DYNA-HEX 2 (CHLORHEXIDINE GLUCONATE 2%) SOLUTION [XTTRIUM LABORATORIES, INC.]

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DYNA-HEX 2 (CHLORHEXIDINE GLUCONATE 2%) SOLUTION [XTTRIUM LABORATORIES, INC.]
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NDC 0116-1022-18
Set ID 36e6abcb-d792-3ef4-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Xttrium Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number NDA019422
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    chlorhexidine gluconate 2% 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
    • skin wound and general skin cleansing
  • Warnings

    For external use only

    Allergy alert:

    This product may cause a severe allergic reaction. Symptoms may include:

    • wheezing/difficulty breathing
    • shock
    • facial swelling
    • hives
    • rash

    If an allergic reaction occurs, stop use and seek medical help right away.

    Do not use

    • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
    • in contact with meninges
    • in the genital area
  • When using this product

    • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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 advised by a health care provider

    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 or 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 8 mL of product (6 full pumps) with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers
    • rinse thoroughly under running water for 30 seconds
    • wash for an additional 1.5 minutes with 8 mL of product (6 full pumps) and rinse under running water for 30 seconds
    • dry thoroughly

    Healthcare personnel handwash:

    • wet hands with water
    • dispense 5 mL of product (4 full pumps) into cupped hands and wash in a vigorous manner for 15 seconds
    • rinse and dry thoroughly

    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 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST

  • PRINCIPAL DISPLAY PANEL

    NDC 0116-1022-18

    DYNA-HEX 2®

    Chlorhexidine Gluconate 2% Solution

    Antiseptic

    Contains: 2% Chlorhexidine Gluconate With Foaming Pump

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

    FOR EXTERNAL USE ONLY

    Net Contents: 18 fl oz (532 mL)

    2DYN18BTLLBLA

    2DYN18 PDP

    2DYN18 DF1

    2DYN18 DF2

  • INGREDIENTS AND APPEARANCE
    DYNA-HEX 2 
    chlorhexidine gluconate 2% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-1022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0116-1022-18535 mL in 1 BOTTLE; Type 0: Not a Combination Product01/29/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01942201/29/2016
    Labeler - Xttrium Laboratories, Inc. (007470579)
    Registrant - Xttrium Laboratories, Inc. (007470579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories, Inc.007470579manufacture(0116-1022)
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