Active Ingredient
Undecylenic Acid 25%
Beukow Antifungal Pen Liquid
FDA Label NDC 85248-200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Beukow Antifungal Pen (NDC 85248-200). 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.
Label Section Quick Index
Purpose
Antifungal
Use
Helps prevent fungal infections, including tinea pedis (toenail onychomycosis). Relieves itching, burning, and cracking. Cures athlete’s foot.
Warnings
For external use only.
Do Not Use
If pregnant or breastfeeding, consult a healthcare professional before use.
Do not use on children under 2 years of age unless directed by a doctor.
When Using
avoid contact with eyes.
Use only as directed by a doctor on persons with highly sensitive skin.
Stop Use
if there is no improvement within 4 weeks or if irritation occurs.
Ask Doctor
if there is no improvement within 4 weeks or if irritation occurs.
Keep Out Of Reach Of Children
If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.
Directions
Prep: Wash the affected area with soap and water. Soak the nail to soften it.
For toenail fungus:
Gently file thickened areas of the nail every 2-3 days (avoid damaging nail bed).
Apply a thin layer over the entire nail surface, under the nail edge, and around the cuticle.
Use twice daily: morning and evening for at least 6 weeks.
For best results, continue use for 3-6 months or as directed by a doctor.
For athlete’s foot:
Apply to affected areas and between toes.
Allow product to dry fully before putting on socks or shoes.
Other Information
Store at room temperature 15°C-30°C (59°F-86°F).
Close cap tightly after each use.
Keep away from direct sunlight and excessive moisture.
Inactive Ingredients
Almond Oil, Tea Tree Oil, Mineral Oil, Peppermint Oil, Tocopherol (Vitamin E).
Principal Display Panel
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