Part 1: Chlorhexidine Gluconate
Drug Facts
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.
Drug Facts
Chlorhexidine Gluconate 4% solution
Dimethicone 5.0%
Antiseptic
■ for the treatment and/or prevention of diaper rash
■ temporarily protects and helps relieve chapped or cracked skin
For external use only
Do not use
When using this product
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.
use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns.
Patient preoperative skin preparation:
Skin wound and general skin cleaning:
■ apply cream liberally as needed
■ protect from freezing ■ avoid excessive heat
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.
Drug Facts
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.
* Please review the disclaimer below.