{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 229
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Clotrimazole Clotrimazole MINERAL OIL DIMETHYL SULFOXIDE ETHYLPARABEN GLYCERIN LAURETH-23 PETROLATUM WATER EDETATE DISODIUM CLOTRIMAZOLE CLOTRIMAZOLE GLYCERYL MONO- AND DIPALMITOSTEARATE BUTYLATED HYDROXYTOLUENE ALCOHOL CETOSTEARYL ALCOHOL"
      ],
      "active_ingredient": [
        "Active ingredient Clotrimazole USP 1% w/w"
      ],
      "purpose": [
        "Purpose Antifungal Cream"
      ],
      "indications_and_usage": [
        "Uses Cures athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions."
      ],
      "warnings": [
        "Warnings For External use only."
      ],
      "keep_out_of_reach_of_children": [
        "Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.",
        "Keep this and all drugs out of the reach of children In case of accidental ingestion, seek professional assistance or contact Poison Control Centre right away."
      ],
      "do_not_use": [
        "Do Not Use Do not use on children under 2 years of age unless direcgted by a doctor"
      ],
      "when_using": [
        "When using this product When using this product avoid contact with eyes"
      ],
      "stop_use": [
        "Stop use and ask doctor if • irritaion occurs • There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch)."
      ],
      "dosage_and_administration": [
        "Directions • Wash the affected area and dry thoroughly. ● Apply a thin layer of this product over affected area twice daily (morning and night), or as directed by a doctor. ● Supervise children in the use of this product. ● For athlete’s foot, pay special attention to the 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 4 weeks. For jock itch, use daily for 2 weeks. ● If conditions persists longer, consult a doctor. ● This product is not effective on the scalp or nails."
      ],
      "storage_and_handling": [
        "Other Information • store at controlled room temperature 15°-30°C (59°- 86°F) • Close cap tightly after use."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Dimethyl Sulfoxide, Ethylparaben, Glycerin, Laureth-23, Mineral Oil, Petrolatum, Water, alcohol, Glyceryl mono and dipalmitostearate, Cetostearyl alcohol, edetate disodium, Butylated Hydroxytoluene."
      ],
      "questions": [
        "Questions? Adverse drug event call 1-888-296-9067 Dist. By Trifecta Pharmaceuticals USA® 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL 33301, USA Relabeled By: Preferred Pharmaceuticals Inc. NDC 68788-8330-2"
      ],
      "package_label_principal_display_panel": [
        "Clotrimazole Cream USP 1%"
      ],
      "set_id": "0052992a-819c-4c55-bd88-201a09a3573a",
      "id": "0052992a-819c-4c55-bd88-201a09a3573a",
      "effective_time": "20250221",
      "version": "1",
      "openfda": {
        "application_number": [
          "M005"
        ],
        "brand_name": [
          "Clotrimazole"
        ],
        "generic_name": [
          "CLOTRIMAZOLE"
        ],
        "manufacturer_name": [
          "Preferred Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "68788-8830"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CLOTRIMAZOLE"
        ],
        "rxcui": [
          "309367"
        ],
        "spl_id": [
          "0052992a-819c-4c55-bd88-201a09a3573a"
        ],
        "spl_set_id": [
          "0052992a-819c-4c55-bd88-201a09a3573a"
        ],
        "package_ndc": [
          "68788-8830-2"
        ],
        "original_packager_product_ndc": [
          "69396-001"
        ],
        "nui": [
          "N0000175487",
          "M0002083"
        ],
        "pharm_class_epc": [
          "Azole Antifungal [EPC]"
        ],
        "pharm_class_cs": [
          "Azoles [CS]"
        ],
        "unii": [
          "G07GZ97H65"
        ]
      }
    }
  ]
}