{
  "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,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "REMEDY Calazime Skin Protectant calamine, menthol, white petrolatum, zinc oxide ALOE VERA LEAF ASCORBIC ACID ASCORBYL PALMITATE SAFFLOWER OIL CHOLECALCIFEROL CITRIC ACID MONOHYDRATE ORANGE OIL CITRUS MAXIMA FRUIT RIND OIL GLYCINE SUNFLOWER OIL HYDROXYTYROSOL METHYLPARABEN MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) DIMETHYL SULFONE ACETYLCYSTEINE NIACINAMIDE OLIVE OIL POLYETHYLENE GLYCOL 400 PYRIDOXINE HYDROCHLORIDE VITAMIN A PALMITATE .ALPHA.-TOCOPHEROL VANILLIN CORN OIL FERRIC OXIDE RED FERRIC OXIDE RED MENTHOL MENTHOL ZINC OXIDE ZINC OXIDE PETROLATUM PETROLATUM"
      ],
      "active_ingredient": [
        "Active ingredient Calamine 3.5% Menthol 0.2% White Petrolatum 69% Zinc Oxide 16.5%"
      ],
      "purpose": [
        "Purpose Protectant Protectant Prot Protectant"
      ],
      "indications_and_usage": [
        "Uses Provides temporary relief from skin irritations, itching and discomfort in the perianal area For the temporary relief of pain May provide a cooling sensation"
      ],
      "warnings": [
        "Warnings For External Use Only Do not use in the eyes on deep or puncture wounds on animal bites on serious burns. When using this product 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 or applicator 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, stop use and consult a doctor Stop use and ask a doctor if condition worsens or does not improved within 7 days you experience bleeding Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "do_not_use": [
        "Do not use in the eyes on deep or puncture wounds on animal bites on serious burns."
      ],
      "when_using": [
        "When using this product 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 or applicator 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, stop use and consult a doctor"
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens or does not improved within 7 days you experience bleeding"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Adults Cleanse the affected area with Remedy No-rinse cleanser Gently dry Apply externally to the affected area up to 6 times daily For peri-G tubes, cleanse as directed, apply thin layer and secure with drain sponge or product as directed. Children under 12 years of age Consult a doctor"
      ],
      "storage_and_handling": [
        "Other information Protect from freezing, Avoid excessive heat."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Aloe Barbadensis Leaf Juice, Ascorbic Acid, Ascorbyl Palmitate, Carthamus Tinctorius (Safflower) Seed Oil, Cholecalciferol, Citric Acid, Citrus Aurantium Dulcis Peel Oil, Citrus Grandis Peel Oil, Glycine, Helianthus Annuus (Sunflower) Seed Oil, Hydroxytyrosol, L-proline, L-taurine, Methylparaben, Modified Corn Starch, Methylsulfonymethane, N-acetyl-L-cysteine, Niacinamide, Olea Europaea (Olive) Fruit Oil, PEG-8, Pyridoxine Hydrochloride, Retinyl Palmitate, Tapioca Starch Polymethylsilsesquioxane, Tocopherol, Vanillin, Zea Mays (Corn) Oil."
      ],
      "spl_unclassified_section": [
        "Medline Remedy is a registered trademark of Medline Industries, Inc. Olivamine is a registered trademark of McCord Research, Inc. Manufactured for Medline Industries, Inc., Mundelein, IL 60060 www.medline.com 1-800-MEDLINE"
      ],
      "package_label_principal_display_panel": [
        "Package Label Package Label"
      ],
      "set_id": "1295cfcc-5b61-481b-964b-f53ffd0cb58e",
      "id": "2cdaa63c-2a2f-2fde-e063-6394a90a70c6",
      "effective_time": "20250129",
      "version": "9",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "REMEDY Calazime Skin Protectant"
        ],
        "generic_name": [
          "CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Medline Industries, LP"
        ],
        "product_ndc": [
          "53329-165"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "FERRIC OXIDE RED",
          "MENTHOL",
          "PETROLATUM",
          "ZINC OXIDE"
        ],
        "rxcui": [
          "1921772"
        ],
        "spl_id": [
          "2cdaa63c-2a2f-2fde-e063-6394a90a70c6"
        ],
        "spl_set_id": [
          "1295cfcc-5b61-481b-964b-f53ffd0cb58e"
        ],
        "package_ndc": [
          "53329-165-44",
          "53329-165-96",
          "53329-165-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "1K09F3G675",
          "L7T10EIP3A",
          "4T6H12BN9U",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}