Purpose
Skin Protectant
Prequel Skin Utility Balm Multi-purpose Skin Protectant Ointment
FDA Label NDC 82800-060
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 Skin Utility Balm Multi-purpose Skin Protectant (NDC 82800-060). 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. if swallowed, get medical help or contact a poison control center right away., 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
Dimethicone 5.25%
Uses
Temporarily protects and helps releive chafed, chapper or cracked skin
Helps protect fomr the drying effects of wind and cold weather
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
Keep Out Of Reach Of Children. If Swallowed, Get Medical Help Or Contact A Poison Control Center Right Away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Apply as needed.
Inactive Ingredients
Water (Aqua), Propanediol, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Undecane, Glycerin, Dipentaerythryityl Hexahydrostearate/Hexastearate/Hexarosinate, Isosorbate Dicaprylate, Cetearyl Olivate, Tridecane, Sorbitan Olivate, Silica, Ceramide NP, Cholesterol, Phytospingosine, Hydrogentaed Lecithin, Centella Asiatica Extract, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ammonium Acryloyldimethyltuarate/VP Copolymer, Hydrogenated Polydecene, Xanthan Gum, Stearic Acid, Sodium Phytate, Tocopheryl Acetate, Camomilla Recutita Flower Extract, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Ethylhexylglycerin, Citric Acid, Caprylic/Capric Trigylceride, Lactic Acid, Oleic Acid, Laureth-8, Caprylyl Glycol, Caprylhydroxamic Acid, Tocopherol, Potassium Sorbate, Sodium Benzoate, Sodium Sulfate, t-Butyl Acohol
Other Information
• Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place.
Questions?
Visit prequelskin.com
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