{
  "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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      "total": 12
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  "results": [
    {
      "spl_product_data_elements": [
        "Dyna-Hex 2 Chlorhexidine Gluconate 2% CITRIC ACID MONOHYDRATE HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) CHLORHEXIDINE GLUCONATE CHLORHEXIDINE COCO DIETHANOLAMIDE ISOPROPYL ALCOHOL WATER LAURAMINE OXIDE"
      ],
      "active_ingredient": [
        "Active Ingredient Chlorhexidine gluconate 2% solution"
      ],
      "purpose": [
        "Purpose Antiseptic"
      ],
      "indications_and_usage": [
        "Uses surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease"
      ],
      "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 or the patient 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  wounds which involve more than the superficial layers of the skin should not be routinely treated 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 or the patient 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  wounds which involve more than the superficial layers of the skin should not be routinely treated"
      ],
      "ask_doctor": [
        "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 or infants under 2 months of age. These products may cause irritation or chemical burns. Surgical hand scrub:  wet hands and forearms with water  scrub for 3 minutes with 5 mL of solution (4 full strokes) and a wet brush, paying close attention to the nails, cuticles and interdigital spaces  a separate nail cleaner may be used  rinse thoroughly  wash for an additional 3 minutes with 5 mL of solution (4 full strokes) and rinse under running water  dry thoroughly Healthcare personnel handwash:  wet hands with water  dispense 5 mL of solution (4 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds  rinse and dry thoroughly"
      ],
      "other_safety_information": [
        "Other information  store at 20-25°C (68-77°F)  avoid excessive heat above 40°C (104°F)"
      ],
      "inactive_ingredient": [
        "citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water"
      ],
      "questions": [
        "Questions or comments? Questions or comments? call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST"
      ],
      "cleaning": [
        "Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach. Rinse completely and use only non-chlorine detergents."
      ],
      "package_label_principal_display_panel": [
        "NDC 0116-1022-32 DYNA-HEX 2® Chlorhexidine Gluconate 2% Solution Antiseptic Contains: 2% Chlorhexidine Gluconate Distributed By: Xttrium Laboratories, Inc. Mount Prospect, IL 60056 CHLORHEXIDINE GLUCONATE Net Contents: 32 fl oz (1 qt) (946 mL) 2DYN32SQLBL Dyna-Hex 2 Square Bottle"
      ],
      "set_id": "0c808ebd-1bf7-175d-e063-6294a90ae7df",
      "id": "3400ba9f-d027-b3f7-e063-6394a90ac53a",
      "effective_time": "20250430",
      "version": "2",
      "openfda": {
        "application_number": [
          "NDA019422"
        ],
        "brand_name": [
          "Dyna-Hex 2"
        ],
        "generic_name": [
          "CHLORHEXIDINE GLUCONATE 2%"
        ],
        "manufacturer_name": [
          "Xttrium Laboratories, Inc."
        ],
        "product_ndc": [
          "0116-1022"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CHLORHEXIDINE GLUCONATE"
        ],
        "rxcui": [
          "834160",
          "1245230"
        ],
        "spl_id": [
          "3400ba9f-d027-b3f7-e063-6394a90ac53a"
        ],
        "spl_set_id": [
          "0c808ebd-1bf7-175d-e063-6294a90ae7df"
        ],
        "package_ndc": [
          "0116-1022-32"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "MOR84MUD8E"
        ]
      }
    }
  ]
}