{
  "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": "2026-10-14",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Lotrimin Ultra Butenafine hydrochloride STEARIC ACID TROLAMINE GLYCERIN WHITE PETROLATUM BENZYL ALCOHOL BUTENAFINE HYDROCHLORIDE BUTENAFINE CETYL ALCOHOL WATER SODIUM BENZOATE CETETH-23 GLYCERYL MONOSTEARATE PROPYLENE GLYCOL DICAPRYLATE white to off white"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredient Butenafine hydrochloride 1%"
      ],
      "purpose": [
        "Purpose Antifungal"
      ],
      "indications_and_usage": [
        "Uses cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown. relieves itching, burning, cracking, and scaling which accompany this condition"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "do_not_use": [
        "on nails or scalp in or near the mouth or the eyes for vaginal yeast infections"
      ],
      "when_using": [
        "When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water."
      ],
      "stop_use": [
        "Stop use and ask a doctor if too much irritation occurs or irritation gets worse"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions adults and children 12 years and older: wash the affected skin with soap and water and dry completely before applying to open the applicator, twist the base to the ON position. Squeeze tube to dispense cream. for athlete's foot between the toes: apply to affected skin between and around the toes twice a day for 1 week (morning and night), or once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. wipe applicator tip with a tissue and close the applicator by twisting the base to the OFF position wash hands after each use children under 12 years: ask a doctor"
      ],
      "storage_and_handling": [
        "Other information store between 20° to 25°C (68° to 77°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients benzyl alcohol, cetyl alcohol, glycerin, glyceryl monostearate SE, polyoxyethylene (23) cetyl ether, propylene glycol dicaprylate, purified water, sodium benzoate, stearic acid, trolamine, white petrolatum"
      ],
      "questions": [
        "Questions? 1-866-360-3266 or visit us at www.lotrimin.com"
      ],
      "package_label_principal_display_panel": [
        "​LOTRIMIN ULTRA ® BUTENAFINE HYDROCHLORIDE CREAM 1% ANTIFUNGAL NET WT 20g (0.70 OZ) Lotrimin Ultra"
      ],
      "set_id": "d11dfdf6-9b36-03bc-e053-2995a90a0bc3",
      "id": "4526ca36-993f-b574-e063-6294a90a8fba",
      "effective_time": "20251204",
      "version": "7",
      "openfda": {
        "application_number": [
          "NDA021307"
        ],
        "brand_name": [
          "Lotrimin Ultra"
        ],
        "generic_name": [
          "BUTENAFINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Bayer Healthcare LLC."
        ],
        "product_ndc": [
          "11523-0082"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BUTENAFINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1298448"
        ],
        "spl_id": [
          "4526ca36-993f-b574-e063-6294a90a8fba"
        ],
        "spl_set_id": [
          "d11dfdf6-9b36-03bc-e053-2995a90a0bc3"
        ],
        "package_ndc": [
          "11523-0082-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0000000000000"
        ],
        "unii": [
          "R8XA2029ZI"
        ]
      }
    }
  ]
}