{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 7
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Sarna Pramoxine Hydrochloride, Menthol STEARIC ACID MENTHOL MENTHOL PEG-100 STEARATE BENZYL ALCOHOL CAPRYLYL GLYCOL TOCOPHEROL WATER CARBOMER HOMOPOLYMER TYPE C PENTYLENE GLYCOL GLYCERYL MONOSTEARATE BUTYLENE GLYCOL CETYL ALCOHOL ETHYLHEXYLGLYCERIN ISOPROPYL MYRISTATE PRAMOXINE HYDROCHLORIDE PRAMOXINE HAMAMELIS VIRGINIANA LEAF ALOE VERA LEAF PEG-8 STEARATE DIMETHICONE GLYCERIN PALMITIC ACID SODIUM HYDROXIDE YEAST .BETA.-D-GLUCAN"
      ],
      "active_ingredient": [
        "Active Ingredients Menthol 0.5% Pramoxine Hydrochloride 1%"
      ],
      "purpose": [
        "Purpose External analgesic"
      ],
      "indications_and_usage": [
        "Uses for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac"
      ],
      "warnings": [
        "Warnings For external use only. Do not use in the eyes or nose over large areas of the body for prolonged periods When using this product avoid contact with the eyes. if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Stop use and ask a doctor if redness, irritation, swelling, or pain persists or increases. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "do_not_use": [
        "Do not use in the eyes or nose over large areas of the body for prolonged periods"
      ],
      "when_using": [
        "When using this product avoid contact with the eyes. if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor."
      ],
      "stop_use": [
        "Stop use and ask a doctor if redness, irritation, swelling, or pain persists or increases."
      ],
      "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 to open, hold cap and turn pump clockwise. 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, consult a doctor."
      ],
      "storage_and_handling": [
        "Other information store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Beta-Glucan, Butylene Glycol, C12-18 Alkanoyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Isopropyl Myristate, Palmitic Acid, PEG-100 Stearate, PEG-8 Stearate, Pentylene Glycol, Sodium Hydroxide, Stearic Acid, Tocopherol, Water"
      ],
      "questions": [
        "Questions? call 1-833-279-6522"
      ],
      "package_label_principal_display_panel": [
        "Sarna Calm + Cool Principal Display Panel #1 DERMATOLOGIST RECOMMENDED TOPICAL ANTI-ITCH BRAND Sarna Pramoxine Hydrochloride 1% Menthol 0.5% External Analgesic Lotion Steroid Free CALM + COOL ANTI-ITCH LOTION Eases pain and itch associated with insect bites, sunburn, and poison ivy Infused with Witch Hazel Extract Cools with Menthol NET WT. 7.5fl oz (222 ml) P12288.00 Sarna Calm_Cool"
      ],
      "set_id": "19c41e75-a654-90cf-e063-6394a90a7e97",
      "id": "483436b1-9031-4992-e063-6394a90ad0c5",
      "effective_time": "20260112",
      "version": "4",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Sarna"
        ],
        "generic_name": [
          "PRAMOXINE HYDROCHLORIDE, MENTHOL"
        ],
        "manufacturer_name": [
          "Crown Laboratories, Inc"
        ],
        "product_ndc": [
          "0316-0234"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "MENTHOL",
          "PRAMOXINE HYDROCHLORIDE"
        ],
        "spl_id": [
          "483436b1-9031-4992-e063-6394a90ad0c5"
        ],
        "spl_set_id": [
          "19c41e75-a654-90cf-e063-6394a90a7e97"
        ],
        "package_ndc": [
          "0316-0234-75",
          "0316-0234-12",
          "0316-0234-24"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "L7T10EIP3A",
          "88AYB867L5"
        ]
      }
    }
  ]
}