FDA.reportPublic FDA data

Defense Antifungal Medicated Bar

Manufacturer
Defense Soap LLC
Effective date
2017-11-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:09:39

Label at a glance#

ProductDefense Antifungal Medicated Bar
Active ingredientTOLNAFTATE
Label structure9 sections

Indications and uses

Proven clinically effective in the treatment of most athlete's foot (tinea pedis) & ringworm (tinea corporis). For effective relief of itching, burning & cracking.

Dosage and administration

Wash affected area well and let product sit 1-2 minutes before rinsing. Make sure to dry affected area thoroughly. Supervise children in the use of this product. For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily. Use 1-2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor. This prod...

Storage and handling

Store between 20 to 25C (68 to 77F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • Proven clinically effective in the treatment of most athlete's foot (tinea pedis) & ringworm (tinea corporis).
  • For effective relief of itching, burning & cracking.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

When using this product avoid contact with the eye

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

Do not use

OTC - DO NOT USE SECTION

Do Not use on children under 2 under of age except under the advice and supervision of a doctor.

Keep out of reach of children.

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

  • Wash affected area well and let product sit 1-2 minutes before rinsing.
  • Make sure to dry affected area thoroughly. Supervise children in the use of this product.
  • For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
  • Use 1-2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor.
  • This product is not effective on the scalp or nails.

Other information

STORAGE AND HANDLING SECTION

Store between 20 to 25C (68 to 77F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Sodium Gluconate, Eucalyptus Globulus Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Palm Acid, Sodium Chloride, Palm Kernel Acid

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tolnaftate 1%

Antifungal
Medicated Bar Soap
Cures and Prevents Most Fungal Skin Infections, Including Athlete’s Foot, Ringworm and Tinea Versicolor.

External boxExternal box

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70856-3434-32026-01-06C16284748780-1f386c649-f190-0266-e053-dadaa90a7c1aDefense Antifungal Medicated Bar
70856-3434-32023-01-30C16284748780-1f386c649-f190-0266-e053-dadaa90a7c1aDefense Antifungal Medicated Bar

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70856-3434DEFENSE ANTIFUNGAL MEDICATED BAR (TOLNAFTATE) SOAP [DEFENSE SOAP LLC]2Legacy NDC20171130_38fd2c97-cd43-2f7d-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70856-343470856-3434-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTUS OIL2R04ONI662IACT
WATER059QF0KO0RIACT
SODIUM PALMATES0A6004K3ZIACT
SODIUM GLUCONATER6Q3791S76IACT
SODIUM PALM KERNELATE6H91L1NXTWIACT
GLYCERINPDC6A3C0OXIACT
TOLNAFTATE06KB629TKVACTIB
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
PALM ACIDB6G0Y5Z616IACT
SODIUM CHLORIDE451W47IQ8XIACT
PALM KERNEL ACID79P21R4317IACT

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
46bac10f-6181-41c5-e063-6294a90a115d38fd2c97-cd43-2f7d-e054-00144ff8d46c2025-12-24WarningsExact identifier
spl set id: 38fd2c97-cd43-2f7d-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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