Tolnaftate Cream 1% Antifungal Cream
FDA Label NDC 69396-042
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa, Llc for the product Tolnaftate Cream 1% Antifungal (NDC 69396-042). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Tolnaftate 1%
Purpose
Anti-Fungal
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.
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.
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 Ingredients
Cetyl alcohol, ethylparaben, glycerol, light mineral oil, glycerol monostearate, petrolatum, purified water, sodium dodecyl sulfate
Other Information
● store between 20° to 25°C ( 68° to 77°F) ● Lot No & Expiration Date: See box or crimp of tube.
Other
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®
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