{
  "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 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"
      ],
      "adverse_reactions": [
        "ADVERSE REACTION Distributed by CMDA, Inc. Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362 SATISFACTION GUARANTEED 100% QC"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL NDC 83324-248-06 QC QUALITY CHOICE Calamine Lotion Calamine Topical Suspension USP Skin Protectant Dries the Oozing and Weeping of Poison: Ivy, Oak & Sumac 6 FL OZ (177 mL) image description"
      ],
      "set_id": "86ff4875-9007-4b7b-8f46-16cbd475d4bb",
      "id": "4bcf3ffc-3e53-c2af-e063-6294a90a6188",
      "effective_time": "20260227",
      "version": "3",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Calamine"
        ],
        "generic_name": [
          "FERRIC OXIDE RED"
        ],
        "manufacturer_name": [
          "Chain Drug Marketing Association"
        ],
        "product_ndc": [
          "83324-248"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "FERRIC OXIDE RED",
          "ZINC OXIDE"
        ],
        "rxcui": [
          "617954"
        ],
        "spl_id": [
          "4bcf3ffc-3e53-c2af-e063-6294a90a6188"
        ],
        "spl_set_id": [
          "86ff4875-9007-4b7b-8f46-16cbd475d4bb"
        ],
        "package_ndc": [
          "83324-248-06"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "1K09F3G675",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}