{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Foster and Thrive Caldyphen Calamine and Pramoxine Hydrochloride CAMPHOR (NATURAL) DIAZOLIDINYL UREA GLYCERIN HYPROMELLOSE, UNSPECIFIED METHYLPARABEN POLYSORBATE 80 PROPYLENE GLYCOL PROPYLPARABEN WATER ZINC OXIDE ZINC CATION PRAMOXINE HYDROCHLORIDE PRAMOXINE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: McKesson Corp. SSSL., Memphis, TN 38141"
      ],
      "active_ingredient": [
        "Active Ingredients Calamine 8% Pramoxine HCl 1%"
      ],
      "purpose": [
        "Purpose Skin Protectant External analgesic"
      ],
      "indications_and_usage": [
        "Uses Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and sumac or other skin irritations."
      ],
      "warnings": [
        "Warnings For external use only. Use only as directed. When using this product. Avoid contact with eyes and moucous membranes."
      ],
      "when_using": [
        "When using this product do not 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": [
        "Keep out of reach of children. In case of accidental ingestion, seek profesional assistance or contact a Poison Control Center immediately. (1-800-222-1222)"
      ],
      "dosage_and_administration": [
        "Directions 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": [
        "Inactive Ingredients SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methycelulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben and Purified Water."
      ],
      "other_safety_information": [
        "Other information Store at room temperature 15-30C (59-86F)"
      ],
      "questions": [
        "Questions? Call 833-358-6431"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel FT Caldyphen Lotion"
      ],
      "set_id": "29945734-4ea6-b702-e063-6294a90ae6f2",
      "id": "29945218-aa80-7a4e-e063-6394a90acf67",
      "effective_time": "20241218",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Foster and Thrive Caldyphen"
        ],
        "generic_name": [
          "CALAMINE AND PRAMOXINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Strategic Sourcing Services, LLC"
        ],
        "product_ndc": [
          "70677-1198"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "PRAMOXINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1234532"
        ],
        "spl_id": [
          "29945218-aa80-7a4e-e063-6394a90acf67"
        ],
        "spl_set_id": [
          "29945734-4ea6-b702-e063-6294a90ae6f2"
        ],
        "package_ndc": [
          "70677-1198-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z",
          "88AYB867L5"
        ]
      }
    }
  ]
}