FDA.reportPublic FDA data

Initial Drug Listing - RoyceDerm Rosacea Treatment Cream

Manufacturer
RoyceDerm LLC
Effective date
2025-09-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:15:04

Label at a glance#

ProductRoyceDerm Rosacea Treatment Cream.
Active ingredientSULFUR
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sulphur 1X HPUS*(10%)

OTC - PURPOSE SECTION

Rosacea/acne treatment

DOSAGE & ADMINISTRATION SECTION

  • Protects and helps relieve red, irritated, or sensitive skin
  • Reduce visible dryness and discomfort
  • Helps improve the lookuneven skin tone

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

conduct a patch test on a small area of skin, such as in front of the ear or under the jawline. Avoid contact with eyes. lf contact occurs, rinse thoroughly with water.

OTC - DO NOT USE SECTION

  • On damaged or wounded skin
  • large areasof skin

OTC - ASK DOCTOR SECTION

condition worsens or persists for more than 7 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)

INDICATIONS & USAGE SECTION

  • Cleanse and dry skin.
  • Apply a thin layer toaffected areas.
  • Use thrice daily or as directed by a doctor.

OTHER SAFETY INFORMATION

store at room temperature.

INACTIVE INGREDIENT SECTION

Aqua, Propylene Glycol, Cetearyl Alcohol,Niacinamide, lsohexadecane, Ethylhexyl Palmitate, Azelaic Acid, Caprylic/Capric Triglyceride, Hydroxypropyl Cyclodextrin, Dimethicone, Disodium Phosphate, Glyceryl Stearate, Panthenol, Polyacrylate Crosspolymer-6, Ceteareth-25, Potassium Cetyl Phosphate, Allantoin, Cetearyl Glucoside.PEG-100 Stearate, Phenoxyethanol, Methyl Cyclodextrin, 1,2-Hexanediol,Centella Asiatica Extract, Chlorphenesin, Xanthan Gum, Aloe Barbadensis Extract, Camellia Sinensis Leaf Extract, Glycerin, Acacia Senegal Gum,Maltodextrin, Butylene Glycol, Pentylene Glycol, Betaine Salicylate,Sodium Hyaluronate, Sodium Acetylated Hyaluronate, Sodium Hyaluronate Crosspolymer, Hydroxyacetophenone, Hydrolyzed Sodium Hyaluronate, Phosphatidylcholine, Ethylhexylglycerin,Ceramide NP, Beta-Glucan, Sodium Stearoyl Glutamate

OTC - QUESTIONS SECTION

Email service@roycederm.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-009-01RoyceDerm Rosacea Treatment Cream.114 g in 1 CARTONCREAM1141

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85424-00985424-009-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
SULFUR70FD1KFU70ACTIB
CETEARYL ALCOHOL2DMT128M1SIACT
TRANSFORMING GROWTH FACTOR BETA RECEPTOR TYPE 318YWT2KYS8IACT
ETHYLHEXYL PALMITATE2865993309IACT
DIMETHICONE92RU3N3Y1OIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
LYSOPHOSPHATIDYLCHOLINE, SOYBEANCQD833204ZIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
PENTYLENE GLYCOL50C1307PZGIACT
HYALURONATE SODIUMYSE9PPT4THIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ISOHEXADECANE918X1OUF1EIACT
PANTHENOLWV9CM0O67ZIACT
SODIUM ACETYLATED HYALURONATEWN66R7GL93IACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
CERAMIDE NP4370DF050BIACT
HYDROXYPROPYL BETADEX1I96OHX6EKIACT
ACACIA SENEGAL GUM5C5403N26OIACT
BETAINE SALICYLATEDRF395F9AYIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
AZELAIC ACIDF2VW3D43YTIACT
DISODIUM PHOSPHATE22ADO53M6FIACT
XANTHAN GUMTTV12P4NEEIACT
NIACINAMIDE25X51I8RD4IACT
AQUA059QF0KO0RIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
ALLANTOIN344S277G0ZIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
PEG-100 STEARATEYD01N1999RIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
CHLORPHENESINI670DAL4SZIACT
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
POLYACRYLATE CROSSPOLYMER-6Q7UI015FF9IACT
CETEARETH-258FA93U5T67IACT
MALTODEXTRIN7CVR7L4A2DIACT
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER788QAG3W8AIACT
GLYCERYL STEARATE230OU9XXE4IACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT

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
RoyceDerm Rosacea Treatment Cream.SULPHUR 1X HPUS(10%)RoyceDerm LLC3df717fc-cf2f-8a9a-e063-6394a90ae4e22025-09-04WarningsExact identifier
ndc (package): 85424-009-01
ndc (product): 85424-009
ndc11 (package): 85424000901
spl id: 3df717fc-cf30-8a9a-e063-6394a90ae4e2
spl set id: 3df717fc-cf2f-8a9a-e063-6394a90ae4e2

Reported adverse events (FAERS/openFDA)#

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