Active Ingredient
ZINC UNDECYLENATE 5%
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Beambalm Antifungal Foot Soaking Pack (NDC 85248-192). 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.
ZINC UNDECYLENATE 5%
ANTI-FUNGAL
FOR THE TREATMENT OF MOST ATHLETE'S FOOT (TINEA PEDIS), JOCK ITCH (TINEA CRURIS) AND RINGWORM (TINEA CORPORIS).
FOR EFFECTIVE RELIEF OF ITCHING, CRACKING, BURNING, REDNESS, SORENESS, IRRITATION AND DISCOMFORT
FOR EXTERNAL USE ONLY
DO NOT APPLY TO WOUNDS OR DAMAGED SKIN
IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.
DO NOT USE ON CHILDREN UNDER 2 YEARS OF AGE UNLESS DIRECTED BY A DOCTOR.
DO NOT USE ON CHILDREN UNDER 2 YEARS OF AGE UNLESS DIRECTED BY A DOCTOR.
WHEN USING THIS PRODUCT AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.
IF YOU EXPERIENCE ANY IRRITATION OR DISCOMFORT, PLEASE STOP USING IT AND CONSULT A DOCTOR.
IF YOU EXPERIENCE ANY IRRITATION OR DISCOMFORT, PLEASE STOP USING IT AND CONSULT A DOCTOR.
IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
FILL THE FOOT BASIN WITH WARM WATER AND ADD 2-3 PACKS OF FOOT BATH BAGS TO IT. SOAK YOUR FEET IN IT FOR 30 MINUTES ONCE A DAY. IF YOU WANT TO ENHANCE THE EFFECT
TALCUM POWDER, MUGWORT, SILICON DIOXIDE, SOPHORA FLAVESCENS
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