Initial Drug Listing - RoyceDerm tinea ANTIFUNGAL CREAM and SOAP-176
- Manufacturer
- RoyceDerm LLC
- Effective date
- 2026-04-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:55:49
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Miconazole Nitrate 2%
Clotrimazole 1%
OTC - PURPOSE SECTION
Antifungal
DOSAGE & ADMINISTRATION 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, cracking and discomfort associated with these conditions.
WARNINGS SECTION
- For external use only
- When using this product, avoid contact with the eye.
- Stop and ask a doctor 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.
- Do not use on children under 2 of age except under the advice and supervision of a doctro.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
If swallowed, get medical help or contact a Poision Control Center right away.
INDICATIONS & USAGE SECTION
- Wash the affected area and dry thoroughly.
- Apply a thin layer of the productover affected area twice daily (morning and night) or as directed by a doctor.
- Supervise children in the use of this product.
- For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
- For athlete's foot and ringworm,use daily for 4 weeks;
- For jock itch, use daily for 2 weeks.
- If condition persistslonger, ask a doctor.
- This product is not effective on the scalp or nails.
OTHER SAFETY INFORMATION
Store at room temperature and out of direct sunlight.
INACTIVE INGREDIENT SECTION
Cream:
Water, Artemisia Extract, Sophora Flavescens Root Extract, Cnidium MonnieriFruit Extract, Kochia Scoparia Fruit Extract, Dictamnus Dasycarpus Root Extract,Smilax Glabra Root Extract
Soap:
Sorbitol, Sucrose, Stearic Acid, Propanediol, Sodium Lauroamphoacetate, Water,Lauric Acid, Glycerin, Sodium Hydroxide, Butyrospermum Parkii (Shea) Butter,Aloe Barbadensis Leaf Extract, Potassium Cocoyl Glycinate, Olea Europaea (Olive)Fruit Oil, Sulfur, Fragrance
OTC - QUESTIONS SECTION
Visit:
www.roycederm.com
Tel: +1 (307) 461 0958
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 251267 | clotrimazole 1 % Medicated Bar Soap | PSN | 1 |
| 998483 | miconazole nitrate 2 % Topical Cream | PSN | 1 |
| 251267 | clotrimazole 0.01 MG/MG Medicated Bar Soap | SCD | 1 |
| 998483 | miconazole nitrate 20 MG/ML Topical Cream | SCD | 1 |
| 251267 | clotrimazole 1 % Medicated Bar Soap | SY | 1 |
| 998483 | miconazole nitrate 2 % Topical Cream | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CLOTRIMAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| MICONAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b64d2752-34ef-378a-1f4f-8bff32b0d1ae | Product name | 4 | 20250626 |
| cb7783e0-feaa-7e56-fb3b-d43b6efa77c9 | Product name | 2 | 20250121 |
| f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6 | Product name | 2 | 20151106 |
| 3a55f4fb-5aec-4c88-0ff7-4d608ad4866a | Product name | 1 | 20140508 |
| 5b9a7965-36d2-8412-dcaf-f76a65411611 | Product name | 1 | 20140508 |
| f5395dd2-4395-d8c6-3477-8c2d4a2f951c | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85424-011-01 | RoyceDerm tinea ANTIFUNGAL .cream. and .soap. | 57 g in 1 TUBE | CREAM | 1 g in 57 | 20 mg in 1g | 1 |
| 85424-022-01 | RoyceDerm tinea ANTIFUNGAL .cream. and .soap. | 226 g in 1 CARTON | SOAP | 2 g in 226 | 2.26 g in 226g | 1 |
| 85424-023-01 | RoyceDerm tinea ANTIFUNGAL .cream. and .soap. | 1 in 1 CARTON | KIT | 1 | 1 |
Products#
Every source-derived product name is available through these pages.
- RoyceDerm tinea ANTIFUNGAL .cream. and .soap.
- Cream and Soap
- RoyceDerm Tinea ANTIFUNGAL .soap.
- Clotrimazole 1%
- BUTYROSPERMUM PARKII (SHEA) BUTTER
- FRAGRANCE LAVENDER ORC1800979
- PROPANEDIOL
- SODIUM LAUROAMPHOACETATE
- STEARIC ACID
- SUCROSE
- SORBITOL
- OLEA EUROPAEA (OLIVE) FRUIT OIL
- CLOTRIMAZOLE
- POTASSIUM COCOYL GLYCINATE
- GLYCERIN
- SULFUR
- SODIUM HYDROXIDE
- ALOE VERA LEAF JUICE
- LAURIC ACID
- WATER
- RoyceDerm Tinea Antifungal Cream
- Miconazole nitrate 2%
- SMILAX GLABRA WHOLE
- BASSIA SCOPARIA POLLEN
- DICTAMNUS DASYCARPUS ROOT
- CNIDIUM MONNIERI FRUIT
- WORMWOOD
- MICONAZOLE NITRATE
- MICONAZOLE
- SOPHORA FLAVESCENS ROOT
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85424-023 | 85424-023-01 |
| 85424-022 | 85424-022-01 |
| 85424-011 | 85424-011-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 85424001101 |
| RoyceDerm tinea ANTIFUNGAL .cream. and .soap. | CREAM AND SOAP | RoyceDerm LLC | 4f4ef2d0-98fa-e791-e063-6394a90a7045 | 2026-04-12 | Warnings | 85424-022-01 85424-023-01 85424-011-01 85424-023 85424002301 85424002201 85424001101 4f4ef2d0-98fb-e791-e063-6394a90a7045 4f4ef2d0-98fa-e791-e063-6394a90a7045 |
| RoyceDerm Tinea ANTIFUNGAL .soap. | CLOTRIMAZOLE 1% | RoyceDerm LLC | 4e889f2b-9ea1-b1a6-e063-6394a90a4654 | 2026-04-03 | Warnings | 85424-022-01 85424-022 85424002201 |
