PREQUEL BARRIER CREAM- skin protectant cream cream 
The Center Brands, LLC

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THE05-Barrier Therapy Skin Protectant Cream

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

PREQUEL BARRIER CREAM 
skin protectant cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82800-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82800-009-01296 g in 1 TUBE; Type 0: Not a Combination Product08/23/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00608/23/2023
Labeler - The Center Brands, LLC (076228814)
Registrant - Westwood Laboratories, LLC (832280635)
Establishment
NameAddressID/FEIBusiness Operations
Westwood Laboratories832280635manufacture(82800-009) , label(82800-009) , pack(82800-009)

Revised: 11/2023
Document Id: 0b26450d-311f-fef1-e063-6394a90a7f6f
Set id: ffc39cf2-617e-1e81-e053-6294a90a075f
Version: 5
Effective Time: 20231127
 
The Center Brands, LLC