Label: DERMA-E ECZEMA RELIEF- oatmeal cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 19, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Colloidal Oatmeal 1%

  • Purpose

    Skin protectant

  • Uses

    Temporarily protects and helps relieve minor skin irritation and itching due to Eczema or Rashes.

  • 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 swallowed, get medical help or contact a Poison Control Center immediately

  • Directions

    • Apply as needed to entire body, concentrating on areas of dryness.
  • Inactive ingredients

    Allantoin, Arctium Lappa Root Extract, Arctostaphylos Uva-Ursi Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Glucoside, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower, Coco-Caprylate, Coptis Chinensis Root Extract, Dimethicone, Ethylhexylglycerin, Fagara Zanthoxyloides Fruit Extract, Glycerin, Glyceryl Stearate, Glyceryl Stearate Citrate, Leuconostoc/Radish Root Ferment Filtrate, Melia Azadirachta Leaf, Phenoxyethanol, Potassium Sorbate, Purifed Water, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Tocopheryl Acetate.

  • SPL UNCLASSIFIED SECTION

    Distributed by DERMA E®
    Simi Valley, CA 93065, USA

  • PRINCIPAL DISPLAY PANEL - 113 g Jar Box

    THERAPEUTIC

    100% VEGAN ∙ GMO-FREE
    ECO-ETHICAL
    CRUELTY-FREE
    DOCTOR DEVELOPED

    DOCTOR
    DEVELOPED

    DERMA∙E

    Eczema Relief Cream

    Neem, Burdock & Bearberry Extracts

    For dry skin symptoms associated
    with Psoriasis and Eczema

    4 OZ / 113 g

    Principal Display Panel - 113 g Jar Box
  • INGREDIENTS AND APPEARANCE
    DERMA-E ECZEMA RELIEF 
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-870
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.01 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51326-870-041 in 1 BOX09/01/2020
    1113 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM01609/01/2020
    Labeler - Topiderm, Inc (049121643)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc049121643MANUFACTURE(51326-870)
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