DermacinRx Surgical ComboPak
DERMACINRX SURGICAL COMBOPAK- chlorhexidine gluconate surgical combo kit
PureTek Corporation
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
PART 1: Chlorhexidine Gluconate
Drug Facts
Active ingredient
Chlorhexidine Gluconate 4% solution
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
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.
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
Other information
- store at 20-25ºC (68-77ºF)
- avoid excessive heat above 40ºC (104ºF)
Inactive ingredients
cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol
PART 2: Skin Repair Complex
Drug Facts
Active ingredient
Dimethicone 5.0%
Uses
■ 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 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
■ apply cream liberally as needed
Other information
■ protect from freezing ■ avoid excessive heat
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.
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.
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Labeler — PureTek Corporation (785961046) |
Registrant — PureTek Corporation (785961046) |
Establishment | |||
Name | Address | ID/FEI | Operations |
PureTek Corporation | 785961046 | pack (59088-334), manufacture (59088-333) |
Revised: 01/2023 PureTek Corporation
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