{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "NUMSTAT Antiseptic and Pain Relieving Prep Pad alcohol, menthol, and benzocaine prep pad WATER BENZOCAINE BENZOCAINE ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL MENTHOL MENTHOL"
      ],
      "active_ingredient": [
        "Active Ingredients Active Ingredients (per application in each pad) Percent Purpose Isopropyl Alcohol................................. 71% Antiseptic Benzocaine......................................... 15% Topical Analgesic Menthol.............................................. 1% Topical Analgesic"
      ],
      "purpose": [
        "Purpose Antiseptic & Pain Relieving"
      ],
      "indications_and_usage": [
        "Uses Uses • For the temporary relief of pain associated with needle sticks, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, and insect bites • Reduces the risk of infection • Kills germs"
      ],
      "warnings": [
        "Warnings Warnings Flammable . Keep away from heat or open flame. When using this product • Use glove with application hand or always wash application hand immediately after application For external use only"
      ],
      "do_not_use": [
        "Do Not Use Do not use • Avoid contact with eyes, mouth, or mucous membranes. In case of contact with eyes, mouth, or mucous membranes, flush with water, call a doctor."
      ],
      "stop_use": [
        "Stop use Discontinue use if irritation occurs. If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children Keep out of reach of children . If swallowed, call a doctor or poison control center."
      ],
      "dosage_and_administration": [
        "Directions Directions for Use Adults and children 2 years of age and older. • Apply to affected area. Do not apply more than 4 times daily. • Apply pad solution to the skin and gently rub in and let dry. • Test for effect by touching area before performing procedure May need to reapply on certain skin types. For children under 2 years of age, consult a doctor."
      ],
      "spl_unclassified_section": [
        "Other Information Other Information • Protect from excessive heat.",
        "Carton Information Antiseptic & Pain Relieving Prep Pad NUMSTAT Fast Needle Pain Relief • Quickly Relieve Minor Topical Pain with 15% Benzocaine and 1% Menthol • Easily Clean and Kill Germs with 71% Isopropyl Alcohol Afraid of Needle Pain? To Relieve Minor Topical Pain Fast, Gently Rub In and Let Dry! Manufactured for: Spectra Medical Devices, LLC 299 Ballardvale Street, Suite 1, Wilmington, MA 01887 NUMSTAT (TM) and © Copyright 2023 Spectra Medical Devices LLC, All Rights Reserved."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Inactive Ingredients Neopentyl Glycol Diheptanoate Neopentyl Glycol Diheptanoate Isododecane Purified Water"
      ],
      "questions": [
        "Questions or Comments? Questions or Comments? Call (978) 657-0889 or visit num-stat.com"
      ],
      "package_label_principal_display_panel": [
        "Package Label Principal Display Panel NUMSTAT Carton NUMSTAT Carton Numstat Packet Front Numstat Packet Back"
      ],
      "set_id": "07d20040-9dd9-0aba-e063-6294a90ab7cf",
      "id": "0ceeef4e-90fe-d542-e063-6394a90abc8d",
      "effective_time": "20231220",
      "version": "2",
      "openfda": {
        "application_number": [
          "M003"
        ],
        "brand_name": [
          "NUMSTAT Antiseptic and Pain Relieving Prep Pad"
        ],
        "generic_name": [
          "ALCOHOL, MENTHOL, AND BENZOCAINE PREP PAD"
        ],
        "manufacturer_name": [
          "Spectra Medical Devices, LLC"
        ],
        "product_ndc": [
          "65282-1815"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZOCAINE",
          "ISOPROPYL ALCOHOL",
          "MENTHOL"
        ],
        "rxcui": [
          "2667820",
          "2667826"
        ],
        "spl_id": [
          "0ceeef4e-90fe-d542-e063-6394a90abc8d"
        ],
        "spl_set_id": [
          "07d20040-9dd9-0aba-e063-6294a90ab7cf"
        ],
        "package_ndc": [
          "65282-1815-1",
          "65282-1815-2"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0365282000002"
        ],
        "nui": [
          "N0000185508",
          "N0000175629",
          "N0000184306",
          "M0000728"
        ],
        "pharm_class_epc": [
          "Standardized Chemical Allergen [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]"
        ],
        "unii": [
          "U3RSY48JW5",
          "ND2M416302",
          "L7T10EIP3A"
        ]
      }
    }
  ]
}