Label: PREQUEL SKIN UTILITY BALM MULTI-PURPOSE SKIN PROTECTANT- skin protectant balm ointment

  • NDC Code(s): 82800-060-01
  • Packager: The Center Brands, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2024

If you are a consumer or patient please visit this version.

  • Purpose

    Skin Protectant

  • Active Ingredients

    Dimethicone 5.25%

  • Uses

    Temporarily protects and helps releive chafed, chapper or cracked skin

    Helps protect fomr the drying effects of wind and cold weather

  • 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), Propanediol, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Undecane, Glycerin, Dipentaerythryityl Hexahydrostearate/Hexastearate/Hexarosinate, Isosorbate Dicaprylate, Cetearyl Olivate, Tridecane, Sorbitan Olivate, Silica, Ceramide NP, Cholesterol, Phytospingosine, Hydrogentaed Lecithin, Centella Asiatica Extract, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ammonium Acryloyldimethyltuarate/VP Copolymer, Hydrogenated Polydecene, Xanthan Gum, Stearic Acid, Sodium Phytate, Tocopheryl Acetate, Camomilla Recutita Flower Extract, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Ethylhexylglycerin, Citric Acid, Caprylic/Capric Trigylceride, Lactic Acid, Oleic Acid, Laureth-8, Caprylyl Glycol, Caprylhydroxamic Acid, Tocopherol, Potassium Sorbate, Sodium Benzoate, Sodium Sulfate, t-Butyl Acohol

  • Other Information

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

  • Questions?

    Visit prequelskin.com

  • Principal Display Panel

    82800-060-01.jpg

  • INGREDIENTS AND APPEARANCE
    PREQUEL SKIN UTILITY BALM MULTI-PURPOSE SKIN PROTECTANT 
    skin protectant balm ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82800-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5.25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    UNDECANE (UNII: JV0QT00NUE)  
    DIPENTAERYTHRITYL HEXASTEARATE (UNII: WTF09990PK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOSORBIDE DICAPRYLATE (UNII: 0IK29C4889)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HEXASODIUM PHYTATE (UNII: ZBX50UG81V)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    LAURETH-8 (UNII: QU7U88D04I)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    TERT-BUTYL ACETATE (UNII: 76N22HKP3X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82800-060-011 in 1 PACKAGE10/30/2023
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01610/30/2023
    Labeler - The Center Brands, LLC (076228814)