{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Colloidal oatmeal Colloidal oatmeal GLYCERIN DISTEARYLDIMONIUM CHLORIDE PETROLATUM ISOPROPYL PALMITATE CETYL ALCOHOL DIMETHICONE PANTHENOL OAT KERNEL OIL STEARETH-20 BENZALKONIUM CHLORIDE CERAMIDE 3 SODIUM CHLORIDE BENZYL ALCOHOL SODIUM HYDROXIDE OATMEAL OATMEAL WATER"
      ],
      "active_ingredient": [
        "Active ingredient Colloidal oatmeal 1%"
      ],
      "purpose": [
        "Purpose Skin protectant"
      ],
      "indications_and_usage": [
        "Uses temporarily protects and helps relieve minor skin irritation and itching due to: eczema rashes"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "when_using": [
        "When using this product do not get into eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again withing a few days"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions apply as needed"
      ],
      "spl_unclassified_section": [
        "Other information store at room temperature",
        "Disclaimer *This product is not manufactured or distributed by Kenvue, Inc., distributor of Aveeno Baby Eczema Therapy Moisturizing Cream."
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, dimethicone, pathenol, Avena sativa (oat) kernel oil, steareth-20, benzalkonium chloride, ceramide NP, sodium chloride, benzyl alcohol, sodium hydroxide"
      ],
      "adverse_reactions": [
        "Adverse reaction Questions 1-888-593-0593 DISTRIBUTED BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544 www.meijer.com PLASTIC TUBE how2recycle.info OUR QUALITY GUARANTEE The Meijer Family www.meijer.com/satisfaction"
      ],
      "package_label_principal_display_panel": [
        "Principal Panel Display NDC 79481-6601-1 meijer ® baby eczema therapy cream Colloidal Oatmeal Skin Protectant COMPARE TO AVEENO ® BABY ECZEMA THERAPY MOISTURIZING CREAM* Steroid & fragrance free Paraben & phthalate free HYPOALLERGENIC NET WT. 5 OZ (141 g) image description"
      ],
      "set_id": "d36a7479-7b3b-49fe-8144-b5cce0e173fb",
      "id": "4b3406cd-97a0-a919-e063-6294a90a0f95",
      "effective_time": "20260219",
      "version": "4",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Colloidal oatmeal"
        ],
        "generic_name": [
          "COLLOIDAL OATMEAL"
        ],
        "manufacturer_name": [
          "Meijer, Inc."
        ],
        "product_ndc": [
          "79481-6601"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "rxcui": [
          "240651"
        ],
        "spl_id": [
          "4b3406cd-97a0-a919-e063-6294a90a0f95"
        ],
        "spl_set_id": [
          "d36a7479-7b3b-49fe-8144-b5cce0e173fb"
        ],
        "package_ndc": [
          "79481-6601-1"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185371",
          "N0000185375",
          "N0000175629",
          "N0000184306",
          "M0000728",
          "M0006342",
          "M0016962",
          "N0000185016"
        ],
        "pharm_class_epc": [
          "Non-Standardized Food Allergenic Extract [EPC]",
          "Non-Standardized Plant Allergenic Extract [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Dietary Proteins [CS]",
          "Plant Proteins [CS]"
        ],
        "unii": [
          "8PI54V663Y"
        ]
      }
    }
  ]
}