{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Balmex Diaper Rash Zinc Oxide Zinc Oxide Zinc Oxide Yellow Wax Benzoic Acid Dimethicone 100 Soybean Oil Magnesium Aspartate Anhydrous Methylparaben Microcrystalline Wax Mineral Oil Oenothera Biennis Olea Europaea Leaf Dexpanthenol Potassium Aspartate Potassium Hydroxide Propylene Glycol Propylparaben Sarcosine Sorbitan Sesquioleate Tocopherol Water Sodium Cocoyl Glycinate White Wax"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information do not use if quality seal is broken see bottom of carton and or top of tube for lot number and expiration date"
      ],
      "active_ingredient": [
        "Active ingredients Purpose Zinc Oxide 11.3% Skin protectant"
      ],
      "active_ingredient_table": [
        "<table border=\"1\" cellpadding=\"4\" cellspacing=\"0\" width=\"40%\"> <tbody> <tr> <td align=\"left\" styleCode=\"Lrule Toprule\"> <content styleCode=\"italics\"> <content styleCode=\"bold\">Active ingredients</content> </content> </td> <td align=\"right\" styleCode=\"Rrule Toprule\"> <content styleCode=\"bold\"> <content styleCode=\"italics\">Purpose</content> </content> </td> </tr> <tr> <td align=\"left\" styleCode=\"Botrule Lrule\">Zinc Oxide 11.3%</td> <td align=\"right\" styleCode=\"Botrule Rrule\">Skin protectant</td> </tr> </tbody> </table>"
      ],
      "purpose": [
        "Active ingredients Purpose Zinc Oxide 11.3% Skin protectant"
      ],
      "purpose_table": [
        "<table border=\"1\" cellpadding=\"4\" cellspacing=\"0\" width=\"40%\"> <tbody> <tr> <td align=\"left\" styleCode=\"Lrule Toprule\"> <content styleCode=\"italics\"> <content styleCode=\"bold\">Active ingredients</content> </content> </td> <td align=\"right\" styleCode=\"Rrule Toprule\"> <content styleCode=\"bold\"> <content styleCode=\"italics\">Purpose</content> </content> </td> </tr> <tr> <td align=\"left\" styleCode=\"Botrule Lrule\">Zinc Oxide 11.3%</td> <td align=\"right\" styleCode=\"Botrule Rrule\">Skin protectant</td> </tr> </tbody> </table>"
      ],
      "indications_and_usage": [
        "Uses 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 this product do not get into 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 reach of children. If swallowed, get medical help or contact a Poison Control Center immediately."
      ],
      "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 immediately."
      ],
      "dosage_and_administration": [
        "Directions change wet or soiled diapers promptly, cleanse the diaper area, and allow to dry apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Beeswax, benzoic acid, dimethicone, fragrance, glycine soja (soybean) oil, magnesium aspartate, methylparaben, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europea (olive) leaf extract, panthenol, potassium aspartate, potassium hydroxide, propylparaben, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water (245-230)"
      ],
      "questions": [
        "Questions? 1-833-389-9450 Dist. by: RANDOB LABS LTD. Box 440, Cornwall, NY 12518"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 113 g Tube Carton NEW LOOK-SAME PRODUCT Balmex® COMPLETE PROTECTION™ Zinc Oxide DIAPER RASH CREAM Prevents & Heals ✔ Protects against all 3 leading causes of diaper rash ✔ Reduces rash in just 1 diaper change Pediatrician Recommended Advanced Formula NET WT 4 OZ (113 g) PRINCIPAL DISPLAY PANEL - 113 g Tube Carton"
      ],
      "set_id": "f202dd0e-7c61-4ea1-a5f6-e90898366ba3",
      "id": "18af2fdd-d234-4675-afc6-e0bdd19cdbbd",
      "effective_time": "20181113",
      "version": "1",
      "openfda": {
        "application_number": [
          "part347"
        ],
        "brand_name": [
          "Balmex Diaper Rash"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Randob Labs,Ltd."
        ],
        "product_ndc": [
          "52412-400"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "630923",
          "967558"
        ],
        "spl_id": [
          "18af2fdd-d234-4675-afc6-e0bdd19cdbbd"
        ],
        "spl_set_id": [
          "f202dd0e-7c61-4ea1-a5f6-e90898366ba3"
        ],
        "package_ndc": [
          "52412-400-04",
          "52412-400-16",
          "52412-400-02",
          "52412-400-05"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}