{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 15
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "zinc oxide 20% zinc oxide 20% CETETH-20 CETOSTEARYL ALCOHOL LIGHT MINERAL OIL WHITE PETROLATUM ZINC OXIDE ZINC OXIDE"
      ],
      "active_ingredient": [
        "Active ingredient Zinc Oxide 20 %"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses ■ Dries the oozing and weeping of poison • ivy • oak • sumac ■ Helps treat and prevent diaper rash ■ Protects chafed skin due to diaper rash and helps seal out wetness"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "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 ■ For poison ivy, oak & sumac: apply as needed ■ For Diaper Rash 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 bed time or anytime when exposure to wet diapers may be prolonged"
      ],
      "storage_and_handling": [
        "Other information ■ Store at 15°C – 30°C (59°F – 86°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients ceteareth 20, cetostearyl alcohol, light mineral oil, white petrolatum"
      ],
      "spl_unclassified_section": [
        "Manufactured for: Bionpharma Inc. Princeton, NJ 08540 MADE IN INDIA L0000798 KBP0581L-0 R0324 GUJ/DRUGS/G/25/2134"
      ],
      "package_label_principal_display_panel": [
        "NDC 69452-450-58 • dye-free • paraben-free • phthalate-free • fragrance-free a+ health TM healing ointment zinc oxide 20% / skin protectant • protects chafed skin due to diaper rash and helps seal out wetness • dries the oozing and weeping of poison ivy, oak and sumac net wt. 15 oz image001"
      ],
      "set_id": "1549500a-0941-0fba-e063-6394a90a564e",
      "id": "1549491b-a7b0-2b4a-e063-6294a90a9196",
      "effective_time": "20240418",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "zinc oxide 20%"
        ],
        "generic_name": [
          "ZINC OXIDE 20%"
        ],
        "manufacturer_name": [
          "Bionpharma Inc"
        ],
        "product_ndc": [
          "69452-450"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "198911"
        ],
        "spl_id": [
          "1549491b-a7b0-2b4a-e063-6294a90a9196"
        ],
        "spl_set_id": [
          "1549500a-0941-0fba-e063-6394a90a564e"
        ],
        "package_ndc": [
          "69452-450-58"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}