FDA.reportPublic FDA data

85593-126-01 Topica lAntifungal Pen

Manufacturer
Guangzhou ChuanMa International Trading Co.,Ltd.
Effective date
2026-09-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-08 02:02:16

Label at a glance#

ProductFGPER Topical Antifungal Pen
Active ingredientUNDECYLENIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25%W/W
Purpose Antifungal

OTC - PURPOSE SECTION

treats most athlete's foot (tinea pedis),jock itch (tinea cruris), and ringworm(tinea corporis)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control
Center right away.

WARNINGS SECTION

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 SECTION

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 SECTION

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 SECTION

Inactive ingredients

ISOPROPYL ALCOHOL, ISOPROPYL MYRISTATE, MELALEUCAALTERNIFOLIA (TEA TREE) LEAF OIL, EUCALYPTOL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage85593-126-0185593-126-01

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85593-12685593-126-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
UNDECYLENIC ACIDK3D86KJ24NACTIB
ISOPROPYL ALCOHOLND2M416302IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
EUCALYPTOLRV6J6604TKIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FGPER Topical Antifungal PenUNDECYLENIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.5abdcbff-6ab1-2f0a-e063-6294a90a57ef2026-09-05WarningsExact identifier
ndc (package): 85593-126-01
ndc (product): 85593-126
ndc11 (package): 85593012601
spl id: 5abdcbff-6ab2-2f0a-e063-6294a90a57ef
spl set id: 5abdcbff-6ab1-2f0a-e063-6294a90a57ef

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.