{
  "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": "2026-10-29",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "FDS intimate Whole Body Medicated Chafing FDS intimate Whole Body Medicated Chafing LANOLIN LANOLIN PETROLATUM PETROLATUM MINERAL OIL PARAFFIN MICROCRYSTALLINE WAX COD LIVER OIL"
      ],
      "active_ingredient": [
        "Active Ingredients Lanolin 15.5% Petrolatum 53.4%"
      ],
      "purpose": [
        "Purpose Skin protectant Skin protectant"
      ],
      "indications_and_usage": [
        "Uses Helps prevent and temporarily protects chafed, chapped or cracked skin"
      ],
      "warnings": [
        "Warnings For external use only When using this product do not get into eyes 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 Do not use on deep or puncture wounds animal bites serious burns Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "when_using": [
        "When using this product do not get into eyes"
      ],
      "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 If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions apply as needed"
      ],
      "storage_and_handling": [
        "Other information store between 20° to 25°C (68° to 77°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients mineral oil, paraffin, microcrystalline wax, cod liver oil (contains vitamin A & vitamin D), fragrance"
      ],
      "questions": [
        "Questions? 1-844-241-5454 or FDSforHer.com"
      ],
      "spl_unclassified_section": [
        "Distributed by: WellSpring Pharmaceutical Corporation Sarasota, FL 34243 © 2024 WellSpring Pharmaceutical Corporation"
      ],
      "package_label_principal_display_panel": [
        "PACKAGE LABEL. PRINCIPAL DISPLAY PANEL FDS intimate Whole Body Medicated Chafing Ointment 1.5 oz (42.5g) HELPS PREVENT AND TREAT Chafing Enriched with Vitamins A+D Non-Irritating Odor Control Technology NET WT 1.5 oz (42.5g) CT70030B NDC# 65197-730-15 CT70030B Carton CT70030B"
      ],
      "set_id": "ef01fcd8-2fe4-4076-a4d4-e730a5c2b31c",
      "id": "6657c175-174e-4843-9152-fc3e3fddeb72",
      "effective_time": "20260707",
      "version": "2",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "FDS intimate Whole Body Medicated Chafing"
        ],
        "generic_name": [
          "FDS INTIMATE WHOLE BODY MEDICATED CHAFING"
        ],
        "manufacturer_name": [
          "WellSpring Pharmaceutical Corporation"
        ],
        "product_ndc": [
          "65197-730"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "LANOLIN",
          "PETROLATUM"
        ],
        "rxcui": [
          "664981"
        ],
        "spl_id": [
          "6657c175-174e-4843-9152-fc3e3fddeb72"
        ],
        "spl_set_id": [
          "ef01fcd8-2fe4-4076-a4d4-e730a5c2b31c"
        ],
        "package_ndc": [
          "65197-730-15"
        ],
        "is_original_packager": [
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        ],
        "unii": [
          "7EV65EAW6H",
          "4T6H12BN9U"
        ]
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}