Active Ingredient
Tolnaftate 1%
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Alveora Nail Fungus Treatment (NDC 85248-033). 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.
Tolnaftate 1%
Antifungal
Cures 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) with daily use.
For external use only.
on children under 2 years of age unless directed by a doctor.
avoid contact with eyes.
irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).
irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).
If swallowed, get medical help or contact a Poison Control Center right away.
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 child ren in the use of this product. This product is not effective for the treatment of ringworm of the scalp or nails. For athlete's foot: pay special attention to spaces between the toes, wear well-fitting, ventil ated 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.
Store at room temperature 15-30℃ (59-86℉)
water, euphorbia hirta whole, glycerin, hydracrylic acid, pseudolarix amabilis bark, resorcinol.
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