Initial Drug Listing - Roycederm Rosacea Treatment Cream

Initial Drug Listing - Roycederm Rosacea Treatment Cream
SPL v1
SPL
SPL Set ID 3df717fc-cf2f-8a9a-e063-6394a90ae4e2
Route
TOPICAL
Published
Effective Date 2025-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (11.4 g)
Inactive Ingredients
Cetearyl Alcohol Transforming Growth Factor Beta Receptor Type 3 Ethylhexyl Palmitate Dimethicone 1,2-hexanediol Lysophosphatidylcholine, Soybean Camellia Sinensis Leaf Hydroxyacetophenone Pentylene Glycol Hyaluronate Sodium Propylene Glycol Isohexadecane Panthenol Sodium Acetylated Hyaluronate Sodium Stearoyl Glutamate Ceramide Np Hydroxypropyl Betadex Acacia Senegal Gum Betaine Salicylate Ethylhexylglycerin Azelaic Acid Disodium Phosphate Xanthan Gum Niacinamide Aqua Caprylic/capric Triglyceride Allantoin Cetearyl Glucoside Peg-100 Stearate Centella Asiatica Triterpenoids Chlorphenesin Glycerin Butylene Glycol Polyacrylate Crosspolymer-6 Ceteareth-25 Maltodextrin Peg-9 Diglycidyl Ether/sodium Hyaluronate Crosspolymer Glyceryl Stearate Potassium Cetyl Phosphate Phenoxyethanol Aloe Vera Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-30
Description

Sulphur 1X HPUS*(10%)

Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • Cleanse and dry skin.
  • Apply a thin layer toaffected areas.
  • Use thrice daily or as directed by a doctor.
Dosage and Administration
  • Protects and helps relieve red, irritated, or sensitive skin
  • Reduce visible dryness and discomfort
  • Helps improve the lookuneven skin tone
Description

Sulphur 1X HPUS*(10%)

Section 50565-1

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

Section 50567-7

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.

Section 50569-3

condition worsens or persists for more than 7 days

Section 50570-1
  • On damaged or wounded skin
  • large areasof skin
Section 51727-6

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

Section 51945-4

Section 53413-1

Email [email protected]

Section 53414-9

ask a health professional before

Section 55105-1

Rosacea/acne treatment

Section 55106-9

Sulphur 1X HPUS*(10%)

Section 60561-8

store at room temperature.

Structured Label Content

Indications and Usage (34067-9)
  • Cleanse and dry skin.
  • Apply a thin layer toaffected areas.
  • Use thrice daily or as directed by a doctor.
Dosage and Administration (34068-7)
  • Protects and helps relieve red, irritated, or sensitive skin
  • Reduce visible dryness and discomfort
  • Helps improve the lookuneven skin tone
Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

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.

Section 50569-3 (50569-3)

condition worsens or persists for more than 7 days

Section 50570-1 (50570-1)
  • On damaged or wounded skin
  • large areasof skin
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Email [email protected]

Section 53414-9 (53414-9)

ask a health professional before

Section 55105-1 (55105-1)

Rosacea/acne treatment

Section 55106-9 (55106-9)

Sulphur 1X HPUS*(10%)

Section 60561-8 (60561-8)

store at room temperature.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:06.740116 · Updated: 2026-03-14T23:10:19.800513