Label: DERMA SANTE ANTI ECZEMA CREAM- oatmeal cream

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

Drug Label Information

Updated November 11, 2023

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  • Drug Facts

  • Active Ingredient:

    Colloidal Oatmeal 1.00%

    Purpose:

    Skin Protectant

  • Uses:

    • Temporarily protects and helps relieve minor skin irritations due to: • rashes • eczema • poison ivy oak, or sumac • insect bites

  • Warnings:

    • For external use only.

    When using this product

    • keep out of eyes.

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    • physician if condition worsens; if symptoms last for more than seven days; or if symptoms clear up and occur again within a few days.

    Keep out of reach of children

  • Directions:

    • Apply twice daily as needed.

  • Other Ingredients:

    Aqua (Deionized Water), Calcium Magnesium Inositol Hexaphosphate IP6, Cetearyl Olivate, Cetyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Inositol, Phenoxyethanol, Sorbitan Olivate, Xanthan Gum, Zemea (Corn) Propanediol.

  • Other Information:

    • Protect this product from excessive heat and direct sunlight.

  • Package Labeling:

    Label01

  • INGREDIENTS AND APPEARANCE
    DERMA SANTE ANTI ECZEMA CREAM 
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71970-324
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    INOSITOL (UNII: 4L6452S749)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN (UNII: 0N8672707O)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71970-324-001 in 1 BOX07/01/2022
    159 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01607/01/2022
    Labeler - Hope Science Inc. (049917199)
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