DYNA-HEX 2 (CHLORHEXIDINE GLUCONATE) LIQUID [TEAM TECHNOLOGIES, INC]

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DYNA-HEX 2 (CHLORHEXIDINE GLUCONATE) LIQUID [TEAM TECHNOLOGIES, INC]
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NDC 67659-901-98
Set ID 3ad6fa05-81e7-4055-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Team Technologies, Inc
Generic Name
Product Class
Product Number
Application Number NDA019422
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  • ACTIVE INGREDIENT

     Chlorhexidine gluconate 2% Solution

  • Purposes

    surgical hand scrub
    healthcare personnel handwash
    patient operative skin preparation
    skin wound and general skin cleansing

  • 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: preparation of the patient's skin prior to surgery
    • skin wound and general 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
    • wound which involve more than the superficial layers of 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 the skin

    Stop use and ask a doctor

    if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious conditions.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Direction

    • 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 under running water for 30 seconds. Clean fingernails using a nailstick or similar cleaner.
    • scrub for 1.5 minutes with about 8 ml of product with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers
    • rinse throughly under running water for 30 seconds
    • wash for an additional 1.5 minutes with 8 ml of product and rinse under running water for 30 seconds
    • 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 minutes
    • dry with sterile towel
    • repeat procedure for an additional 2 minutes and dry with sterile towel

    Patient preoperative skin preparation:

    • apply product liberally to surgical site and swab for at least 2 minutes
    • dry with sterile towel
    • repeat procecedure for an additional 2 minutes and dry with sterile towel

    Skin wound and general skin cleansing:

    • 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 20-25 C (68-77 F)
    • avoid excessive heat above 40 C (104 F)
  • Inactive ingredients

    citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

  • Questions or comments?

     Call 1-800-587-3271 Monday through Friday 8:00 AM to 4:30 PM

  • Package Label

    NDC 0116-1021-04

    DYNA-HEX 2 ®

    (Chlorhexidine Gluconate 2% Solution)

    Antispeptic

    Contains:  2% Chlorhexidine Gluconate

    Distributed By: Xttrium Laboratories, Inc., Mount Prospect, IL 60056

    For External Use Only.

    Net Contents: 4 fl OZ (118 mL)

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  • INGREDIENTS AND APPEARANCE
    DYNA-HEX  2
    chlorhexidine gluconate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67659-901(NDC:0116-1021)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67659-901-98118 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package08/24/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01942201/01/2014
    Labeler - Team Technologies, Inc (192339703)
    Registrant - Team Technologies, Inc (192339703)
    Establishment
    NameAddressID/FEIBusiness Operations
    Team Technologies, Inc079527756repack(67659-901) , relabel(67659-901)
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