{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "Aveeno Baby Calming Comfort Bath Plus Set Dimethicone Aveeno Baby Calming Comfort Dimethicone BENZYL ALCOHOL SODIUM CHLORIDE DIMETHICONE DIMETHICONE WATER GLYCERIN DISTEARYLDIMONIUM CHLORIDE PETROLATUM ISOPROPYL PALMITATE CETYL ALCOHOL OATMEAL Aveeno Baby Calming Comfort Bath WATER COCAMIDOPROPYL BETAINE SODIUM LAUROAMPHOACETATE GLYCERIN COCO GLUCOSIDE SODIUM CHLORIDE CITRIC ACID MONOHYDRATE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) SODIUM BENZOATE GLYCERYL OLEATE POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) SODIUM HYDROXIDE OAT"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558"
      ],
      "active_ingredient": [
        "Active ingredient Dimethicone 1.2%"
      ],
      "purpose": [
        "Purpose Skin protectant"
      ],
      "indications_and_usage": [
        "Uses Temporarily protects and helps relieve chafed, chapped, or cracked skin Helps prevent and protect from the drying effects of wind and cold weather."
      ],
      "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. Do not use on Deep or puncture wounds Animal bites Serious burns 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."
      ],
      "do_not_use": [
        "Do not use on Deep or puncture wounds Animal bites Serious burns"
      ],
      "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 To open, twist off cap and remove quality seal. Do not use if seal is broken. Store at room temperature."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Water , Glycerin, Distearyldimonium Chloride ,Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Fragrance, Sodium Chloride"
      ],
      "questions": [
        "Questions? 866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - Kit Packet Aveeno ® baby calming comfort ® bath + lotion set 18 FL OZ (532 mL) NET WT. 8 OZ (227 g) PRINCIPAL DISPLAY PANEL - Kit Packet"
      ],
      "set_id": "2c44fbc7-588f-41e2-953c-eebf24eecbf9",
      "id": "21eb65dd-5180-a1df-e063-6294a90ae27f",
      "effective_time": "20241106",
      "version": "6",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Aveeno Baby Calming Comfort Bath Plus Set"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "Kenvue Brands LLC"
        ],
        "product_ndc": [
          "69968-0631"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "rxcui": [
          "876980"
        ],
        "spl_id": [
          "21eb65dd-5180-a1df-e063-6294a90ae27f"
        ],
        "spl_set_id": [
          "2c44fbc7-588f-41e2-953c-eebf24eecbf9"
        ],
        "package_ndc": [
          "69968-0631-9",
          "69968-0656-8"
        ],
        "is_original_packager": [
          true
        ]
      }
    }
  ]
}