Active Ingredient
Tolnaftate 1%
Dermfree Fungi Nail Liquid
FDA Label NDC 85248-037
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 Dermfree Fungi Nail (NDC 85248-037). 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
Soothes most Athlete's Foot (Tinea Pedis)and Ringworm (Tinea Corporis).Relieves itching,scaling, cracking, burning, redness, sorenes, and irritation and discomfort. Helps prevent most athlete's foot(dermatophytosis) withdaily use.
Warnings
For external use only.
Do Not Use
on children under 2 years of age unless directed by a doctor.
When Using
avoid contact with eyes.
Stop Use
irritation occurs, there is no improvement with in 4 weeks (for athlete's foot and ringworm).
Ask Doctor
irritation occurs, there is no improvement with in 4 weeks (for athlete's foot and ringworm).This product cannot replace medication
Keep Oot Of Reach Of Children
lf swallowed, get medical help or contact a Poison Control Center right away.
Directions
For athlete's foot and ringworm: use daily for 4 weeks. Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product.This productis not effective for the prevention of ring worm of the scalp or nails. 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. To prevent athlete's foot, apply once or twice daily(morning and/or night).Apply to skin around the nail and cuticle.
Other Information
Store at room temperature 15-30℃(59-86)
Inactive Ingredients
water, euphorbia hirta whole, glycerin,hydracrylic acid,pseudolarix amabilis bark, resorcinol.
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