{
  "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": "2026-10-28",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "KleenSwell Gel Hand Sanitizer ALCOHOL TROLAMINE WEST INDIAN LEMONGRASS OIL ALOE VERA LEAF HYDROGEN PEROXIDE ALCOHOL ALCOHOL METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) PEG-10 DIMETHICONE (600 CST) MYRISTYL LACTATE WATER GLYCERIN"
      ],
      "spl_unclassified_section": [
        "KLEENSWELL GEL HAND SANITIZER - 70% alcohol gel Hygienic Labs, LLC. 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. ---------- This is hand sanitizer is manufactured using United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation)."
      ],
      "active_ingredient": [
        "Active Ingredients Medicinal ingredient: Ethyl alcohol 70% v/v............... Purpose: Antiseptic"
      ],
      "purpose": [
        "Purpose Antiseptic, Hand Sanitizer"
      ],
      "indications_and_usage": [
        "Use Hand Sanitizer to help reduce viruses and bacteria that potentially can cause disease. For use when soap and water are not available."
      ],
      "warnings": [
        "Warnings For external use only. Flammable. Keep away from heat or flame."
      ],
      "do_not_use": [
        "Do Not Use in children less than 2 months of age on open skin wounds"
      ],
      "when_using": [
        "When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water."
      ],
      "stop_use": [
        "Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition."
      ],
      "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 Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing."
      ],
      "storage_and_handling": [
        "Other Information Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)"
      ],
      "inactive_ingredient": [
        "Water (Aqua), Glycerin, Hydrogen Peroxide, Alkyl Acrylate Crosspolymer, Triethanolamine, Aloe, Lauryl Alcohol, Myristyl Alcohol, Fragrance (Parfum), PEG Dimethicone"
      ],
      "recent_major_changes": [
        "Dosage and Administration Section was added"
      ],
      "package_label_principal_display_panel": [
        "Package Label - Principal Product Label 3800 mL NDC: 79692-003-01 19000 mL NDC: 79692-003-05 189000 mL NDC: 79692-003-50 250 mL NDC: 79692-003-08 500 mL NDC: 79692-003-16 KleenSwell Gel Hand Sanitizer - 1 Gallon KleenSwell Gel Hand Sanitizer - 5 Gallon Pail KleenSwell Gel Hand Sanitizer 50-Gallon Drum 250mL Gel Hand Sanitizer Label 500mL Gel Hand Sanitizer Label"
      ],
      "set_id": "acf0fc2b-e3bf-307f-e053-2a95a90a0e9c",
      "id": "b63e3fc1-6d45-2655-e053-2a95a90a469c",
      "effective_time": "20201211",
      "version": "7",
      "openfda": {}
    }
  ]
}