FDA.reportPublic FDA data

NDC更新 - 85424-004

Manufacturer
RoyceDerm LLC
Effective date
2026-02-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:44:09

Label at a glance#

ProductRoyceDerm Tea Tree Oil Antifungal soap.
Active ingredientCLOTRIMAZOLE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

OTC - PURPOSE SECTION

Anti-fungal

INDICATIONS & USAGE SECTION

  • For effective 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 & ADMINISTRATION SECTION

  • Clean the affected area and dry thoroughly.product over the affected area twice daily (morning and night) doctor.
  • Supervise children in the use of this product.
  • For attention to spaces between the toes; wear well-fitting, ventshoes and socks at least once daily.
  • For athlete's foot and rweeks.
  • For jock itch, use daily for 2 weeks.
  • If condition pdoctor.
  • This product is not effective on the scalp or nails.

OTHER SAFETY INFORMATION

  • Store at room temperature
  • Avoid excessive heat and direct sunlight.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

on children under 2 years of age unless directed by adoctor.

OTC - WHEN USING SECTION

When using this product

avoid contact withthe eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if

irritationoccurs, there is no improvement within 4 weeks forathlete's foot or ringworm, there is no improvementwithin 2 weeks for jock itch.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INACTIVE INGREDIENT SECTION

Sodium Myristoyl Glutamate, Sodium Hydroxide, Sorbitol, Glycerin, Water, Propylene Glycol, Sodium Dodecylbenzenesulfonate, Cocos Nucifera (Coconut) OIl, Elaels Guineensis(Palm) Oil, Hamamelis Virginiana (Witch Hazel) Extract, Olea Europaea (Olive) Fruit Oil,Ceramide NP, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Stearic Acid, Lauric Acid, Myristic Acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

antifungal soapantifungal soap

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251267clotrimazole 1 % Medicated Bar SoapPSN4
251267clotrimazole 0.01 MG/MG Medicated Bar SoapSCD4
251267clotrimazole 1 % Medicated Bar SoapSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOTRIMAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850082536085GTIN-13: 0850082536085
EAN-13: 0850082536085
GTIN-12: 850082536085
UPC-A: 850082536085
GTIN storage (14 digits): 00850082536085		package.jpg, screenshot-20260213-084600.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-004-01RoyceDerm Tea Tree Oil Antifungal soap.232 g in 1 CARTONSOAP2324
85424-004-02RoyceDerm Tea Tree Oil Antifungal soap.232 g in 1 CARTONSOAP2324

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85424-00485424-004-01, 85424-004-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCONUT OILQ9L0O73W7LIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM GLUTAMATEW81N5U6R6UIACT
SODIUM DODECYLBENZENESULFONATE554127163YIACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
AQUA059QF0KO0RIACT
WITCH HAZEL101I4J0U34IACT
MYRISTIC ACID0I3V7S25AWIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM MYRISTOYL GLUTAMATEAYU7QD893WIACT
SODIUM MYRISTATE06BLC4V0IVIACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
OLEA EUROPAEA (OLIVE) FRUIT OIL6UYK2W1W1EIACT
CLOTRIMAZOLEG07GZ97H65ACTIB

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
RoyceDerm Tea Tree Oil Antifungal soap.TEA TREE OIL ANTIFUNGAL SOAPRoyceDerm LLC3a6d1e32-a38b-3dde-e063-6394a90a88f32026-02-13WarningsExact identifier
ndc (package): 85424-004-01
ndc (package): 85424-004-02
ndc (product): 85424-004
ndc11 (package): 85424000401
ndc11 (package): 85424000402
spl id: 4ab6a114-2227-d4de-e063-6294a90a9bf6
spl set id: 3a6d1e32-a38b-3dde-e063-6394a90a88f3

Reported adverse events (FAERS/openFDA)#

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