{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Remedy Essentials White Petrolatum,Zinc Oxide MINERAL OIL ZINC OXIDE ZINC OXIDE PETROLATUM PETROLATUM"
      ],
      "active_ingredient": [
        "Active ingredient White Petrolatum 75% Zinc Oxide 20%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses temporarily protects minor cuts, scrapes, and burns temporarily protects and helps relieve chapped or cracked skin helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness"
      ],
      "warnings": [
        "Warnings For external use only. Do not use on deep or puncture wounds animal bites serious burns When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last 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."
      ],
      "do_not_use": [
        "Do not use on deep or puncture wounds animal bites serious burns"
      ],
      "when_using": [
        "When using this product do not get into eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens symptoms last 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 for skin protection : apply as needed for diaper rash: change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged"
      ],
      "storage_and_handling": [
        "Other information store at controlled room temperature protect from freezing avoid excessive heat"
      ],
      "inactive_ingredient": [
        "Inactive ingredients mineral oil"
      ],
      "spl_unclassified_section": [
        "Manufacturing Information Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA Made in India www.medline.com 1-800-MEDLINE REF: MSC092ZP04 V4 RH23GZP"
      ],
      "package_label_principal_display_panel": [
        "Package Label Label V4 RH23GZP"
      ],
      "set_id": "42a033d6-782b-2d7f-e054-00144ff8d46c",
      "id": "47a8adf6-e5fd-f0c5-e063-6294a90a9e3d",
      "effective_time": "20260105",
      "version": "8",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Remedy Essentials"
        ],
        "generic_name": [
          "WHITE PETROLATUM,ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Medline Industries, LP"
        ],
        "product_ndc": [
          "53329-097"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "PETROLATUM"
        ],
        "rxcui": [
          "1860083"
        ],
        "spl_id": [
          "47a8adf6-e5fd-f0c5-e063-6294a90a9e3d"
        ],
        "spl_set_id": [
          "42a033d6-782b-2d7f-e054-00144ff8d46c"
        ],
        "package_ndc": [
          "53329-097-44",
          "53329-097-16",
          "53329-097-96"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z",
          "4T6H12BN9U"
        ]
      }
    }
  ]
}