Otc - Active Ingredient
Colloidal Oatmeal 1%
Roycederm Eczema Relief Cream
FDA Label NDC 85424-010
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 Eczema Relief Cream (NDC 85424-010). 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 - ask doctor, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Skin Protectant
Dosage & Administration
Temporarily protects and helps relieve minor skin irritationand itching due to Eczema and Rashes
Warnings
For external use only
Otc - When Using
do not get into eyes
Otc - Ask Doctor
condition worsens or symptoms last morethan 7 days or clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Centerright away.(1-800-222-1222)
Indications & Usage
- Conduct a patch test on a small area of skin to checkfor sensitivity or allergic reaction.
- Apply as needed to affectedarea.
- Use 1-2 times daily or as directed by a doctor.
- For childrenunder 6 months of age: ask a doctor.
Other Safety Information
store at room temperature. Avoid excessive heat and direct sunlight.
Inactive Ingredient
Aqua, Butylene Glycol, Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Camellia Japonica Seed Oil,Cetearyl Alcohol, Butyrospermum Parkii (Shea Butter), Tocopheryl Acetate, Cetearyl Glucoside, Panthenol, 1,2-Hexanediol, Hydroxyacetophenone, Ceramide 1, Ceramide 3, Ceramide 6 ll, Ectoin,Carboxymethyl Chitosan, Camellia Sinensis Leaf Extract, Tremella Fuciformis Polysaccharide, Avena Sativa (Oat) Kernel Extract, Aloe Barbadensis Leaf Extract, Portulaca Oleracea Extract, Maltodex-trin, Chrysanthellum Indicum Extract, Houttuynia Cordata ExtractOpuntia Streptacantha Stem Extract, Scutellaria Baicalensis Root Extract, Paeonia Suffruticosa Root Extract, Allantoin, Sodium Hyaluronate, Sodium Polyglutamate, Centella Asiatica Extract, Madecassoside, Asiaticoside
Otc - Questions
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