FDA.reportPublic FDA data

Antifungal Medicated Bar

Manufacturer
RoyceDerm LLC
Effective date
2025-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:23

Label at a glance#

ProductAntifungal Medicated Bar
Active ingredientTOLNAFTATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

OTC - PURPOSE SECTION

anti-fungal

INDICATIONS & USAGE SECTION

  • Cures & prevents most athlete's foot(tinea pedis), jock itch(tinea cruris) & ringworm (tinea corporis).
  • Relieves itching, irritation, redness, scaling, and discomfort associated with these conditions.

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

on children under 2 years of age except under the advice and supervision of a doctor.

OTC - WHEN USING SECTION

avoid contact with the eyes. If contact occurs, rinse the eyes thoroughly with water.

OTC - STOP USE SECTION

if condition worsens or does not improve after 4 weeks of regular use as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

  • Wash the affected area thoroughly with water.
  • Lather the soap and apply it to the affected area.
  • Allow the lather to sit on the skin for 2-3 minutes before rinsing thoroughly.
  • For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • Use 1-2 times daily for 4 weeks; if the condition persists longer, consult a doctor.
  • Supervise children in the use of this product.

OTHER SAFETY INFORMATION

  • Store at room temperature.
  • Protect from freezing.

INACTIVE INGREDIENT SECTION

Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aqua (Water), Sorbitol, Elaeis Guineensis (Palm) Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Propylene Glycol, Glycerin, Stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzene Sulfonate, Sulfur, Hamamelis Virginiana (Witch Hazel) Extract, Ceramide NP.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

antifungal soapantifungal soap

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1807715tolnaftate 1 % Medicated Bar SoapPSN1
1807715tolnaftate 0.01 MG/MG Medicated Bar SoapSCD1
1807715tolnaftate 1 % Medicated Bar SoapSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-001-01Antifungal Medicated Bar232 g in 1 CARTONSOAP2321

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85424-001ANTIFUNGAL MEDICATED BAR (TOLNAFTATE) SOAP [ROYCEDERM LLC]1Current NDC, 1 package rows20250420_31305ed2-a0a0-6d4c-e063-6294a90a6ba5.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85424-00185424-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOLNAFTATE06KB629TKVACTIB
SODIUM HYDROXIDE55X04QC32IIACT
GLYCERINPDC6A3C0OXIACT
SODIUM DODECYLBENZENESULFONATE554127163YIACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
ELAEIS GUINEENSIS (PALM) OIL5QUO05548ZIACT
LAURIC ACID1160N9NU9UIACT
SODIUM GLUTAMATEW81N5U6R6UIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM MYRISTATE06BLC4V0IVIACT
MYRISTIC ACID0I3V7S25AWIACT
STEARIC ACID4ELV7Z65APIACT
HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF WATER8FP93ED6H2IACT
SORBITOL506T60A25RIACT
OLEA EUROPAEA (OLIVE) FRUIT OIL6UYK2W1W1EIACT
COCOS NUCIFERA (COCONUT) OILQ9L0O73W7LIACT
WATER059QF0KO0RIACT
CERAMIDE NP4370DF050BIACT
SULFUR70FD1KFU70IACT

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
Antifungal Medicated BarTOLNAFTATERoyceDerm LLC31305ed2-a0a0-6d4c-e063-6294a90a6ba52025-03-25WarningsExact identifier
ndc (package): 85424-001-01
ndc (product): 85424-001
ndc11 (package): 85424000101
spl id: 31305ed2-a0a1-6d4c-e063-6294a90a6ba5
spl set id: 31305ed2-a0a0-6d4c-e063-6294a90a6ba5

Reported adverse events (FAERS/openFDA)#

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