Active Ingredient
Tolnaftate 1%
Xbofpen Multi-purpose Treatment Liquid
FDA Label NDC 87786-038
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wenzhou Yuyuan Pharmaceutical Co., Ltd. for the product Xbofpen Multi-purpose Treatment (NDC 87786-038). 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, uses, 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
Uses
Relieve most Toenail Fungus, Athlete's Foot and Ringworm .Relieves itching, soreness, discoloration, thickening, and nail brittleness. Prevents recurrence with consistent application.
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 Toenail Fungus athlete's foot and ringworm:
use daily for 4 weeks or more. 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 children in the use of this product.
For athlete's foot: pay special attention to spaces between the toes, wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
To prevent reinfection, continue use for 2 weeks after symptoms resolve. Apply to skin around the nail and cuticle.
Other Information
Store at room temperature 15-30℃ (59-86℉)
Inactive Ingredients
water, euphorbia hirta whole, glycerin, hydracrylic acid, pseudolarix amabilis bark, resorcinol.
Principal Display Panel
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