{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Calprotect Menthol, Zinc Oxide ZINC OXIDE ZINC OXIDE PHENOL FERRIC OXIDE RED CHLOROTHYMOL MENTHOL MENTHOL GLYCERIN THYMOL LANOLIN SODIUM BICARBONATE"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredients Menthol 0.44% Zinc Oxide 20.6%"
      ],
      "purpose": [
        "Purpose External analgesic / Anti-itch Skin protectant / Anorectal astrigent"
      ],
      "indications_and_usage": [
        "Uses A moisture barrier that prevents and helps heal skin irritations from urine diarrhea perspiration fistula drainage feeding tube site leakage wound drainage (per-wound skin) minor burns cuts scrapes itching"
      ],
      "warnings": [
        "Warnings For external use only Not for deep or puncture wounds Avoid contact with eyes Incase of accidental ingestion, contact a physician or posion contril immediately If condition worsens or does not improve in 7 days, consult a doctor Do not put this product into the rectum by using fingers or any machanical device or applicator Children under 12 years of age: consult a doctor"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children"
      ],
      "dosage_and_administration": [
        "Directions Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Calprotect Ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection."
      ],
      "storage_and_handling": [
        "Other information Store between 15-30°C (59-86°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients calamine, chlorothymol, glycerin, lanolin, phenol, sodium bicarbonate, and thymol in a suitable ointment base"
      ],
      "questions": [
        "Questions or comments? 1-516-341-0666 8:30 am-4:30 pm EST Mon-Fri"
      ],
      "package_label_principal_display_panel": [
        "Protects, Soothes & Promotes Healing NDC 69618-067-82 Compare to active ingredients in Calmoseptine* CalProtect Ointment External use only Made in the USA *Reliable-1 Labs is not affiliated with the owner of the registered trademark Calmoseptine Calprotect 113g Tube"
      ],
      "set_id": "09fb2810-0cc1-b2e2-e063-6294a90a4576",
      "id": "4b32706a-c97a-589c-e063-6294a90abc11",
      "effective_time": "20260219",
      "version": "5",
      "openfda": {
        "application_number": [
          "M015"
        ],
        "brand_name": [
          "Calprotect"
        ],
        "generic_name": [
          "MENTHOL, ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Reliable 1 Laboratories LLC"
        ],
        "product_ndc": [
          "69618-067"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "MENTHOL"
        ],
        "rxcui": [
          "2123045",
          "2702497"
        ],
        "spl_id": [
          "4b32706a-c97a-589c-e063-6294a90abc11"
        ],
        "spl_set_id": [
          "09fb2810-0cc1-b2e2-e063-6294a90a4576"
        ],
        "package_ndc": [
          "69618-067-82",
          "69618-067-71"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0369618067820"
        ],
        "unii": [
          "SOI2LOH54Z",
          "L7T10EIP3A"
        ]
      }
    }
  ]
}