{
  "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 FERRIC OXIDE RED FERRIC OXIDE RED ZINC OXIDE ZINC OXIDE BENTONITE CALCIUM HYDROXIDE GLYCERIN WATER"
      ],
      "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 Relabeled By: Preferred Pharmaceuticals Inc."
      ],
      "package_label_principal_display_panel": [
        "principal display panel NDC 68788-0292-1 MAJOR Calamine Lotion Calamine Topical Suspension USP Skin Protectant Poison Ivy, Oak, Sumac Drying Lotion Shake well before using 6 FL OZ (177 mL) Calamine Lotion"
      ],
      "set_id": "326f3d80-c1bf-4cf0-a662-58e02ed7ee67",
      "id": "671e5bc7-7fa2-48d7-b251-9b1249d2dfa6",
      "effective_time": "20250212",
      "version": "6",
      "openfda": {
        "application_number": [
          "347"
        ],
        "brand_name": [
          "Calamine"
        ],
        "generic_name": [
          "FERRIC OXIDE RED"
        ],
        "manufacturer_name": [
          "Preferred Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "68788-0292"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "FERRIC OXIDE RED",
          "ZINC OXIDE"
        ],
        "rxcui": [
          "617954"
        ],
        "spl_id": [
          "671e5bc7-7fa2-48d7-b251-9b1249d2dfa6"
        ],
        "spl_set_id": [
          "326f3d80-c1bf-4cf0-a662-58e02ed7ee67"
        ],
        "package_ndc": [
          "68788-0292-1"
        ],
        "original_packager_product_ndc": [
          "0904-2533"
        ],
        "unii": [
          "1K09F3G675",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}