Otc - Active Ingredient
Sulphur 1X HPUS*(10%)
Roycederm Rosacea Treatment Cream. Cream
FDA Label NDC 85424-009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Roycederm Llc for the product Roycederm Rosacea Treatment Cream. (NDC 85424-009). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, dosage & administration, warnings, otc - when using, otc - do not use, otc - ask doctor, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Otc - When Using
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
- On damaged or wounded skin
- large areasof skin
Otc - Ask Doctor
condition worsens or persists for more than 7 days
Otc - Pregnancy Or Breast Feeding
ask a health professional before
Otc - Keep Out Of Reach Of Children
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
Otc - Questions
Email [email protected]
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