{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "DermacinRx Surgical ComboPak Chlorhexidine Gluconate Surgical Combo Kit ANTISEPTIC SKIN CLEANSER Chlorhexidine Gluconate COCO DIETHANOLAMIDE HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) ISOPROPYL ALCOHOL LAURAMINE OXIDE WATER TRIDECYL ALCOHOL GLUCONOLACTONE PEG-75 LANOLIN CHLORHEXIDINE GLUCONATE CHLORHEXIDINE Skin Repair Complex Dimethicone KUKUI NUT OIL ALOE VERA LEAF BUTYLENE GLYCOL CAPRYLYL GLYCOL SAFFLOWER OIL CETYL ALCOHOL CHLORPHENESIN DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER EDETATE DISODIUM GLYCERIN GLYCERYL MONOSTEARATE LEVOMENOL CALCIUM PANTOTHENATE CARTHAMUS TINCTORIUS SEED OLEOSOMES MALTODEXTRIN NIACINAMIDE PYRIDOXINE HYDROCHLORIDE SILICON DIOXIDE SODIUM ASCORBYL PHOSPHATE .ALPHA.-TOCOPHEROL ACETATE, DL- GINGER PEG-100 STEARATE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PHENOXYETHANOL WATER HYALURONATE SODIUM STEARIC ACID TROLAMINE DIMETHICONE DIMETHICONE"
      ],
      "spl_unclassified_section": [
        "PART 1: Chlorhexidine Gluconate Drug Facts",
        "PART 2: Skin Repair Complex Drug Facts",
        "PART 3: Silicone Tape Uses • To be applied to wounds or scars as a protective silicone barrier. • As a dressing for abrasions, surgical wounds, donor sites, lacerations, ulcers, skin tears, superficial partial thickness burns, venous leg ulcers. • As a dressing/securement for IV related uses, pressure ulcers, skin care, and wound care Precautions • Do not use if you are allergic to silicone • Keep out of reach of children Directions for use • Apply tape to wound or scar as needed or as directed by your physician. Remove tape, wash area, and apply new tape at least every 24 hours."
      ],
      "active_ingredient": [
        "Active ingredient Chlorhexidine Gluconate 4% solution Purpose Antiseptic",
        "Active ingredient Dimethicone 5.0%"
      ],
      "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 patient preoperative skin preparation: for the preparation of the patient's skin prior to surgeryskin wound and general skin cleansing skin wound and general skin cleansing",
        "Uses ■ for the treatment and/or prevention of diaper rash ■ temporarily protects and helps relieve chapped or cracked skin"
      ],
      "warnings": [
        "Warnings For external use only Do not use if you are allergic to chlorhexidine gluconate or any other ingredients in contact with meninges in the genital area as a preoperative skin preparation of the head or face When using this product keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures 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 repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of 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.",
        "Warnings For external use only Do not use on ■ deep or puncture wounds ■ animal bites ■ serious burns When using this product ■ do not get into eyes Stop use and ask a doctor if ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days 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. Surgical hand scrub: wet hands and forearms with water scrub for 3 minutes with about 5 ml of product 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 product and rinse under running water 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 15 seconds rinse and dry thoroughly Patient preoperative skin preparation: apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel repeat procedure for an additional 2 minutes and dry with a sterile towel Skin wound and general skin cleaning: thoroughly rinse the area to be cleaned with water apply the minimum amount of product necessary to cover the skin or wound area and wash gently rinse again thoroughly",
        "Directions ■ apply cream liberally as needed"
      ],
      "storage_and_handling": [
        "Other information store at 20-25ºC (68-77ºF) avoid excessive heat above 40ºC (104ºF)",
        "Other information ■ protect from freezing ■ avoid excessive heat"
      ],
      "inactive_ingredient": [
        "Inactive ingredients cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol",
        "Inactive ingredients Aleurites moluccana seed oil, Aloe barbadensis ( Aloe vera ) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, DermacinRx Complex ® [consisting of: bisabolol, calcium pantothenate (vitamin B 5 ), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B 3 ), pyridoxine HCl (vitamin B 6 ), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine."
      ],
      "package_label_principal_display_panel": [
        "image description"
      ],
      "set_id": "7aff8c66-e758-438a-872d-804a35bb372a",
      "id": "292fb349-6c9d-d1dd-e063-6394a90a5ed9",
      "effective_time": "20241213",
      "version": "8",
      "openfda": {
        "brand_name": [
          "DermacinRx Surgical ComboPak"
        ],
        "generic_name": [
          "CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT"
        ],
        "manufacturer_name": [
          "PureTek Corporation"
        ],
        "product_ndc": [
          "59088-334"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "rxcui": [
          "211365",
          "259090"
        ],
        "spl_id": [
          "292fb349-6c9d-d1dd-e063-6394a90a5ed9"
        ],
        "spl_set_id": [
          "7aff8c66-e758-438a-872d-804a35bb372a"
        ],
        "package_ndc": [
          "59088-334-00",
          "0116-1061-08",
          "59088-333-08"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0731477391932"
        ]
      }
    }
  ]
}