Label: DERMACINRX SURGICAL COMBOPAK- chlorhexidine gluconate surgical combo kit kit

  • NDC Code(s): 0116-1061-08, 59088-333-08, 59088-334-00
  • Packager: PureTek Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 11, 2023

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  • 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 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.

    • 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%

  • PURPOSE

  • 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.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    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)