Fungicure Athlete's Foot Cream

Manufacturer
Denison Pharmaceuticals, LLC
Effective date
2019-01-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:33:45

Label at a glance#

ProductFungicure Athletes Foot
Active ingredientTOLNAFTATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Tolnaftate 1% w/v.

OTC - PURPOSE SECTION

Purpose

Antifungal

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a poison center right away.

INDICATIONS & USAGE SECTION

Uses

For the cure of most:

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

For relief of:

  • itching
  • scaling
  • cracking
  • burning
  • redness
  • soreness
  • irritation
  • discomforts which may accompany these conditions. Clears up most athlete's foot infections and with daily use helps them from coming back.

WARNINGS SECTION

Warnings

For external use only.

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

When using this product avoid contact with the eyes.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

INACTIVE INGREDIENT SECTION

Inactive ingredient

Butylated hydroxytoluene, menthol, PEG-75, PEG-400, titanium dioxide, white petrolatum

DOSAGE & ADMINISTRATION SECTION

Directions

  • Read and all package directions and warnings before use.
  • Use only as directed.
  • Clean the affected area with soap with warm water and dry thoroughly.
  • Apply a thin layer of FUNGICURE over the affected area twice daily (morning and night), or as directed by a doctor.
  • This product is not effective on scalp or nails.
  • 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.
  • For athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.
  • Intented 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 SAFETY INFORMATION

Other information

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

OTC - QUESTIONS SECTION

Questions? 1-800-792-2582

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0295-13900295-1390-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d57d04b4-7c69-82e0-e053-2995a90ab01b7f9b4ea5-e507-2346-e053-2991aa0a0b8b2022-01-13WarningsExact identifier
spl set id: 7f9b4ea5-e507-2346-e053-2991aa0a0b8b

Reported adverse events (FAERS/openFDA)#

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