Purpose
Skin Protectant
Prequel Barrier Therapy Rich Skin Protectant Cream
FDA Label NDC 82800-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Center Brands, Llc for the product Prequel Barrier Therapy Rich Skin Protectant Cream (NDC 82800-100). 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 purpose, active ingredients, uses, warnings, keep out of reach of children., directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Colloidal Oatmeal 1.0%
Uses
Temporarily protects and helps releive minor skin irritation and itching due to:
-rashes
-eczema
-poison ivy, oak, or sumac
-insect bites
Warnings
Fox external use only.
When using this product do not get into eyes
Stop use and ask a doctor if condition worsens
symptoms last more than 7 days or clear up and occur again within a few days
If swallowed, get medial help or contact a Poison Control Center right away.
Keep Out Of Reach Of Children.
Keep out of reach of children.
Directions
Apply as needed.
Inactive Ingredients
Water (Aqua), Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Glycerin, Caprylic/Capric Triglyceride, Dimethicone, Butyrospermum Parkii (Shea) Butter, Cetearyl Olivate, C10-18 Triglycerides, Sorbitan Olivate, Adenosine, Allantoin, Behenyl/Oleyl Behenate/Oleate Esters, Ceramide NP, Ceramide NS, Ceramide AP, Ceramide EOP, Ceramide EOS, Cholesterol, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Phospholipids, Glycolipids, Sodium Stearoyl Glutamate, Behenic Acid, Ceteareth-25, Glycine Soja (Soybean) Oil, Glycine Soja (Soybean) Sterols, Ascorbyl Palmitate, Tocopherol, Lecithin, Glyceryl Stearate, Glyceryl Oleate, Carbomer, hydroxyacetophenone, Phenoxyethanol, Ethylhexylglycerin, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Sodium Chloride, Lactic Acid, Sodium Hydroxide, Citric Acid.
Other Information
Store in controlled temperatures (4-20C/39-68F). Keep in a dark and dry place,
Questions?
Visit prequelskin.com
Principal Display Panel
82800-100 (82800 100 01)
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