{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "TopCare Calagesic calamine and pramoxine hydrochloride lotion GLYCERIN CAMPHOR (NATURAL) POLYSORBATE 80 PROPYLENE GLYCOL DIAZOLIDINYL UREA WATER METHYLPARABEN PROPYLPARABEN ZINC OXIDE ZINC CATION PRAMOXINE HYDROCHLORIDE PRAMOXINE"
      ],
      "active_ingredient": [
        "Calamine 8% Pramoxine Hydochloride 1%"
      ],
      "purpose": [
        "Skin Protectant External analgesic"
      ],
      "indications_and_usage": [
        "Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and sumac or other skin irritations."
      ],
      "warnings": [
        "For external use only. Use only as directed. When using this product. Avoid contact with eyes and moucous membranes."
      ],
      "keep_out_of_reach_of_children": [
        "In case of accidental ingestion, seek profesional assistance or contact a Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "Adults and children 2 yr. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort. Children under 2 yrs. of age. Consult a doctor before use."
      ],
      "inactive_ingredient": [
        "SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methycelulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben and Purified Water."
      ],
      "package_label_principal_display_panel": [
        "Top Care Calagesic 2022 TCGesig.jpg"
      ],
      "set_id": "8dced3ea-147b-3d46-e053-2a95a90aa1c0",
      "id": "0ccb3962-d499-0a6c-e063-6294a90a0d41",
      "effective_time": "20231218",
      "version": "5",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "TopCare Calagesic"
        ],
        "generic_name": [
          "CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION"
        ],
        "manufacturer_name": [
          "TOPCO ASSOCIATES LLC"
        ],
        "product_ndc": [
          "36800-268"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "PRAMOXINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1234532"
        ],
        "spl_id": [
          "0ccb3962-d499-0a6c-e063-6294a90a0d41"
        ],
        "spl_set_id": [
          "8dced3ea-147b-3d46-e053-2a95a90aa1c0"
        ],
        "package_ndc": [
          "36800-268-96"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0036800443419"
        ],
        "unii": [
          "SOI2LOH54Z",
          "88AYB867L5"
        ]
      }
    }
  ]
}