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Toenail fungus treatment maximum strength liquid - Medication Information

Product NDC Code 84614-002
Drug Name

Toenail fungus treatment maximum strength liquid

Type Brand
Active Ingredients
Tolnaftate 1 g/100ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 313423
Application Number M005
Labeler Name Shenzhen Ctrip Technology Co., Ltd.
Packages
Package NDC Code Description
84614-002-01 2 bottle in 1 package (84614-002-01) / 30 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
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.
Use once daily, preferably before bedtimeUnscrew the cap and tilt the bottle to apply the medicine directly to thenail. The medication will then penetrate deeply into the nail.If the nail area is infected, spray the medication onto the affected toearea.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
UNDECYLENIC ACID ALCOHOL DIMETHICONE C12-15 ALKYL LACTATE ETHYLHEXYLGLYCERIN TOCOPHEROL EDETATE DISODIUM 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. Fungal nails, Athlete's Foot, Tinea Manuum, Ringwomcaused byfungus and bacterial infection. 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.
TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH Liquid Tolnaftate UNDECYLENIC ACID ALCOHOL WATER TOLNAFTATE TOLNAFTATE PHENOXYETHANOL EDETATE DISODIUM DIMETHICONE C12-15 ALKYL LACTATE ETHYLHEXYLGLYCERIN TOCOPHEROL

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.
TOENAIL FUNGUS 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.
If a reaction suggesting sensitivity or iritation occurs.

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, seek medical assistance or contact a Poison Control Center immediately.

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.
lf the area of application shows signs of increased iritation. There is no improvement within 8 weeks. When Pregnant or breast-feeding

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.
Not for ophthalmic, oral, or intravaginal use

Storage and handling

Information about safe storage and handling of the drug product.
SHAKE WELL BEFORE USE Store at room temperature 5--30°C(41°-86°F), Please store in a cool,dry place away from direct sunlight. 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.
Keep away from fire and flame. Keep out of reach of children. For use on nails and the immediately adjacent skin 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