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.

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DermacinRx Surgical ComboPak

PART 1: Chlorhexidine Gluconate

Drug Facts

Active ingredient

Chlorhexidine Gluconate 4% solution

Purpose

Antiseptic

Uses

Warnings

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.

Directions

use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns.

Other information

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.

image description

DERMACINRX SURGICAL COMBOPAK 
chlorhexidine gluconate surgical combo kit kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-334
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-334-001 in 1 PACKAGE; Type 0: Not a Combination Product04/28/2015
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 237 mL
Part 21 TUBE 118 mL
Part 1 of 2
ANTISEPTIC SKIN CLEANSER 
chlorhexidine gluconate solution
Product Information
Item Code (Source)NDC:0116-1061
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0116-1061-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA019125
Part 2 of 2
SKIN REPAIR COMPLEX 
dimethicone cream
Product Information
Item Code (Source)NDC:59088-333
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
KUKUI NUT OIL (UNII: TP11QR7B8R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
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 SEED OLEOSOMES (UNII: 9S60Q72309)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
GINGER (UNII: C5529G5JPQ)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-333-08118 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart347
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/28/2015
Labeler - PureTek Corporation (785961046)
Registrant - PureTek Corporation (785961046)
Establishment
NameAddressID/FEIBusiness Operations
PureTek Corporation785961046pack(59088-334) , manufacture(59088-333)

Revised: 1/2023
Document Id: f204d934-e915-49e2-e053-2995a90a2383
Set id: 7aff8c66-e758-438a-872d-804a35bb372a
Version: 7
Effective Time: 20230111
 
PureTek Corporation