Otc - Active Ingredient
Sulfur 1X HPUS 10%
Roycederm Rosacea Relief Cream. Cream
FDA Label NDC 85424-018
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 Relief Cream. (NDC 85424-018). 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 - do not use, otc - when using, 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
Skin relief
Dosage & Administration
Temporarily relieves minor redness and skin discomfort associated with rosacea.
Warnings
For external use only.
Otc - Do Not Use
- on damaged or broken skin
- if you are allergic to sulfur or any of this product's ingredients.
Otc - When Using
- avoid contact with eyes
- do not apply to large areas of skin.
Otc - Ask Doctor
Stop use andask a docor if
symptomspersist for more than 7 days or worsen.
Otc - Pregnancy Or Breast Feeding
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
Otc - Questions
- Visit www.roycederm.com
- Tel: +(307)461-0958
Package Label.Principal Display Panel
Package (Package)
* Please review the disclaimer below.
