Update-RoyceDerm Tinea Antifungal Cream-186

Manufacturer
RoyceDerm LLC
Effective date
2026-05-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:56:01

Label at a glance#

ProductRoyceDerm Tinea Antifungal Cream
Active ingredientMICONAZOLE NITRATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

OTC - PURPOSE SECTION

Antifungal

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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless directed by a doctor.

OTC - WHEN USING SECTION

Avoid contact with the eyes.

OTC - STOP USE SECTION

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.

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 anddry thoroughly.

Apply a thinlayer of the product over affected area twice daily (morning and night) or as directed by a doctor.

Supervise children in the use of this product.

For Athlete'sfoot: pay special attention tothe spaces between the toes;wear well-fitting, ventilated shoesand change shoes and socks atleast once daily.

For athlete'sfoot and ringworm, use daily for4 weeks.

For jock itch, usedaily for 2 weeks.

If condition persists longer, ask a doctor.This product is not effective onthe scalp or nails.

OTHER SAFETY INFORMATION

Store at room temperature

59°-86°F(15°-60°C)

INACTIVE INGREDIENT SECTION

WATER, ARTEMISIA EXTRACT IFHFI], SOPHORA FLAVESCENS ROOT. CNIDIUM MONNIERI FRUITKOCHIA SCOPARIA POLLEN
DICTAMNUS DASYCARPUSROOT, SMILAX GLABRA WHOLE

RECENT MAJOR CHANGES SECTION

Uses
-For effective treatment of mostathlete's foot (tinea pedis),ringworm (tinea corporis) andjock itch (tinea cruris).
For effective relief of itching,burning and cracking skin.

Warnings

For external use only.

When using this product Avoidcontact with the eye

Stop and ask a doctor if
irritation occurs or if there is noimprovement within 2 weeks forjock itch or within 4 weeks forathlete's foot and ringworm.

Do not use on children under 2of age except under the adviceand supervision of a doctor.

Keep out of reach of children. Ifswallowed, get medical help orcontact a Poison Control Centerright away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN2
998483miconazole nitrate 20 MG/ML Topical CreamSCD2
998483miconazole nitrate 2 % Topical CreamSY2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850068161362GTIN-13: 0850068161362
EAN-13: 0850068161362
GTIN-12: 850068161362
UPC-A: 850068161362
GTIN storage (14 digits): 00850068161362
package.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-011-01RoyceDerm Tinea Antifungal Cream57 g in 1 TUBECREAM572
85424-011-02RoyceDerm Tinea Antifungal Cream57 g in 1 CARTONCREAM572

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
85424-01185424-011-01, 85424-011-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-09-30monthly-update2026-06-03 17:38:41

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RoyceDerm Tinea Antifungal CreamMICONAZOLE NITRATE 2%RoyceDerm LLC40089a7d-c893-4e90-e063-6294a90aa6f92026-05-06WarningsExact identifier
ndc (package): 85424-011-01
ndc (package): 85424-011-02
ndc (product): 85424-011
ndc11 (package): 85424001101
ndc11 (package): 85424001102
spl id: 51214ad2-0c70-a6d2-e063-6394a90a9649
spl set id: 40089a7d-c893-4e90-e063-6294a90aa6f9
RoyceDerm tinea ANTIFUNGAL .cream. and .soap.CREAM AND SOAPRoyceDerm LLC4f4ef2d0-98fa-e791-e063-6394a90a70452026-04-12WarningsExact identifier
ndc (package): 85424-011-01
ndc11 (package): 85424001101

Reported adverse events (FAERS/openFDA)#

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