{
  "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": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "PBZ OTC Tripelennamine HCl 1% TRIPELENNAMINE TRIPELENNAMINE ALLANTOIN ALOE VERA LEAF MEDIUM-CHAIN TRIGLYCERIDES CETYL ALCOHOL DIMETHICONE, UNSPECIFIED .ALPHA.-TOCOPHEROL ACETATE, DL- ETHYLHEXYLGLYCERIN GLYCERIN GLYCERYL MONOSTEARATE MINERAL OIL PANTHENOL PEG-100 MONOSTEARATE PHENOXYETHANOL POLYSORBATE 80 POLYSORBATE 85 SODIUM POLYACRYLATE (8000 MW) STEARIC ACID TROLAMINE WATER"
      ],
      "active_ingredient": [
        "Active Ingredient Tripelennamine HCL 1%"
      ],
      "purpose": [
        "Purpose Topical Analgesic"
      ],
      "indications_and_usage": [
        "Use Temporarily relieves pain and itching associated with: • insect bites • minor burns • minor cuts • minor skin irritations • scrapes • sunburn • rashes due to poison ivy, poison oak, or poison sumac"
      ],
      "warnings": [
        "Warnings For external use only. 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 physician. Do not use if packaging is damaged or opened. If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children and pets. If swallowed, get medical help or contact Poison Control Center right away."
      ],
      "do_not_use": [
        "Do not use if packaging is damaged or opened."
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children and pets. If swallowed, get medical help or contact 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: Do not use, consult a physician. Storage Information: Protect from freezing and excessive heat, store at 68°-77°F (20°-25°C)."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Acrylates/Acrylamide Copolymer, Allantoin, Aloe Barbadensis Leaf Extract, Caprylic/Capric Triglyceride, Cetyl Alcohol, Dimethicone, dl-Alpha Tocopheryl Acetate, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Mineral Oil, Panthenol, PEG 100 Stearate, Phenoxyethanol, Polysorbate 80, Polysorbate 85, Sodium Polyacrylate, Stearic Acid, Triethanolamine, Water"
      ],
      "spl_unclassified_section": [
        "MANUFACTURED IN THE USA Distributed By: Kingsway Pharmaceuticals dba NFI Consumer Products 636 Shelby Street, Suite 300, Bristol, TN 37620 800-432-9334"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL – CARTON LABEL SAFE FOR THE ENTRIE FAMILY pbz ™ OTC Pyribenzamine ™ NOW AVAILABLE OTC POWERFUL ITCH RELIEF ANTIHISTAMINE CREAM AGES 2+ YRS ✓ Insect Bites ✓ Minor Burns, Cuts, Scrapes ✓ Minor Skin Irritations ✓ Poison Ivy, Oak, & Sumac ✓ Sunburn ITCH Net WT 1 OZ. (28g) image-01",
        "PRINCIPAL DISPLAY PANEL – POUCH LABEL SAFE FOR THE ENTRIE FAMILY pbz ™ OTC Pyribenzamine ™ ITCH NET WT 3.25g (0.115oz) VOTED PRODUCT of THE YEAR Consumer Survey of Product Innovation 2025 * WINNER IN IMMEDIATE RELIEF CATEGORY 2025 PRODUCT OF THE YEAR AWARD, CHOSEN BY A KANTAR SURVEY OF 40,000 PEOPLE ANTIHISTAMINE CREAM SAMPLE, NOT FOR RESALE image-02"
      ],
      "set_id": "12f72d74-018f-4bc6-acd4-175ca3af4c6d",
      "id": "d144cc3d-1fca-4a3e-932c-7ca07b85068b",
      "effective_time": "20250829",
      "version": "3",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "PBZ OTC"
        ],
        "generic_name": [
          "TRIPELENNAMINE HCL 1%"
        ],
        "manufacturer_name": [
          "Kingsway Pharmaceuticals dba NFI, LLC"
        ],
        "product_ndc": [
          "69993-151"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TRIPELENNAMINE"
        ],
        "rxcui": [
          "2711712"
        ],
        "spl_id": [
          "d144cc3d-1fca-4a3e-932c-7ca07b85068b"
        ],
        "spl_set_id": [
          "12f72d74-018f-4bc6-acd4-175ca3af4c6d"
        ],
        "package_ndc": [
          "69993-151-01",
          "69993-151-02"
        ],
        "original_packager_product_ndc": [
          "75587-151"
        ],
        "unii": [
          "3C5ORO99TY"
        ]
      }
    }
  ]
}