Label: DERMA SANTE ANTI ECZEMA CREAM- 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 June 16, 2022

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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 finalpart34707/01/2022
    Labeler - Hope Science Inc. (049917199)
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