{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Calamine Clear Pramoxine Hydrochloride and Zinc Acetate Lotion DIAZOLIDINYL UREA POLYSORBATE 80 CAMPHOR (NATURAL) ALCOHOL GLYCERIN HYPROMELLOSE, UNSPECIFIED METHYLPARABEN PROPYLENE GLYCOL WATER PROPYLPARABEN PRAMOXINE HYDROCHLORIDE PRAMOXINE ZINC ACETATE ZINC CATION"
      ],
      "active_ingredient": [
        "Pramoxine HCl 1% Zinc 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"
      ],
      "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 accidental ingestion, seek professional assistance or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "dosage_and_administration": [
        "Adults and children 2 years of age and older: Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion fo 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: do not use, consult a doctor."
      ],
      "other_safety_information": [
        "Other information Store at room temperature 15-30C (59-86F)"
      ],
      "inactive_ingredient": [
        "SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Usea, Fragrances, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Purified Water"
      ],
      "questions": [
        "Questions or comments? 1-833-551-0932"
      ],
      "package_label_principal_display_panel": [
        "Freskaro Calamine Clear 2026"
      ],
      "set_id": "4f853183-5925-2c73-e063-6394a90adf6c",
      "id": "4f852c10-3978-1f04-e063-6394a90a5c1d",
      "effective_time": "20260415",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Calamine Clear"
        ],
        "generic_name": [
          "PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION"
        ],
        "manufacturer_name": [
          "Pharma Nobis, LLC"
        ],
        "product_ndc": [
          "82645-400"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PRAMOXINE HYDROCHLORIDE",
          "ZINC ACETATE"
        ],
        "rxcui": [
          "1234546"
        ],
        "spl_id": [
          "4f852c10-3978-1f04-e063-6394a90a5c1d"
        ],
        "spl_set_id": [
          "4f853183-5925-2c73-e063-6394a90adf6c"
        ],
        "package_ndc": [
          "82645-400-96"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0382645400965"
        ],
        "unii": [
          "88AYB867L5",
          "FM5526K07A"
        ]
      }
    }
  ]
}