{
  "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 Calaclear pramoxine hydrochloride and zinc acetate lotion PROPYLENE GLYCOL PROPYLPARABEN WATER GLYCERIN CAMPHOR (NATURAL) ALCOHOL DIAZOLIDINYL UREA HYPROMELLOSE, UNSPECIFIED METHYLPARABEN POLYSORBATE 80 PRAMOXINE HYDROCHLORIDE PRAMOXINE ZINC ACETATE ZINC CATION"
      ],
      "active_ingredient": [
        "Pramoxine HCl 1% Zing Acetate 0.1%"
      ],
      "purpose": [
        "External Analgesic Skin Protectant"
      ],
      "indications_and_usage": [
        "Dries the oozing and weeping and temporarily relieves pain and itching of poison ivy, poison oak, and poison sumac or other minor skin irritations."
      ],
      "warnings": [
        "For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Ask a doctor before using on children under 2 years of age. When using this product. Discontinue use if condition worsens, does not improve or if symptoms persist for more than 7 days, or clear up and occur again within a few days. and consult a doctor. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "Adults and children 2 yrs. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort. Children under 2 years of age: Consult a doctor before use."
      ],
      "inactive_ingredient": [
        "SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Purified Water."
      ],
      "keep_out_of_reach_of_children": [
        "In case of accidental ingestion, seek professional assistance or contact a poison control center immediately."
      ],
      "package_label_principal_display_panel": [
        "Top Care Calaclear 2022 TCClear.jpg cc"
      ],
      "set_id": "8dce8817-b905-4064-e053-2995a90a071e",
      "id": "0ccb3e8a-3d01-1364-e063-6294a90a70e8",
      "effective_time": "20231218",
      "version": "5",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "TopCare Calaclear"
        ],
        "generic_name": [
          "PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION"
        ],
        "manufacturer_name": [
          "TOPCO ASSOCIATES LLC"
        ],
        "product_ndc": [
          "36800-267"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PRAMOXINE HYDROCHLORIDE",
          "ZINC ACETATE"
        ],
        "rxcui": [
          "1234546"
        ],
        "spl_id": [
          "0ccb3e8a-3d01-1364-e063-6294a90a70e8"
        ],
        "spl_set_id": [
          "8dce8817-b905-4064-e053-2995a90a071e"
        ],
        "package_ndc": [
          "36800-267-96"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "88AYB867L5",
          "FM5526K07A"
        ]
      }
    }
  ]
}