{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Calamine Calamine 8%, Zinc Oxide 8% MICROCRYSTALLINE CELLULOSE WATER CARRAGEENAN CALCIUM HYDROXIDE BENTONITE XANTHAN GUM GLYCERIN FERRIC OXIDE RED FERRIC OXIDE RED ZINC OXIDE ZINC CATION"
      ],
      "active_ingredient": [
        "Drug Facts Active ingredient Calamine 8% Zinc Oxide 8%"
      ],
      "purpose": [
        "Purpose Calamine 8%, Zinc Oxide 8% Skin protectant"
      ],
      "purpose_table": [
        "<table border=\"0\" width=\"40%\"><tbody><tr><td><paragraph>Calamine 8%,</paragraph><paragraph>Zinc Oxide 8%</paragraph></td><td>Skin protectant</td></tr></tbody></table>"
      ],
      "indications_and_usage": [
        "Uses Dries the oozing and weeping of poison: ■ ivy ■ oak ■ sumac"
      ],
      "warnings": [
        "Warnings ■ For external use only ■ Use only as directed When using this product ■ do not get into eyes 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. In case of overdose, get medical help or contact a Poison Control Center right away."
      ],
      "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. In case of overdose, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions ■ Adults and children of 2 years of age and older: Shake well before using. Cleanse the skin with soap and water and dry the area before application. Apply lotion to the affected area using cotton or soft cloth, as often as needed for comfort. ■ Children under 2 years of age: Consult a doctor before use."
      ],
      "other_safety_information": [
        "Other information Store at room temperature 15° - 30°C (59° - 86°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Avicel, bentonite magma, calcium hydroxide, carrageenan, glycerin, purified water, and xanthan gum."
      ],
      "questions": [
        "Questions or comments? (855)-280-1079"
      ],
      "spl_unclassified_section": [
        "Principal Display Panel NDC: 85786-703-06 DR. SIMI Calamine Lotion Calamine Topical Suspension Skin Protectant Poison Ivy, Oak, and Sumac Drying Lotion 6 fl oz (177 mL) WARNING: DO NOT USE IF TAMPER EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING. Distributed by: FARMACIAS DE SIMILARES TX LLC 800 Brazos St Ste 260, Austin, TX, 78701, USA customerservice@drsimi.com www.drsimi.com"
      ],
      "package_label_principal_display_panel": [
        "Immediate container labeling Immediate container labeling"
      ],
      "set_id": "4ecd0add-11c9-cf3b-e063-6394a90adff6",
      "id": "4ecd0add-11ca-cf3b-e063-6394a90adff6",
      "effective_time": "20260406",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Calamine"
        ],
        "generic_name": [
          "CALAMINE 8%, ZINC OXIDE 8%"
        ],
        "manufacturer_name": [
          "Farmacias De Similares TX LLC"
        ],
        "product_ndc": [
          "85786-703"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "FERRIC OXIDE RED",
          "ZINC OXIDE"
        ],
        "rxcui": [
          "617954"
        ],
        "spl_id": [
          "4ecd0add-11ca-cf3b-e063-6394a90adff6"
        ],
        "spl_set_id": [
          "4ecd0add-11c9-cf3b-e063-6394a90adff6"
        ],
        "package_ndc": [
          "85786-703-06"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0199961000065"
        ],
        "unii": [
          "1K09F3G675",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}