{
  "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": [
        "Calming Itch and Irritation Colloidal Oatmeal OLIVE OIL SUNFLOWER OIL WATER ALOE VERA LEAF HIPPOPHAE RHAMNOIDES SEED OIL SQUALANE TOCOPHEROL ANHYDROUS CITRIC ACID CHIA SEED OIL SHEA BUTTER CETEARYL OLIVATE GLYCERYL LAURATE SAFFLOWER OIL GLYCERYL STEARATE SE GLYCERIN QUINOA OIL SORBITAN OLIVATE POTASSIUM SORBATE MEADOWFOAM SEED OIL COCO-GLYCERIDES SODIUM LEVULINATE COCOA BUTTER XANTHAN GUM OATMEAL OATMEAL"
      ],
      "active_ingredient": [
        "Active Ingredients Colloidal Oatmeal 2.0%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses temporarily protects and helps relieve minor skin irritation and itching due to: rashes • eczema poison ivy, oak, or sumac • insect bites"
      ],
      "warnings": [
        "Warnings For external use When using this product Do not get into eyes Stop use and ask 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 product is 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 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 product is swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Apply as needed."
      ],
      "other_safety_information": [
        "Other information Remove quality seal. Do not use if quality seal is broken. Store at room temperature."
      ],
      "inactive_ingredient": [
        "Inactive ingredients WATER, ALOE BARBADENSIS LEAF JUICE POWDER*, CETEARYL OLIVATE, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, THEOBROMA CACAO (COCOA) SEED BUTTER*, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL, SORBITAN OLIVATE, GLYCERIN, COCOGLYCERIDES, GLYCERYL STEARATE SE, TOCOPHEROL, HIPPOPHAE RHAMNOIDES FRUIT OIL*, BUTYROSPERMUM PARKII (SHEA) BUTTER, OLEA EUROPABA (OLIVE) FRUIT OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SALVIA HISPANICA SEED OIL, CHENOPODIUM QUINOA SEED OIL, XANTHAN GUM, SQUALANE, SODIUM LEVULINATE, GLYCERYL LAURATE, POTASSIUM SORBATE, CITRIC ACID."
      ],
      "questions": [
        "Questions? Call toll-free 877.902.2873"
      ],
      "package_label_principal_display_panel": [
        "Label"
      ],
      "set_id": "1dd7e712-56a4-86c0-e063-6294a90a75cd",
      "id": "45132ba3-8160-c77a-e063-6294a90a0868",
      "effective_time": "20251203",
      "version": "5",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Calming Itch and Irritation"
        ],
        "generic_name": [
          "COLLOIDAL OATMEAL"
        ],
        "manufacturer_name": [
          "Better Planet Brands LLC"
        ],
        "product_ndc": [
          "54136-183"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "rxcui": [
          "1591951"
        ],
        "spl_id": [
          "45132ba3-8160-c77a-e063-6294a90a0868"
        ],
        "spl_set_id": [
          "1dd7e712-56a4-86c0-e063-6294a90a75cd"
        ],
        "package_ndc": [
          "54136-183-24"
        ],
        "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"
        ]
      }
    }
  ]
}