{
  "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": "2026-06-01",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Chlorhexidine Gluconate Solution 0.75% Antiseptic Chlorhexidine Gluconate Solution 0.75% Antiseptic COCO DIETHANOLAMIDE HYDROXYETHYL CELLULOSE (140 CPS AT 5%) ISOPROPYL ALCOHOL LAURAMINE OXIDE RICINOLEAMIDOPROPYLTRIMONIUM CHLORIDE WATER CITRIC ACID MONOHYDRATE FD&C YELLOW NO. 5 FD&C RED NO. 4 CHLORHEXIDINE GLUCONATE CHLORHEXIDINE"
      ],
      "active_ingredient": [
        "Active ingredient Chlorhexidine gluconate solution, 0.75%"
      ],
      "purpose": [
        "Purpose Antiseptic"
      ],
      "indications_and_usage": [
        "Use healthcare personnel handwash: helps reduce bacteria that potentially can cause disease"
      ],
      "warnings": [
        "Warnings For external use only Allergy 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 if you are allergic to chlorhexidine gluconate or any other ingredient in this product When using this product keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardrums. if solution should contact these areas, rinse out promptly and thoroughly with water do not use routinely if you have wounds which involve more than the superficial layers of the skin Stop use and ask a doctor if 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."
      ],
      "do_not_use": [
        "Do not use if you are allergic to chlorhexidine gluconate or any other ingredient in this product"
      ],
      "when_using": [
        "When using this product keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardrums. if solution should contact these areas, rinse out promptly and thoroughly with water do not use routinely if you have wounds which involve more than the superficial layers of the skin"
      ],
      "stop_use": [
        "Stop use and ask a doctor if irritation, sensitization, or allergic reaction 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 use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns. Healthcare personnel handwash: wet hands with water dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 30 seconds rinse and dry thoroughly",
        "Healthcare personnel handwash: wet hands with water dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 30 seconds rinse and dry thoroughly"
      ],
      "storage_and_handling": [
        "Other information store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)",
        "Keep from freezing."
      ],
      "inactive_ingredient": [
        "Inactive ingredients citric acid, cocamide DEA, FD&C yellow #5, FD&C red #4, fragrance, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water, ricinoleamidopropyl trimethyl ammonium chloride"
      ],
      "questions": [
        "Questions or comments? call 1-800-581-2528 , 24 hours a day, 7 days a week"
      ],
      "package_label_principal_display_panel": [
        "Package/Label Principal Display Panel Chlorhexidine Gluconate Solution 0.75% ANTISEPTIC FOR EXTERNAL USE ONLY Bajaj Medical Chicago IL 60609 4 fl oz (118 mL) NDC 61037-414-01 MADE IN THE USA FDA APPROVED Chlorhexidine Gluconate Solution 0.75% ANTISEPTIC FOR EXTERNAL USE ONLY Bajaj Medical Chicago IL 60609 8 fl oz (236 mL) NDC 61037-414-02 MADE IN THE USA FDA APPROVED Chlorhexidine Gluconate Solution 0.75% ANTISEPTIC FOR EXTERNAL USE ONLY Bajaj Medical Chicago IL 60609 16 fl oz (473 mL) NDC 61037-414-05 MADE IN THE USA FDA APPROVED Chlorhexidine Gluconate Solution 0.75% ANTISEPTIC FOR EXTERNAL USE ONLY Bajaj Medical Chicago IL 60609 32 fl oz (946 mL) NDC 61037-414-06 MADE IN THE USA FDA APPROVED Chlorhexidine Gluconate Solution 0.75% ANTISEPTIC FOR EXTERNAL USE ONLY Bajaj Medical Chicago IL 60609 128 fl oz (3785 mL) NDC 61037-414-07 MADE IN THE USA FDA APPROVED Chlorhexidine Gluconate Solution 0.75% ANTISEPTIC FOR EXTERNAL USE ONLY Bajaj Medical Chicago IL 60609 8 fl oz (236 mL) NDC 61037-414-03 MADE IN THE USA FDA APPROVED Chlorhexidine Gluconate Solution 0.75% ANTISEPTIC FOR EXTERNAL USE ONLY Bajaj Medical Chicago IL 60609 8 fl oz (236 mL) NDC 61037-414-04 MADE IN THE USA FDA APPROVED Chlorhexidine Gluconate Solution 0.75% ANTISEPTIC FOR EXTERNAL USE ONLY Bajaj Medical Chicago IL 60609 40.6 fl oz (1.2 L) NDC 61037-414-08 MADE IN THE USA FDA APPROVED 4ozlbl 8ozlbl 16ozlbl 32ozlbl 128ozlbl 8ozlblclr 8ozlblwht 1200mllbl Keep from freezing."
      ],
      "set_id": "014a5f36-0396-498b-901f-9a86df4e11fe",
      "id": "f0b7b337-be39-2e5f-e053-2995a90a3c8c",
      "effective_time": "20221226",
      "version": "15",
      "openfda": {
        "application_number": [
          "NDA020111"
        ],
        "brand_name": [
          "Chlorhexidine Gluconate Solution 0.75% Antiseptic"
        ],
        "generic_name": [
          "CHLORHEXIDINE GLUCONATE SOLUTION 0.75% ANTISEPTIC"
        ],
        "manufacturer_name": [
          "Bajaj Medical, LLC"
        ],
        "product_ndc": [
          "61037-414"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CHLORHEXIDINE GLUCONATE"
        ],
        "spl_id": [
          "f0b7b337-be39-2e5f-e053-2995a90a3c8c"
        ],
        "spl_set_id": [
          "014a5f36-0396-498b-901f-9a86df4e11fe"
        ],
        "package_ndc": [
          "61037-414-01",
          "61037-414-02",
          "61037-414-05",
          "61037-414-06",
          "61037-414-07",
          "61037-414-03",
          "61037-414-04",
          "61037-414-08"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0361037414070",
          "0361037414087",
          "0361037414063",
          "0361037414032",
          "0361037414049",
          "0361037414025"
        ],
        "unii": [
          "MOR84MUD8E"
        ]
      }
    }
  ]
}