Otc - Active Ingredient
UNDECYLENIC ACID 25%
Sfeixe Antifungal Pen Paste
FDA Label NDC 87259-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zhejiang Joozena Medical Technology Co., Ltd. for the product Sfeixe Antifungal Pen (NDC 87259-001). 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, otc - keep out of reach of children, warnings, indications & usage, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Cures most Athlete's Foot (Tinea Pedis) and Ringworm(Tinea Corporis). Relieves itching, scaling, cracking, burning,redness, sorenes, and irritation and discomfort.Helpsprevent most athlete's foot (dermatophytosis) with daily use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. lf swallowed, get medical helpor contact a Poison Control Center right away.
Warnings
Warnings
For external use only.
Do not use on children under 2 years of age unless directedby a doctor.
When using this product, avoid contact with eyes.Stop use and ask a doctor if irritation occurs, there is noimprovement within 4 weeks (for athlete's foot andringworm).
Indications & Usage
This product is not effective for thetreatment of ringworm of the scalp or nails. For athlete's foot:pay special attention to spaces between the toes, wearwell-fitting, ventilated shoes, and change shoes and socks atleast once daily. To prevent athlete's foot, apply once ortwice daily(morning and/or night). Apply to skin around thenail and cuticle.
Dosage & Administration
For athlete's foot and ringworm: use daily for 4 weeks, Cleanthe affected area and dry thoroughly. Apply a thin layer ofthe product over affected area twice daily (morning andnight) or as directed by a doctor. Supervise children in theuse of this product,
Inactive Ingredient
water, euphorbia hirta whole, glycerin,hydracrylic acid,pseudolarix amabilis bark, resorcinol,
Package Label.Principal Display Panel
Labeling (87259 001 01)
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