Active Ingredient
Tolnaftate 1%
Antifungal Liquid
FDA Label NDC 36800-399
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates for the product Antifungal Liquid (NDC 36800-399). 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, when using this product, stop use and consult a doctor if, 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
proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
prevents the recurrence of most athlete's foot with daily use
for effective relief of itching, burning, cracking, redness and scaling
Warnings
For external use only.
Do Not Use
on children under 2 years of age unless directed by a doctor.
When Using This Product
avoid contact with the eyes.
Stop Use And Consult A Doctor If
- irritation occurs
- there is no improvement within 4 weeks
Keep Out Of Reach Of Children.
If accidental ingestion occurs, 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 the affected area twice daily (morning and night) 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
- to prevent athlete's foot: wash the feet and dry thoroughly; apply a thin layer of the product to the feet once or twice daily (morning and/or night)
- this product is not effective on the scalp or nails
Other Information
- SHAKE WELL BEFORE USE
- store at room temperature 15°-30°C (59° - 86°F)
- protect from freezing; if freezing occurs, warm to room temperature
- keep tightly closed when not in use
Inactive Ingredient
WATER, GLYCERIN, SCLEROTIUM GUM, PHENOXYETHANOL, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, XANTHAN GUM
Questions?
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MAXIMUM
STRENGTH
Antifungal
Liquid
TOLNAFTATE 1%/
ANTIFUNGAL
Proven Clinically Effective
in the Treatment of
Fungus on Fingers, Toes
and Skin Around Nails
Prevents the Recurrence
of Most Athlete's Foot
with Daily Use
Relieves Itching, Burning
& Scaling
Built-in Brush for Easy
Application
With Moisturizing
Ingredients
SHAKE WELL BEFORE USE
NET 1 FL. OZ. (30 mL)
* Please review the disclaimer below.
