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Product NDC Code | 83767-501 | ||||
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Drug Name | Fungal nail treatment maximum strength liquid |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 2691548 | ||||
Application Number | M005 | ||||
Labeler Name | Guangzhou Ruijiu Electronic Technology Co., Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.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.Apply once daily, preferably at bedtime or at least eight hours beforewashing. Clean and thoroughly dry the affected area, then use theapplicator brush provided to cover all affected nails. Ensure that theapplication is evenly distrnbuted across the entire nail plate
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.ALCOHOL DIMETHICONE C12-15 ALKYL LACTATE ETHYLHEXYLGLYCERIN SOPHORA FLAVESCENS ROOT TOCOPHEROL PHENOXYETHANOL 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.Antifungal use on fingemails, toenails, and the immediately adjacent skin. Prevents the recurence of most athlete's foot with daily use For all caused by nail fungus, nail discoloration, nail thickening,nailsplitting, nail crumbling.
Purpose
Information about the drug product’s indications for use.Anti-fungal and Nail Renewal
Spl product data elements
Usually a list of ingredients in a drug product.FUNGAL NAIL TREATMENT MAXIMUM STRENGTH Liquid Tolnaftate C12-15 ALKYL LACTATE SOPHORA FLAVESCENS ROOT ETHYLHEXYLGLYCERIN PHENOXYETHANOL TOCOPHEROL WATER UNDECYLENIC ACID UNDECYLENIC ACID DIMETHICONE ALCOHOL TOLNAFTATE TOLNAFTATE
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.label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.FUNGAL NAIL TREATMENT MAXIMUM STRENGTH Liquid
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.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.If accidental ingestion occurs, get medical help or contact a PoisonControl Center right away.
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.Imitation 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.avoid contact with the eyes.
Storage and handling
Information about safe storage and handling of the drug product.Store at room temperature 15--30°C(59°-86°F) Protect from freezing; if freezingoccurs, wamm to room temperature Keep tightly closed when not in 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.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