{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "CVS Calamine Plus zinc oxide ALCOHOL CAMPHOR (SYNTHETIC) DIAZOLIDINYL UREA GLYCERIN HYPROMELLOSES METHYLPARABEN POLYSORBATE 80 PROPYLENE GLYCOL PROPYLPARABEN WATER ZINC OXIDE ZINC CATION PRAMOXINE HYDROCHLORIDE PRAMOXINE"
      ],
      "spl_unclassified_section": [
        "CVS Calamine Plus Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredient Calamine 8%",
        "Active Ingredient Pramoxine HCl 1%"
      ],
      "purpose": [
        "Purpose Skin Protectant",
        "Purpose External Analgesic"
      ],
      "indications_and_usage": [
        "Use Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and sumac or other minor skin irritations."
      ],
      "warnings": [
        "Warnings For external use only. Use only as directed. When using this product avoid contact with eyes. Stop use and ask a doctor if condition worsens symptoms last for more than 7 days or clear up and occur again within a few days. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately."
      ],
      "when_using": [
        "When using this product avoid contact with eyes."
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens symptoms last for more than 7 days or clear up and occur again within a few days."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 2 yrs. o f age and older . Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth not more than 3 to 4 times daily as needed for comfort. Children under 2 yrs. of age: Consult a doctor."
      ],
      "other_safety_information": [
        "Other Information store at room temperature 15 o – 30 o C (59 o – 85 o F)"
      ],
      "inactive_ingredient": [
        "Inactive Ingredient SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hypromellose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, and Purified Water."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL Calamine Plus Itch Relief 6 FL OZ (177 mL) PRINCIPAL DISPLAY PANEL Calamine Plus Itch Relief 6 FL OZ (177 mL)"
      ],
      "set_id": "b90cd214-d44a-4458-876d-59cc0795226d",
      "id": "0d19a0a5-ed0b-1796-e063-6294a90a7e8f",
      "effective_time": "20231222",
      "version": "5",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "CVS Calamine Plus"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "CVS Pharmacy"
        ],
        "product_ndc": [
          "69842-420"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "PRAMOXINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1234532"
        ],
        "spl_id": [
          "0d19a0a5-ed0b-1796-e063-6294a90a7e8f"
        ],
        "spl_set_id": [
          "b90cd214-d44a-4458-876d-59cc0795226d"
        ],
        "package_ndc": [
          "69842-420-96"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z",
          "88AYB867L5"
        ]
      }
    }
  ]
}