Label: JOSIE MARAN INTENSIVE DAILY REPAIR BODY BUTTER -VANILLA AND SHEA- colloidal oatmeal 0.8% cream

  • NDC Code(s): 54111-165-50
  • 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

    Directions apply as needed.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Aloe Barbadensis Leaf Juice**, Caprylic/Capric Triglyceride**, Argania Spinosa
    Kernel Oil**, Butyrospermum Parkii (Shea) Butter**, Glyceryl Stearate**, Stearyl Alcohol**, Fragrance**,
    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

  • OTHER SAFETY INFORMATION

    Other information
    • Store at room temperature.

  • QUESTIONS

    Questions or comments? Call us at (888) 215-8733
    or visit us at www.josiemaran.com Monday to Friday 6am-6pm PST

  • Product Package

    JOSIE MARAN

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

    Vanilla and Shea

    Net Wt. 170 g | 6 oz.

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

    @josiemaran

    Carton Label

    165-50 170g Crtn Van+Shea

    Jar Label

    165-50 170g Crtn Van+Shea

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  • INGREDIENTS AND APPEARANCE
    JOSIE MARAN INTENSIVE DAILY REPAIR BODY BUTTER -VANILLA AND SHEA 
    colloidal oatmeal 0.8% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-165
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL8.0 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    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 PCA (UNII: E25TY46YTD)  
    XYMENYNIC ACID (UNII: IA0Z48P13W)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54111-165-501 in 1 CARTON07/08/2022
    1170 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01607/08/2022
    Labeler - Bentley Laboratories, LLC (068351753)
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