FDA.reportPublic FDA data

87217-004

Manufacturer
BENLONG HALL LLC
Effective date
2026-09-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-25 02:01:41

Label at a glance#

ProductPureskin Antifungal Pen
Active ingredientUNDECYLENIC ACID
Label structure12 sections

Indications and uses

for the treatment of most athlete's foot, jock itch and ringworm

Dosage and administration

wash the affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) 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; for jock itch, use daily for 2 weeks; if conditio...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • for the treatment of most athlete's foot, jock itch and ringworm

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks for athlete's foot or ringworm; or there is no improvement within 2 weeks for jock itch

Keep out of reach of children

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash the affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • 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; for jock itch, use daily for 2 weeks; if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Inactive ingredients

INACTIVE INGREDIENT SECTION

1,2-Hexanediol, Acacia Senegal Gum, Alcohol, Butylene Glycol, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Disodium EDTA, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Propylene Glycol, Scutellaria Baicalensis Root Extract, Water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeqrco.de/bgsi5dLabel.jpg

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87217-00487217-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
UNDECYLENIC ACIDK3D86KJ24NACTIB
1,2-HEXANEDIOLTR046Y3K1GIACT
ACACIA5C5403N26OIACT
ALCOHOL3K9958V90MIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER2788Z9758HIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
WATER059QF0KO0RIACT

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 3 · 52 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-e063-6294a90a57ef2026-09-05WarningsName fallback
generic name: UNDECYLENIC ACID
JELVOXA ANTIFUNGALUNDECYLENIC ACIDWuhan Ruihengjie Technology Co., Ltd.59a2f16e-ef72-f1cb-e063-6394a90abb282026-08-22WarningsName fallback
generic name: UNDECYLENIC ACID
ANTIFUNGAL NAILUNDECYLENIC ACIDGuangzhou Huanmei Cosmetics Co., Ltd.598b9712-001c-4148-e063-6394a90a97b12026-08-21WarningsName fallback
generic name: UNDECYLENIC ACID
TOTCLEAR NAIL RENEWALUNDECYLENIC ACIDGOOD BRIDGE LLC93605e22-920d-43c3-bb2b-6e3116a19f5e2026-08-12WarningsName fallback
generic name: UNDECYLENIC ACID
TOTCLEAR NAIL RENEWALUNDECYLENIC ACIDGOOD BRIDGE LLCfde7d6ea-1b44-4a88-820a-0f2e033727e12026-08-11WarningsName fallback
generic name: UNDECYLENIC ACID
QualiLife persimmon foot and shoeUNDECYLENIC ACIDGuangdong Aimu Biological Technology Co., Ltd584966c7-ceae-91af-e063-6294a90ac1eb2026-08-10WarningsName fallback
generic name: UNDECYLENIC ACID
Persiancat ANTIFUNGAL PENUNDECYLENIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.58affb96-6cfc-b1fb-e063-6294a90a340c2026-08-10WarningsName fallback
generic name: UNDECYLENIC ACID
FUNGAL NAIL PATCHESUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.5240412c-4257-8e9d-e063-6394a90a0a122026-07-28WarningsName fallback
generic name: UNDECYLENIC ACID
Foot Choice-Nail Fungal PenUNDECYLENIC ACIDFoot Choice LLC4b0036a6-8751-4f44-b6b1-5be57fa92cdc2026-07-17WarningsName fallback
generic name: UNDECYLENIC ACID
FUNGINIX ANTI-FUNGAL TREATMENTUNDECYLENIC ACIDThe Sisquoc Healthcare Corporation92db5433-5a1b-4cb9-b8eb-217c2a807a992026-07-02WarningsName fallback
generic name: UNDECYLENIC ACID
VENROCKUNDECYLENIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.558af06e-6fe1-c926-e063-6394a90a738c2026-07-01WarningsName fallback
generic name: UNDECYLENIC ACID
Remedy NailsUNDECYLENIC ACIDAdwill Labs Inc4e87b76c-c430-466a-bc30-fe1785c7c6602026-06-01WarningsName fallback
generic name: UNDECYLENIC ACID
ANTIFUNGAL PENUNDECYLENIC ACIDGuangzhou Mizi Biotechnology Co., Ltd.52b51877-e04c-569e-e063-6394a90a2fc92026-05-26WarningsName fallback
generic name: UNDECYLENIC ACID
NAIL EXTRA STRENGTH REPAIR PENUNDECYLENIC ACIDGuangzhou Mizi Biotechnology Co., Ltd.52b6208d-53e4-eaa0-e063-6394a90abe7a2026-05-26WarningsName fallback
generic name: UNDECYLENIC ACID
Toenail Fungus Pen PreventativeUNDECYLENIC ACIDGuangzhou Mizi Biotechnology Co., Ltd.52b6766f-948b-2602-e063-6294a90a03cf2026-05-26WarningsName fallback
generic name: UNDECYLENIC ACID
Fungal Nail Repair PenUNDECYLENIC ACIDYunqi Cosmetics (Shenzhen) Co., Ltd523c32f7-b803-bf79-e063-6394a90aad5a2026-05-20WarningsName fallback
generic name: UNDECYLENIC ACID
ANTIFUNGALUNDECYLENIC ACIDChemco Corporation50893584-c1c6-9ffa-e063-6394a90ae1772026-04-29WarningsName fallback
generic name: UNDECYLENIC ACID
Nail Fungal PenUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.4d5b5c22-4781-6391-e063-6294a90a70102026-03-19WarningsName fallback
generic name: UNDECYLENIC ACID
Toenail Fungus PenUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.4d5e256f-7fd5-f903-e063-6394a90a11602026-03-19WarningsName fallback
generic name: UNDECYLENIC ACID
NERANTE FUNGUS NAIL PENUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4ce3984b-53cd-a665-e063-6394a90afe5f2026-03-13WarningsName fallback
generic name: UNDECYLENIC ACID

Reported adverse events (FAERS/openFDA)#

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