{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 186
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Medline menthol, white petrolatum, zinc oxide MEDIUM-CHAIN TRIGLYCERIDES HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) PHYTONADIONE YEAST, UNSPECIFIED CORN OIL ALPHA-TOCOPHEROL ACETATE CHOLECALCIFEROL COCONUT OIL GLYCERIN HEXYLDECANOL HONEY OLIVE OIL JOJOBA OIL STEARIC ACID WATER GREEN TEA LEAF CETYLHYDROXYPROLINE PALMITAMIDE ZINC OXIDE ZINC OXIDE APHANIZOMENON FLOSAQUAE YELLOW WAX RAPESEED STEROL FERRIC OXIDE RED MENTHOL MENTHOL STARCH, CORN PETROLATUM PETROLATUM 7-DEHYDROCHOLESTEROL LEVOMENOL SAFFLOWER OIL DIMETHICONE CLOVE"
      ],
      "active_ingredient": [
        "Active ingredients Menthol 0.44% w/w White petrolatum 53% w/w Zinc oxide 20.6% w/w"
      ],
      "purpose": [
        "Purpose Analgesic Protectant Protectant"
      ],
      "indications_and_usage": [
        "Uses for the temporary relief of anorectal itching and discomfort in the perianal area associated with anorectal inflammation temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues temporarily protects irritated areas temporarily relieves burning provides temporary relief from skin irritations temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful temporarily protects inflamed perianal skin temporarily relieves the symptoms of perianal skin irritation may provide a cooling sensation"
      ],
      "warnings": [
        "Warnings For external use only Allergy Alert: 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 Do not use on deep or puncture wounds animal bites serious burns When using this product do not get into eyes do not exceed the recommended daily dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device applicator 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 in case of bleeding Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away."
      ],
      "do_not_use": [
        "Do not use on deep or puncture wounds animal bites serious burns"
      ],
      "when_using": [
        "When using this product do not get into eyes do not exceed the recommended daily dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device applicator"
      ],
      "stop_use": [
        "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 in case of bleeding"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions adults : when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply to the affected area up to 6 times daily Children under 12 years of age : consult a doctor"
      ],
      "other_safety_information": [
        "Other information protect from freezing avoid excessive heat not made with Natural rubber Latex"
      ],
      "inactive_ingredient": [
        "Inactive ingredients 7-dehydrocholesterol, algae extract (aphanizomenon flos-aquae), beeswax, bisabolol, brassica campestris (rapeseed) sterols, calamine, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, carthamus tinctorius (safflower) seed oil, cetylhydroxyproline palmitamide, cholecalciferol, cocos nucifera (coconut) oil, dimethicone, eugenia caryophyllus (clove) flower extract, glycerin, hexyldecanol, hydrolyzed soy protein, manuka honey, olea europaea (olive) oil, phospholipids, phytonadione, simmondsia chinensis (jojoba) seed oil, stearic acid, tocopheryl acetate, water, yeast ferment extract, zea mays (corn) oil, zea mays (corn) starch."
      ],
      "spl_unclassified_section": [
        "Manufacturing information Manufactured for: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA Made in USA of domestic and imported materials 1-800-MEDLINE (633-5463) REF: MSC092554PACK"
      ],
      "package_label_principal_display_panel": [
        "Package Label Box_V1 RJ22PUA Packet_V1 RJ22PUA"
      ],
      "set_id": "006539c9-1982-d6de-e063-6294a90a1a5a",
      "id": "4161a6b2-cc86-f208-e063-6294a90ad120",
      "effective_time": "20251017",
      "version": "3",
      "openfda": {
        "application_number": [
          "M015"
        ],
        "brand_name": [
          "Medline"
        ],
        "generic_name": [
          "MENTHOL, WHITE PETROLATUM, ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Medline Industries, LP"
        ],
        "product_ndc": [
          "53329-156"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "MENTHOL",
          "PETROLATUM",
          "ZINC OXIDE"
        ],
        "rxcui": [
          "2642278"
        ],
        "spl_id": [
          "4161a6b2-cc86-f208-e063-6294a90ad120"
        ],
        "spl_set_id": [
          "006539c9-1982-d6de-e063-6294a90a1a5a"
        ],
        "package_ndc": [
          "53329-156-83",
          "53329-156-96",
          "53329-156-14",
          "53329-156-44"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "L7T10EIP3A",
          "4T6H12BN9U",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}