{
  "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": [
        "Theraworx Joint Relief Roll On FRANKINCENSE ALLANTOIN ALOE VERA LEAF WATER BENZYL ALCOHOL CALCIUM CARBONATE CITRIC ACID MONOHYDRATE COCAMIDOPROPYL BETAINE SILVER CROTON LECHLERI RESIN DECYL GLUCOSIDE ETHYLHEXYLGLYCERIN GLYCERIN PEG/PPG-4/12 DIMETHICONE POTASSIUM SORBATE SODIUM BENZOATE EDETATE SODIUM .ALPHA.-TOCOPHEROL ACETATE CHASTE TREE FRUIT XANTHAN GUM YEAST, UNSPECIFIED YUCCA SCHIDIGERA WHOLE FRANKINCENSE FRANKINCENSE"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredient Olibanum 8X 0.05% HPUS The letters H.P.U.S. indicate that the components in this product are officially monographed in the homeopathic pharmacopoeia of the United State. Purpose Anti Inflammatory"
      ],
      "purpose": [
        "Purpose Anti Inflammatory"
      ],
      "indications_and_usage": [
        "Uses relieves joint discomfort increase range of motion improves daily function"
      ],
      "warnings": [
        "Warnings For external use only. If eye contact occurs, rinse thoroughly with water. When using this product avoid eye contact store between 32°F and 120°F use only as directed not for ingestion Stop use and ask a doctor if unintended effects occur. If pregnant or breastfeeding, ask a health professional before use. 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 avoid eye contact store between 32°F and 120°F use only as directed not for ingestion"
      ],
      "stop_use": [
        "Stop use and ask a doctor if unintended effects occur."
      ],
      "pregnancy_or_breast_feeding": [
        "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": [
        "Directions shake well roll a thin layer to each affected area and allow to air dry if applicable put on compression repeat use as needed"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients (Alphabetical) Allantoin, Aloe barbadensis Leaf Extract, Aloe barbadensis Leaf Juice, Aqua (Water), Benzyl Alcohol, Calcium Carbonate, Citric Acid, Cocamidopropyl Betaine, Colloidal Silver, Croton Lechieri Resin Extract, Decyl Glucoside, Ethylhexylglycerin, Glycerin, PEG/PPG-4/12 Dimethicone, Parfum (Fragrance), Potassium Sorbate, Sodium Benzoate, Tetrasodium EDTA, Tocopherol Acetate, Vitex Agnus- Castus Extract, Xanthan Gum, Yeast Extract, Yucca shidigera Extract"
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: Label"
      ],
      "set_id": "0437aa53-e3e7-0ac6-e063-6394a90a71dd",
      "id": "0437aa5f-57f9-973a-e063-6294a90a9b30",
      "effective_time": "20230831",
      "version": "1",
      "openfda": {
        "brand_name": [
          "Theraworx Joint Relief Roll On"
        ],
        "generic_name": [
          "FRANKINCENSE"
        ],
        "manufacturer_name": [
          "AVADIM HOLDINGS, INC."
        ],
        "product_ndc": [
          "61594-027"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "FRANKINCENSE"
        ],
        "spl_id": [
          "0437aa5f-57f9-973a-e063-6294a90a9b30"
        ],
        "spl_set_id": [
          "0437aa53-e3e7-0ac6-e063-6394a90a71dd"
        ],
        "package_ndc": [
          "61594-027-00"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0850005308928"
        ],
        "unii": [
          "R9XLF1R1WM"
        ]
      }
    }
  ]
}