DERMAWERX SURGICAL PREPAK- chlorhexidine gluconate pre-surgical kit kit

Dermawerx Surgical PrePak by

Drug Labeling and Warnings

Dermawerx Surgical PrePak by is a Prescription medication manufactured, distributed, or labeled by Patchwerx Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Chlorhexidine Gluconate Solution, 4%

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.

Skin Repair Cream (5% Dimethicone)

Drug Facts

Active ingredient

Dimethicone 5.0%

Purpose

Skin Protectant

Uses

• 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

• gently cleanse and dry affected area
• apply liberally to affected area as needed.

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, 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

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.

Dermawerx Surgical Pre Pak

INGREDIENTS AND APPEARANCE

DERMAWERX SURGICAL PREPAK 
chlorhexidine gluconate pre-surgical kit kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69329-260

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69329-260-01	1 in 1 KIT; Type 0: Not a Combination Product

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	237 mL
Part 2	1 TUBE	118 mL

Part 1 of 2

ANTISEPTIC SKIN CLEANSER 
chlorhexidine gluconate solution

Product Information
Item Code (Source)	NDC: 0116-1061
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLUCONOLACTONE (UNII: WQ29KQ9POT)
PEG-75 LANOLIN (UNII: 09179OX7TB)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
WATER (UNII: 059QF0KO0R)
TRIDECYL ALCOHOL (UNII: 8I9428H868)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0116-1061-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019125

Part 2 of 2

SKIN REPAIR COMPLEX 
dimethicone cream

Product Information
Item Code (Source)	NDC: 69329-253
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SAFFLOWER OIL (UNII: 65UEH262IS)
CETYL ALCOHOL (UNII: 936JST6JCN)
KUKUI NUT OIL (UNII: TP11QR7B8R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LEVOMENOL (UNII: 24WE03BX2T)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
TROLAMINE (UNII: 9O3K93S3TK)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
NIACINAMIDE (UNII: 25X51I8RD4)
GINGER (UNII: C5529G5JPQ)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PEG-100 STEARATE (UNII: YD01N1999R)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69329-253-02	118 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019125	12/10/2015

Labeler - Patchwerx Labs, Inc. (079584480)