{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "ClaraVie Menthol, Zinc Oxide ZINC OXIDE ZINC OXIDE MENTHOL MENTHOL GLYCERIN LANOLIN LIGHT MINERAL OIL PETROLATUM THYMOL .ALPHA.-TOCOPHEROL ACETATE, D- FERRIC OXIDE RED"
      ],
      "active_ingredient": [
        "Menthol 0.44% w/w Zinc Oxide 20.625% w/w"
      ],
      "purpose": [
        "External Analgesic Skin Protectant"
      ],
      "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."
      ],
      "inactive_ingredient": [
        "Calamine, Glycerin, Lanolin, Light liquid Paraffin, Petrolatum, Thymol, Tocopheryl Acetate"
      ],
      "warnings": [
        "For external use only Not for deep or puncture wounds Avoid contact with eyes"
      ],
      "ask_doctor": [
        "Stop use and ask a doctor if Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days"
      ],
      "dosage_and_administration": [
        "Apply as recommended"
      ],
      "indications_and_usage": [
        "A moisture barrier that prevents & helps heal skin irritation from : urine diarrhea perspiration fistula drainage feeding tube site leakage wound drainage (peri-wound skin) minor burn cuts scrapes itching"
      ],
      "questions": [
        "Store at room temperature 68-77 0 F (20-25 0 C)"
      ],
      "package_label_principal_display_panel": [
        "Image Image"
      ],
      "set_id": "596c467f-a056-ea78-e063-6394a90a79f2",
      "id": "596c467f-a057-ea78-e063-6394a90a79f2",
      "effective_time": "20260819",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "ClaraVie"
        ],
        "generic_name": [
          "MENTHOL, ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Gentell LLC"
        ],
        "product_ndc": [
          "61554-306"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "MENTHOL"
        ],
        "rxcui": [
          "2123045"
        ],
        "spl_id": [
          "596c467f-a057-ea78-e063-6394a90a79f2"
        ],
        "spl_set_id": [
          "596c467f-a056-ea78-e063-6394a90a79f2"
        ],
        "package_ndc": [
          "61554-306-11",
          "61554-306-21"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0361554012636"
        ],
        "unii": [
          "SOI2LOH54Z",
          "L7T10EIP3A"
        ]
      }
    }
  ]
}