Maximum Strength Anti Fungal Tolnaftate 1%

Manufacturer
Denison Pharmaceuticals, LLC
Effective date
2023-08-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:27:06

Label at a glance#

ProductMaximum Strength Anti Fungal Tolnaftate 1%
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)
  • 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. For toe fungus, apply under nail and around cuticle areas. 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, Benzoic Acid, Caprylyl Glycol, Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked), Citric Acid, Dimethicone 350, Ethylhexyl Glycerin, Eucalyptol, Glycerin, Glyceryl Monostearate, Lavender Oil, Olive Oil, Phenoxyethanol, Poloxamer 188, Purified Water USP, Sodium Hydroxide, Tea Tree Oil, Triethyl Citrate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0295-90170295-9017-07, 0295-9017-02, 0295-9017-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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
01e69332-b21f-e725-e063-6294a90a0c368d6e4450-2d82-c6d9-e053-2995a90adf862023-08-01WarningsExact identifier
spl id: 01e69332-b21f-e725-e063-6294a90a0c36
spl set id: 8d6e4450-2d82-c6d9-e053-2995a90adf86

Reported adverse events (FAERS/openFDA)#

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