{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 22
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Athletes Foot Ultra Butenafine Hydrochloride BENZYL ALCOHOL CETYL ALCOHOL GLYCERIN GLYCERYL STEARATE SE CETETH-23 PROPYLENE GLYCOL DICAPRYLATE WATER SODIUM BENZOATE STEARIC ACID TROLAMINE PETROLATUM BUTENAFINE HYDROCHLORIDE BUTENAFINE"
      ],
      "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. cures most jock itch and ringworm relieves itching, burning, cracking, and scaling which accompany these conditions"
      ],
      "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 this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if too much irritation occurs or irritation gets worse Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "do_not_use": [
        "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: use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying 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. Apply between and around the toes 1 week twice a day or 4 weeks once a day for jock itch and ringworm: apply once a day to affected skin for 2 weeks or as directed by a doctor. wash hands after each use children under 12 years: ask a doctor image"
      ],
      "storage_and_handling": [
        "Other information do not use if seal on tube is broken or not visible 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? Call 1-866-923-4914"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 12 g Tube Carton Compare to Lotrimin Ultra ® * active ingredient NDC 37808-013-02 H-E-B ® Clinically Proven to Cure Most Athlete's Foot between the Toes Athlete's Foot Cream Ultra Butenafine Hydrochloride Cream 1% Antifungal NET WT 12 g (0.42 oz) PRINCIPAL DISPLAY PANEL - 12 g Tube Carton"
      ],
      "set_id": "0841f741-6409-4d93-a6a7-901808f77bcd",
      "id": "3906a83a-cbe3-2864-e063-6394a90a4be2",
      "effective_time": "20250703",
      "version": "2",
      "openfda": {
        "application_number": [
          "ANDA205181"
        ],
        "brand_name": [
          "Athletes Foot Ultra"
        ],
        "generic_name": [
          "BUTENAFINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "H E B"
        ],
        "product_ndc": [
          "37808-013"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BUTENAFINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1298448"
        ],
        "spl_id": [
          "3906a83a-cbe3-2864-e063-6394a90a4be2"
        ],
        "spl_set_id": [
          "0841f741-6409-4d93-a6a7-901808f77bcd"
        ],
        "package_ndc": [
          "37808-013-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0041220573646"
        ],
        "unii": [
          "R8XA2029ZI"
        ]
      }
    }
  ]
}