{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Clear Anti-Itch Pramoxine HCl, Zinc acetate ALCOHOL BENZOIC ACID CAMPHOR (SYNTHETIC) CITRIC ACID MONOHYDRATE GLYCERIN HYPROMELLOSE, UNSPECIFIED LAVENDER OIL POLYSORBATE 40 ROSEMARY OIL SODIUM CITRATE WATER PRAMOXINE HYDROCHLORIDE PRAMOXINE ZINC ACETATE ZINC CATION"
      ],
      "active_ingredient": [
        "Active ingredients Pramoxine HCl 1% Zinc acetate 0.1%"
      ],
      "purpose": [
        "Purpose External analgesic Skin protectant"
      ],
      "indications_and_usage": [
        "Uses for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak or poison sumac dries the oozing and weeping of poison: -ivy -oak -sumac"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "when_using": [
        "When using this product do not get into eyes"
      ],
      "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"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions shake well before applying wash affected area of skin adults and children 2 years of age and older - apply to affected area not more than 3 to 4 times daily children under 2 years - ask a doctor"
      ],
      "storage_and_handling": [
        "Other information store at room temperature (59°-77°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients alcohol, benzoic acid, camphor, citric acid, fragrance, glycerin, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, polysorbate 40, Rosmarinus officinalis (rosemary) leaf oil, sodium citrate, water"
      ],
      "spl_unclassified_section": [
        "Disclaimer *This product is not manufactured or distributed by Bausch Health US, LLC, distributor of Caladryl ® Clear ® Lotion."
      ],
      "adverse_reactions": [
        "ADVERSE REACTION DISTRIBUTED BY ADUSA DISTRIBUTION, LLC SALISBURY, NC 28147 1-833-992-3872 Quality guaranteed or your money back."
      ],
      "package_label_principal_display_panel": [
        "Principal display panel CAREONE ® Clear Anti-Itch Lotion EXTERNAL ANALGESIC/SKIN PROTECTANT Drying Action Plus Itch Relief PRAMOXINE HCl 1% ZINC ACETATE 0.1% Compare to the active ingredents of Caladryl ® Clear ® Lotion* NET 6 FL OZ (177 mL) image description"
      ],
      "set_id": "a80b8fee-2dd9-4640-a4f8-4cf940df8563",
      "id": "4a2b287c-4757-e1a2-e063-6394a90a80e1",
      "effective_time": "20260206",
      "version": "17",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Clear Anti-Itch"
        ],
        "generic_name": [
          "PRAMOXINE HCL, ZINC ACETATE"
        ],
        "manufacturer_name": [
          "Retail Business Services, LLC"
        ],
        "product_ndc": [
          "72476-218"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PRAMOXINE HYDROCHLORIDE",
          "ZINC ACETATE"
        ],
        "rxcui": [
          "1234546"
        ],
        "spl_id": [
          "4a2b287c-4757-e1a2-e063-6394a90a80e1"
        ],
        "spl_set_id": [
          "a80b8fee-2dd9-4640-a4f8-4cf940df8563"
        ],
        "package_ndc": [
          "72476-218-30"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "88AYB867L5",
          "FM5526K07A"
        ]
      }
    }
  ]
}