Label: PREQUEL BARRIER CREAM- skin protectant cream cream

  • NDC Code(s): 82800-009-01
  • Packager: The Center Brands, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 27, 2023

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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