{
  "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": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Triflora Urtica doicia, Rhus Toxicodendron, Ledum Palustre URTICA DIOICA URTICA DIOICA TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF LEDUM PALUSTRE twig LEDUM PALUSTRE TWIG CARBOMER HOMOPOLYMER TYPE C ALCOHOL PINE NEEDLE OIL (PINUS SYLVESTRIS) WATER SODIUM HYDROXIDE WITCH HAZEL"
      ],
      "active_ingredient": [
        "Active Ingredients Contains 5% Ledum palustre 2X Contains 12.5% Urtica diocia 1X Contains 2.5% Rhus tox 4X"
      ],
      "inactive_ingredient": [
        "Inactive Ingredient Carbomer Ethyl Alcohol Pine Needle Oil Purified Water Sodium Hydroxide Witch Hazel Distillate"
      ],
      "dosage_and_administration": [
        "Dosage and Administration Directions Adults and children 6 years of age and older: apply to affected area up to 4 times daily; rub in gently. Patch test recommended on sensitive skin."
      ],
      "indications_and_usage": [
        "Indications & Usage Temporarily relieves minor aches, pains, and joint/muscle stiffness associated with arthritis, rheumatism, simple backache, and tendinitis."
      ],
      "purpose": [
        "Purpose Temporarily relieves minor aches, pains, and joint/muscle stiffness associated with arthritis, rheumatism, simple backache, and tendinitis."
      ],
      "warnings": [
        "Warnings For external use only. Avoid contact with eyes and broken skin. Do Not Use Do not use if hypersensitive to Poison Ivy (Rhus tox) or any other ingredient in this product. Breast-feeding women should not apply to breast area."
      ],
      "do_not_use": [
        "Do Not Use Do not use if hypersensitive to Poison Ivy (Rhus tox) or any other ingredient in this product. Breast-feeding women should not apply to breast area."
      ],
      "stop_use": [
        "Stop Use Stop use and ask a doctor if skin irritation, rash, or other allergic reaction develops, condition worsens or does not improve within 7 days, symptoms clear up and occur again within a few days. These could be signs of a serious condition."
      ],
      "pregnancy_or_breast_feeding": [
        "Pregnancy or Breast feeding If pregnant or breast-feeding , ask a healthcare professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children Keep out of reach of children."
      ],
      "overdosage": [
        "Overdose If swallowed, seek medical help or contact a Poison Control Center right away ."
      ],
      "package_label_principal_display_panel": [
        "LHBN21825297_B01_TRIFLORA_2_75OZ_CTN_FNL.jpg LHT21825297_B01_Triflora_2_75oz_Tube_FNL.jpg"
      ],
      "set_id": "0f7796ae-a20e-431f-bdec-bca7415b468f",
      "id": "be615942-cb86-4d3d-8177-efc815ac4ff8",
      "effective_time": "20251118",
      "version": "5",
      "openfda": {
        "brand_name": [
          "Triflora"
        ],
        "generic_name": [
          "URTICA DOICIA, RHUS TOXICODENDRON, LEDUM PALUSTRE"
        ],
        "manufacturer_name": [
          "Schwabe North America, Inc"
        ],
        "product_ndc": [
          "53499-7290"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "LEDUM PALUSTRE TWIG",
          "TOXICODENDRON PUBESCENS LEAF",
          "URTICA DIOICA"
        ],
        "spl_id": [
          "be615942-cb86-4d3d-8177-efc815ac4ff8"
        ],
        "spl_set_id": [
          "0f7796ae-a20e-431f-bdec-bca7415b468f"
        ],
        "package_ndc": [
          "53499-7290-8",
          "53499-7290-4"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0308078252971"
        ],
        "unii": [
          "877L01IZ0P",
          "6IO182RP7A",
          "710FLW4U46"
        ]
      }
    }
  ]
}