FDA.reportPublic FDA data

Defense Antifungal Medicated Bar

Manufacturer
Defense Soap LLC
Effective date
2026-09-09
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-09-11 03:02:20

Label at a glance#

ProductDefense Antifungal Medicated Bar
Active ingredientTOLNAFTATE
Label structure7 sections

Indications and uses

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

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...

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) and jock itch (tinea cruris).
  • For effective relief of itching, burning and cracking skin.

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 or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.

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.

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, Charcoal Powder

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 Jock Itch.

CartonCarton




DEFENSE SOAP LLC, 3390 LIBERTY ATHENS AVE VERMILLION, OH 44089 866-544-1689

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70856-358170856-3581-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOLNAFTATE06KB629TKVACTIB
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
EUCALYPTUS OIL2R04ONI662IACT
WATER059QF0KO0RIACT
SODIUM GLUCONATER6Q3791S76IACT
SODIUM PALM KERNELATE6H91L1NXTWIACT
GLYCERINPDC6A3C0OXIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
SODIUM CHLORIDE451W47IQ8XIACT
ACTIVATED CHARCOAL2P3VWU3H10IACT
SODIUM PALMATES0A6004K3ZIACT
SODIUM COCOATER1TQH25F4IIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-12-19full-release2026-06-01 01:27:17

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
Defense Antifungal Medicated BarTOLNAFTATEDefense Soap LLC812d78ea-a14a-e3a2-e053-2a91aa0a6ff52026-09-09WarningsExact identifier
ndc (package): 70856-3581-3
ndc (product): 70856-3581
ndc11 (package): 70856358103
spl id: 5b115704-9941-40ec-e063-6394a90a7d9b
spl set id: 812d78ea-a14a-e3a2-e053-2a91aa0a6ff5

Reported adverse events (FAERS/openFDA)#

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