{
  "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": "2026-08-11",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "CHLORAPREP CHLORAPREP ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL CHLORHEXIDINE GLUCONATE CHLORHEXIDINE WATER"
      ],
      "active_ingredient": [
        "Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v"
      ],
      "purpose": [
        "Antiseptic"
      ],
      "indications_and_usage": [
        "for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection."
      ],
      "warnings": [
        "For external use only. Flammable, keep away from fire or flame. do not use with electrocautery procedures"
      ],
      "spl_unclassified_section": [
        "Allegery Alert This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away."
      ],
      "do_not_use": [
        "on patients allergic to chlorhexidine gluconate or any other ingredient in this product for lumbar puncture or in contact with the meninges on open skin wounds or as a general skin cleanser"
      ],
      "when_using": [
        "keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor."
      ],
      "stop_use": [
        "irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition."
      ],
      "ask_doctor": [
        "irritation, sensitization, or allergic reaction 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."
      ],
      "dosage_and_administration": [
        "use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. maximal treatment area for one applicator one single swabstick applicator is approximately 2.5 in. x 2.5 in. (42 cm 2) tear pouch at side notch to reveal applicator handles. Do not touch foam applicator tip. Place foam flat side down on the treatment area. completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds. (When using the triple swabstick applicators, use each swabstick sequentially within the 30 seconds). Allow the area to air dry for approximately 30 seconds. Do not blot or wipe away. moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes. (When using the triple swabstick applicators, use each swabstick sequentially within the 2 minutes). Allow the area to air dry for approximately 1 minute. Do not blot or wipe away. discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available."
      ],
      "inactive_ingredient": [
        "USP purified water"
      ],
      "other_safety_information": [
        "store between 15-30 ºC (59-86 °F) avoid freezing and excessive heat above 40 ºC (104 °F)"
      ],
      "package_label_principal_display_panel": [
        "Label"
      ],
      "set_id": "44fe08e0-4e9c-8bd6-e063-6394a90a0e2b",
      "id": "44fe08e0-4e9d-8bd6-e063-6394a90a0e2b",
      "effective_time": "20251202",
      "version": "1",
      "openfda": {
        "application_number": [
          "NDA021555"
        ],
        "brand_name": [
          "CHLORAPREP"
        ],
        "generic_name": [
          "CHLORAPREP"
        ],
        "manufacturer_name": [
          "HF Acquisition Co LLC, DBA HealthFirst"
        ],
        "product_ndc": [
          "51662-1675"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ISOPROPYL ALCOHOL",
          "CHLORHEXIDINE GLUCONATE"
        ],
        "spl_id": [
          "44fe08e0-4e9d-8bd6-e063-6394a90a0e2b"
        ],
        "spl_set_id": [
          "44fe08e0-4e9c-8bd6-e063-6394a90a0e2b"
        ],
        "package_ndc": [
          "51662-1675-1"
        ],
        "original_packager_product_ndc": [
          "54365-401"
        ],
        "unii": [
          "ND2M416302",
          "MOR84MUD8E"
        ]
      }
    }
  ]
}