4% Dyna-hex, 18-oz

4% Dyna-hex, 18-oz
SPL v4
SPL
SPL Set ID 245c41e6-a0f6-0825-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2023-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (4 g)
Inactive Ingredients
Isopropyl Alcohol Lauramine Oxide Peg-75 Lanolin Water Tridecyl Alcohol Coco Diethanolamide Gluconolactone Hydroxyethyl Cellulose (140 Cps At 5%)

Identifiers & Packaging

Marketing Status
NDA Active Since 2016-01-01

Description

Chlorhexidine gluconate 4% solution

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Chlorhexidine gluconate 4% solution

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

Section 43683-2

Indications and Usage

Dosage and Administration

addition of "skin wounf and general skin cleansing (11/23)

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.

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

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

Do Not Use
  • if you are allergic to chlorhexidine gluconate or any other ingredient in this product
Active Ingredient

Chlorhexidine gluconate 4% solution

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

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.

Laundering/cleaning Instructions

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach. Rinse completely and use only non-chlorine detergents.

Package/label Principal Display Panel

NDC 0116-1060-18

DYNA-HEX 4®

Chlorhexidine Gluconate 4% Solution

Antiseptic

Contains: 4% Chlorhexidine Gluconate With foam pump

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

Net Contents: 18 fl oz (532 mL)

4DYN18BTLLBLB


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

Section 43683-2 (43683-2)

Indications and Usage

Dosage and Administration

addition of "skin wounf and general skin cleansing (11/23)

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.

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

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

Do Not Use (Do not use)
  • if you are allergic to chlorhexidine gluconate or any other ingredient in this product
Active Ingredient (Active ingredient)

Chlorhexidine gluconate 4% solution

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

When Using 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 (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.

Laundering/cleaning Instructions (Laundering/Cleaning Instructions)

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach. Rinse completely and use only non-chlorine detergents.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

NDC 0116-1060-18

DYNA-HEX 4®

Chlorhexidine Gluconate 4% Solution

Antiseptic

Contains: 4% Chlorhexidine Gluconate With foam pump

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

Net Contents: 18 fl oz (532 mL)

4DYN18BTLLBLB


Advanced Ingredient Data


Raw Label Data

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