{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Balmex Diaper Rash Zinc Oxide 11.3% BENZOIC ACID DIMETHICONE 350 SOYBEAN OIL MAGNESIUM ASPARTATE MICROCRYSTALLINE WAX MINERAL OIL EVENING PRIMROSE OIL OLEA EUROPAEA LEAF PANTHENOL BALSAM PERU PHENOXYETHANOL POTASSIUM ASPARTATE ZINC OXIDE ZINC OXIDE POTASSIUM HYDROXIDE SARCOSINE COCO ACID CHLORIDES SORBITAN SESQUIOLEATE SYNTHETIC BEESWAX TOCOPHEROL WATER YELLOW WAX"
      ],
      "active_ingredient": [
        "Zinc Oxide 11.3%"
      ],
      "purpose": [
        "Skin Protectant"
      ],
      "indications_and_usage": [
        "Helps treat and prevent diaper rash, protects chafed skin due to diaper rash and helps seal out wetness."
      ],
      "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, seek medical help or contact a Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "Change wet and 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 anytime when exposure to wet diapers may be prolonged."
      ],
      "inactive_ingredient": [
        "Beeswax, benzoic acid, dimethicone, glycine soja (soybean) oil, magnesium aspartate, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europae (olive) leaf extract, panthenol, Peruvian balsam, Phenoxyethanol, potassium aspartate, potassium hydroxide, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water."
      ],
      "package_label_principal_display_panel": [
        "Label"
      ],
      "set_id": "f7f7a89d-d4e0-9faa-e053-6294a90aaf7b",
      "id": "29577ef9-f215-1dc6-e063-6394a90a44ab",
      "effective_time": "20241215",
      "version": "3",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Balmex Diaper Rash"
        ],
        "generic_name": [
          "ZINC OXIDE 11.3%"
        ],
        "manufacturer_name": [
          "Randob Labs, LTD"
        ],
        "product_ndc": [
          "52412-285"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "630923",
          "967558"
        ],
        "spl_id": [
          "29577ef9-f215-1dc6-e063-6394a90a44ab"
        ],
        "spl_set_id": [
          "f7f7a89d-d4e0-9faa-e053-6294a90aaf7b"
        ],
        "package_ndc": [
          "52412-285-16",
          "52412-285-12",
          "52412-285-04",
          "52412-285-02",
          "52412-285-03"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0030103042003"
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}