{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "effective_time": "20120601",
      "inactive_ingredient": [
        "Inactive Ingredients Inactive ingredients: Calamine, chlorothymol, glycerin, lanolin, phenol, sodium bicarbonate, and thymol in a suitable ointment base"
      ],
      "purpose": [
        "Purpose External analgesic / Anti-itch Skin protectant / Anorectal astringent"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children"
      ],
      "warnings": [
        "Warnings Warnings: For external use only. Not for deep or puncture wounds. Avoid contact with eyes. In case of accidental ingestion contact a physician or poison control center immediately. If condition worsens or does not improve within 7 days, consult a doctor."
      ],
      "spl_product_data_elements": [
        "Calmoseptine Zinc Oxide and menthol ZINC OXIDE ZINC OXIDE MENTHOL LEVOMENTHOL FERRIC OXIDE RED Chlorothymol Glycerin Lanolin Phenol Sodium Bicarbonate Thymol"
      ],
      "openfda": {},
      "version": "1",
      "dosage_and_administration": [
        "Directions Directions: Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Calmoseptine 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."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL Calmoseptine Ointment Menthol 0.44% Zinc Oxide 20.6% 71 gram tube NDC 54868-5287-0 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146 image of tube"
      ],
      "indications_and_usage": [
        "Uses Uses: A moisture barrier that prevents and helps heal skin irritation from: urine, diarrhea, perspiration, fistula damage, feeding tube site leakage, wound drainage (peri-wound skin), minor burns, cuts, scrapes, itching"
      ],
      "set_id": "9aa48789-dc1c-452e-8125-f0cd0c792d5b",
      "id": "ef488235-15c6-4466-8540-5f30e365ab68",
      "active_ingredient": [
        "Active Ingredients Menthol 0.44% Zinc Oxide 20.625%"
      ]
    }
  ]
}