{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Secura Extra Protective ZINC OXIDE CELLULOSE GUM BENZETHONIUM CHLORIDE BUTYLPARABEN DIAZOLIDINYL UREA XANTHAN GUM METHYLPARABEN MINERAL OIL PETROLATUM WATER ALPHA-TOCOPHEROL ACETATE CETOSTEARYL ALCOHOL ZINC OXIDE ZINC CATION METHYL GLUCOSE DIOLEATE Secura Extra Protective Cream ZINC OXIDE CELLULOSE GUM BENZETHONIUM CHLORIDE BUTYLPARABEN DIAZOLIDINYL UREA KARAYA GUM METHYLPARABEN MINERAL OIL PETROLATUM WATER ALPHA-TOCOPHEROL ACETATE CETOSTEARYL ALCOHOL ZINC OXIDE ZINC OXIDE METHYL GLUCOSE DIOLEATE"
      ],
      "spl_unclassified_section": [
        "DRUG FACTS"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENT Zinc Oxide 30.6%"
      ],
      "purpose": [
        "PURPOSE Skin protectant"
      ],
      "indications_and_usage": [
        "USES skin protectant helps treat and prevent diaper rash protects minor skin irritation associated with diaper rash and helps seal out wetness Update in line with OTC Monograph Amendment from reference to 'dermatitis' to 'rash' Apr 2025"
      ],
      "recent_major_changes": [
        "Update in line with OTC Monograph Amendment from reference to 'dermatitis' to 'rash' Apr 2025"
      ],
      "warnings": [
        "WARNINGS For external use only Stop use and ask a doctor if condition worsens , symptoms last more than 7 days or clears up and occur again within a few days When using this product do not get into eyes Not to be applied over deep or puncture wounds, infections, or lacerations Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Certer immediately 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"
      ],
      "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. 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 change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged"
      ],
      "storage_and_handling": [
        "OTHER INFORMATION Store at controlled room temperature 59 o F-86 o F (15 o C-30 o C)"
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS benzethonium chloride, butylparaben, cellulose gum, cetearyl alcohol, diazolidinyl urea, methyl glucose dioleate, methylparaben, mineral oil, petrolatum, tocopheryl acetate, water, xanthan gum."
      ],
      "questions": [
        "QUESTIONS OR COMMENTS? 1 800 876-1261"
      ],
      "package_label_principal_display_panel": [
        "PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - TUBE (92g) Item #59432400 NDC 69740-324-00 Extra Protective Cream Skin Protectant For treatment and prevention of incontinence-associated dermatitis For use on denuded skin associated with exposure to feces or urine Adheres to macerated skin Pediatric tested CHG compatible Smith & Nephew Secura ◊ Extra Protective Cream Made in India for Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN, England ◊ Trademark of Smith & Nephew Certain marks reg'd U.S. Pat. and Tm. Off. PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (219g) Item #59432500 NDC 69740-325-00 Extra Protective Cream Skin Protectant For treatment and prevention of incontinence-associated dermatitis For use on denuded skin associated with exposure to feces or urine Adheres to macerated skin Pediatric tested CHG compatible Smith & Nephew Secura◊ Extra Protective Cream Made in India for Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN, England ◊Trademark of Smith & Nephew Certain marks reg'd U.S. Pat. and Tm. Off. 69740-324-00 219grams-secura-label"
      ],
      "set_id": "499a1944-1682-4798-9058-3748a5eaa420",
      "id": "32f9f454-2e5a-01df-e063-6294a90af651",
      "effective_time": "20250417",
      "version": "17",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Secura Extra Protective",
          "Secura Extra Protective Cream"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Smith & Nephew Medical Ltd"
        ],
        "product_ndc": [
          "69740-324",
          "69740-325"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "477180"
        ],
        "spl_id": [
          "32f9f454-2e5a-01df-e063-6294a90af651"
        ],
        "spl_set_id": [
          "499a1944-1682-4798-9058-3748a5eaa420"
        ],
        "package_ndc": [
          "69740-324-00",
          "69740-325-00"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}