of the area that needs repair. Recommended use: 2-3 times a day.
Purpose
Information about the drug product’s indications for use.Uses Treatment of fingernail and toenail fungus For external use only Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with eyes. 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.FUNGIFREE Nail Repair Solution Tolnaftate GLYCERYL MONOOLEATE STEARYL ALCOHOL UREA TOLNAFTATE TOLNAFTATE ACETIC ACID MINERAL OIL CETYL ALCOHOL SALICYLIC ACID 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.Drug Facts Drug Facts Active ingredients Purpose Tolnaftate 1% ..…………………………………………………………………………….Anti-fungal Uses Treatment of fingernail and toenail fungus For external use only Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with eyes. 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 -Soak your feet in hot water for 5 minutes, then dry your toes. -Use a nail cutter and file (not included) to trim nails that need repair so that the liquid can soak in better. -Gently turn the end of the pen to dispense treatment liquid onto the brush applicator. -Apply the liquid over the areas that need to be repaired, and make sure to cover all affected parts. -Use daily for 2-4 weeks, according to the condition of the area that needs repair. Recommended use: 2-3 times a day. Other information store at 15-28°C (59.0-82.4°F) Inactive ingredients Cetyl alcohol, Glycerin, Monoolein, Salicylic acid, Stearyl alcohol, Urea, Acetic acid, mineral oil, etc.
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 2 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 15-28°C (59.0-82.4°F)
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.
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