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#
Contacts and useful links#
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
Products#
Every source-derived product name is available through these pages.
- Fungicure Athletes Foot
- Tolnaftate
- PETROLATUM
- BUTYLATED HYDROXYTOLUENE
- MENTHOL
- POLYETHYLENE GLYCOL 3350
- POLYETHYLENE GLYCOL 400
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0295-1390 | 0295-1390-32 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TOLNAFTATE | 06KB629TKV | ACTIB |
| PETROLATUM | 4T6H12BN9U | IACT |
| BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| d57d04b4-7c69-82e0-e053-2995a90ab01b | 7f9b4ea5-e507-2346-e053-2991aa0a0b8b | 2022-01-13 | Warnings | 7f9b4ea5-e507-2346-e053-2991aa0a0b8b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
