{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Triple 3x Max Diaper Rash ZINC OXIDE BEESWAX WHITE PETROLATUM STARCH, CORN LANOLIN .ALPHA.-BISABOLOL, (+/-)- CHOLESTEROL WATER GLYCERIN OAT ZINC OXIDE ZINC OXIDE MINERAL OIL"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by Advantice Health, LLC Bridgewater, NJ 08807"
      ],
      "active_ingredient": [
        "Active ingredient Zinc oxide 40%"
      ],
      "purpose": [
        "Purpose Skin protectant"
      ],
      "indications_and_usage": [
        "Uses helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps protect from wetness"
      ],
      "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 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 change wet and soiled diapers promptly cleanse the diaper area and allow skin to dry apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time exposure to wet diapers may be prolonged"
      ],
      "storage_and_handling": [
        "Other information Store at room temperature 15°-30°C (59°-86°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients avena sativa (oat) kernel extract, beeswax, bisabolol, cholesterol, glycerin, lanolin, mineral oil, water, white petrolatum, zea mays (corn) starch"
      ],
      "questions": [
        "Questions? 1-800-345-0032"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 57 g Tube Carton PEDIATRICIAN RECOMMENDED TRIPLE PASTE ® 40% Zinc Oxide / Skin Protectant ACCEPTED e National Eczema Association Diaper Rash Relief 3X* MAX 3X ZINC OXIDE PLUS SKIN NOURISHING INGREDIENTS Oat Extract Beeswax Glycerin Fragrance Free • Hypoallergenic • Talc Free Prevents • Treats • Soothes Net Wt. 2oz. (57g) Principal Display Panel - 57 g Tube Carton"
      ],
      "set_id": "e554046b-cd0a-4a6e-8f24-2e610c697432",
      "id": "51d0a7c7-f1fa-2e15-e063-6394a90a678b",
      "effective_time": "20260514",
      "version": "5",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Triple 3x Max Diaper Rash"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Advantice Health, LLC"
        ],
        "product_ndc": [
          "16864-061"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "spl_id": [
          "51d0a7c7-f1fa-2e15-e063-6394a90a678b"
        ],
        "spl_set_id": [
          "e554046b-cd0a-4a6e-8f24-2e610c697432"
        ],
        "package_ndc": [
          "16864-061-01",
          "16864-061-02",
          "16864-061-03",
          "16864-061-04"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}