Active Ingredient (In Each Gram)
Tolnaftate 1%
Tolnaftate
FDA Label NDC 63941-354
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Valu Merchandisers, Co. for the product Tolnaftate (NDC 63941-354). 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 (in each gram), purpose, uses, warnings, when using this product, stop use and ask a doctor if, do not use, 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
- clinically proven to cure most athlete's foot (tinea pedis) and ringworm (tinea corporis)
- helps prevnet most athlete's foot from recurring when used daily
- effectively soothes and relieves symptoms of athlete's foot, including itching, burning and cracking
Warnings
For external use only
When Using This Product
avoid contact with the eyes
Stop Use And Ask A Doctor If
- irritation occurs
- there is no improvement within 4 weeks
Do Not Use
on children under 2 years of age except under the advice and supervision of a doctor.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
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 condition 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
Carbomer, Cetyl alcohol, Cholesterol, Dibasic sodium phosphate hydrate, Glycerin, Glyceryl monostearate, Light liquid paraffin, Myristoyl/palmitoyl oxostearamide/arachamide MEA, PEG-15 glyceryl stearate, Stearic acid, Water
Other Information
- store between 2 and 30C (36 and 86F)
Package Label
Best Choice Tolnaftate 1%
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