Active Ingredient
Tolnaftate 1%
The following Structured Product Label (SPL) was submitted to the FDA by Wenzhou Yuyuan Pharmaceutical Co., Ltd. for the product Beambalm Antifungal Foot Care Spary (NDC 87786-005). 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
· effective in the treatment of most athlete's foot (tinea pedis). Helps prevent most athlete's foot with daily use
· For effective relief of itching, cracking, burning, scaling and discomfort
For external use only
do not use while smoking or near heat or flame.
on children under 2 years of age unless directed by a doctor.
avoid contact with eyes.
.Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F
·Irritation occurs. There is no improvement within 4 weeks.
·Irritation occurs. There is no improvement within 4 weeks.
If swallowed, get medical help or contact a poison control center right away.
Wash the affected area and dry thoroughly.
Shake can well and spray a thin layer over affected area twice daily (morning and night).
Supervise children in the use of this product.
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, or as directed by a doctor).
This product is not effective on the scalp or nails.
Store between 20-25°C (68-77°F)
alcohol, benzoic acid, euphorbia hirta whole, phellodendron amurense bark, phenylephrine hydrochloride, pseudolarix amabilis bark,tea tree oil, sophora flavescens root
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