{
  "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": "2026-06-01",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Capsaicin 0.1 Percent Capsaicin CAPSAICIN CAPSAICIN STEARIC ACID TROLAMINE CHONDROITIN SULFATE (BOVINE) POLYACRYLAMIDE (10000 MW) SODIUM POLYACRYLATE (2500000 MW) WATER ARNICA MONTANA FLOWER INDIAN FRANKINCENSE CETOSTEARYL ALCOHOL ETHYLHEXYLGLYCERIN GLUCOSAMINE SULFATE GLYCERIN GLYCERYL MONOSTEARATE C13-14 ISOPARAFFIN ISOSTEARYL PALMITATE LAURETH-7 DIMETHYL SULFONE PEG-100 STEARATE PHENOXYETHANOL PROPYLENE GLYCOL"
      ],
      "spl_unclassified_section": [
        "CAPSAICIN – Capsaicin 0.1 % Cream Alexso, Inc. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Capsaicin 0.1 % Cream Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient Capsaicin 0.1%"
      ],
      "purpose": [
        "Purpose External analgesic"
      ],
      "indications_and_usage": [
        "Uses Temporarily relieves minor aches and pains of muscles and joints due to: • simple backache • arthritis • strains • sprains"
      ],
      "warnings": [
        "Warnings For external use only Read all warnings and directions before use. Test first on small area of skin. Do not use • On wounds or damaged skin • If you are allergic to capsicum or chili peppers Whe n us ing this product • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days. • Avoid contact with the eyes, lips, nose and mucous membranes • Do not tightly wrap or bandage the treated area • Do not apply heat to the treated area immediately before or after use Stop use and as k a doctor if • Condition worsens or does not improve after regular use • Severe burning persists or blistering occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately."
      ],
      "do_not_use": [
        "Do not use • On wounds or damaged skin • If you are allergic to capsicum or chili peppers"
      ],
      "when_using": [
        "Whe n us ing this product • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days. • Avoid contact with the eyes, lips, nose and mucous membranes • Do not tightly wrap or bandage the treated area • Do not apply heat to the treated area immediately before or after use"
      ],
      "stop_use": [
        "Stop use and as k a doctor if • Condition worsens or does not improve after regular use • Severe burning persists or blistering occurs"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 18 years of age and older: Apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands. Wash hands thoroughly with soap and water immediately after application for best results. Apply 3 to 4 times daily. Children under 18 years : Ask a doctor"
      ],
      "storage_and_handling": [
        "Other information Store at room temperature 15°-30°C (59°-86°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsufonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, and Triethanolamine"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL Capsaicin 0.1 % C ream NDC 50488-1060-6 6 0 grams Alexso, Inc PRINCIPAL DISPLAY PANEL Capsaicin 0.1% Cream NDC 50488-1060-6 60 grams Alexso, Inc"
      ],
      "set_id": "0090ca38-6433-45c4-9453-edf2788c14c6",
      "id": "4dd9a4a8-6316-41d9-b9cc-75b31e9a0fb7",
      "effective_time": "20241206",
      "version": "3",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Capsaicin 0.1 Percent"
        ],
        "generic_name": [
          "CAPSAICIN"
        ],
        "manufacturer_name": [
          "Alexso, Inc"
        ],
        "product_ndc": [
          "50488-1060"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CAPSAICIN"
        ],
        "rxcui": [
          "646333"
        ],
        "spl_id": [
          "4dd9a4a8-6316-41d9-b9cc-75b31e9a0fb7"
        ],
        "spl_set_id": [
          "0090ca38-6433-45c4-9453-edf2788c14c6"
        ],
        "package_ndc": [
          "50488-1060-6"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0350488106061"
        ],
        "unii": [
          "S07O44R1ZM"
        ]
      }
    }
  ]
}