ROYCEDERM ROSACEA TREATMENT CREAM. (sulphur 1x hpus- 10% cream

RoyceDerm Rosacea Treatment Cream. by

Drug Labeling and Warnings

RoyceDerm Rosacea Treatment Cream. by is a Otc medication manufactured, distributed, or labeled by RoyceDerm LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sulphur 1X HPUS*(10%)

PURPOSE

Rosacea/acne treatment

DOSAGE & ADMINISTRATION

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

WARNINGS

For external use only

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.

• On damaged or wounded skin
• large areasof skin

condition worsens or persists for more than 7 days

ask a health professional before

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

INDICATIONS & USAGE

• 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

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

QUESTIONS

Email service@roycederm.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYCEDERM ROSACEA TREATMENT CREAM. 
sulphur 1x hpus(10%) cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85424-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	11.4 g  in 114 g

Inactive Ingredients
Ingredient Name	Strength
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
TRANSFORMING GROWTH FACTOR BETA RECEPTOR TYPE 3 (UNII: 18YWT2KYS8)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DIMETHICONE (UNII: 92RU3N3Y1O)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOHEXADECANE (UNII: 918X1OUF1E)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CERAMIDE NP (UNII: 4370DF050B)
HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)
ACACIA SENEGAL GUM (UNII: 5C5403N26O)
BETAINE SALICYLATE (UNII: DRF395F9AY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
AZELAIC ACID (UNII: F2VW3D43YT)
DISODIUM PHOSPHATE (UNII: 22ADO53M6F)
XANTHAN GUM (UNII: TTV12P4NEE)
NIACINAMIDE (UNII: 25X51I8RD4)
AQUA (UNII: 059QF0KO0R)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
ALLANTOIN (UNII: 344S277G0Z)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
PEG-100 STEARATE (UNII: YD01N1999R)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYACRYLATE CROSSPOLYMER-6 (UNII: Q7UI015FF9)
CETEARETH-25 (UNII: 8FA93U5T67)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85424-009-01	114 g in 1 CARTON; Type 0: Not a Combination Product	09/30/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	09/30/2025

Labeler - RoyceDerm LLC (130329531)

Registrant - RoyceDerm LLC (130329531)