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Tolnaftate cream 1% antifungal - Prescription Drug Labeling

Product NDC Code 69396-042
Drug Name

Tolnaftate cream 1% antifungal

Type Brand
Active Ingredients
Tolnaftate 1 g/100g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 103951
Application Number part333C
Labeler Name Trifecta Pharmaceuticals USA, LLC
Packages
Package NDC Code Description
69396-042-05 1 tube in 1 box (69396-042-05) > 15 g in 1 tube

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 ● wash affected area and dry thoroughly ● apply a thin layer over affected area twice daily (morning and night) ● 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. ● use daily for 4 weeks; if conditions persists longer, ask a doctor. ● to prevent athlete's foot, apply once or twice daily (morning and/or night) ● this product is not effective on the scalp or nails.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Cetyl alcohol, ethylparaben, glycerol, light mineral oil, glycerol monostearate, petrolatum, purified water, sodium dodecyl sulfate

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 ● proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis) ● helps prevent most athlete's foot with daily use ● for effective relief of itching, burning and cracking.

Purpose

Information about the drug product’s indications for use.
Purpose Anti-Fungal

Spl product data elements

Usually a list of ingredients in a drug product.
Tolnaftate Cream 1% ANTIFUNGAL Family Wellness Tolnaftate ETHYLPARABEN GLYCERIN LIGHT MINERAL OIL GLYCERYL MONOSTEARATE PETROLATUM WATER SODIUM DODECYLBENZENESULFONATE TOLNAFTATE TOLNAFTATE CETYL ALCOHOL

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.
family wellness tolnaftate 05oz.

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.
Drug Facts DISTRIBUTED BY: MIDWOOD BRANDS, LLC. 500 VOLVO PARKWAY, CHESAPEAKE, VA. 23320 NOT SATISFIED? Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange. This product is not manufactured or distributed by Bayer, owner of the registered trademark Tinactin®

Storage and handling

Information about safe storage and handling of the drug product.
Other information ● store between 20° to 25°C ( 68° to 77°F) ● Lot No & Expiration Date: See box or crimp of tube.

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. When using this product avoid contact with the eyes. Stop use and ask a healthcare professional if ● irritation occurs ● there is no improvement within 4 weeks improvement Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Disclaimer: Do not rely on openFDA 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