{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Calamine Plus Calamine Plus Pramoxine HCL FERRIC OXIDE RED FERRIC OXIDE RED PRAMOXINE HYDROCHLORIDE PRAMOXINE ZINC OXIDE ZINC OXIDE CAMPHOR (SYNTHETIC) ISOBUTANE BENZYL ALCOHOL OLEYL ALCOHOL SORBITAN TRIOLEATE ALCOHOL HYDRATED SILICA DISTEARDIMONIUM HECTORITE"
      ],
      "active_ingredient": [
        "Active ingredients Calamine 8% Pramoxine HCI 1%"
      ],
      "purpose": [
        "Purpose Skin protectant External analgesic"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves pain and itching associated with: insect bites rashes minor skin irritations minor cuts dries the oozing and weeping of poison ivy, poison oak and poison sumac"
      ],
      "warnings": [
        "Warnings For external use only. Flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal. When using this product do not get into eyes ask a doctor before using on children under 2 years of age Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again in a few days Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.",
        "Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again in a few days"
      ],
      "safe_handling_warning": [
        "Flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal."
      ],
      "when_using": [
        "When using this product do not get into eyes ask a doctor before using on children under 2 years of age"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions shake well before using adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily cleanse the skin with soap and water let dry before use children under 2 years of age: consult a doctor Other Information store between 20° to 25°C (68° to 77°F)"
      ],
      "other_safety_information": [
        "Other Information store between 20° to 25°C (68° to 77°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients benzyl alcohol, camphor, disteardimonium hectorite, fragrance, hydrated silica, isobutane, oleyl alcohol, SD alcohol 40-B, sorbitan trioleate"
      ],
      "questions": [
        "Questions? Call 1-866-964-0939"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel meijer NO-RUB calamine plus spray Calamine 8%/Skin Protectant Pramoxine HCI 1%/External analgesic Relieves itching from poison ivy, oak & sumac, & insect bites Soothes minor skin irritations & cuts SHAKE WELL BEFORE USE NET WT 4.1 OZ (116 g) image 1"
      ],
      "set_id": "03c46823-0b1f-4101-e063-6294a90aaf94",
      "id": "42660d75-8443-3e31-e063-6294a90a284d",
      "effective_time": "20251030",
      "version": "3",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Calamine Plus"
        ],
        "generic_name": [
          "CALAMINE PLUS PRAMOXINE HCL"
        ],
        "manufacturer_name": [
          "Meijer Distribution Inc."
        ],
        "product_ndc": [
          "79481-0615"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "FERRIC OXIDE RED",
          "PRAMOXINE HYDROCHLORIDE",
          "ZINC OXIDE"
        ],
        "spl_id": [
          "42660d75-8443-3e31-e063-6294a90a284d"
        ],
        "spl_set_id": [
          "03c46823-0b1f-4101-e063-6294a90aaf94"
        ],
        "package_ndc": [
          "79481-0615-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "1K09F3G675",
          "88AYB867L5",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}