FDA.reportPublic FDA data

Fungicure

Manufacturer
Kobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC
Effective date
2025-10-21
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 02:37:11

Label at a glance#

ProductFungicure AF Wash
Active ingredientSEPIA OFFICINALIS JUICE
Label structure13 sections

Indications and uses

For the treatment of most athlete's foot (tinea pedis) ringworm (tinea corporis) tinea versicolor For relief of: itching scaling cracking burning redness soreness irritation discomforts which may accompany these conditions.

Dosage and administration

Read all package directions and warnings before use. Use only as directed. Clean the affected area with Fungicure Anti-Fungal Wash and warm water, rinse and dry thoroughly. For best results, leave on for 1-2 minutes before rinsing and drying. Use twice daily (morning and night), or as directed by a doctor. This product is not effective on scalp or nails. For athlete's foot, ringworm and tinea versicolor use daily ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sepia 12x

Purpose

OTC - PURPOSE SECTION

Antifungal treatment

Uses

INDICATIONS & USAGE SECTION

For the treatment of most

  • athlete's foot (tinea pedis)
  • ringworm (tinea corporis)
  • tinea versicolor

For relief of:

  • itching
  • scaling
  • cracking
  • burning
  • redness
  • soreness
  • irritation
  • discomforts which may accompany these conditions.

Warnings

WARNINGS SECTION

For external use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use on children under 2 years of age.

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes.  If contact occurs rinse thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks.

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

  • Read all package directions and warnings before use.
  • Use only as directed.
  • Clean the affected area with Fungicure Anti-Fungal Wash and warm water, rinse and dry thoroughly.
  • For best results, leave on for 1-2 minutes before rinsing and drying.
  • Use twice daily (morning and night), or as directed by a doctor.
  • This product is not effective on scalp or nails.
  • For athlete's foot, ringworm and tinea versicolor use daily for 4 weeks. If condition persists longer, consult a doctor.
  • For athlete's foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • Intended for use by normally healthy adults only.
  • Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
  • Supervise children in the use of this product.

Other information

INFORMATION FOR PATIENTS SECTION

You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Lauramidopropyl betaine, panthenol, phospholipid EFA, purified water, sodium chloride, sodium C14 - 16 olefin sulfonate, tea tree oil.

OTC - QUESTIONS SECTION

Questions?  1-800-792-2582

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FungicureAthletesFootWashPDPFungicureAthletesFootWashPDP

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130072959010669GTIN-13: 0072959010669
EAN-13: 0072959010669
GTIN-12: 072959010669
UPC-A: 072959010669
GTIN storage (14 digits): 00072959010669		T166-5RD.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-666-06FungicureAF Wash177 mL in 1 TUBESOAP1778

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52389-66652389-666-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAURAMIDOPROPYL BETAINE23D6XVI233IACT
PANTHENOLWV9CM0O67ZIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
TEA TREE OILVIF565UC2GIACT
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-05-08full-release2026-06-01 02:26:53

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
Fungicure AF WashSEPIAKobayashi Healthcare International, Inc.6f298fcd-8aba-8f66-e053-2991aa0adb102025-10-21WarningsExact identifier
ndc (package): 52389-666-06
ndc (product): 52389-666
ndc11 (package): 52389066606
spl id: 41ae6d4e-3dcf-cce3-e063-6394a90a36cc
spl set id: 6f298fcd-8aba-8f66-e053-2991aa0adb10

Reported adverse events (FAERS/openFDA)#

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