{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Secura Protective ZINC OXIDE ALOE VERA LEAF PROPYLPARABEN POLYSORBATE 20 OCTYL STEARATE WATER ALLANTOIN CLOVE OIL METHYLPARABEN SODIUM CETOSTEARYL SULFATE ALPHA-TOCOPHEROL ACETATE PETROLATUM CETOSTEARYL ALCOHOL POLYOXYL 40 CASTOR OIL ZINC OXIDE ZINC CATION OCTYL PALMITATE DIOCTYL ADIPATE Secura Protective ZINC OXIDE ALOE VERA LEAF PEG-40 CASTOR OIL PROPYLPARABEN ALLANTOIN SODIUM CETOSTEARYL SULFATE CLOVE OIL METHYLPARABEN POLYSORBATE 20 WATER ALPHA-TOCOPHEROL ACETATE PETROLATUM CETOSTEARYL ALCOHOL DIOCTYL ADIPATE OCTYL PALMITATE ZINC OXIDE ZINC OXIDE OCTYL STEARATE"
      ],
      "spl_unclassified_section": [
        "DRUG FACTS"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENT Zinc oxide 10%"
      ],
      "purpose": [
        "PURPOSE Skin protectant"
      ],
      "indications_and_usage": [
        "USES skin protectant helps treat and prevent diaper dermatitis protects minor skin irritation associated with diaper dermatitis and helps seal out wetness"
      ],
      "warnings": [
        "WARNINGS For external use only Avoid contact with eyes Not to be applied over deep or puncture wounds, infections or lacerations If condition worsens or does not improve within 7 days, contact a doctor Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately Avoid contact with eyes Not to be applied over deep or puncture wounds, infections or lacerations If condition worsens or does not improve within 7 days, contact a doctor KEEP OUT OF REACH OF CHILDREN Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately"
      ],
      "when_using": [
        "Avoid contact with eyes"
      ],
      "do_not_use": [
        "Not to be applied over deep or puncture wounds, infections or lacerations"
      ],
      "stop_use": [
        "If condition worsens or does not improve within 7 days, contact a doctor"
      ],
      "keep_out_of_reach_of_children": [
        "KEEP OUT OF REACH OF CHILDREN Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately"
      ],
      "dosage_and_administration": [
        "DIRECTIONS change wet and soiled diapers, garments, and linens promptly cleanse the affected area and allow to dry apply cream liberally as often as necessary with each diaper, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged"
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS water, petrolatum, cetearyl alcohol, PEG-40 castor oil, polysorbate 20, octyl palmitate, sodium cetearyl sulfate, octyl stearate, dioctyl adipate, tocopheryl acetate, methylparaben, allantoin, clove oil, propylparaben, aloe barbadensis"
      ],
      "questions": [
        "QUESTION OR COMMENTS? 1 800 876-1261"
      ],
      "package_label_principal_display_panel": [
        "PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (50g) REF 59431100 NDC 69740-311-00 Protective Cream Skin Protectant For treatment and prevention of incontinence-asssociated dermatitis Pediatric tested CHG compatible Enriched with Allantoin, Vitamin E and Aloe Clove Oil controls odor Conditions and soothes Smith & Nephew Secura ◊ Protective Cream Made in India for: Smith & Nephew Medical Ltd, 101 Hessle Road Hull, HU3 2BN, England www.smith-nephew.com ◊Trademark of Smith & Nephew Certain markes reg’d US Pat. And Tm Off. 59431100",
        "PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (78g) REF 59431200 NDC 69740-312-00 Protective Cream Skin Protectant For treatment and prevention of incontinence-asssociated dermatitis Pediatric tested CHG compatible Enriched with Allantoin, Vitamin E and Aloe Clove Oil controls odor Conditions and soothes Smith & Nephew Secura ◊ Protective Cream Made in India for: Smith & Nephew Medical Ltd, 101 Hessle Road Hull, HU3 2BN, England www.smith-nephew.com ◊Trademark of Smith & Nephew Certain markes reg’d US Pat. And Tm Off. 59431200"
      ],
      "set_id": "b077aa64-49a3-42ee-abb3-88f833635b93",
      "id": "1ab291a4-b8b3-e4f6-e063-6394a90a3d30",
      "effective_time": "20240612",
      "version": "153",
      "openfda": {
        "application_number": [
          "M005"
        ],
        "brand_name": [
          "Secura Protective"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Smith & Nephew Medical Ltd"
        ],
        "product_ndc": [
          "69740-311",
          "69740-312"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "248279"
        ],
        "spl_id": [
          "1ab291a4-b8b3-e4f6-e063-6394a90a3d30"
        ],
        "spl_set_id": [
          "b077aa64-49a3-42ee-abb3-88f833635b93"
        ],
        "package_ndc": [
          "69740-312-00",
          "69740-311-00"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0369740311006"
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}