{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Hand Sanitizer ALCOHOL HYDROGEN PEROXIDE WATER ALCOHOL ALCOHOL GLYCERIN"
      ],
      "spl_unclassified_section": [
        "This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry . The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations: Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol (1.45% v/v). Hydrogen peroxide (0.125% v/v). Sterile distilled water or boiled cold water. The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product."
      ],
      "active_ingredient": [
        "Active Ingredient(s) Alcohol 80% v/v. Purpose: Antiseptic"
      ],
      "purpose": [
        "Purpose Antiseptic, Hand Sanitizer"
      ],
      "indications_and_usage": [
        "Use Hand Sanitizer to help reduce 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 and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "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": [
        "Inactive ingredients glycerin, hydrogen peroxide, purified water USP"
      ],
      "package_label_principal_display_panel": [
        "118 ML NDC: 77556-580-04 118 ML Hand Sanitizer 118 ML Hand Rub",
        "59 ML NDC: 77556-580-02 59 ML Hand Sanitizer 59 ML Hand Rub",
        "354 ML NDC: 77556-580-12 354 ML Hand Sanitizer 354 Hand Rub",
        "236 ML NDC: 77556-580-08 236 ML Hand Sanitizer 236 Hand Rub",
        "400 ML NDC: 77556-580-13 400 ML Hand Sanitizer 400 ML Hand Rub",
        "473 ML NDC: 77556-580-16 473 ML Hand Sanitizer 473 ML Hand Rub",
        "946 ML NDC: 77556-580-32 946 ML Hand Sanitizer 946 ML Hand Rub",
        "1000 ML NDC: 77556-580-33 1000 ML Hand Sanitizer 1000 ML Hand Rub",
        "2000 ML NDC: 77556-580-67 2000 ML Hand Sanitizer 2000 ML Hand Rub",
        "30 ML NDC: 77556-580-01 77556-580-01 1 oz hand sanitizer 77556-580-01 1 oz hand rub",
        "3785 ML NDC: 77556-580-93 77556-580-93 128 oz hand sanitizer 77556-580-93 128 oz hand rub",
        "18927 ML NDC: 77556-580-94 77556-580-94 640 oz hand sanitizer 77556-580-94 640 oz hand rub",
        "208198 ML NDC: 77556-580-95 77556-580-95 7040 oz hand sanitizer 77556-580-95 7040 oz hand rub",
        "1040990 ML NDC: 77556-580-97 77556-580-97 35200 oz hand sanitizer 77556-580-97 35200 oz hand rub",
        "1249190 ML NDC: 77556-580-99 77556-580-99 42240 oz hand sanitizer 77556-580-99 42240 oz hand rub"
      ],
      "set_id": "a5189240-19ce-7715-e053-2995a90ad043",
      "id": "473aaaa2-fbd0-c3fe-e063-6294a90a45f0",
      "effective_time": "20251231",
      "version": "9",
      "openfda": {
        "application_number": [
          "M003"
        ],
        "brand_name": [
          "Hand Sanitizer"
        ],
        "generic_name": [
          "ALCOHOL"
        ],
        "manufacturer_name": [
          "Astera International LLC"
        ],
        "product_ndc": [
          "77556-580"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ALCOHOL"
        ],
        "rxcui": [
          "1039339"
        ],
        "spl_id": [
          "473aaaa2-fbd0-c3fe-e063-6294a90a45f0"
        ],
        "spl_set_id": [
          "a5189240-19ce-7715-e053-2995a90ad043"
        ],
        "package_ndc": [
          "77556-580-04",
          "77556-580-02",
          "77556-580-08",
          "77556-580-12",
          "77556-580-13",
          "77556-580-16",
          "77556-580-32",
          "77556-580-33",
          "77556-580-67",
          "77556-580-93",
          "77556-580-01",
          "77556-580-94",
          "77556-580-95",
          "77556-580-97",
          "77556-580-99"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3K9958V90M"
        ]
      }
    }
  ]
}