{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Calamine, Pramoxind HCl Calamine, Pramoxind HCl ALCOHOL BENZYL ALCOHOL CAMPHOR (SYNTHETIC) HYPROMELLOSE, UNSPECIFIED LAVENDER OIL PHENOXYETHANOL POLYSORBATE 80 PROPYLENE GLYCOL ROSEMARY OIL WATER XANTHAN GUM FERRIC OXIDE RED FERRIC OXIDE RED PRAMOXINE HYDROCHLORIDE PRAMOXINE"
      ],
      "active_ingredient": [
        "Active ingredients Calamine 8% Pramoxine HCl 1%"
      ],
      "purpose": [
        "Purpose Skin protectant External analgesic"
      ],
      "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 of age: do not use, ask a doctor"
      ],
      "other_safety_information": [
        "Other information store at room temperature 59°–77°F (15°–25°C)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients alcohol, benzyl alcohol, camphor, fragrance, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, phenoxyethanol, polysorbate 80, propylene glycol, Rosmarinus officinalis (rosemary) leaf oil, water, xanthan gum"
      ],
      "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 ® Lotion Calamine Plus Itch Reliever."
      ],
      "adverse_reactions": [
        "Adverse Reactions MADE WITH PRIDE & CARE FOR H-E-B ® SAN ANTONIO, TX 78204"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Compare to Caladryl ® Calamine Itch Reliever* H-E-B ® Medicated Calamine Lotion External Analgesic/Skin Protectant Relieves itching due to insect bites, poison oak or ivy, or other minor skin irritation 6 FL OZ (177 mL) image description"
      ],
      "set_id": "4a7a0b09-d9bc-e752-e063-6394a90a9f2c",
      "id": "544fe61e-3dd0-605b-e063-6294a90a5d77",
      "effective_time": "20260615",
      "version": "2",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Calamine, Pramoxind HCl"
        ],
        "generic_name": [
          "CALAMINE, PRAMOXIND HCL"
        ],
        "manufacturer_name": [
          "H E B"
        ],
        "product_ndc": [
          "37808-616"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "FERRIC OXIDE RED",
          "PRAMOXINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1234532"
        ],
        "spl_id": [
          "544fe61e-3dd0-605b-e063-6294a90a5d77"
        ],
        "spl_set_id": [
          "4a7a0b09-d9bc-e752-e063-6394a90a9f2c"
        ],
        "package_ndc": [
          "37808-616-30"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "1K09F3G675",
          "88AYB867L5"
        ]
      }
    }
  ]
}