Dyna-hex 4: 4oz Fm, 8oz, 16oz, 32oz, 1 Gallon

Dyna-hex 4: 4oz Fm, 8oz, 16oz, 32oz, 1 Gallon
SPL v10
SPL
SPL Set ID 9f6342f7-faa3-4d23-a860-054d04cb8d42
Route
TOPICAL
Published
Effective Date 2023-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (4 g)
Inactive Ingredients
Hydroxyethyl Cellulose (2000 Cps At 1%) Isopropyl Alcohol Lauramine Oxide Water Tridecyl Alcohol Gluconolactone Peg-75 Lanolin Coco Diethanolamide

Identifiers & Packaging

Marketing Status
NDA Active Since 2011-08-31 Until 2026-08-31

Description

Chlorhexidine gluconate

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Chlorhexidine gluconate

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.

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 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

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
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

  • as a preoperative skin preparation of the head or face (only in 4-oz)

Active Ingredient

Chlorhexidine gluconate

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

Questions Or Comments?

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

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 Doctor If

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

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.

Keep Out of Reach of Children.

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

Package Label and Principal Display Panel

NDC 0116-1061-08

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: 8 fl oz (237 mL)

4DY08BTLLBLF

NDC 0116-1061-16

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: 16 fl oz (473 mL)

4DY16BTLLBLF

NDC 0116-1061-32

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: 32 fl oz (946 mL)

4DY32BTLLBLB

NDC 0116-1061-01

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: 128 fl oz (1 gal)

4DYN1GBTLLBLC

NDC 0116-1061-40

DYNA-HEX 4®

Chlorhexidine Gluconate 4% Solution

Antiseptic

Contains:

4% Chlorhexidine Gluconate With foam pump

Distributed By:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

FOR EXTERNAL USE ONLY

Net Contents: 4 fl oz (118mL)

4DY04FM1061LBLB

NDC 0116-1061-18

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 (532mL)

4DY18FM1061LBLB


Structured Label Content

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
Purpose

Antiseptic

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.

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 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

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
Do Not Use (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

  • as a preoperative skin preparation of the head or face (only in 4-oz)

Active Ingredient

Chlorhexidine gluconate

Other Information (Other information)
  • store at 20-25ºC (68-77ºF)

  • avoid excessive heat above 40ºC (104ºF)
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

When Using This Product (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 Doctor If (Stop use and ask doctor if)

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

Stop Use and Ask A Doctor If (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 (Keep out of reach of children)

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

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Package Label and Principal Display Panel (Package label and principal display panel)

NDC 0116-1061-08

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: 8 fl oz (237 mL)

4DY08BTLLBLF

NDC 0116-1061-16

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: 16 fl oz (473 mL)

4DY16BTLLBLF

NDC 0116-1061-32

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: 32 fl oz (946 mL)

4DY32BTLLBLB

NDC 0116-1061-01

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: 128 fl oz (1 gal)

4DYN1GBTLLBLC

NDC 0116-1061-40

DYNA-HEX 4®

Chlorhexidine Gluconate 4% Solution

Antiseptic

Contains:

4% Chlorhexidine Gluconate With foam pump

Distributed By:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

FOR EXTERNAL USE ONLY

Net Contents: 4 fl oz (118mL)

4DY04FM1061LBLB

NDC 0116-1061-18

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 (532mL)

4DY18FM1061LBLB


Advanced Ingredient Data


Raw Label Data

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