{
  "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": 104
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Tripenicol C Undecylenic Acid UNDECYLENIC ACID UNDECYLENIC ACID WATER HYDROXYETHYL CELLULOSE, UNSPECIFIED ALOE VERA LEAF EDETATE DISODIUM UREA MEDIUM-CHAIN TRIGLYCERIDES POLYSORBATE 60 PEG-100 MONOSTEARATE CETYL ALCOHOL GLYCERYL MONOSTEARATE STEARIC ACID METHYLPARABEN PROPYLPARABEN TROLAMINE CLOTRIMAZOLE LAVENDER OIL TEA TREE OIL SODIUM POLYACRYLATE (8000 MW) HYDROGENATED POLYDECENE (1500 CST) TRIDECETH-6"
      ],
      "spl_unclassified_section": [
        "DRUG FACTS"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENT Undecylenic Acid 13%"
      ],
      "purpose": [
        "PURPOSE Antifungal"
      ],
      "indications_and_usage": [
        "USES Cures most Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis). Relives discomfort, itching, cracking, burning and scaling, which accompany these conditions."
      ],
      "warnings": [
        "WARNING Do not use on children under two years of age unless directed by a physician. For external use only. Avoid contact with eyes. If irritation occurs or if there is no improvement within four (4) weeks (for Athlete's Foot or Ringworm) or within two (2) weeks (for Jock Itch), discontinue use and consult a physician. Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact poison control center immediately (800)-222-1222."
      ],
      "keep_out_of_reach_of_children": [
        "Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact poison control center immediately (800)-222-1222."
      ],
      "dosage_and_administration": [
        "DIRECTIONS Wash the affected area with soap and water and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a physician. Supervise children in the use of this product. For Athlete's Foot, pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily. For Athlete's Foot and Ringworm, use daily for four (4) weeks; for Jock Itch, use daily for two (2) weeks. If condition persists longer, consult a physician. This product is not effective on the scalp or nails. Wash hands after each use."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS Aloe barbadensis (Aloe Vera) Leaf Juice, Caprylic/Capric Triglyceride, Cetyl Alcohol, Clotrimazole, Disodium EDTA Dihydrate, Glyceryl Stearate, Hydrogenated Polydecene, Hydroxyethylcellulose, Lavandula angustifolia (Lavender) Oil, Melaleuca alternifolia (Tea Tree) Oil, Methylparaben, PEG-100 Stearate, Polysorbate 60, Propylparaben, Purified Water, Sodium Polyacrylate, Stearic Acid, Trideceth-6, Triethanolamine, Urea"
      ],
      "storage_and_handling": [
        "OTHER INFORMATION Store in dry area at 20-25°C (68-77°F)"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 37.0 mL Bottle Label TRIFLUENT PHARMA ® TRIPENICOL™ C ANTIFUNGAL CREAM UNDECYLENIC ACID NDC 73352-555-01 1.25 FL OZ (37.0 mL) PRODUCT SHOULD BE ADMINISTERED UNDER THE SUPERVISION OF A LICENSED MEDICAL PRACTITIONER PRINCIPAL DISPLAY PANEL - 37.0 mL Bottle Label"
      ],
      "set_id": "0a7477da-370f-451f-8993-8c675c168696",
      "id": "c872059f-48b3-479c-8c1c-0893d67cc1e2",
      "effective_time": "20251014",
      "version": "4",
      "openfda": {
        "application_number": [
          "M005"
        ],
        "brand_name": [
          "Tripenicol C"
        ],
        "generic_name": [
          "UNDECYLENIC ACID"
        ],
        "manufacturer_name": [
          "Trifluent Pharma LLC"
        ],
        "product_ndc": [
          "73352-555"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "UNDECYLENIC ACID"
        ],
        "rxcui": [
          "1250978",
          "2677085"
        ],
        "spl_id": [
          "c872059f-48b3-479c-8c1c-0893d67cc1e2"
        ],
        "spl_set_id": [
          "0a7477da-370f-451f-8993-8c675c168696"
        ],
        "package_ndc": [
          "73352-555-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "K3D86KJ24N"
        ]
      }
    }
  ]
}