PREQUEL BARRIER CREAM- skin protectant cream cream

Prequel Barrier Cream by

Drug Labeling and Warnings

Prequel Barrier Cream by is a Otc medication manufactured, distributed, or labeled by The Center Brands, LLC, Westwood Laboratories, LLC, Westwood Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PREQUEL BARRIER CREAM 
skin protectant cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82800-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETEARETH-25 (UNII: 8FA93U5T67)
SOY STEROL (UNII: PL360EPO9J)
CAPROOYL PHYTOSPHINGOSINE (UNII: 2FD4Y5XL2L)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
ALLANTOIN (UNII: 344S277G0Z)
ADENOSINE (UNII: K72T3FS567)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE EOS (UNII: CR0J8RN66K)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)
CERAMIDE NP (UNII: 4370DF050B)
GLYCERIN (UNII: PDC6A3C0OX)
SHEA BUTTER (UNII: K49155WL9Y)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SORBITAN OLIVATE (UNII: MDL271E3GR)
N-HEXANOYLSPHINGOSINE (UNII: 038753E78J)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CERAMIDE 2 (UNII: C04977SRJ5)
WATER (UNII: 059QF0KO0R)
CERAMIDE 1 (UNII: 5THT33P7X7)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BEHENIC ACID (UNII: H390488X0A)
SOYBEAN OIL (UNII: 241ATL177A)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SAFFLOWER OIL (UNII: 65UEH262IS)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
HYDROGENATED PALM KERNEL GLYCERIDES (UNII: UM8Y22J4JW)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82800-009-01	296 g in 1 TUBE; Type 0: Not a Combination Product	08/23/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	08/23/2023	08/31/2026

Labeler - The Center Brands, LLC (076228814)

Registrant - Westwood Laboratories, LLC (832280635)

Establishment
Name	Address	ID/FEI	Business Operations
Westwood Laboratories		832280635	manufacture(82800-009) , label(82800-009) , pack(82800-009)