{
  "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": "2026-10-30",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "ProloGel Urgent Care LIDOCAINE and SODIUM BICARBONATE LIDOCAINE LIDOCAINE SODIUM BICARBONATE BICARBONATE ION DOCOSANOL SHEA BUTTER ORANGE OIL, COLD PRESSED DIMETHICONE EDETATE DISODIUM GLYCERIN GUAR GUM MANNITOL OLEYL ALCOHOL POLYSORBATE 20 WATER CASTOR OIL SODIUM HYDROXIDE SORBITAN MONOSTEARATE"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredients * Purpose Lidocaine 4% Topical Analgesic Sodium Bicarbonate 5% Skin Protectant"
      ],
      "active_ingredient_table": [
        "<table width=\"55%\"><col width=\"70%\" align=\"left\" valign=\"top\"/><col width=\"30%\" align=\"left\" valign=\"top\"/><thead><tr><th><content styleCode=\"bold italics\">Active Ingredients</content>*</th><th><content styleCode=\"bold italics\">Purpose</content></th></tr></thead><tbody><tr><td>Lidocaine 4%</td><td>Topical Analgesic</td></tr><tr><td>Sodium Bicarbonate 5%</td><td>Skin Protectant</td></tr></tbody></table>"
      ],
      "purpose": [
        "Active Ingredients * Purpose Lidocaine 4% Topical Analgesic Sodium Bicarbonate 5% Skin Protectant"
      ],
      "purpose_table": [
        "<table width=\"55%\"><col width=\"70%\" align=\"left\" valign=\"top\"/><col width=\"30%\" align=\"left\" valign=\"top\"/><thead><tr><th><content styleCode=\"bold italics\">Active Ingredients</content>*</th><th><content styleCode=\"bold italics\">Purpose</content></th></tr></thead><tbody><tr><td>Lidocaine 4%</td><td>Topical Analgesic</td></tr><tr><td>Sodium Bicarbonate 5%</td><td>Skin Protectant</td></tr></tbody></table>"
      ],
      "indications_and_usage": [
        "Uses For relief from minor pain aches & pains of sore muscles & joints associated with arthritis backache bruises strains & sprains."
      ],
      "warnings": [
        "Warnings For external use only Use only as directed Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Store in cool dry place away from direct sunlight. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children If accidentally ingested, get medical help or contact Poison Control Center immediately. Stop use and ask a doctor if Condition worsens Irritation or redness develops. Ask doctor before use If you have sensitive skin. Directions Shake well before each use. Keep cap on between uses. Adults and children 12 years of age or older: Use gloves (or skin barrier) with each application to prevent absorption into hands. Apply generous amount to clean, unbroken skin. Allow lotion to rest on skin for approximately one minute Rub lotion into the target area. Reapply up to four times per day. Wash hands thoroughly after each application."
      ],
      "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 If accidentally ingested, get medical help or contact Poison Control Center immediately."
      ],
      "stop_use": [
        "Stop use and ask a doctor if Condition worsens Irritation or redness develops."
      ],
      "ask_doctor": [
        "Ask doctor before use If you have sensitive skin."
      ],
      "dosage_and_administration": [
        "Directions Shake well before each use. Keep cap on between uses. Adults and children 12 years of age or older: Use gloves (or skin barrier) with each application to prevent absorption into hands. Apply generous amount to clean, unbroken skin. Allow lotion to rest on skin for approximately one minute Rub lotion into the target area. Reapply up to four times per day. Wash hands thoroughly after each application."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients* Behenyl alcohol, Citrus Sinensis Peel Oil, Dimethicone, Disodium ETDA, Emulsfying wax NF, Glycerin, Guar gum, Mannitol, Oleyl alcohol, Polysorbate 20, Purified water, Ricinus Communis (Castor) Seed Oil, Sodium hydroxide, Sorbitan stearate."
      ],
      "questions": [
        "Questions or Comments 1 866-516-5508 or Support@ProloGel.com"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton ProloGel ® URGENT CARE FORMULA For Rapid Relief Deep Penetrating Vanishing Odor Topical Therapeutic Lotion Net Wt. 5 oz / 148 mL PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton"
      ],
      "set_id": "9fc71191-4fcd-4d7b-966c-878a1e28d6c1",
      "id": "877d9d87-17eb-41c2-9ab5-d19cae9b88e8",
      "effective_time": "20210903",
      "version": "2",
      "openfda": {}
    }
  ]
}