Roycederm Tinea Treatment Cream

Manufacturer
Shandong Yuyaotang Pharmaceutical Co., Ltd
Effective date
2024-09-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:21:58

Label at a glance#

ProductRoycederm Tinea Treatment Cream
Active ingredientMICONAZOLE
Label structure14 sections

Dosage and administration

Adult and childrenover 12 years or old. Wash handsbefore and after applying thecream. Apply to affected area atthe first sign of blisters, sores, ortingling sensation. Rub in gentlyand thoroughly. Do not use morethan 3 times daily. Children unde12 years: ask a doctor

Storage and handling

Store atroom temperature and out of directsunlight

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Use

INDICATIONS & USAGE SECTION

Help relieve the itching.discoloration, irritation, anddiscomfort with tinea versicolorcorporis, cruris and tinea pedis.

Warnings

WARNINGS SECTION

for external use only

Do not use

OTC - DO NOT USE SECTION

Children unde12 years: ask a doctor

When Using

OTC - WHEN USING SECTION

avoidcontact with eyes.If contact occurs, rinse the eyesthoroughly with water.

Stop Use

OTC - STOP USE SECTION

if condition worsens or does notimprove after reqular use as directed

Ask Doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if youare allergic to ingredients in thisproduct

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. lfswallowed, get medical help orcontact a Poison Control Cente(1-800-222-1222)right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adult and childrenover 12 years or old. Wash handsbefore and after applying thecream. Apply to affected area atthe first sign of blisters, sores, ortingling sensation. Rub in gentlyand thoroughly. Do not use morethan 3 times daily. Children unde12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

Store atroom temperature and out of directsunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2693771miconazole 2 % Topical CreamPSN1
2693771miconazole 20 MG/ML Topical CreamSCD1
2693771miconazole 2 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

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
84746-003-01Roycederm Tinea Treatment Cream57 g in 1 BOTTLECREAM571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84746-003ROYCEDERM TINEA TREATMENT CREAM CREAM [SHANDONG YUYAOTANG PHARMACEUTICAL CO., LTD]11 package rows20240927_22756ed8-5e38-784a-e063-6394a90a7c02.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84746-00384746-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
22756ed8-5e39-784a-e063-6394a90a7c0222756ed8-5e38-784a-e063-6394a90a7c022024-09-19WarningsExact identifier
spl id: 22756ed8-5e39-784a-e063-6394a90a7c02
spl set id: 22756ed8-5e38-784a-e063-6394a90a7c02

Reported adverse events (FAERS/openFDA)#

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