Prequel Barrier Cream
FDA Label NDC 82800-009

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 Cream (NDC 82800-009). 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, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Purpose

Skin Protectant

Active Ingredients

Colloidal Oatmeal 1.00%

Uses

Temporarily protects and helps releive minor skin irritation and itching due:

rashes

eczema

poison ivy, oak, or sumac

insect biktes

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), Carthamus Tinctorius Seed Oil, Cetyl Alcohol, Glycerin, Butyrospermum Parkii Butter, Caprylic/Capric Triglyceride, Dimethicone, C10-18 Trigylcerides, Allantoin, Adenosine, Cetearyl Olivate, Sorbitan Olivate, Ceramide AP, Ceramide EOS, Ceramide EOP, Ceramide NP, Ceramide NS, Cholesterol, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Glycolipids, Phospholipids, Sodium Stearoyl Glutamate, Behenic Acide, Ceteareth-25, Glycine Soja Sterols, Hydrogenated Palm Glycerides, Hydrogenated Palm Kernel Glycerides, Carbomer, Phenoxyethanol, Ethylhexylglycerin, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Sodium Hydroxide

Questions?

Visit prequelskin.com

Principal Display Panel

82800-009-01 (82800 009 01)

82800-009-01 (82800 009 01)

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