Label: ATOPIS MED- eczema cream 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 December 3, 2021

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  • Warnings

    For external use only

    When using this product for the first time

    -do an allergy patch test

    Stop use and ask a Doctor if

    -condition worsens

    Keep out of reach of children

  • Uses

    temporarily protects and helps relieve minor skin irritation and itching due to rashes, eczema, insect bites

  • Indications & Usage Section

    Uses temporarily protects and helpsrelieve minor skin irritation and itching due to rashes eczema insect bites

    Directions Apply twice daily for best results

  • OTC Active Ingredient Section

    Colloidal Oats 0.5%

  • Keep Out of Reach of Children

    Keep out of reach of children.

  • Dosage & Administration

    Apply twice daily for best results.

  • Inactive ingredients

    Water, Myrecil, Olivem 1000, Cetearyl alcohol, Endmusol 20D, Macadamia oil, Safflower oil, Shea butter, glycerin, Harakeke gel, Geogard 221, Hyaluronic acid, Lavender oil, Tocopherol acetate, Manuka oil, Manuka honey, Citric acid, Xantham gum

  • box

    box

  • INGREDIENTS AND APPEARANCE
    ATOPIS MED 
    eczema cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65112-269
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.005 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 0.676 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65112-269-0175 g in 1 TUBE; Type 0: Not a Combination Product12/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/31/2021
    Labeler - I Shay Cosmetics Inc (151582384)
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Safety

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