{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 7
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Granulotion Medicated MENTHOL, ZINC OXIDE ALOE VERA LEAF WATER CETOSTEARYL ALCOHOL ETHYLHEXYLGLYCERIN GLYCERIN GLYCERYL MONOSTEARATE LICORICE HELIANTHUS ANNUUS FLOWERING TOP TEA TREE OIL OLIVE OIL PEG-100 MONOSTEARATE PHENOXYETHANOL POLYSORBATE 20 POTASSIUM ALUM .ALPHA.-TOCOPHEROL ACETATE FD&C BLUE NO. 1 MENTHOL MENTHOL ZINC OXIDE ZINC CATION"
      ],
      "spl_unclassified_section": [
        "DRUG FACTS"
      ],
      "active_ingredient": [
        "Active Ingredients: Menthol 0.11%, Zinc Oxide 5.1% Purpose: External analgesic, Anti-itch, Skin protectant, Anorectal astringent"
      ],
      "purpose": [
        "Purpose: External analgesic, Anti-itch, Skin protectant, Anorectal astringent"
      ],
      "indications_and_usage": [
        "USES: Helps relieve local itching and discomfort of the perianal area. Temporarily forms a protective barrier over inflamed tissues to help prevent drying of tissues. For the temporary relief of pain, burning and skin irritation. Can help distract the pain and may provide cooling sensation."
      ],
      "warnings": [
        "WARNINGS: For external use only If condition worsens or does not improve within 7 days, consult a doctor Do not exceed the recommended daily dose unless directed by a doctor In case of bleeding, consult a doctor promptly Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor • Keep out of reach of children."
      ],
      "keep_out_of_reach_of_children": [
        "• Keep out of reach of children."
      ],
      "dosage_and_administration": [
        "DIRECTIONS: When practical, cleanse the affected area with mild soap and warm water. Pat or allow to air dry. Apply a layer of GranuLotion® up to 6 times daily for inflammation, 1 time per day for continued site maintenance. Use a soft tipped applicator for hard to reach areas. Repeat as needed to protect the skin or until the condition resolves."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Betaglucans, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycrrhiza Glabra (Licorice Extract, Helianthus Annuus (Sunflower) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Olea Europaea (Olive) Oil, PEG-100 Stearate, Phenoxyethanol, Polysorbate-20, Potassium Alum, Tocopheryl Acetate (Vitamin E), FDandC Blue 1."
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: Label"
      ],
      "set_id": "01701780-b160-415b-b34d-362237179475",
      "id": "259ec15b-2f69-be8c-e063-6294a90ad430",
      "effective_time": "20241029",
      "version": "1",
      "openfda": {
        "application_number": [
          "M015"
        ],
        "brand_name": [
          "Granulotion Medicated"
        ],
        "generic_name": [
          "MENTHOL, ZINC OXIDE"
        ],
        "manufacturer_name": [
          "GL HEALTH, INC."
        ],
        "product_ndc": [
          "82897-544"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "MENTHOL",
          "ZINC OXIDE"
        ],
        "rxcui": [
          "1492398"
        ],
        "spl_id": [
          "259ec15b-2f69-be8c-e063-6294a90ad430"
        ],
        "spl_set_id": [
          "01701780-b160-415b-b34d-362237179475"
        ],
        "package_ndc": [
          "82897-544-00"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0862039000044"
        ],
        "unii": [
          "L7T10EIP3A",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}