{
  "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,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Triple Diaper Rash Zinc Oxide WHITE PETROLATUM STARCH, CORN LANOLIN STEARYL ALCOHOL YELLOW WAX LEVOMENOL CHOLESTEROL WATER GLYCERIN OAT ZINC OXIDE ZINC OXIDE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by Advantice Health, LLC Cedar Knolls, NJ 07927"
      ],
      "active_ingredient": [
        "Active ingredient Zinc oxide 12.8%"
      ],
      "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 lime 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 white petrolatum, com starch, anhydrous lanolin, stearyl alcohol, beeswax, bisabolol, cholesterol, water, glycerin, oat (avena saliva) kernel extract."
      ],
      "questions": [
        "Questions? 1-800-345-0032"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 85 g Tube Carton PEDIATRICIAN RECOMMENDED TRIPLE PASTE ® 12.8% Zinc Oxide / Skin Protectant All-in-One TRIPLE PROTECTION PREVENTS stops diaper rash before it starts TREATS restores irritated skin to health SOOTHES immediate soothing relief for sensitive skin •Fragrance-free• Net Wt. 3oz. (85g) Principal Display Panel - 85 g Tube Carton"
      ],
      "set_id": "d457c58d-8239-41c4-999e-d0ba237e3945",
      "id": "4d63f2a2-f114-d739-e063-6394a90a2d27",
      "effective_time": "20260319",
      "version": "6",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Triple Diaper Rash"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Advantice Health, LLC"
        ],
        "product_ndc": [
          "16864-021"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "637168",
          "729935"
        ],
        "spl_id": [
          "4d63f2a2-f114-d739-e063-6394a90a2d27"
        ],
        "spl_set_id": [
          "d457c58d-8239-41c4-999e-d0ba237e3945"
        ],
        "package_ndc": [
          "16864-021-03",
          "16864-021-04",
          "16864-021-05",
          "16864-021-02",
          "16864-021-01",
          "16864-021-06",
          "16864-021-07"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}