{
  "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,
      "limit": 1,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Caldyphen Clear Pramoxine Hydrochloride and Zinc acetate CAMPHOR (NATURAL) DIAZOLIDINYL UREA GLYCERIN HYPROMELLOSE, UNSPECIFIED METHYLPARABEN POLYSORBATE 80 PROPYLENE GLYCOL PROPYLPARABEN WATER PRAMOXINE HYDROCHLORIDE PRAMOXINE ZINC ACETATE ZINC CATION"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: AmerisourceBergen 1300 Morris Drive, Chesterbrook, PA 19087"
      ],
      "active_ingredient": [
        "Active Ingredient Pramoxine HCl 1%",
        "Active Ingredient Zinc Acetate 0.1%"
      ],
      "purpose": [
        "Purpose External analgesic",
        "Purpose Skin protectant"
      ],
      "indications_and_usage": [
        "Uses Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, poison oak, and poison sumac and other minor skin irritations."
      ],
      "warnings": [
        "Warnings For External Use Only. Use only as directed. Avoid contact with eye and mucous membranes. ask a doctor before using on children under 2 years of age."
      ],
      "ask_doctor": [
        "Stop use and as a doctor if condition worsens. Symptoms last for more than 7 days or celar up and occur again whitin 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 immediately."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 2 yrs. of age and older. Shake well before using. cleanse the skin with soap and water. 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 unedr 2 yrs. of age. Consult a doctor before use."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients SD alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, and Purified Water."
      ],
      "other_safety_information": [
        "Other information Store at room temperature 15 - 30 (59-86F)"
      ],
      "questions": [
        "Questions or comments? 1-800-662-3435 www.goodneighborpharmacy.com"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel GNPCaldy.jpg"
      ],
      "set_id": "d8802e56-649e-4494-86ee-7ca8841cc28b",
      "id": "52d4acc7-7f67-f62a-e063-6394a90a245d",
      "effective_time": "20260527",
      "version": "4",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Caldyphen Clear"
        ],
        "generic_name": [
          "PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE"
        ],
        "manufacturer_name": [
          "Amerisource Bergen"
        ],
        "product_ndc": [
          "24385-439"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PRAMOXINE HYDROCHLORIDE",
          "ZINC ACETATE"
        ],
        "rxcui": [
          "1234546"
        ],
        "spl_id": [
          "52d4acc7-7f67-f62a-e063-6394a90a245d"
        ],
        "spl_set_id": [
          "d8802e56-649e-4494-86ee-7ca8841cc28b"
        ],
        "package_ndc": [
          "24385-439-30"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0087701400452"
        ],
        "unii": [
          "88AYB867L5",
          "FM5526K07A"
        ]
      }
    }
  ]
}