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| Product NDC Code | 83872-326 | ||||
|---|---|---|---|---|---|
| Drug Name | Fugal nall treatment |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Shenzhen Xiaomai Manufacturing 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 Tolnaftate 1% Undecylenic Acid 25%
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 Apply the product twice a day, in the morning and at night.For initial use, soak the affected nail in warm water to soften itGently file the nail to make it thinner and remove dirt, beingcautious not to ham the nail bed. Apply the product after this step.After the first application, repeat every 2-3 days. File the surfaceof the affected nail and continue regular usage.*In case ofingestion, seek medical assistance or contact apoison control center immediately.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Undecylenic Acid, Tolnaftate, Ethyl Lactate, Aqua, Lactic AcidResacetophenone, Acetic Acid, Sophora Flavescens Extract,Stellera Chamaejasme Leaf/Stem Extract, Crocus Sativus StyleExtract, Eucalyptol, Aloe Barbadensis Leaf Extract, CarthamusTinctorius (Safflower) Seed Oil, Hydrogenated Polyisobutene,Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia(Tea Tree) Leaf Oil, Oryza Sativa (Rice) Bran Oil, PrunusAmygdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum(Sesame) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil,Tocopheryl Acetate, Olea Europaea (Olive) Fruit Oil.
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 For nails
Purpose
Information about the drug product’s indications for use.Purpose Fungal nails, Athlete's Foot, Tinea Manuum, Jock ltch, Ringwormcaused by fungus and bacterial infection.For all caused by nail fungus, nail discoloration, nail thickening,nail splitting, nail crumbling.
Spl product data elements
Usually a list of ingredients in a drug product.Fugal nall treatment oil RESACETOPHENONE SOPHORA FLAVESCENS ROOT ACETIC ACID EUCALYPTOL CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES UNDECYLENIC ACID UNDECYLENIC ACID ETHYL LACTATE LACTIC ACID TOLNAFTATE TOLNAFTATE WATER
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.LBEAL
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 When Pregnant or breast-feeding.
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 This product is not a substitute for medication.
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 Keep Oot Of Reach Of Children
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 Keep Out Of Reach Of Chlidren:if swallowed,get medical help or contact a Poison Control Center right away."
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 For external use only, do not ingest. Avoid eye contact; maintain dry and clean skin. Exercise caution when using on severely ulcerated skin. Keep out of reach of children.
Storage and handling
Information about safe storage and handling of the drug product.Other information Please store in a cool, dry place away from direct sunlight.
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 -Keep away from fire and flame
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