{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Dermagesic Pramoxine HCl, Zinc Oxide, Calamine ALOE AVENA SATIVA WHOLE CETOSTEARYL ALCOHOL CETEARETH-6 CETEARETH-25 DIAZOLIDINYL UREA MENTHOL METHYLPARABEN MINERAL OIL PROPYLENE GLYCOL PROPYLPARABEN WATER STEARYL ALCOHOL PRAMOXINE HYDROCHLORIDE PRAMOXINE ZINC OXIDE ZINC CATION FERRIC OXIDE RED FERRIC OXIDE RED"
      ],
      "active_ingredient": [
        "Active Ingredients Pramoxine HCl 1% Zinc Oxide 0.4% Calamine 0.4%"
      ],
      "purpose": [
        "Purpose Anestheric/Analgesic Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses for temporary reilef of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor irritation dries the oozing and weeping of poison ivy, poison oak and poison sumac."
      ],
      "warnings": [
        "Warnings For external use only. Avoid contact with the eyes Not for Pediatric use Hypersensitivity to \"caine\" anesthetics Do not use on large areas of the body with any other product containing diphenhydramine, even one taken by mouth. Ask a doctor before use on chicken pox on measles Stop use and ask a doctor if condition worsens or does not improve within 7 days symptoms persist 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions 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 ask a doctor Do not use more often than directed"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Aloe Badbadensis Leaf juice (Aloe Vera), Avena Sativa (Oat) Kernal colloidal, cetyl stearyl alcohol, ceteareth-6, ceteareth-25, diazolidinyl urea, fragrance, menthol, methyl paraben, paraffinum liquidum, propylene glycol, propyl paraben, purified water, stearyl alcohol"
      ],
      "questions": [
        "Questions or Comments 1-866-595-5598"
      ],
      "package_label_principal_display_panel": [
        "Dermagesic Cream"
      ],
      "set_id": "bbff6b53-29da-45c1-8ccd-3e9df7f250e0",
      "id": "47467902-6ca7-2b20-e063-6394a90aeff1",
      "effective_time": "20251231",
      "version": "9",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Dermagesic"
        ],
        "generic_name": [
          "PRAMOXINE HCL, ZINC OXIDE, CALAMINE"
        ],
        "manufacturer_name": [
          "Llorens Pharmaceutical International Division"
        ],
        "product_ndc": [
          "54859-202"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PRAMOXINE HYDROCHLORIDE",
          "ZINC OXIDE",
          "FERRIC OXIDE RED"
        ],
        "rxcui": [
          "1798481"
        ],
        "spl_id": [
          "47467902-6ca7-2b20-e063-6394a90aeff1"
        ],
        "spl_set_id": [
          "bbff6b53-29da-45c1-8ccd-3e9df7f250e0"
        ],
        "package_ndc": [
          "54859-202-04"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "88AYB867L5",
          "SOI2LOH54Z",
          "1K09F3G675"
        ]
      }
    }
  ]
}