{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Calaclear 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": [
        "Humco Calamine Lotion Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredient Pramoxine HCl 1%",
        "Active Ingredient Zinc Acetate 0.1%"
      ],
      "purpose": [
        "Purpose External Analgesic",
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Use Dries the oozing and weeping and temporarily relieves pain and itching of poison ivy, poison oak, and poison sumac or other minor skin irritations."
      ],
      "warnings": [
        "Warnings For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Ask a doctor before using on children under 2 years of age. When using this product . Discontinue use if condition worsens, does not improve or if symptoms persist for more than 7 days, or clear up and occur again within a few days. and consult a doctor. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately."
      ],
      "ask_doctor": [
        "Ask a doctor before using on children under 2 years of age."
      ],
      "when_using": [
        "When using this product . Discontinue use if condition worsens, does not improve or if symptoms persist for more than 7 days, or clear up and occur again within a few days. and consult a doctor."
      ],
      "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. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort. Children under 2 years of age: Consult a doctor before use."
      ],
      "other_safety_information": [
        "Other Information store at room temperature 15 o – 30 o C (50 o – 85 o F)"
      ],
      "inactive_ingredient": [
        "Inactive Ingredient SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Purified Water."
      ],
      "package_label_principal_display_panel": [
        "GNP Label GNPClear.jpg",
        "Leader Label LDRClear.jpg",
        "Quality Choice Label QCClear.jpg",
        "Sunmark Label SMClear.jpg",
        "Publix Label PublixClear.jpg",
        "Premiere Value Label PV",
        "DDM Label DDMClear.jpg",
        "CVS Label CVS Calaclear CVS",
        "Harris Teeter Label HT",
        "Best Choice Label Best Choice",
        "HEB Label HEB",
        "Equate Label Equate Calaclear Equate",
        "WM Label WMClear.jpg",
        "RA Label RAClear.jpg",
        "Top Care Label TCClear.jpg"
      ],
      "set_id": "e42fccc2-1b4e-e7f3-e053-2a95a90aef39",
      "id": "0d6cc629-bac0-1229-e063-6294a90a2610",
      "effective_time": "20231226",
      "version": "2",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Calaclear"
        ],
        "generic_name": [
          "PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE"
        ],
        "manufacturer_name": [
          "Pharma Nobis, LLC"
        ],
        "product_ndc": [
          "82645-923"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PRAMOXINE HYDROCHLORIDE",
          "ZINC ACETATE"
        ],
        "rxcui": [
          "1234546",
          "1248193"
        ],
        "spl_id": [
          "0d6cc629-bac0-1229-e063-6294a90a2610"
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        "spl_set_id": [
          "e42fccc2-1b4e-e7f3-e053-2a95a90aef39"
        ],
        "package_ndc": [
          "82645-923-96"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0840986012976",
          "0072036987259",
          "0036800443402",
          "0681131176019",
          "0070038200529",
          "0087701400452",
          "0010939146335",
          "0041220797950",
          "0041415067752",
          "0050428290880",
          "0093351013645"
        ],
        "unii": [
          "88AYB867L5",
          "FM5526K07A"
        ]
      }
    }
  ]
}