Initial Drug Listing - RoyceDerm Sulfur Soap Bar
- Manufacturer
- RoyceDerm LLC
- Effective date
- 2025-07-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:09:00
Label at a glance#
ProductRoyceDerm Sulfur Soap.
Active ingredientSULFUR
Label structure10 sections
Contacts and useful links#
Websitewww.roycederm.com
www.roycederm.com
www.roycederm.comLabel contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Sulfur 10.0%
OTC - PURPOSE SECTION
Acne Treatment
OTC - WHEN USING SECTION
For the treatment of acne.
DOSAGE & ADMINISTRATION SECTION
Create a rich lather with the mesh bag, gently apply to affected areas, leaving it on the skin for 3 to 5 minutes. Rinse thoroughly with waterand pat dry with a clean towel. Incorporate into your routine 1 to 3 times a day, or as directed by a doctor, for optimal results.
OTHER SAFETY INFORMATION
Store at room temperature and out of direct sunlight
OTC - QUESTIONS SECTION
Visit www.roycederm.com
WARNINGS SECTION
- For external use only.
- Apply solely to acne-affected areas.Use caution when combining with other topical acne medications to prevent skin
- irritation and dryness.
- Avoid use on broken or large skin areas.
- Discontinue use and consult a doctor ifexcessive skin irritation occurs.
- When using this product avoid contact with eyes. lf contact occurs, rinse the eyes thoroughly with water.
OTC - STOP USE SECTION
Stop use and ask a doctor if condition worsens or does not improve after regula ruse as directed.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
lf swallowed, get medical help or contact a Poison Control center(1-800-222-1222) right away.
INACTIVE INGREDIENT SECTION
Water, Olea Europaea Fruit Oil, 0,25% Salicylic Acid, Lauric Acid, Stearic Acid,Sorbitol,Glycerin, Cocos Nucifera Oil, Elaeis Guineensis Oil, Botanical Acaricide.Potassium Cocoate, Lanolin, Sophor ajaponica Extract, Aloe Extract, Sulfur Spring Extract, Ginseng, Coleus Forskohlii Root Oil, Tea Tree Essential Oil.
INDICATIONS & USAGE SECTION
Uses for the treatment of acne
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85424-003-01 | RoyceDerm Sulfur Soap. | 232 g in 1 CARTON | SOAP | 232 | 1 |
Products#
Every source-derived product name is available through these pages.
- RoyceDerm Sulfur Soap.
- Sulfur
- WATER
- OLEA EUROPAEA (OLIVE) FRUIT OIL
- STYPHNOLOBIUM JAPONICUM FLOWER BUD
- ALOE
- SORBITOL
- LAURIC ACID
- ELAEIS GUINEENSIS (PALM) OIL
- COCOS NUCIFERA (COCONUT) OIL
- STEARIC ACID
- GLYCERIN
- SALICYLIC ACID
- COLEUS FORSKOHLII ROOT OIL
- POTASSIUM COCOATE
- LANOLIN
- ASIAN GINSENG
- TEA TREE OIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85424-003 | 85424-003-01 |
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 Sulfur Soap. | SULFUR | RoyceDerm LLC | 3a323a77-eff4-973f-e063-6394a90a02a0 | 2025-07-18 | Warnings | 85424-003-01 85424-003 85424000301 3a323a77-eff5-973f-e063-6394a90a02a0 3a323a77-eff4-973f-e063-6394a90a02a0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.