Otc - Active Ingredient
Colloidal Oatmeal 2%
Roycederm Eczema Relief Body Wash Gel
FDA Label NDC 85424-027
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 Body Wash (NDC 85424-027). 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 - keep out of reach of children, indications & usage, other safety information, inactive ingredient, 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 irritation and itching due to: eczema, rashes
Warnings
For external use only
When using this product
Avoid contact with the eye
Stop and ask a doctor
if condition worsens or symptoms last more than 7 days or symptoms clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
- apply as needed.
- gently massage onto wet skin.
- rinse thoroughly and pat dry.
Other Safety Information
- For mild to moderate eczema. Store at room temperature 59°-85°F(15°-30°C).
- Avoid excessive heat and direct sunlight.
Inactive Ingredient
Water (Aqua), Sodium Laureth Sulfate, AcrylatesCopolymer, Glycerin, Cocamidopropyl Betaine,Sodium Chloride, Lauryl Hydroxysultaine, Sodium Benzoate, Phenoxyethanol, PEG-160 SorbitanTriisostearate, PEG-7 Glyceryl Cocoate, Sodium Hydroxide, Hydroxyethylcellulose, Disodium EDTA.
Otc - Questions
Email: [email protected]
Tel:+(307)461-0958
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