{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Calamine Calamine and Zinc Oxide CARRAGEENAN BENTONITE XANTHAN GUM CALCIUM HYDROXIDE GLYCERIN WATER MICROCRYSTALLINE CELLULOSE ZINC OXIDE ZINC CATION"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredients Calamine 8% and Zinc Oxide 8%"
      ],
      "purpose": [
        "Purpose Skin protectant"
      ],
      "indications_and_usage": [
        "Uses dries the oozing and weeping o poison ivy, poison oak, and poison sumac."
      ],
      "warnings": [
        "Warnings For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Ask a doctor before using on chilren 6 months of age."
      ],
      "when_using": [
        "When using this product Discontinue use if condition worsens or does not improve within 7 days and consult a doctor."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately."
      ],
      "dosage_and_administration": [
        "Directions Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, as often as needed for comfort. Children under 2 years of age: Consult a doctor before use Directions Children under 2 years of age: Consult a doctor before use (12/2021)"
      ],
      "recent_major_changes": [
        "Directions Children under 2 years of age: Consult a doctor before use (12/2021)"
      ],
      "other_safety_information": [
        "Other information Store at room temperature 15-30C (59-86F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Bentonite magma, calcium hydroxide, carrageenan, glycerin, microcrystalline cellulose, purified water, xanthan gum."
      ],
      "package_label_principal_display_panel": [
        "2026 Label Equate Calamine 5 26 2026",
        "label Equate Calamine label"
      ],
      "set_id": "61929c97-bd6b-0d7c-e053-2991aa0aa571",
      "id": "52b88341-bb0b-9bfa-e063-6394a90ad9bf",
      "effective_time": "20260526",
      "version": "9",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Calamine"
        ],
        "generic_name": [
          "CALAMINE AND ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Wal-Mart Stores, Inc."
        ],
        "product_ndc": [
          "49035-413"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "617954"
        ],
        "spl_id": [
          "52b88341-bb0b-9bfa-e063-6394a90ad9bf"
        ],
        "spl_set_id": [
          "61929c97-bd6b-0d7c-e053-2991aa0aa571"
        ],
        "package_ndc": [
          "49035-413-96"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0681131176002"
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}