DYNA-HEX 4 (CHLORHEXIDINE GLUCONATE) LIQUID [XTTRIUM LABORATORIES, INC.]

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DYNA-HEX 4 (CHLORHEXIDINE GLUCONATE) LIQUID [XTTRIUM LABORATORIES, INC.]
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NDC 0116-1060-18
Set ID 245c41e6-a0f6-0825-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Xttrium Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number NDA019125
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  • 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

  • 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 are allergic to chlorhexidine gluconate or any other ingredient in this product

    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
    • do not use routinely if you have wounds which involve more than the superficial layers of the 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 or 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 3 full pumps (5 grams) of product and a wet brush paying close attention to the nails, cuticles, and interdigital spaces
    • a seperate nail cleaner may be used
    • rinse thoroughly
    • wash for an additional 3 minutes with 3 full pumps (5 grams) of product and rinse under running water
    • dry thoroughly

    Healthcare personnel handwash:

    • wet hands with water
    • dispense 3 full pumps (5 grams) of product into cupped hands and wash in a vigorous manner for 15 seconds
    • rinse and dry thoroughly

  • Other information

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

    cocamide DEA, fragrance, glucono-delta-lactone, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

  • Questions of Comments?

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

  • Package/Label Principal Display Panel

    NDC 0116-1060-18

    DYNA-HEX 4®

    Chlorhexidine Gluconate 4% Solution

    Antiseptic

    Contains: 4% Chlorhexidine Gluconate

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

    FOR EXTERNAL USE ONLY

    Net Contents: 18 fl oz (532 mL)

    4DYN18BTLLBLB

    4DYN18 PDP

    4DYN18 DF1

    4DYN18 DF2

  • INGREDIENTS AND APPEARANCE
    DYNA-HEX 4 
    chlorhexidine gluconate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-1060
    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
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    WATER (UNII: 059QF0KO0R)  
    TRIDECYL ALCOHOL (UNII: 8I9428H868)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0116-1060-18535 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01912501/01/2016
    Labeler - Xttrium Laboratories, Inc. (007470579)
    Registrant - Xttrium Laboratories, Inc. (007470579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories, Inc.007470579manufacture(0116-1060)
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