Dermacinrx Surgical Combopak Kit
FDA Label NDC 59088-334

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puretek Corporation for the product Dermacinrx Surgical Combopak (NDC 59088-334). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding part 1: chlorhexidine gluconate, active ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Part 1: Chlorhexidine Gluconate

Drug Facts

Active Ingredient

Chlorhexidine Gluconate 4% solution

Dimethicone 5.0%

Purpose

Antiseptic

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
  • ■ for the treatment and/or prevention of diaper rash
    ■ temporarily protects and helps relieve chapped or cracked skin

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 doctorif 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.

      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.

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
                              • ■ apply cream liberally as needed

Other Information

  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
  • ■ protect from freezing ■ avoid excessive heat

Inactive Ingredients

cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

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 B5), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B3), pyridoxine HCl (vitamin B6), 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.

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.

Package Label.Principal Display Panel

Image Description (Carton V6)

Image Description (Carton V6)

* Please review the disclaimer below.