Otc - Active Ingredient
Tolnaftate 1%
Ezbiort 1% Tolnaftate Nail Essence With Biotin Liquid
FDA Label NDC 85304-032
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Borderless Technology Co., Ltd. for the product Ezbiort 1% Tolnaftate Nail Essence With Biotin (NDC 85304-032). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
Indications & Usage
Antifungal treatment for fingernails,toenails, and surrounding skin.Effective against fungal nails and athlete's foot caused by fungi
Warnings
For external use only.
Otc - Do Not Use
Do not use if you experience any signs of sensitivity or irritation
Otc - When Using
While using this product: Not for use in the eyes, mouth, or vaginal area.
Otc - Stop Use
Stop use and consult a doctor if: If the area of application shows increased irritation If there is Consult a doctor if symptoms worsen. If pregnant or breastfeeding
Otc - Keep Out Of Reach Of Children
If accidental ingestion occurs, seek medical assistance or contact a Poison Control Center immediately.
Dosage & Administration
For athlete's foot and ringworm: use daily for 4 weeks.Clean the affected area and dry thoroughly.
For external use on nails and the immediately adjacent skin only. Twice a day lonce in the morning and once in the evening), apply or spray the medicine on the nails. Afterwards, the medicine will be able to penetrate deeply into the interior of the nails.
If the nail area is infected, spray the medication onto the affected area.
SHAKE WELL BEFORE USE. Store at 5°C to 30°C(41°F to 86F) in a cool dry place. Keep tightly closed and away from sunlight.
Inactive Ingredient
water
euphorbia hirta whole
glycerin
hydracrylic acid
pseudolarix amabilis bark
resorcinol
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Label (Label1)
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