Active Ingredient
Undecylenic acid 25% Tolnaftate 1%
Htrcsw Fungal Nail Renewal Liquid
FDA Label NDC 85248-217
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 Htrcsw Fungal Nail Renewal (NDC 85248-217). 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
Treats most Athlete's Foot(Tinea Pedis) and Ringworm. Relieves itching, scaling, cracking, burning, redness, soreness, and irritation and discomfort.
Helps prevent most athlete's foot (dermatophytosis) with daily 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 within 4 weeks (for athlete's foot and ringworm).
Ask Doctor
irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).
Keep Out Of Reach Of Children
If 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. Press the pen and apply a thin layer to the affected area twice daily (morning and night) or as directed by a doctor.
Supervise children in the use of this product.
For tinea pedis: Pay special attention to the spaces between toes.
Wear well‑fitting and breathable shoes, and change socks and shoes at least once daily. To prevent tinea pedis, use the spray pen once or twice a day (morning and evening are both acceptable), spraying onto shoes, socks or the skin around the nails.
Other Information
Store at room temperature 15‑30℃ (59‑86℉)
Inactive Ingredients
Tea tree oil, glycerin, polyethylene glycol
Principal Display Panel
25 1 (89a26198a0b99f1b1728fc88da590ebb)
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