Fungicure

Manufacturer
Denison Pharmaceuticals, LLC.
Effective date
2019-01-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:32:51

Label at a glance#

ProductFungicure Anti-Fungal Wash
Active ingredientSEPIA OFFICINALIS JUICE
Label structure13 sections

Indications and uses

For the treatment of most jock itch (tinea cruris) ringworm (tinea corporis) athlete's foot (tinea pedis) 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 jock itch, use daily for 2 weeks. For ringworm, tinea ve...

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

  • jock itch (tinea cruris)
  • ringworm (tinea corporis)
  • athlete's foot (tinea pedis)
  • 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 2 weeks (4 weeks for ringworm, athlete's foot and tinea versicolor).

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 jock itch, use daily for 2 weeks.
  • For ringworm, tinea versicolor and athlete's foot, use daily for 4 weeks. If condition persists longer, consult a doctor.
  • 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.
  • 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

Fungicure SoapFungicure Soap

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0295-26000295-2600-23

Ingredients#

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

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

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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
80b659ee-5d4e-6f34-e053-2991aa0a7861a438c163-2175-4937-94ed-0064b540b91c2019-01-30WarningsExact identifier
spl id: 80b659ee-5d4e-6f34-e053-2991aa0a7861
spl set id: a438c163-2175-4937-94ed-0064b540b91c

Reported adverse events (FAERS/openFDA)#

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