FDA.reportPublic FDA data

Prequel Barrier Cream

Manufacturer
The Center Brands, LLC | Westwood Laboratories, LLC | Westwood Laboratories
Effective date
2025-10-31
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:42:12

Label at a glance#

ProductPrequel Barrier Cream
Active ingredientOATMEAL
Label structure9 sections

Indications and uses

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

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 1.00%

Uses

INDICATIONS & USAGE SECTION

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

rashes

eczema

poison ivy, oak, or sumac

insect biktes

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

SPL UNCLASSIFIED SECTION

Visit prequelskin.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82800-009-0182800-009-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN9
240651colloidal oatmeal 10 MG/ML Topical CreamSCD9
240651Avena sativa 1 % Topical CreamSY9
240651colloidal oatmeal 1 % Topical CreamSY9

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82800-009-01Prequel Barrier Cream296 g in 1 TUBECREAM2969

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82800-00982800-009-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETEARETH-258FA93U5T67IACT
SOY STEROLPL360EPO9JIACT
CAPROOYL PHYTOSPHINGOSINE2FD4Y5XL2LIACT
C10-18 TRIGLYCERIDES43AGM4PHPIIACT
ALLANTOIN344S277G0ZIACT
ADENOSINEK72T3FS567IACT
CERAMIDE APF1X8L2B00JIACT
CERAMIDE EOSCR0J8RN66KIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
OMEGA-3 FATTY ACIDS71M78END5SIACT
CERAMIDE NP4370DF050BIACT
GLYCERINPDC6A3C0OXIACT
SHEA BUTTERK49155WL9YIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SORBITAN OLIVATEMDL271E3GRIACT
N-HEXANOYLSPHINGOSINE038753E78JIACT
CETEARYL OLIVATE58B69Q84JOIACT
CERAMIDE 2C04977SRJ5IACT
WATER059QF0KO0RIACT
CERAMIDE 15THT33P7X7IACT
CHOLESTEROL97C5T2UQ7JIACT
BEHENIC ACIDH390488X0AIACT
SOYBEAN OIL241ATL177AIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SAFFLOWER OIL65UEH262ISIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
HYDROGENATED PALM GLYCERIDESYCZ8EM144QIACT
HYDROGENATED PALM KERNEL GLYCERIDESUM8Y22J4JWIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM HYDROXIDE55X04QC32IIACT
OATMEAL8PI54V663YACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-05-01full-release2026-06-01 01:00:16

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
42798d25-77cd-7d3b-e063-6294a90aad52ffc39cf2-617e-1e81-e053-6294a90a075f2025-10-31WarningsExact identifier
spl id: 42798d25-77cd-7d3b-e063-6294a90aad52
spl set id: ffc39cf2-617e-1e81-e053-6294a90a075f

Reported adverse events (FAERS/openFDA)#

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