Label: INTENSIVE DAILY REPAIR BODY BUTTER- colloidal oatmeal cream

  • NDC Code(s): 54111-162-50
  • Packager: Bentley Laboratories, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2023

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  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredient
    Colloidal Oatmeal 0.8%

  • PURPOSE

    Purpose

    Skin protectant

  • INDICATIONS & USAGE

    Uses
    • temporarily protects and helps relieve minor skin irritation and itching due to eczema

  • WARNINGS

    Warnings

    For 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

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

  • DOSAGE & ADMINISTRATION

    HOW TO USE: Apply twice daily or as needed to soothe irritation and itching due to eczema.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Aloe Barbadensis Leaf Juice**, Caprylic/Capric Triglyceride**, Butyrospermum
    Parkii (Shea) Butter**, Argania Spinosa Kernel Oil*, Glyceryl Stearate**, Stearyl Alcohol**, Glycerin**,
    Alpha-Glucan Oligosaccharide**, Diisopropyl Adipate, Glyceryl Behenate**, Sodium Stearoyl Glutamate**,
    Squalane**, Water/Aqua/Eau**, Bisabolol**, Octyldodecyl PCA**, Xymenynic Acid, Citric Acid**,
    Ethylhexylglycerin, Phenoxyethanol.

    *ORGANIC **NATURALLY-DERIVED

  • Product Package

    JOSIE MARAN

    ARGAN APOTHECARY

    Intensive Daily Repair Body Butter
    Eczema Relief with Argan Oil + Colloidal Oatmeal

    10mL | 0.34 fl. oz.

    Dist. by Josie Maran Cosmetics, LLC
    Hollywood, CA 90038
    josiemaran.com | @josiemaran

    162-50 10mL Pakt

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  • INGREDIENTS AND APPEARANCE
    INTENSIVE DAILY REPAIR BODY BUTTER 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-162
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    SQUALANE (UNII: GW89575KF9)  
    WATER (UNII: 059QF0KO0R)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    OCTYLDODECYL BEHENATE (UNII: BZM9WE5P6F)  
    XYMENYNIC ACID (UNII: IA0Z48P13W)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54111-162-5010 mL in 1 PACKET; Type 0: Not a Combination Product02/21/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01602/21/2022
    Labeler - Bentley Laboratories, LLC (068351753)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bentley Laboratories, LLC068351753manufacture(54111-162)
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