Otc - Active Ingredient
Undecylenic Acid 25%W/W
Purpose Antifungal
Fgper Topical Antifungal Pen Liquid
FDA Label NDC 85593-126
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 Chuanma International Trading Co.,ltd. for the product Fgper Topical Antifungal Pen (NDC 85593-126). 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, dosage & administration, indications & usage, 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
treats most athlete's foot (tinea pedis),jock itch (tinea cruris), and ringworm(tinea corporis)
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.
Warnings
WarningsFor external use only.
Do not use on children under 2 years of age unless directed by a doctor
When using this product avoid contact with the eyes.
Dosage & Administration
Stop use and aska doctor if irritation occurs; there is noimprovement within 4 weeks for athlete's foot or ringworm;or there is no improvement within 2 weeks for jock itch.
Indications & Usage
Directions
·wash the affected area and dry thoroughlyremove cap, hold brush downward, and twist base slowly until productreaches brushapply a thin layer over affected area twice daily, morning and night, oras directed byadoctor
supervise children in the use of this productfor athlete's foot, pay special attention to spaces between the toes;wear well-fiting,ventilated shoes and change shoes and socks at leastonce dailyfor athlete's foot and rinaworm. use daily for 4 weks,for jock itch, usedail for 2 weeksif condition persists longer, consult a doctorthis product is not effective on the scalp or nails
Inactive Ingredient
Inactive ingredients
ISOPROPYL ALCOHOL, ISOPROPYL MYRISTATE, MELALEUCAALTERNIFOLIA (TEA TREE) LEAF OIL, EUCALYPTOL
Package Label.Principal Display Panel
Package (85593 126 01)
Package (85593 126 01)
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