{
  "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": [
    {
      "effective_time": "20130506",
      "inactive_ingredient": [
        "Inactive ingredients SD alcohol 38-B, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, zanthan gum"
      ],
      "purpose": [
        "Purpose Skin protectant Topical analgesic"
      ],
      "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."
      ],
      "warnings": [
        "Warnings For external use only. When using this product do not get into eyes 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. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "when_using": [
        "When using this product do not get into eyes"
      ],
      "spl_product_data_elements": [
        "Calamine zinc oxide, ferric oxide red, pramozine HCl ZINC OXIDE ZINC OXIDE FERRIC OXIDE RED FERRIC OXIDE RED PRAMOXINE HYDROCHLORIDE PRAMOXINE ALCOHOL CAMPHOR (NATURAL) HYPROMELLOSES METHYLPARABEN POLYSORBATE 80 PROPYLENE GLYCOL PROPYLPARABEN WATER XANTHAN GUM"
      ],
      "other_safety_information": [
        "Other information store at 20° to 25°C (68° to 77°F)"
      ],
      "openfda": {},
      "version": "1",
      "dosage_and_administration": [
        "Directions shake well before use 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"
      ],
      "stop_use": [
        "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"
      ],
      "package_label_principal_display_panel": [
        "Package Label image of bottle label"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves pain and itching associated with: rashes due to poison ivy, poison oac or poison sumac insect bites minor skin irritation minor cuts dries the oozing and weeping of poison ivy, poison oak and poison sumac"
      ],
      "set_id": "7f2c5adf-92ca-4257-b71b-f7578a481c92",
      "id": "31cda82e-11b2-4537-9f32-f54b01141bb8",
      "active_ingredient": [
        "Active ingredients Calamine 8% Pramoxine HCl 1%"
      ]
    }
  ]
}