{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Sarna Colloidal Oatmeal ACETYL HEPTAPEPTIDE-4 YEAST .BETA.-D-GLUCAN C12-15 ALKYL BENZOATE SODIUM PCA FRUCTOSE GLYCERYL STEARATE CETYL ACETATE CAPRYLYL GLYCOL CAPRYLIC/CAPRIC TRIGLYCERIDE CETEARYL ALCOHOL DIMETHICONE SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL SODIUM CHLORIDE SODIUM HYALURONATE TRICETEARETH-4 PHOSPHATE CITRIC ACID GLUCOSE HYDROXYACETOPHENONE CETEARETH-20 SODIUM HYDROXIDE CARBOMER INTERPOLYMER TYPE A (55000 CPS) ALLANTOIN 1,2-HEXANEDIOL OATMEAL OATMEAL BUTYROSPERMUM PARKII (SHEA) BUTTER SODIUM LACTATE TREHALOSE UREA WATER PENTYLENE GLYCOL GLYCERIN MALTOSE"
      ],
      "active_ingredient": [
        "Active ingredient Colloidal Oatmeal 2%"
      ],
      "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 store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]"
      ],
      "inactive_ingredient": [
        "Inactive ingredients 1,2-Hexanediol, Acetyl Heptapeptide-4, Allantoin, Bacillus Ferment, Beta-Glucan, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Acetate, Citric Acid, Dimethicone, Fructose, Glucose, Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Maltose, Pentylene Glycol, Simmondsia Chinesis (Jojoba) Seed Oil, Sodium Chloride, Sodium Hyaluronate, Sodium Hydroxide, Sodium Lactate, Sodium PCA, Trehalose, Triceteareth-4 Phosphate, Urea, Water"
      ],
      "questions": [
        "Questions? call 1-833-279-6522"
      ],
      "package_label_principal_display_panel": [
        "#1 DERMATOLOGIST RECOMMENDED TOPICAL ANTI-ITCH BRAND Sarna 2% Colloidal Oatmeal Skin Protectant Lotion Stroid Free ECZEMA RELIEF SKIN PROTECTANT LOTION Helps relieve minor skin irritation and ithcing due to eczema Helps soothe and hydrate with Shea Butter, Jojoba Oil and Beta Glucan Helps restore the skin's moisture barrier with Moisture Peptide Complex Vegan Accepted National Eczema Association 7.5 fl oz (222 ml) Cruelty Free Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604 P12718.00 Sarna Eczema Tube"
      ],
      "set_id": "2d6b1872-9f4d-9eb3-e063-6394a90ab675",
      "id": "483418a9-057e-f63f-e063-6294a90a4f38",
      "effective_time": "20260112",
      "version": "3",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Sarna"
        ],
        "generic_name": [
          "COLLOIDAL OATMEAL"
        ],
        "manufacturer_name": [
          "Crown Laboratories, Inc."
        ],
        "product_ndc": [
          "0316-0256"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "rxcui": [
          "1591951"
        ],
        "spl_id": [
          "483418a9-057e-f63f-e063-6294a90a4f38"
        ],
        "spl_set_id": [
          "2d6b1872-9f4d-9eb3-e063-6394a90ab675"
        ],
        "package_ndc": [
          "0316-0256-75",
          "0316-0256-17"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0303160256752"
        ],
        "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"
        ]
      }
    }
  ]
}