{
  "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": [
        "Calamine FERRIC OXIDE RED BENTONITE CALCIUM HYDROXIDE GLYCERIN WATER FERRIC OXIDE RED FERRIC OXIDE RED ZINC OXIDE ZINC OXIDE"
      ],
      "active_ingredient": [
        "Active ingredients 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? 1-888-593-0593"
      ],
      "adverse_reactions": [
        "Adverse reactions Distributed By: MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Rev. 03/25 M-97 Re-order No. 014283"
      ],
      "package_label_principal_display_panel": [
        "principal display panel NDC 0904-2533-21 MAJOR ® Calamine Lotion Calamine Topical Suspension USP Calamine 8%, Zinc Oxide 8% Skin Protectant dries the oozing and weeping of poison: ivy, oak, and sumac Shake well before using 6 FL OZ (177 mL) image description"
      ],
      "set_id": "c25be68d-834a-4959-8d47-01ec789406ba",
      "id": "4a057dbb-483c-a4b4-e063-6394a90aa36a",
      "effective_time": "20260204",
      "version": "15",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Calamine"
        ],
        "generic_name": [
          "FERRIC OXIDE RED"
        ],
        "manufacturer_name": [
          "Major Pharmaceuticals"
        ],
        "product_ndc": [
          "0904-2533"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "FERRIC OXIDE RED",
          "ZINC OXIDE"
        ],
        "rxcui": [
          "617954"
        ],
        "spl_id": [
          "4a057dbb-483c-a4b4-e063-6394a90aa36a"
        ],
        "spl_set_id": [
          "c25be68d-834a-4959-8d47-01ec789406ba"
        ],
        "package_ndc": [
          "0904-2533-21"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "1K09F3G675",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}