Label: DERMA-E ECZEMA RELIEF- oatmeal cream

  • 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 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 FINALpart34709/01/2020
    Labeler - Topiderm, Inc. (049121643)
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