{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
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  "results": [
    {
      "spl_product_data_elements": [
        "Florasone CARDIOSPERMUM HALICACABUM FLOWERING TOP CARDIOSPERMUM HALICACABUM FLOWERING TOP CARDIOSPERMUM HALICACABUM FLOWERING TOP BENZYL ALCOHOL CETYL ALCOHOL GLYCOL STEARATE GLYCERIN ISOPROPYL MYRISTATE MINERAL OIL POTASSIUM HYDROXIDE WATER STEARYL HEPTANOATE ALCOHOL"
      ],
      "active_ingredient": [
        "Active Ingredient Contains 10% Cardiospermum halicacabum tincture"
      ],
      "inactive_ingredient": [
        "Inactive Ingredient Benzyl Alcohol Cetyl Alcohol Ethyl Alcohol Glycerin Glycol Stearate Isopropyl Myristate Mineral Oil Potassium Hydroxide Purified Water Stearyl Heptanoate"
      ],
      "dosage_and_administration": [
        "Dosage & Administration Directions Adults & children 6 years of age and older: apply to affected area up to 4 times daily; r ub in gently. Patch test recommended on sensitive skin."
      ],
      "indications_and_usage": [
        "Indications and Usage Temporarily relieves itch, rash, and skin irritation/inflammation."
      ],
      "purpose": [
        "Purpose Temporarily relieves itch, rash, and skin irritation/inflammation."
      ],
      "warnings": [
        "Warnings For external use only. Avoid contact with eyes and broken skin."
      ],
      "do_not_use": [
        "Do Not Use Do not use if hypersensitive to any ingredients in this product. Breast-feeding woman should not apply to breast area."
      ],
      "stop_use": [
        "Stop Use Stop use and ask a doctor if increased skin irritation, rash or other allergic reaction develops, condition worsens or does not improve within 7 days, symptoms clear up and occur again within a few days. These could be signs of a serious condition."
      ],
      "pregnancy_or_breast_feeding": [
        "Pregnancy or Breast-feeding If pregnant or breast-feeding, ask a healthcare professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children Keep out of reach of children."
      ],
      "overdosage": [
        "Overdose If swallowed, seek medical help or contact a Poison Control Center right away."
      ],
      "package_label_principal_display_panel": [
        "LHBN21850390.A01-Z-Florasone-Cream-1-oz.jpg LHT21850390.A01-Z-Florasone-Cream-1-oz.jpg"
      ],
      "set_id": "0ea5879c-5955-427d-8604-a0677a4bb5cd",
      "id": "a15a9800-1914-4287-a3b4-2f399c318744",
      "effective_time": "20251118",
      "version": "12",
      "openfda": {
        "brand_name": [
          "Florasone"
        ],
        "generic_name": [
          "CARDIOSPERMUM HALICACABUM FLOWERING TOP"
        ],
        "manufacturer_name": [
          "Schwabe North America"
        ],
        "product_ndc": [
          "53499-0390"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CARDIOSPERMUM HALICACABUM FLOWERING TOP"
        ],
        "spl_id": [
          "a15a9800-1914-4287-a3b4-2f399c318744"
        ],
        "spl_set_id": [
          "0ea5879c-5955-427d-8604-a0677a4bb5cd"
        ],
        "package_ndc": [
          "53499-0390-4"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0308078503905"
        ],
        "unii": [
          "MZP2508BRR"
        ]
      }
    }
  ]
}