Maximum Strength Anti Fungal Liquid

Manufacturer
Denison Pharmaceuticals, LLC
Effective date
2019-11-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:58:27

Label at a glance#

ProductMaximum Strength Anti Fungal Liquid
Active ingredientTOLNAFTATE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Tolnaftate 1%

OTC - PURPOSE SECTION

Purpose

Anti-fungal

INDICATIONS & USAGE SECTION

Uses

  • Proven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • Helps prevent most athlete's foot with daily use
  • For effective relief of itching, burning and cracking.

WARNINGS SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Clean affected area with soap and warm water and dry thoroughly.
  • Apply a thin layer of Fungi-Nail® Anti-Fungal Liquid over affected area twice daily (morning and night) or as directed by a doctor.
  • The brush applicator allows for easy application on skin around the nail and cuticle areas.
  • Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • For athlete's foot pay special attention to spaces between the toes.
  • For athlete's foot and ringworm, use daily for 4 weeks.
  • To prevent athlete's foot apply under nail and cuticle area. If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.
  • Supervise children in the use of this product.

OTHER SAFETY INFORMATION

Other information: Store at room temperature 15°-30°C (59°-86°). Protect from freezing. If freezing occurs warm to room temperature.

INACTIVE INGREDIENT SECTION

Inactive ingredient

Aloe Vera Leaf, Dimethicone 350, DMDM Hydantoin, Ededtate Disodium Dihydrate, Eucalyptol, Glycerin, Glyceryl Monostearate, Lavender Oil, Mineral Oil, Olive Oil, PEG 100 Stearate, Phenoxyethanol, Propylene Glycol, Water, Sodium Hydroxide, Tea Tree Oil, Titanium Dioxide, Xanthan Gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0295-90240295-9024-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
97ce14eb-0168-1765-e053-2a95a90a969897ce0989-ecd3-174c-e053-2a95a90a3da92019-11-20WarningsExact identifier
spl id: 97ce14eb-0168-1765-e053-2a95a90a9698
spl set id: 97ce0989-ecd3-174c-e053-2a95a90a3da9

Reported adverse events (FAERS/openFDA)#

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