Active Ingredient
UNDECYLENIC ACID 25%
Zenjbust Undecylenic Acid 25% Antifungal Pen Liquid
FDA Label NDC 87273-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Xituo Electronics Co., Ltd for the product Zenjbust Undecylenic Acid 25% Antifungal Pen (NDC 87273-006). 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
For the treatment of athlete's foot,jock, itch, and ringworm.
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 the eyes. If contact occurs, rinse thoroughly with water.
Stop Use
Stop use and ask a doctor if irritation occurs, or there is no improvement within 2 weeks for jock itch, or within 4 weeks for athlete's foot and ringworm.
Ask Doctor
Stop use and ask a doctor if irritation occurs, or there is no improvement within 2 weeks for jock itch, or 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
■Read all warnings and directions
■Use only as directed
■Clean the affected area with soap and water and dry thoroughly
■Remove cap from pen, twist the base of the pen, with brush pointing downward, until product is expressed
■Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor
■For athlete's foot, pay special attention to spaces between the toes; wear well-fitting, ventilated shoe, and change shoes and socks at least once daily.
Other Information
■ Store at 15"–30°C (59" – 86°F)
■ Keep cap on pen when not in use
Inactive Ingredients
ISOPROPYL ALCOHOL, ISOPROPYL MYRISTATE, MELALEUCA , ALTERNIFOLIA (TEA TREE) LEAF OIL, EUCALYPTOL
Principal Display Panel
1 (Pack)
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