{
  "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": "2026-06-09",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "AD Medicated Rash AD Medicated Rash MINERAL OIL MINERAL OIL OATMEAL OATMEAL PETROLATUM PARAFFIN MICROCRYSTALLINE WAX CANDELILLA WAX LANOLIN GLYCERIN COD LIVER OIL WATER CALENDULA OFFICINALIS FLOWER CHAMOMILE POTASSIUM SORBATE SORBIC ACID"
      ],
      "active_ingredient": [
        "Active Ingredients Mineral Oil 30% Colloidal Oatmeal 2%"
      ],
      "purpose": [
        "Purpose Skin protectant Skin protectant"
      ],
      "indications_and_usage": [
        "Uses Temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema"
      ],
      "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 persist for more than 7 days, or clear up and occur again within a few days 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 persist for 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 Petrolatum, Paraffin, Microcrystalline Wax, Euphorbia Cerifera (Candelilla) Wax, Lanolin,Fragrance (Parfum), Glycerin, Cod Liver Oil (contains vitamin A & vitamin D), Water, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Potassium Sorbate, Sorbic Acid."
      ],
      "questions": [
        "Questions? 1-844-241-5454 or ADskinhealth.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 65197-406-15 A+D MEDICATED RASH OINTMENT 1.5oz A+D Medicated Rash Ointment SOOTHES, PROTECTS, RELIEVES RASH AND IRRITATED SKIN WITH VITAMIN A & VITAMIN D plus COLLOIDAL OATMEAL & EUCALYPTUS PARABEN-FREE DYE-FREE PHTHALATE-FREE NET WT 1.5 OZ (42.5g) Skin nourishing formula with Vitamin A and Vitamin D helps heal and moisturize irritated skin CLINICALLY PROVEN TO IMPROVE: Itching Stinging Irritated Skin Redness Dryness CT40600A P13018.00 NDC# 65197-406-15 UPC: 365197406005 Carton A+D MEDICATED RASH OINTMENT 1.5oz 65197-406-52 A+D Medicated Rash Ointment 15.2 oz 65197-406-52 Label Jar"
      ],
      "set_id": "aac345bf-ea66-4f5b-a497-c24ea72f93ea",
      "id": "89effa3a-900f-4f5b-98cc-e33644bba091",
      "effective_time": "20241227",
      "version": "5",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "AD Medicated Rash"
        ],
        "generic_name": [
          "AD MEDICATED RASH"
        ],
        "manufacturer_name": [
          "WellSpring Pharmaceutical Corporation"
        ],
        "product_ndc": [
          "65197-406"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "MINERAL OIL",
          "OATMEAL"
        ],
        "rxcui": [
          "2710836"
        ],
        "spl_id": [
          "89effa3a-900f-4f5b-98cc-e33644bba091"
        ],
        "spl_set_id": [
          "aac345bf-ea66-4f5b-a497-c24ea72f93ea"
        ],
        "package_ndc": [
          "65197-406-15",
          "65197-406-52"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185371",
          "N0000185375",
          "N0000175629",
          "N0000184306",
          "M0000728",
          "M0006342",
          "M0016962",
          "N0000185016"
        ],
        "pharm_class_epc": [
          "Non-Standardized Food Allergenic Extract [EPC]",
          "Non-Standardized Plant Allergenic Extract [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Dietary Proteins [CS]",
          "Plant Proteins [CS]"
        ],
        "unii": [
          "T5L8T28FGP",
          "8PI54V663Y"
        ]
      }
    }
  ]
}