{
  "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": [
        "Pediadermics eczema 3 Colloidal Oatmeal, Dimethicone MEADOWFOAM SEED OIL CETOSTEARYL ALCOHOL XANTHAN GUM CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE HELIANTHUS ANNUUS SEED WAX CERAMIDE 1 JOJOBA OIL DIMETHICONE DIMETHICONE RICE BRAN GLYCERYL MONOSTEARATE SODIUM STEAROYL LACTYLATE OATMEAL OATMEAL GLYCERIN CETYL ALCOHOL ASCORBYL PALMITATE CANDELILLA WAX PROPANEDIOL NIACINAMIDE STEARIC ACID WATER PHYTOSPHINGOSINE PALMITIC ACID BIOSACCHARIDE GUM-1 SODIUM LAUROYL LACTYLATE CHOLESTEROL CERAMIDE NP POLYGLYCERIN-3 CAPRYLYL GLYCOL SACCHARIDE ISOMERATE CAPRYLHYDROXAMIC ACID CERAMIDE AP EDETATE DISODIUM HEXANEDIOL SODIUM HYDROXIDE HYALURONATE SODIUM OAT MALTODEXTRIN TOCOPHEROL SODIUM PYRROLIDONE CARBOXYLATE OPHIOPOGON JAPONICUS ROOT"
      ],
      "active_ingredient": [
        "Active Ingredients Colloidal oatmeal 0.1% Dimethicone 2%"
      ],
      "purpose": [
        "Purpose Skin protectant Skin protectant"
      ],
      "indications_and_usage": [
        "Uses Temporarily protects sensitive skin and helps relieve minor skin irritation due to eczema. Temporarily helps prevent and relieve chapped or cracked skin."
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "when_using": [
        "When using this product Do not get into eyes Do not apply before bathing or showering"
      ],
      "stop_use": [
        "Stop use and ask a doctor if Condition worsens Symptoms last more than 2 weeks 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 For best results, follow the rule of \"3\" Apply liberally to skin at least \"3\" times a day Apply within \"3\" minutes of bathing Keep a \"3\" location supply (Home, On-the-Go and School) !"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients 1,2 Hexanediol, Ascorbyl Palmitate, Bio-Saccharide 1, Candelilla / Jojoba / Rice bran, Polyglyceryl-3 Esters, Glyceryl Stearate, Cetearyl Alcohol, Sodium Stearoyl Lactylate, Caprylyl Glycol, Glycerin, Caprylhydroxamic Acid, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NP, Cetyl Alcohol, Cholesterol, Deionized Water, Helianthus Annuus (Sunflower) Seed Wax, Limnanthes Alba (Meadowfoam) Seed Oil, Niacinamide, Ophiopogon Japonicus Root Extract, Maltodextrin, Phytosphingosine, Propanediol, Saccharide Isomerate, Sodium EDTA, Sodium Hyaluronate, Sodium PCA, Stearic Acid, Tocopherol, Xanthan Gum"
      ],
      "other_safety_information": [
        "Other information Store at room temperature."
      ],
      "questions": [
        "Questions? pediadermics@gmail.com"
      ],
      "statement_of_identity": [
        "eczema 3 skin barrier repair cream"
      ],
      "package_label_principal_display_panel": [
        "ECZEMA 3 tube artwork Eczema 3 Tube Art"
      ],
      "set_id": "af861f0b-4387-6861-e053-2995a90a8bfa",
      "id": "44fe1bad-8844-9960-e063-6394a90a8a7a",
      "effective_time": "20251202",
      "version": "4",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Pediadermics eczema 3"
        ],
        "generic_name": [
          "COLLOIDAL OATMEAL, DIMETHICONE"
        ],
        "manufacturer_name": [
          "Renu Laboratories, LLC"
        ],
        "product_ndc": [
          "76348-580"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE",
          "OATMEAL"
        ],
        "spl_id": [
          "44fe1bad-8844-9960-e063-6394a90a8a7a"
        ],
        "spl_set_id": [
          "af861f0b-4387-6861-e053-2995a90a8bfa"
        ],
        "package_ndc": [
          "76348-580-06"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282",
          "N0000185371",
          "N0000185375",
          "N0000175629",
          "N0000184306",
          "M0000728",
          "M0006342",
          "M0016962",
          "N0000185016"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]",
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]"
        ],
        "pharm_class_epc": [
          "Non-Standardized Food Allergenic Extract [EPC]",
          "Non-Standardized Plant Allergenic Extract [EPC]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Dietary Proteins [CS]",
          "Plant Proteins [CS]"
        ],
        "unii": [
          "92RU3N3Y1O",
          "8PI54V663Y"
        ]
      }
    }
  ]
}