Active Ingredient
Tolnaftate 1%
Tolfyra Liquid
FDA Label NDC 85477-331
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oncora Pharma, Llc for the product Tolfyra (NDC 85477-331). 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 active ingredient, purpose, uses, warnings, do not use on, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
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.
Warnings
For external use only
Do Not Use On
children under 2 years of age unless directed by a doctor.
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
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
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.
Use under the direction of a medical practitioner
Other Information
■ Store at 15 - 30°C (59° - 86°F) [see USP Controlled Room Temperature].
■ avoid excessive heat
■ do not use if package is damaged
How Supplied
Tolfyra™ Tolnaftate 1% Antifungal Solution is supplied in a 1 fl oz / 30 mL glass bottle with a screw cap fitted with a brush (NDC 85477-331-01)
Inactive Ingredients
The inactive ingredients in Tolvyra™ (tolnaftate 1% solution) are purified water, PEG-8, cetearyl alcohol, ceteth-20 phosphate, decetyl phosphate, propylene glycol, cocamidopropyl betaine, polysorbate 20, glyceryl stearate, stearyl alcohol, hydroxyethyl cellulose, imidazolidinyl urea, cetyl alcohol, methylparaben, propylparaben, triethanolamine, and citric acid.
Tolfyra™
Manufactured in the USA by:
Oncora Pharma LLC
Dallas TX 75228
For questions or information
call toll-free:
833-242-4493
Pdp (Tolfyra 1)
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