{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "CLEAR ANTI ITCH pramoxine hcl, zinc acetate lotion SODIUM CITRATE PRAMOXINE HCL PRAMOXINE CITRIC ACID MONOHYDRATE ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL HYPROMELLOSE, UNSPECIFIED LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL WATER CAMPHOR (NATURAL) ALCOHOL BENZOIC ACID GLYCERIN POLYSORBATE 40 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 (15°–25°C)"
      ],
      "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"
      ],
      "questions": [
        "Questions? 1-888-593-0593"
      ],
      "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 MADE WITH PRIDE & CARE FOR H-E-B ® SAN ANTONIO, TX 78204"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Compare to Caladryl ® Clear ® * H-E-B ® Clear Anti-Itch Lotion External Analgesic/Skin Protectant Relieves pain & itching caused by: poison ivy, poison sumanc, poison oak, and insect bites Dries Clear 6 FL OZ (177 mL) mm01"
      ],
      "set_id": "54f04056-d805-8c62-e063-6394a90ab740",
      "id": "54f04056-d806-8c62-e063-6394a90ab740",
      "effective_time": "20260623",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "CLEAR ANTI ITCH"
        ],
        "generic_name": [
          "PRAMOXINE HCL, ZINC ACETATE LOTION"
        ],
        "manufacturer_name": [
          "H E B"
        ],
        "product_ndc": [
          "59640-218"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PRAMOXINE HCL",
          "ZINC ACETATE"
        ],
        "rxcui": [
          "1234546"
        ],
        "spl_id": [
          "54f04056-d806-8c62-e063-6394a90ab740"
        ],
        "spl_set_id": [
          "54f04056-d805-8c62-e063-6394a90ab740"
        ],
        "package_ndc": [
          "59640-218-30"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "88AYB867L5",
          "FM5526K07A"
        ]
      }
    }
  ]
}