Label: EPIONCE RENEWAL CALMING CREAM- oatmeal cream

  • NDC Code(s): 42673-009-00, 42673-009-01
  • Packager: Episciences, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 20, 2022

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

  • Active ingredient

    Colloidal Oatmeal 0.03%

  • Purpose

    Skin Protectant

  • Uses

    • temporarily protects and helps relieve minor skin irritation and itching due to:
      • rashes
      • eczema
  • 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.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply as needed
  • Inactive ingredients

    Water, Glycerin, Petrolatum, Meadowfoam Seed Oil, Safflower Oil, PPG-2 Myristyl Ether Propionate, Hydrogenated Polybutene (1300MW), Cyclomethicone 5, Rosa Canina Fruit Oil, White Wax, Gluconolactone, Allium Fistulosum Bulb, Alteromonas Ferment Filtrate, Apple, Arachidyl Alcohol, Arachidyl Glucoside, Butylene Glycol, C10-30 Cholesterol/Lanosterol Esters, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Carboxypolymethylene, Ceramide 1, Ceramide AP, Ceramide NP, Cetearyl Glucoside, Cetostearyl Alcohol, Cetyl Alcohol, Cholesterol, Cyclomethicone 4, Cyclomethicone 6, Dimethiconol (14000 CST), Docosanol, Edetate Disodium, Glyceryl Monostearate, Levomenol, Magnesium Salicylate, Magnesium Stearate, Manganese Gluconate, Meadowfoam Estolide, Nymphaea Alba Flower, PEG-100 Stearate, Phytosphingosine, Sodium Benzoate, Sodium Lauroyl Lactylate, Sodium Palmitoyl Proline, Trolamine, Xanthan Gum, Zinc Stearate.

  • Questions?

    Call toll free 1-866-374-6623

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  • INGREDIENTS AND APPEARANCE
    EPIONCE RENEWAL CALMING CREAM 
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42673-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    CERAMIDE NP (UNII: 4370DF050B)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ALLIUM FISTULOSUM BULB (UNII: F8DD33CGGR)  
    APPLE (UNII: B423VGH5S9)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    MAGNESIUM SALICYLATE (UNII: 41728CY7UX)  
    MANGANESE GLUCONATE (UNII: 9YY2F980SV)  
    NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42673-009-011 in 1 BOX09/24/201812/31/2024
    1NDC:42673-009-0030 g in 1 TUBE; Type 7: Separate Products Requiring Cross Labeling
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/24/201812/31/2024
    Labeler - Episciences, Inc. (144733040)
    Establishment
    NameAddressID/FEIBusiness Operations
    Episciences, Inc.144733040manufacture(42673-009)