{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Pranicura 5 GLYCERIN, KAOLIN, CALAMINE, MENTHOL CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) CETOSTEARYL ALCOHOL WATER DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) ISOPROPYL PALMITATE MAGNESIUM ALUMINUM SILICATE PHENOXYETHANOL POLYSORBATE 20 PROPYLENE GLYCOL ALCOHOL SILICON DIOXIDE STEARYL ALCOHOL GLYCERIN GLYCERIN KAOLIN KAOLIN ZINC OXIDE ZINC CATION MENTHOL MENTHOL"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredients Glycerin 25% Kaolin 12.5% Calamine 12.5% Menthol 1%"
      ],
      "purpose": [
        "Purposes Glycerin ....................................................Protectant Kaolin .........................................Protectant/Anti-Itch Calamine ....................................Protectant/Anti-Itch Menthol .....................................................Analgesic"
      ],
      "indications_and_usage": [
        "Uses • Helps relieve the itching and discomfort associated with anorectal disorders • Provides temporary relief from the symptoms of perianal skin irritation • For the temporary relief of itching associated with moist anorectal conditions • For the temporary relief of irritation and burning"
      ],
      "warnings": [
        "Warnings For rectal use only Do not use unless a prior doctor’s diagnosis of anorectal condition has been made When using this product do not exceed the recommended daily dosage unless directed by a doctor Stop use and ask a doctor if • bleeding occurs • condition worsens or does not improve within 7 days • allergic reaction develops • symptoms being treated do not subside or if redness, irritation, swelling, pain, other symptoms develop or increase • Do not put this product into the rectum by using fingers or any mechanical device or applicator. • Remove petrolatum or greasy ointment before using this product because they interfere with the ability of this product to adhere properly to the skin area If pregnant or breastfeeding , ask a health professional before use"
      ],
      "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": [
        "Other Information store at 15-30º C (59-86º F)"
      ],
      "other_safety_information": [
        "Other Information store at 15-30º C (59-86º F)"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetearyl Alcohol, Deionized Water, Dimethicone/Vinyl Dimethicone Crosspolymer, Isopropyl Palmitate, Magnesium Aluminum Silicate, Phenoxyethanol, Polysorbate 20, Propylene Glycol, SD Alcohol, Silica, Stearyl Alcohol"
      ],
      "questions": [
        "Questions or Comments? Call weekdays 9 AM to 5 PM CST at 763-537-3419"
      ],
      "package_label_principal_display_panel": [
        "PRANICURA 5 ​Ultimate Relief from Pruritus Ani, Fissures and Hemmorhoids Available only at: www.pranicura.com Net Wt. 2.1 oz. (60 g) RES Pranicura 5 image description"
      ],
      "set_id": "0fe10710-ac59-4fc5-e063-6294a90a48fc",
      "id": "0fdf8d98-4b30-5102-e063-6394a90ae437",
      "effective_time": "20240126",
      "version": "4",
      "openfda": {
        "application_number": [
          "M015"
        ],
        "brand_name": [
          "Pranicura 5"
        ],
        "generic_name": [
          "GLYCERIN, KAOLIN, CALAMINE, MENTHOL"
        ],
        "manufacturer_name": [
          "Sarati International, Inc."
        ],
        "product_ndc": [
          "67676-007"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "GLYCERIN",
          "KAOLIN",
          "MENTHOL",
          "ZINC OXIDE"
        ],
        "spl_id": [
          "0fdf8d98-4b30-5102-e063-6394a90ae437"
        ],
        "spl_set_id": [
          "0fe10710-ac59-4fc5-e063-6294a90a48fc"
        ],
        "package_ndc": [
          "67676-007-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185370",
          "N0000175629",
          "N0000184306",
          "N0000185001",
          "M0000728",
          "M0009417"
        ],
        "pharm_class_epc": [
          "Non-Standardized Chemical Allergen [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]",
          "Increased IgG Production [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Glycerol [CS]"
        ],
        "unii": [
          "PDC6A3C0OX",
          "24H4NWX5CO",
          "L7T10EIP3A",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}