{
  "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 Plus Pramoxine HCl Calamine Plus Spray BENZYL ALCOHOL CAMPHOR (SYNTHETIC) DISTEARDIMONIUM HECTORITE HYDRATED SILICA ISOBUTANE OLEYL ALCOHOL ALCOHOL SORBITAN TRIOLEATE FERRIC OXIDE RED FERRIC OXIDE RED ZINC OXIDE ZINC CATION PRAMOXINE HYDROCHLORIDE PRAMOXINE"
      ],
      "active_ingredient": [
        "Active ingredient Calamine 8% Pramoxine HCl 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. Use only as directed. Intentional misuse by deliberately concentrating and inhailing 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 conditions worsens symtomps last more than 7 days or clear up and occur again in a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "other_safety_information": [
        "When using this product do not get into eyes ask a doctor before using on children under 2 years of age",
        "Other information store between 20° to 25°C (68° to 77°F)"
      ],
      "stop_use": [
        "Stop use and ask a doctor if conditions worsens symtomps last more than 7 days or clear up and occur again in 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 adults and children 2 years of age and older: apply as needed to the affected area, not more than 3 or 4 times daily cleanse the skin with soap and water let dry before use children under 2 years of age: consult a doctor"
      ],
      "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 TopCare NO TOUCH Calamine Plus Spray Calamine 8% - Skin Protectant Promoxine HCL 1% - External Analgesic Drying action plus itch relief Ideal for: poison ivy/oak/sumac insect bites, minor skin irritations & cuts SHAKE WELL BEFORE USE NET WT 4.1 OZ (116 g) calamine"
      ],
      "set_id": "af314adb-bd65-4233-b7e1-6cfb819615a3",
      "id": "42f4abc5-8308-e7ed-e063-6394a90a748d",
      "effective_time": "20251106",
      "version": "11",
      "openfda": {}
    }
  ]
}