{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Calamine FERRIC OXIDE RED BENTONITE CALCIUM HYDROXIDE GLYCERIN WATER FERRIC OXIDE RED FERRIC OXIDE RED ZINC OXIDE ZINC OXIDE"
      ],
      "active_ingredient": [
        "Active ingredents Calamine 8% Zinc oxide 8%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Use dries the oozing and weeping of poison:•ivy • oak • sumac"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "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 • shake well before using • apply as needed"
      ],
      "storage_and_handling": [
        "Other information store at 59⁰ - 86⁰ F"
      ],
      "inactive_ingredient": [
        "Inactive ingredients bentonite magma, calcium hydroxide, glycerin, purified water"
      ],
      "questions": [
        "Questions or comments? (800) 616-2471"
      ],
      "adverse_reactions": [
        "Adverse reactions Distributed By: MAJOR PHARMACEUTICALS 17177 N LAUREL PARK DRIVE, SUITE 233 Livonia, MI 48152 Re-Order No 014282 M-97 Rev. 10/16 063.000/063AA"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel pdp"
      ],
      "set_id": "66e98554-e158-a519-e053-2a91aa0a6783",
      "id": "1a3dc619-6b13-21b4-e063-6294a90acb1e",
      "effective_time": "20240606",
      "version": "5",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Calamine"
        ],
        "generic_name": [
          "FERRIC OXIDE RED"
        ],
        "manufacturer_name": [
          "NuCare Pharmaceuticals,Inc."
        ],
        "product_ndc": [
          "68071-4322"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "FERRIC OXIDE RED",
          "ZINC OXIDE"
        ],
        "rxcui": [
          "617954"
        ],
        "spl_id": [
          "1a3dc619-6b13-21b4-e063-6294a90acb1e"
        ],
        "spl_set_id": [
          "66e98554-e158-a519-e053-2a91aa0a6783"
        ],
        "package_ndc": [
          "68071-4322-6"
        ],
        "original_packager_product_ndc": [
          "0904-2533"
        ],
        "upc": [
          "0368071432268"
        ],
        "unii": [
          "1K09F3G675",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}