{
  "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": [
        "Mt Royal Hand Sanitizer 70% Ethyl Alcohol Gel ALCOHOL ALCOHOL WATER ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) GLYCERIN TRIETHANOLAMINE"
      ],
      "spl_unclassified_section": [
        "Product Decription & Introduction This is a gel-form hand sanitizer (topical antiseptic rub) with a minimum of 62% Ethanol concentration and additional cosmetic fragrances manufactured in accordance with 21CFR330 and 21CFR333a."
      ],
      "active_ingredient": [
        "Active Ingredient(s) Ethyl Alcohol 62% v/v. Purpose: Antiseptic"
      ],
      "purpose": [
        "Purpose Antiseptic, Hand Sanitizer"
      ],
      "indications_and_usage": [
        "Use Decreases bacteria on hands"
      ],
      "warnings": [
        "Warnings For external use only Flammable Keep away from flame or high heat",
        "Flammable Keep away from flame or high heat"
      ],
      "when_using": [
        "When using this product keep out of eyes. In case of contact with eyes, flush eyes with water. Avoid contact with broken skin."
      ],
      "stop_use": [
        "Stop use and ask a doctor if irritation or redness develop."
      ],
      "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 Rub hands thoroughly with product and allow to dry."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Water (aqua), Glycerine, Carbomer, Triethanolamine, Citrus Medica Limonum (Lemon) Peel Oil, Eugenia Caryophyllus (Clove) Flower Oil, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Eucalyptus Globulus Leaf Oil"
      ],
      "recent_major_changes": [
        "Initial Registration Updated label content sections from default content included in the COVID-19 Hand Sanitizer template to be consistent with product label."
      ],
      "package_label_principal_display_panel": [
        "Package Label - Principal Display Panel Size: 59.1471 mL (2 Oz) NDC: 74322-002-01 Label: Size: 118.294 mL (4 Oz) NDC: 74322-002-02 Label: Size: 3785.41 mL (1 gal) NDC: 74322-002-03 Label: 2 Oz 74322-002-01 4 Oz 74322-002-02 1 Gal 74322-002-03"
      ],
      "set_id": "a25f5362-b868-5f47-e053-2995a90a05a7",
      "id": "32336cf3-dc07-7e3d-e063-6294a90a78ec",
      "effective_time": "20250501",
      "version": "2",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "Mt Royal Hand Sanitizer"
        ],
        "generic_name": [
          "70% ETHYL ALCOHOL GEL"
        ],
        "manufacturer_name": [
          "Mount Royal Soaps, LLC"
        ],
        "product_ndc": [
          "74322-004"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ALCOHOL"
        ],
        "spl_id": [
          "32336cf3-dc07-7e3d-e063-6294a90a78ec"
        ],
        "spl_set_id": [
          "a25f5362-b868-5f47-e053-2995a90a05a7"
        ],
        "package_ndc": [
          "74322-004-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3K9958V90M"
        ]
      }
    }
  ]
}