{
  "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": "2026-10-29",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Aveeno Baby Eczema Therapy Moisturizing Oatmeal WATER GLYCERIN PANTHENOL DISTEARYLDIMONIUM CHLORIDE PETROLATUM ISOPROPYL PALMITATE CETYL ALCOHOL OAT KERNEL OIL STEARETH-20 BENZALKONIUM CHLORIDE CERAMIDE NP SODIUM CHLORIDE OAT OATMEAL OATMEAL DIMETHICONE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558"
      ],
      "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 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 right away."
      ],
      "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 within 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"
      ],
      "storage_and_handling": [
        "Other information Remove quality seal. Do not use if quality seal is broken. For use on mild to moderate eczema or as directed by a physician. Store at room temperature."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Water, Glycerin, Panthenol, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Dimethicone, Avena Sativa (Oat) Kernel Oil, Steareth-20, Benzalkonium Chloride, Ceramide NP, Sodium Chloride, Avena Sativa (Oat) Kernel Extract"
      ],
      "questions": [
        "Questions? 866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label RECOMMENDED BY PEDIATRICIANS & DERMATOLOGISTS Aveeno® baby NEW LOOK Same Great Formula eczema therapy moisturizing cream colloidal oatmeal skin protectant + vitamin B5 clinically proven to relieve itchy, irritated skin due to eczema ACCEPTED e NATIONALECZEMA.ORG National Eczema Association fragrance-free & steroid-free hypoallergenic 12 FL OZ (354 mL) Aveeno_01"
      ],
      "set_id": "2e07e83c-22dc-d644-e063-6294a90a6833",
      "id": "2e07e828-b377-0232-e063-6394a90a884f",
      "effective_time": "20250213",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Aveeno Baby Eczema Therapy Moisturizing"
        ],
        "generic_name": [
          "OATMEAL"
        ],
        "manufacturer_name": [
          "Kenvue Brands LLC"
        ],
        "product_ndc": [
          "69968-0923"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "rxcui": [
          "240651"
        ],
        "spl_id": [
          "2e07e828-b377-0232-e063-6394a90a884f"
        ],
        "spl_set_id": [
          "2e07e83c-22dc-d644-e063-6294a90a6833"
        ],
        "package_ndc": [
          "69968-0923-2"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0381371169870"
        ],
        "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"
        ]
      }
    }
  ]
}