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| Product NDC Code | 83176-006 | ||||
|---|---|---|---|---|---|
| Drug Name | Dr. luke fungal nail renewal |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | M005 | ||||
| Labeler Name | Dr.luke Healthcare LLC | ||||
| 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 Apply it in the day and night(twice a day). Before using it for the first time.soak the diseased nail withwarm water to soften it, use thenail file to polish the nail, make itthin visibly, and scrape off thedirt on the nail (be careful not tohurt the nail bed), then apply the liquid. After first use, every 2-3 daysuse the nail file to polish thesurface of the diseased nail andthen continue to use it. lf swallowed, get medical helpor contact a poison controlcenter right away.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Acetic Acid, SophoraFlavescens，StelleraChamaejasme Linn., ChineseGolden Larch Bark, FructusCnidii, Crocus Sativus L, Ethanol
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 all caused by nail fungus nail discoloration nail thickening nail splitting nail crumbling
Purpose
Information about the drug product’s indications for use.Purpose Antifungal Disinfectant Treatment Solution
Spl product data elements
Usually a list of ingredients in a drug product.Dr. Luke Fungal Nail Renewal Fungal Nail Renewal PSEUDOLARIX AMABILIS BARK CROCUS SATIVUS WHOLE TOLNAFTATE TOLNAFTATE WATER ACETIC ACID STELLERA CHAMAEJASME WHOLE ALCOHOL SOPHORA FLAVESCENS ROOT CNIDIUM SEED
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 83176-006-01 83176-006-01
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 You are allergic to vinegarsuch as itching, rash swelling of thelips, eyelids, and shortness ofbreath
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 [OTC - DO NOT USE SECTION] On damaged skin(cuts, abrasions, eczema, sunburn). If you are allergic to any of the ingredients in this product. 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 OUT OF REACH OF CHILDREN Keep out 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 section You are allergic to vinegarsuch as itching, rash swelling of thelips, eyelids, and shortness ofbreath
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 SECTION fungal infection itching
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 on nail fungus(onychomycosis) only, pleasedon't use it on healthy nails Don't use it on damaged skin,otherwise, your damaged skin maybe painful. For people with severe skinulceration, please use it with caution. Don't drink, avoid contact with your eye Children use it under thesupervision of adults. This product cannot replacemedicine.
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