{
  "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": [
        "ECZEMA COLLOIDAL OATMEAL ALMOND OIL OATMEAL OATMEAL JOJOBA OIL GLYCERYL MONOSTEARATE PEPPERMINT OIL .ALPHA.-TOCOPHEROL ARNICA MONTANA WHOLE CETYL PALMITATE SODIUM CITRATE STEARIC ACID TEA TREE OIL WATER GLYCERIN PHENOXYETHANOL PANTHENOL"
      ],
      "active_ingredient": [
        "Drug Facts Active Ingredient Colloidal Oatmeal 2.0%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Temporarily protects and helps relieve minor skin irritation and itching due to eczema."
      ],
      "warnings": [
        "Warnings For external use only When using this product do not get into eyes If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days,, discontinue use of this product and consult a doctor. Do not apply to wounds or damaged skin. Do not bandage tightly. If pregnant or breast-feeding, ask a health professional before use."
      ],
      "stop_use": [
        "If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days,, discontinue use of this product and consult a doctor. Do not apply to wounds or damaged skin. Do not bandage tightly."
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use."
      ],
      "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 Adults and children 5 years and over apply gently to the affected area as needed. Not recommended for face."
      ],
      "other_safety_information": [
        "Other information Protect from excessive heat Store at 20-25 o C (68-77F)"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Arnica montana flower extract, cetyl palmitate, ethylhexylglycerin, eucalyptus (Eucalyptus cinerea), glycerin, glyceryl stearate, jojoba (Buxus chinensis) oil, peppermint (mentha piperita) oil, phenoxyethanol, rosemary (Rosmariunus officinalis) oil, sodium citrate, stearic acid, sweet almond (Prunus amydgalus dulcis) oil, tea tree (Melaleuca alternifolia) oil, tocopherol (Vitamin E), water"
      ],
      "questions": [
        "Questions? Call (866) 419-3567 Monday through Friday 8:00am - 2:00pm ET"
      ],
      "spl_unclassified_section": [
        "Tamper evident: Do not use if safety seal under cap is broken or missing. Manufactured for Smith Amish LLC 16350 N Hwy 329 Reddick, FL 32634"
      ],
      "package_label_principal_display_panel": [
        "Label Smith Amish Eczema Cream (72609-704-02) Deep Moisturizing Cream for sensitive, distressed, dry, scaly skin Clean Fresh Scent Easily Absorbed and Non-Greasy Net wt. 2oz (59g) labels"
      ],
      "set_id": "20c4bc16-ba20-47ec-e063-6394a90a8b4e",
      "id": "45c89ca7-3354-d315-e063-6394a90ac647",
      "effective_time": "20251212",
      "version": "5",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "ECZEMA"
        ],
        "generic_name": [
          "COLLOIDAL OATMEAL"
        ],
        "manufacturer_name": [
          "Smith Amish, LLC"
        ],
        "product_ndc": [
          "72609-704"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "spl_id": [
          "45c89ca7-3354-d315-e063-6394a90ac647"
        ],
        "spl_set_id": [
          "20c4bc16-ba20-47ec-e063-6394a90a8b4e"
        ],
        "package_ndc": [
          "72609-704-04"
        ],
        "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"
        ]
      }
    }
  ]
}