Active Ingredient
Tolnaftate 1%
Iraevanes Antifungal Foot Spray
FDA Label NDC 85248-170
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Iraevanes Antifungal Foot (NDC 85248-170). 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, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Use
·cures and prevents most athlete's foot
·relieves itching, burning, cracking and scaling associated with athlete's foot
Warnings
For external use only.
Do Not Use
·on nails or scalp
·in or near the eyes
·for vaginal yeast infections
When Using
·avoid contact with eyes.
Stop Use
·irritation worsens
·symptoms do not improve after 4 weeks.
Ask Doctor
·irritation worsens
·symptoms do not improve after 4 weeks.
Keep Oot Of Reach Of Children
If swallowed, get medical help or contact
a Poison Control Center (1-800-222-1222)right away.
Directions
·wash affected area and dry thoroughly
·spray a thin layer over affected area twice daily (morning and night)
·pay special attention to spaces between toes
·wear well-fitting, ventilated shoes
·change shoes and socks at least once daily For athlete's foot:
·use daily for 4 weeks
If condition persists longer, consult a doctor.
Other Information
·store at 20-25°C (68-77°F)
·protect from excessive heat
·keep container tightly closed
Inactive Ingredients
Water, Alcohol, Pseudolarix Amabilis Bark Extract, Euphorbia Hirta Extract, Phellodendron Amurense Bark Extract, Sophora Flavescens Root Extract, Benzoic Acid.
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