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Tm-tolnaftate lr - Medication Information

Product NDC Code 83035-1262
Drug Name

Tm-tolnaftate lr

Type Brand
Active Ingredients
Tolnaftate 1 g/100ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 313423
Application Number part333C
Labeler Name Singular Dreamer Ltd.dba True Marker
Packages
Package NDC Code Description
83035-1262-4 1 bottle in 1 carton (83035-1262-4) / 45 ml in 1 bottle
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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 clean the affected area and dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night) paying special attention to the edges of the nail, cuticles and skin around the nails or as directed by a doctor supervise children in the use of this product for athlete's foot, pay special attention to spaces between the toes, wear well-fitting,ventilated shoes, and change shoes and socks at least once daily for athlete's foot and ringworm, use daily for 4 weeks if condition persists longer, consult a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients a-Bisabalol, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetearyl Alcohol, Curcuma Longa (Turmeric) Extract, Dimethyl Isosorbide, Ethylhexylglycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Hydroxyethyl Acrylate/Sodium AcryloyldimethylTaurate Copolymer, Isohexadecane, Isopropyl Alcohol, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polysorbate 60, Sodium Hydroxide, Thymus Vulgaris (Thyme) Extract, Zingiber Officinalis (Ginger) Extract.

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.
Uses for the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis). relieves itching, burning, cracking, scaling and discomfort which accompany these conditions. for the prevention of most Athlete's foot with daily use eliminates fungus on fingers, toes and around the nails. eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush.

Purpose

Information about the drug product’s indications for use.
Purpose Antifungal

Spl product data elements

Usually a list of ingredients in a drug product.
TM-Tolnaftate LR Tolnaftate BISABOLOL OXIDE A ALLANTOIN ALOE VERA LEAF WATER TURMERIC DIMETHYL ISOSORBIDE ETHYLHEXYLGLYCERIN GLYCERYL MONOSTEARATE HELIANTHUS ANNUUS FLOWERING TOP HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) ISOHEXADECANE ISOPROPYL ALCOHOL MELALEUCA ALTERNIFOLIA LEAF PHENOXYETHANOL POLYSORBATE 60 SODIUM HYDROXIDE THYME GINGER 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.
Product label image description

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.
Other information Store at 15 - 30°C (59 - 86°F) avoid excessive heat do not use if package is damaged

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 • Do Not Use – On children under 2 years of age • When using this product , do not get into eyes • Stop use and ask a doctor for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks for prevention of athlete's foot - if irritation occurs, discontinue use and consult a doctor for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks for prevention of athlete's foot - if irritation occurs, discontinue use and consult a doctor

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