Initial Drug Listing - RoyceDerm Anti-Fungal Cream-177

Manufacturer: RoyceDerm LLC
Effective date: 2026-04-02
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 01:54:50

Label at a glance#

ProductRoyceDerm Anti-Fungal Cream

Active ingredientMICONAZOLE NITRATE

Label structure9 sections

Contacts and useful links#

Websitewww.roycederm.com

www.roycederm.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

OTC - PURPOSE SECTION

Antifungal

DOSAGE & ADMINISTRATION SECTION

For effective treatment of most athlete's foot(tinea pedis), ringworm(tinea corporis) and jockitch(tinea cruris).
For effective relief of itching, burning and cracking skin.

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

Avoid contact with the eye.

OTC - ASK DOCTOR SECTION

Stop and ask a doct if irritation occurs or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot & ringworm.

OTC - DO NOT USE SECTION

Do not use on children under 2 og age except under the advice and supervision of a doctor.

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.

INDICATIONS & USAGE SECTION

Wash affected area well and let product sit 2-3 minutes before rinsing.
Make sure to dry affected area thoroughly.
Supervise children in the useof this product.
For Athlete's foot: pay special attention to the spacesbetween the toes; wear well-fitting, ventilated shoes and change shoes andsocks at least once daily. Use 1-2 times daily.
Use daily for 4 weeks; ifcondition 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°-30°C).

INACTIVE INGREDIENT SECTION

Water, Artemisia Extract, Sophora Flavescens Root Extract, Cnidium Monnieri Fruit Extract, Kochia Scoparia Fruit Extract, Dictamnus Dasycarpus Root Extract, Smilax Glabra Root Extract.

OTC - QUESTIONS SECTION

Visit www.roycederm.com
Tel: +1(307)461-0958

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
998483	miconazole nitrate 2 % Topical Cream	PSN	1
998483	miconazole nitrate 20 MG/ML Topical Cream	SCD	1
998483	miconazole nitrate 2 % Topical Cream	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
MICONAZOLE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0850068161263	GTIN-13: 0850068161263 EAN-13: 0850068161263 GTIN-12: 850068161263 UPC-A: 850068161263 GTIN storage (14 digits): 00850068161263	package.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866a	Product name	1	20140508
5b9a7965-36d2-8412-dcaf-f76a65411611	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85424-021-01	RoyceDerm Anti-Fungal Cream	100 g in 1 CARTON	CREAM	100		1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

RoyceDerm Anti-Fungal Cream
Miconazole nitrate 2%
WATER
BASSIA SCOPARIA FRUIT
CNIDIUM MONNIERI FRUIT OIL
DICTAMNUS DASYCARPUS ROOT
SMILAX GLABRA TUBER
WORMWOOD
SOPHORA FLAVESCENS ROOT
MICONAZOLE NITRATE
MICONAZOLE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
85424-021	85424-021-01

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
BASSIA SCOPARIA FRUIT	04W97Z676Y	IACT
CNIDIUM MONNIERI FRUIT OIL	JK0MS9P8YL	IACT
DICTAMNUS DASYCARPUS ROOT	6153LEN214	IACT
SMILAX GLABRA TUBER	PES3YXA3LR	IACT
WORMWOOD	F84709P2XV	IACT
SOPHORA FLAVESCENS ROOT	IYR6K8KQ5K	IACT
MICONAZOLE NITRATE	VW4H1CYW1K	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RoyceDerm Anti-Fungal Cream	MICONAZOLE NITRATE 2%	RoyceDerm LLC	4e861073-88e8-b2f7-e063-6394a90ab94a	2026-04-02	Warnings	Exact identifier ndc (package): 85424-021-01 ndc (product): 85424-021 ndc11 (package): 85424002101 spl id: 4e861073-88e9-b2f7-e063-6394a90ab94a spl set id: 4e861073-88e8-b2f7-e063-6394a90ab94a

Reported adverse events (FAERS/openFDA)#

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