{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Koala Kubs Diaper Rash Cream Diaper Rash Cream ETHYLHEXYLGLYCERIN POTASSIUM SORBATE CALENDULA OFFICINALIS FLOWER WATER DECYL OLEATE TOCOPHEROL POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE SOYBEAN OIL ZINC STEARATE OLEYL ERUCATE SODIUM BENZOATE GLYCERIN DICAPRYLYL ETHER POLYGLYCERYL-3 DIISOSTEARATE MAGNESIUM STEARATE SODIUM CHLORIDE BENZYL ALCOHOL ZINC OXIDE ZINC OXIDE"
      ],
      "active_ingredient": [
        "Active Ingredients Active Ingredients Zinc Oxide USP 15%"
      ],
      "purpose": [
        "Purpose Purpose Skin Protectant"
      ],
      "when_using": [
        "Uses Uses Helps treat and prevent diaper rash Protects chaffed skin due to diaper rash and helps seal out wetness",
        "When using this product When using this product do not get into eyes"
      ],
      "stop_use": [
        "Stop use and ask doctor if Stop use and ask 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 immediately."
      ],
      "dosage_and_administration": [
        "Directions Directions Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry Apply cream liberally and as often as necessary with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged."
      ],
      "other_safety_information": [
        "Other Information Other Information to open, twist off cap and remove quality seal do not use if quality seal is broken store at room temperature"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Inactive Ingredients: water, decyl oleate, oleyl erucate, dicaprylyl ether, polyglyceryl-2 dipolyhydroxystearate, glycerin, polyglyceryl-3 diisostearate, magnesium stearate, sodium chloride, zinc stearate, benzyl alcohol, glycine soja (soybean) oil, sodium benzoate, ethylhexylglycerin, potassium sorbate, calendula officinalis (marigold) flower extract, tocopherol"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "indications_and_usage": [
        "Purpose Skin Protectant Uses Helps treat and prevent diaper rash Protects chafed skin due to diaper rash and helps seal out wetness"
      ],
      "package_label_principal_display_panel": [
        "Label Tube"
      ],
      "set_id": "c6b3b0dd-22a8-16f7-e053-2a95a90a51ea",
      "id": "30ce75fa-69c6-932d-e063-6294a90a3a29",
      "effective_time": "20250320",
      "version": "3",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Koala Kubs Diaper Rash Cream"
        ],
        "generic_name": [
          "DIAPER RASH CREAM"
        ],
        "manufacturer_name": [
          "Melaleuca, Inc."
        ],
        "product_ndc": [
          "54473-333"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "spl_id": [
          "30ce75fa-69c6-932d-e063-6294a90a3a29"
        ],
        "spl_set_id": [
          "c6b3b0dd-22a8-16f7-e053-2a95a90a51ea"
        ],
        "package_ndc": [
          "54473-333-03"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}