ROYCEDERM ROSACEA RELIEF CREAM.- sulfur 1x hpus 10% cream

RoyceDerm Rosacea Relief Cream. by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Sulfur 1X HPUS 10%

PURPOSE

Skin relief

DOSAGE & ADMINISTRATION

Temporarily relieves minor redness and skin discomfort associated with rosacea.

WARNINGS

For external use only.

• on damaged or broken skin
• if you are allergic to sulfur or any of this product's ingredients.

• avoid contact with eyes
• do not apply to large areas of skin.

Stop use andask a docor if

symptomspersist for more than 7 days or worsen.

ask a health professional before use.

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

• Cleanse and dry skin before application.
• Apply a thin layer to affected area up tothree times daily.

OTHER SAFETY INFORMATION

Store at room temperature.

INACTIVE INGREDIENT

Aqua, Propylene Glycol, Cetearyl Alcohol, Niacinamide, Isohexadecane, 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 Stearovl Glutamate

QUESTIONS

• Visit www.roycederm.com
• Tel: +(307)461-0958

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYCEDERM ROSACEA RELIEF CREAM. 
sulfur 1x hpus 10% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85424-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	1 [hp_X]  in 114 g

Inactive Ingredients
Ingredient Name	Strength
AQUA (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOHEXADECANE (UNII: 918X1OUF1E)
PANTHENOL (UNII: WV9CM0O67Z)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
DISODIUM PHOSPHATE (UNII: 22ADO53M6F)
CERAMIDE NP (UNII: 4370DF050B)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ALLANTOIN (UNII: 344S277G0Z)
SODIUM HYALURONATE CROSSPOLYMER-1 (UNII: 4D4QKG9VN2)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CAMELLIA SINENSIS LEAF OIL (UNII: VC855RRT77)
CENTELLA ASIATICA LEAF WATER (UNII: C4TH45M3K8)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CHLORPHENESIN (UNII: I670DAL4SZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BETAINE SALICYLATE (UNII: DRF395F9AY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYACRYLATE CROSSPOLYMER-6 (UNII: Q7UI015FF9)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
AZELAIC ACID (UNII: F2VW3D43YT)
ACACIA SENEGAL GUM (UNII: 5C5403N26O)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
NIACINAMIDE (UNII: 25X51I8RD4)
HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)
CETEARETH-25 (UNII: 8FA93U5T67)
XANTHAN GUM (UNII: TTV12P4NEE)
1,3-BETA-GLUCAN SYNTHASE COMPONENT FKS1 (UNII: 4FRY3LJG0V)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
O-METHYL-.BETA.-CYCLODEXTRIN (1.8 METHYLS PER SACCHARIDE) (UNII: F9TVU546K5)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PEG-100 STEARATE (UNII: YD01N1999R)
2-HYDROXYACETOPHENONE (UNII: DQ1N9R01IA)
HYDROLYZED SODIUM HYALURONATE 10 (UNII: AAZ2QV38TA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85424-018-01	114 g in 1 CARTON; Type 0: Not a Combination Product	03/26/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	03/26/2026

Labeler - RoyceDerm LLC (130329531)