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#
Contacts and useful links#
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
OTC - QUESTIONS SECTION
Visit
www.roycederm.com
Tel: +1(307)461-0958
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
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| MICONAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0850068161362 | GTIN-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 | 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85424-011-01 | RoyceDerm Tinea Antifungal Cream | 57 g in 1 TUBE | CREAM | 57 | 2 | |
| 85424-011-02 | RoyceDerm Tinea Antifungal Cream | 57 g in 1 CARTON | CREAM | 57 | 2 |
Products#
Every source-derived product name is available through these pages.
- RoyceDerm Tinea Antifungal Cream
- Miconazole nitrate 2%
- MICONAZOLE NITRATE
- MICONAZOLE
- CNIDIUM MONNIERI FRUIT
- WORMWOOD
- SOPHORA FLAVESCENS ROOT
- SMILAX GLABRA WHOLE
- WATER
- BASSIA SCOPARIA POLLEN
- DICTAMNUS DASYCARPUS ROOT
- ARTEMISIA ABROTANUM FLOWERING TOP
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85424-011 | 85424-011-01, 85424-011-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MICONAZOLE NITRATE | VW4H1CYW1K | ACTIB |
| CNIDIUM MONNIERI FRUIT | V1IA3S3CUS | IACT |
| WORMWOOD | F84709P2XV | IACT |
| SOPHORA FLAVESCENS ROOT | IYR6K8KQ5K | IACT |
| SMILAX GLABRA WHOLE | H51N91QNEB | IACT |
| WATER | 059QF0KO0R | IACT |
| BASSIA SCOPARIA POLLEN | 07A108ZKW5 | IACT |
| DICTAMNUS DASYCARPUS ROOT | 6153LEN214 | IACT |
| ARTEMISIA ABROTANUM FLOWERING TOP | QG07G580U0 | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2025-09-30 | monthly-update | 2026-06-03 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| RoyceDerm Tinea Antifungal Cream | MICONAZOLE NITRATE 2% | RoyceDerm LLC | 40089a7d-c893-4e90-e063-6294a90aa6f9 | 2026-05-06 | Warnings | 85424-011-01 85424-011-02 85424-011 85424001101 85424001102 51214ad2-0c70-a6d2-e063-6394a90a9649 40089a7d-c893-4e90-e063-6294a90aa6f9 |
| RoyceDerm tinea ANTIFUNGAL .cream. and .soap. | CREAM AND SOAP | RoyceDerm LLC | 4f4ef2d0-98fa-e791-e063-6394a90a7045 | 2026-04-12 | Warnings | 85424-011-01 85424001101 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
