FDA.reportPublic FDA data

Prequel Barrier Therapy Rich Skin Protectant Cream

Manufacturer
The Center Brands, LLC
Effective date
2025-12-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:22:46

Label at a glance#

ProductPrequel Barrier Therapy Rich Skin Protectant Cream
Active ingredientOATMEAL
Label structure10 sections

Indications and uses

Temporarily protects and helps releive minor skin irritation and itching due to: -rashes -eczema -poison ivy, oak, or sumac -insect bites

Dosage and administration

Apply as needed.

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1.0%

Uses

INDICATIONS & USAGE SECTION

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

-rashes

-eczema

-poison ivy, oak, or sumac

-insect bites

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

Store in controlled temperatures (4-20C/39-68F). Keep in a dark and dry place,

Questions?

OTC - QUESTIONS SECTION

Visit prequelskin.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

123123

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82800-100-01Prequel Barrier Therapy Rich Skin Protectant Cream296 g in 1 TUBECREAM2963
82800-100-01Prequel Barrier Therapy Rich Skin Protectant Cream1 in 1 PACKAGECREAM13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82800-10082800-100-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
CAPROOYL PHYTOSPHINGOSINE2FD4Y5XL2LIACT
ASCORBYL PALMITATEQN83US2B0NIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
GLYCERYL STEARATE230OU9XXE4IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CARTHAMUS TINCTORIUS WHOLE5EMV416J82IACT
CETYL ALCOHOL936JST6JCNIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
DIMETHICONE92RU3N3Y1OIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
CETEARYL OLIVATE58B69Q84JOIACT
C10-18 TRIGLYCERIDES43AGM4PHPIIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SORBITAN OLIVATEMDL271E3GRIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
CITRIC ACID ACETATEDSO12WL7AUIACT
SODIUM HYDROXIDE55X04QC32IIACT
OATMEAL8PI54V663YACTIB
CERAMIDE APF1X8L2B00JIACT
LACTIC ACID33X04XA5ATIACT
ADENOSINEK72T3FS567IACT
GLYCINE SOJA (SOYBEAN) SEEDL7HT8F1ZODIACT
CARBOMER0A5MM307FCIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
CERAMIDE NSV7M2259XJMIACT
CAPROOYL SPHINGOSINE038753E78JIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
CERAMIDE NP4370DF050BIACT
BEHENIC ACIDH390488X0AIACT
CHOLESTEROL97C5T2UQ7JIACT
CETEARETH-258FA93U5T67IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
GLYCERYL OLEATE4PC054V79PIACT
CERAMIDE EOSCR0J8RN66KIACT
GLYCINE SOJA (SOYBEAN) STEROLSPL360EPO9JIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prequel Barrier Therapy Rich Skin Protectant CreamSKIN PROTECTANT CREAMThe Center Brands, LLC39945806-8f29-020b-e063-6294a90a9fc62025-12-13WarningsExact identifier
ndc (package): 82800-100-01
ndc (product): 82800-100
ndc11 (package): 82800010001
spl id: 45dc65a2-f662-f062-e063-6294a90a813f
spl set id: 39945806-8f29-020b-e063-6294a90a9fc6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.