Otc - Active Ingredient
Undecylenic Acid 25% Antifungal
Ponamfo Antifungal Treatment Pen Solution
FDA Label NDC 85959-004
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 Bixiaoyu Trading Co., Ltd. for the product Ponamfo Antifungal Treatment Pen (NDC 85959-004). 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, inactive ingredient, otc - keep out of reach of children, otc - stop use, otc - when using, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
• Help prevent fungal infections. Treats most athlete's foot (tinea pedis) and ringworm (tinea corporis).
• Relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomfort associated with these conditions.
Indications & Usage
Directions
• Clean the affected area and dry thoroughly.
• Apply a thin layer of this product over the 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.
• For athlete's foot and ringworm, use daily for 4 weeks. If the condition persists longer, consult a doctor.
Inactive Ingredient
Laurocapram, Menthol, Mineral Oil, Tea Tree Oil, Tocopherol (Vitamin E).
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if
• Irritation occurs.
• There is no improvement within 4 weeks for athlete's foot or ringworm.
Otc - When Using
Warnings
For external use only.
Other Safety Information
Other Information
• Store at room temperature 15°C–30°C (59°F–86°F).
• Keep tightly closed.
Otc - Do Not Use
Do not use
• On children under 2 years of age unless directed by a doctor.
Warnings
Warnings
For external use only.
Dosage & Administration
• 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.
• For athlete's foot and ringworm, use daily for 4 weeks. If the condition persists longer, consult a doctor.
Package Label.Principal Display Panel
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