{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "VITACILINA Bebe Diaper Rash ALLANTOIN, ZINC OXIDE PETROLATUM STARCH, CORN LANOLIN METHYLPARABEN MINERAL OIL PROPYLPARABEN VITAMIN A VITAMIN D .ALPHA.-TOCOPHEROL ALLANTOIN ALLANTOIN ZINC OXIDE ZINC CATION"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredients Allantoin 1% Zinc Oxide 25% Purpose Skin Protectant"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses • Helps treat and prevent diaper rash • Protects against minor skin irritation associated with diaper rash • Helps seal out wetness."
      ],
      "warnings": [
        "Warnings For external use only. When using this product avoid contact with the eyes. 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 the reach of children."
      ],
      "when_using": [
        "When using this product avoid contact with the 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 the reach of children."
      ],
      "dosage_and_administration": [
        "Directions • Change wet and soiled diapers promptly, cleanse the diaper area and allow to dry. • Apply ointment as often as necessary with each diaper change, especially at bedtime, or anytime when exposure to wet diapers may be prolonged."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Petrolatum, Corn starch, Fragrance, Lanolin, Methylparaben, Mineral oil, Propylparaben, Vitamin A Palmitate, Vitamin D (calciferol), Vitamin E (tocopherol)."
      ],
      "questions": [
        "Questions or comments? Call 1-855-289-3205 (toll-free) or email contact@ksklab.us"
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: Label Inner label Outer Label00 Inner Label00"
      ],
      "set_id": "39726b59-bd85-4541-80e5-4f2919842dca",
      "id": "471d2450-a938-69cf-e063-6294a90ac7c1",
      "effective_time": "20251229",
      "version": "20",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "VITACILINA Bebe Diaper Rash"
        ],
        "generic_name": [
          "ALLANTOIN, ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Compania Internacional de Comercio, S.A.P.I de C.V."
        ],
        "product_ndc": [
          "54312-525"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ALLANTOIN",
          "ZINC OXIDE"
        ],
        "rxcui": [
          "1441179"
        ],
        "spl_id": [
          "471d2450-a938-69cf-e063-6294a90ac7c1"
        ],
        "spl_set_id": [
          "39726b59-bd85-4541-80e5-4f2919842dca"
        ],
        "package_ndc": [
          "54312-525-16"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0354312225164"
        ],
        "unii": [
          "344S277G0Z",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}