{
  "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": "2026-06-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 25
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Refill 3 BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE GLYCERIN WATER BENZALKONIUM CHLORIDE BENZALKONIUM LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information Store at room temperature"
      ],
      "active_ingredient": [
        "Active Ingredients Benzalkonium chloride 0.13% Lidocaine hydrochloride 0.5% Purpose First aid antiseptic Pain relieving cream"
      ],
      "purpose": [
        "Purpose First aid antiseptic Pain relieving cream"
      ],
      "indications_and_usage": [
        "Uses First aid to help prevent infection in minor cuts, scrapes, and burns. For the temporary relief of pain and itching associated with minor burns , minor cuts, and scrapes"
      ],
      "warnings": [
        "Warnings For external use only. Do not use • in the eyes • over large areas of the body • in large quantities • over raw surfaces or blistered areas • longer than 1 week unless directed by a doctor Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns. Stop use and ask a doctor if • the condition persists or gets worse • symptoms persist for more than 7 days or clear up and occur again within a few days Keep out of reah of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "do_not_use": [
        "Do not use • in the eyes • over large areas of the body • in large quantities • over raw surfaces or blistered areas • longer than 1 week unless directed by a doctor"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns."
      ],
      "stop_use": [
        "Stop use and ask a doctor if • the condition persists or gets worse • symptoms persist for more than 7 days or clear up and occur again within a few days"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reah of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Clean the affected area Adults and children 2 years of age and older: Apply a small amount of this product to affected area not more than 3 times daily Children under 2 years of age: consult a doctor May be covered with a sterile bandage"
      ],
      "inactive_ingredient": [
        "Inactive ingredients glycerin monostearate, glycerol, purified water"
      ],
      "package_label_principal_display_panel": [
        "Burn treatment"
      ],
      "set_id": "0fc6a0df-2b1f-4415-8c7a-ee484b1d21fa",
      "id": "2cb35d2e-bb1e-6ad6-e063-6294a90ac1c9",
      "effective_time": "20250127",
      "version": "8",
      "openfda": {
        "application_number": [
          "M003"
        ],
        "brand_name": [
          "Refill 3"
        ],
        "generic_name": [
          "BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "GFA Production (Xiamen) Co., Ltd."
        ],
        "product_ndc": [
          "50814-017"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZALKONIUM CHLORIDE",
          "LIDOCAINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1012100"
        ],
        "spl_id": [
          "2cb35d2e-bb1e-6ad6-e063-6294a90ac1c9"
        ],
        "spl_set_id": [
          "0fc6a0df-2b1f-4415-8c7a-ee484b1d21fa"
        ],
        "package_ndc": [
          "50814-017-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "F5UM2KM3W7",
          "V13007Z41A"
        ]
      }
    }
  ]
}