{
  "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 Itch Relief Pramoxine Hydrochloride and Zinc Acetate ALCOHOL CAMPHOR (NATURAL) DIAZOLIDINYL UREA GLYCERIN HYPROMELLOSE, UNSPECIFIED METHYLPARABEN POLYSORBATE 80 PROPYLENE GLYCOL PROPYLPARABEN WATER PRAMOXINE HYDROCHLORIDE PRAMOXINE ZINC ACETATE ZINC CATION"
      ],
      "spl_unclassified_section": [
        "CVS Itch Relief Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredient Pramoxine HCl 1% Zinc Acetate 0.1%"
      ],
      "purpose": [
        "Purpose External Analgesic Skin Protectant"
      ],
      "indications_and_usage": [
        "Use Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and poison sumac and other minor skin irritations."
      ],
      "warnings": [
        "Warnings For external use only. Use only as directed. Avoid contact with eyes and mucous membranes, Ask doctor before using in children under 2 years of age. 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."
      ],
      "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 before use."
      ],
      "inactive_ingredient": [
        "Inactive Ingredient SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, and Purified Water."
      ],
      "other_safety_information": [
        "Other Information store at room temperature 15 o – 30 o C (59 o – 85 o F)"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL CVS Health Itch Relief CLEAR SKIN PROTECTANT 6 FL OZ (177 mL) CVS Calaclear CVS Health Itch Relief CLEAR SKIN PROTECTANT 6 FL OZ (177 mL)"
      ],
      "set_id": "c60cfbf2-6788-43dc-b23a-e3433b7f3265",
      "id": "0cf95509-d4ee-83fb-e063-6394a90a4e08",
      "effective_time": "20231220",
      "version": "7",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "CVS Itch Relief"
        ],
        "generic_name": [
          "PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE"
        ],
        "manufacturer_name": [
          "CVS Pharmacy"
        ],
        "product_ndc": [
          "69842-400"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PRAMOXINE HYDROCHLORIDE",
          "ZINC ACETATE"
        ],
        "rxcui": [
          "1234546"
        ],
        "spl_id": [
          "0cf95509-d4ee-83fb-e063-6394a90a4e08"
        ],
        "spl_set_id": [
          "c60cfbf2-6788-43dc-b23a-e3433b7f3265"
        ],
        "package_ndc": [
          "69842-400-96"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0050428290880"
        ],
        "unii": [
          "88AYB867L5",
          "FM5526K07A"
        ]
      }
    }
  ]
}