{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "DiaperRashOintment Zinc Oxide POLYSORBATE 80 ALPHA-TOCOPHEROL ACETATE GLYCERYL MONOSTEARATE PROPYLPARABEN METHYLPARABEN ALOE VERA LEAF PETROLATUM YELLOW WAX STEARIC ACID ZINC OXIDE ZINC OXIDE MINERAL OIL WATER"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Helps treat and prevent diaper rash. Protects skin. Relieves Chafing. Promotes Healing Distributed by: Pharmacy Value Alliance, LLC. 407 East Lancaster Avenue, Wayne, PA. 19087 USA www.emersongroup.com"
      ],
      "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 skin from wetness"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately."
      ],
      "warnings": [
        "Warnings For External Use Only When using this product Avoid contact with eyes"
      ],
      "dosage_and_administration": [
        "Directions Change wet and soiled diapers promptly Cleanse the diaper area and allow to dry Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged."
      ],
      "stop_use": [
        "Stop use and ask a doctor if Condition worsens Symptoms last more than 7 days or clear up and occur again with a few days"
      ],
      "storage_and_handling": [
        "Other Information: Store at controlled room temperature 20° - 25°C (68° - 77°F)"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients BHA, Cod liver oil (high in vitamin A and D), Frangrance, Lanolin, Mineral Oil, Methylparaben, Petrolatum, Purified water, Talc, Tartrazine yellow #4 (FD and C yellow #4)"
      ],
      "package_label_principal_display_panel": [
        "Packaging Packaging"
      ],
      "set_id": "3aace6d8-d24c-00e1-e054-00144ff8d46c",
      "id": "29b767b1-aee6-2365-e063-6294a90a6778",
      "effective_time": "20241220",
      "version": "7",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "DiaperRashOintment"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Pharmacy Value Alliance, LLC"
        ],
        "product_ndc": [
          "68016-128"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "244638"
        ],
        "spl_id": [
          "29b767b1-aee6-2365-e063-6294a90a6778"
        ],
        "spl_set_id": [
          "3aace6d8-d24c-00e1-e054-00144ff8d46c"
        ],
        "package_ndc": [
          "68016-128-20"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0840986012723"
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}