4-oz Dyna-hex 2

4-oz Dyna-hex 2
SPL v5
SPL
SPL Set ID 6e5f9616-ddf5-19c4-e053-2991aa0a372a
Route
TOPICAL
Published
Effective Date 2023-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (2 g)
Inactive Ingredients
Hydroxyethyl Cellulose (2000 Mpa.s At 1%) Isopropyl Alcohol Citric Acid Monohydrate Coco Diethanolamide Lauramine Oxide Water

Identifiers & Packaging

Marketing Status
NDA Active Since 2014-01-01

Description

Drug Facts

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Drug Facts

Uses

  • 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 skin cleansing
Section 42229-5

Drug Facts

Section 43683-2

Directions and Uses updated

Section 51945-4

NDA 0116-1021-04

DYNA-HEX 2 ®

(Chlorhexidine Gluconate 2% Solution)

Antiseptic

Contains: 2% Chlorhexidine Gluconate

FOR EXTERNAL USE ONLY

For single-use

Net Contents: 4 fl oz (118 mL)

Distributed By:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

2BLDY04BTLLBLF

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 awau

Directions
  • use with care in premature infants under 2 months of age. These products may cause irritation or chemical burns.

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

Patient preoperative skin preparation:

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

Skin wound and general skin cleaning:

  • thoroughly rinse the area to be cleaned with water
  • appl 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
Active Ingredient

Chlorhexidine Gluconate 2% Solution

Other Information
  • store at 20-25ºC (68-77ºF)
  • avoid excessive heat above 40ºC (104ºF)
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

When Using This Product
  • keep out of eyes, ears, and mouth. May cause serious and permenent 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
  • 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


Structured Label Content

Uses

  • 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 skin cleansing
Section 42229-5 (42229-5)

Drug Facts

Section 43683-2 (43683-2)

Directions and Uses updated

Section 51945-4 (51945-4)

NDA 0116-1021-04

DYNA-HEX 2 ®

(Chlorhexidine Gluconate 2% Solution)

Antiseptic

Contains: 2% Chlorhexidine Gluconate

FOR EXTERNAL USE ONLY

For single-use

Net Contents: 4 fl oz (118 mL)

Distributed By:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

2BLDY04BTLLBLF

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 awau

Directions
  • use with care in premature infants under 2 months of age. These products may cause irritation or chemical burns.

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

Patient preoperative skin preparation:

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

Skin wound and general skin cleaning:

  • thoroughly rinse the area to be cleaned with water
  • appl 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
Active Ingredient (Active ingredient)

Chlorhexidine Gluconate 2% Solution

Other Information (Other information)
  • store at 20-25ºC (68-77ºF)
  • avoid excessive heat above 40ºC (104ºF)
Inactive Ingredients (Inactive ingredients)

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

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 permenent 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
  • 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 (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


Advanced Ingredient Data


Raw Label Data

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