Dermawerx Surgical Prepak

Dermawerx Surgical Prepak
SPL v1
SPL
SPL Set ID 2687330c-50dc-0339-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2015-10-01
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (4 g) Dimethicone (50 mg)
Inactive Ingredients
Gluconolactone Peg-75 Lanolin Coco Diethanolamide Hydroxyethyl Cellulose (2000 Cps At 1%) Isopropyl Alcohol Lauramine Oxide Water Tridecyl Alcohol Butylene Glycol Safflower Oil Cetyl Alcohol Kukui Nut Oil Aloe Vera Leaf Chlorphenesin Dimethicone/diene Dimethicone Crosspolymer Edetate Disodium Glycerin Glyceryl Monostearate Levomenol Calcium Pantothenate Carthamus Tinctorius (safflower) Oleosomes Maltodextrin Pyridoxine Hydrochloride Trolamine Stearic Acid Hyaluronate Sodium Phenoxyethanol Niacinamide Ginger Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Peg-100 Stearate .alpha.-tocopherol Acetate, Dl- Caprylyl Glycol Methylparaben

Identifiers & Packaging

Marketing Status
NDA Active Since 2015-12-10

Description

Drug Facts

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Drug Facts

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
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

Chlorhexidine Gluconate 4% solution

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.

Dermawerx Surgical Pre Pak

Skin Repair Cream (5% Dimethicone)

Drug Facts

Chlorhexidine Gluconate Solution, 4%

Drug Facts


Structured Label Content

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
Purpose

Antiseptic

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
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

Other Information (Other information)
  • store at 20-25ºC (68-77ºF)
  • avoid excessive heat above 40ºC (104ºF)
Inactive Ingredients (Inactive ingredients)

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

Dermawerx Surgical Pre Pak

Skin Repair Cream (5% Dimethicone)

Drug Facts

Chlorhexidine Gluconate Solution, 4%

Drug Facts


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)