{
  "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": 4
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Theraworx Relief for Muscle Cramps Roll-On MAGNESIUM SULFATE, UNSPECIFIED FORM ALLANTOIN ALOE VERA LEAF WATER BENZYL ALCOHOL CITRIC ACID MONOHYDRATE COCAMIDOPROPYL BETAINE SILVER GLYCERIN LAURYL GLUCOSIDE PEG/PPG-4/12 DIMETHICONE POTASSIUM SORBATE SODIUM BENZOATE EDETATE SODIUM .ALPHA.-TOCOPHEROL ACETATE XANTHAN GUM YEAST, UNSPECIFIED MAGNESIUM SULFATE, UNSPECIFIED FORM MAGNESIUM CATION"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Store between 32°F and 120°F"
      ],
      "active_ingredient": [
        "Active Ingredient Contains Magnesium Sulfate (Magnesia sulphurica) 6X 0.05% HPUS The letters H.P.U.S. indicate that the componets in this product are officially monograped in the Homepathic Pharmacopoeia of the United States. Purpose Muscle Soreness Relief"
      ],
      "purpose": [
        "Purpose Muscle Soreness Relief"
      ],
      "indications_and_usage": [
        "Uses prevents cramps and spasms releases muscle tightness relieves muscle soreness"
      ],
      "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 impacted muscle group and allow to air dry repeat use as needed"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients (Alphabetical) Allantoin, Aloe Barbadensis Leaf Extract, Aloe Barbadensis Leaf Juice, Aqua (Water), Benzyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Colloidal Silver, Glycerin, Lauryl Glucoside, Parfum (Fragrance), PEG/PPG-4/12 Dimethicone, Potassium Sorbate, Sodium Benzoate, Tetrasodium EDTA, Tocopheryl Acetate, Xanthan Gum, Yeast Extract"
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: Label"
      ],
      "set_id": "09bd49cd-ace8-49ac-9b83-2926c0436b56",
      "id": "2308de12-a4fa-d1f3-e063-6394a90a3ca1",
      "effective_time": "20240926",
      "version": "1",
      "openfda": {
        "brand_name": [
          "Theraworx Relief for Muscle Cramps Roll-On"
        ],
        "generic_name": [
          "MAGNESIUM SULFATE, UNSPECIFIED FORM"
        ],
        "manufacturer_name": [
          "AVADIM HOLDINGS, INC."
        ],
        "product_ndc": [
          "61594-046"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "MAGNESIUM SULFATE, UNSPECIFIED FORM"
        ],
        "spl_id": [
          "2308de12-a4fa-d1f3-e063-6394a90a3ca1"
        ],
        "spl_set_id": [
          "09bd49cd-ace8-49ac-9b83-2926c0436b56"
        ],
        "package_ndc": [
          "61594-046-00"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0850060284236"
        ],
        "unii": [
          "DE08037SAB"
        ]
      }
    }
  ]
}