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

DYNA-HEX 2 (CHLORHEXIDINE GLUCONATE) LIQUID [XTTRIUM LABORATORIES, INC.]
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NDC 0116-1021-01, 0116-1021-08, 0116-1021-16, 0116-1021-17, 0116-1021-32
Set ID 6cc89ac1-baef-40bb-85a3-d9ae9e3e7a63
Category HUMAN OTC DRUG LABEL
Packager Xttrium Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number NDA019422
  • 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 that 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.

  • 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 about 8 mL of product 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 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 seconds

    rinse and dry thoroughly

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

    citric add. 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 0116-1021-08

    Chlorhexidine Gluconate 2% Solution

    Antiseptic Foam Handwash

    Distributed by:

    Xttrium Laboratories, Inc.

    Mount Prospect, IL 60056

    2BLDY08BTLLBLB

    Dyna-Hex ®

    Net Wt 8 fl oz (237 mL)

    Dyna-Hex 8oz Page 1

    Dyna-Hex 8-oz Page 2

    Dyna-Hex 8-oz Page 3

    Dyna-Hex 8-oz Page 4

    NDC 0116-1021-85

    DYNA-HEX 2®

    ANTIMICROBIAL HAND SOAP

    Chlorhexidine Gluconate 2% Solution

    Antiseptic

    Contains: 2% Chlorhxidine Gluconate

    FOR EXTERNAL USE ONLY

    FDA approved formula

    Helps Reduce Bacteria

    Fragrance-Free

    Used by Healthcare personnel in hospitals

    Net Contents: 8.5 fl oz (251 mL)

    2DYN85FLBL

    2DYN85 Front

    2DYN85 DF1

    2DYN85 DF2

    2DYN85 DF3

    NDC 0116-1021-16

    Chlorhexidine Gluconate 2% Solution

    Antiseptic Foam Handwash

    Distributed by:

    Xttrium Laboratories, Inc.

    Mount Prospect, IL 60056

    2DYN16BTLLBLC

    Dyna-Hex ®

    Net Wt 16 fl oz (473 mL)

    Dyna-Hex 16-oz Page 1

    Dyna-Hex 16-oz Page 2

    Dyna-Hex 16-oz Page 3

    Dyna-Hex 16-oz Page 4

    NDC 0116-1021-17

    Chlorhexidine Gluconate 2% Solution

    Antiseptic Foam Handwash

    Distributed by:

    Xttrium Laboratories, Inc.

    Mount Prospect, IL 60056

    2BLDYNATLBLD

    Dyna-Hex ®

    Net Wt 16 fl oz (473 mL)

    Dyna-Hex 16-oz NAT Page 1

    Dyna-Hex 1-oz NAT Page 2

    Dyna-Hex NAT

    Dyna-Hex Page 4

    NDC 0116-1021-32

    Chlorhexidine Gluconate 2% Solution

    Antiseptic Foam Handwash

    Distributed by:

    Xttrium Laboratories, Inc.

    Mount Prospect, IL 60056

    2DYN32BTLLBLA

    Dyna-Hex ®

    Net Wt 32 fl oz (946 mL)

    PDP 32-oz Page 1

    PDP 32-oz Page 2

    PDP 32-oz Page 3

    NDC 0116-1021-01

    Chlorhexidine Gluconate 2% Solution

    Antiseptic Foam Handwash

    Distributed by:

    Xttrium Laboratories, Inc.

    Mount Prospect, IL 60056

    2DYN1GBTLLBLA

    Dyna-Hex ®

    Net Wt 128 fl oz (1 gal)

    PDP 1gal Page 1

    PDP 1gal Page 2

    PDP 1gal Page 3

  • INGREDIENTS AND APPEARANCE
    DYNA-HEX  2
    chlorhexidine gluconate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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 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:0116-1021-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2014
    2NDC:0116-1021-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2014
    3NDC:0116-1021-17473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2014
    4NDC:0116-1021-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2014
    5NDC:0116-1021-0115142 mL in 1 JUG; Type 0: Not a Combination Product01/01/2014
    6NDC:0116-1021-85250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01942201/01/2014
    Labeler - Xttrium Laboratories, Inc. (007470579)
    Registrant - Xttrium Laboratories, Inc. (007470579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories, Inc.007470579manufacture(0116-1021)

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