Dyna-hex 32oz Round & Sqaure Bottle

Dyna-hex 32oz Round & Sqaure Bottle
SPL v3
SPL
SPL Set ID 0a32c299-f7ca-d15c-e063-6294a90af2c1
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
Peg-75 Lanolin Isopropyl Alcohol Gluconolactone Water Lauramine Oxide Tridecyl Alcohol Coco Diethanolamide

Identifiers & Packaging

Marketing Status
NDA Active Since 2023-11-15

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

Section 51727-6

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

Section 60561-8

To Install: Remove bottle cap and apply dispensing cap. Slide dispenser into bracket, inserting the open air inlet onto proper receptacle

Container is single use only. Discard when empty.

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 about 2.0 cubic inches 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

 scrub for an additional 3 minutes with 2.0 cubic inches of product and rinse under running water

 dry thoroughly

Healthcare personnel handwash:

 wet hands with water

 dispense about 1.5 cubic inches of product into cupped hands and wash in a vigorous manner for 15 seconds

 rinse and dry thoroughly

Do Not Use
  • if you or the patient 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)

Questions Or Comments?

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

Principle Display Panel

NDC 0116-1060-32

DYNA-HEX 4®

Chlorhexidine Gluconate 4% Solution

Antiseptic

Contains: 4% Chlorhexidine Gluconate

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

CHLORHEXIDINE GLUCONATE

Net Contents: 32 fl oz (1 qt) (946 mL)

4DYN32RNDLBL

NDC 0116-1060-33

DYNA-HEX 4®

Chlorhexidine Gluconate 4% Solution

Antiseptic

Contains: 4% Chlorhexidine Gluconate

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

CHLORHEXIDINE GLUCONATE

Net Contents: 32 fl oz (1 qt) (946 mL)

4DYN32SQLBL

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

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:

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.


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

Section 51727-6 (51727-6)

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

Section 60561-8 (60561-8)

To Install: Remove bottle cap and apply dispensing cap. Slide dispenser into bracket, inserting the open air inlet onto proper receptacle

Container is single use only. Discard when empty.

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 about 2.0 cubic inches 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

 scrub for an additional 3 minutes with 2.0 cubic inches of product and rinse under running water

 dry thoroughly

Healthcare personnel handwash:

 wet hands with water

 dispense about 1.5 cubic inches of product into cupped hands and wash in a vigorous manner for 15 seconds

 rinse and dry thoroughly

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

Chlorhexidine gluconate 4% solution

Other Information

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

Questions Or Comments? (Questions or comments?)

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

Principle Display Panel

NDC 0116-1060-32

DYNA-HEX 4®

Chlorhexidine Gluconate 4% Solution

Antiseptic

Contains: 4% Chlorhexidine Gluconate

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

CHLORHEXIDINE GLUCONATE

Net Contents: 32 fl oz (1 qt) (946 mL)

4DYN32RNDLBL

NDC 0116-1060-33

DYNA-HEX 4®

Chlorhexidine Gluconate 4% Solution

Antiseptic

Contains: 4% Chlorhexidine Gluconate

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

CHLORHEXIDINE GLUCONATE

Net Contents: 32 fl oz (1 qt) (946 mL)

4DYN32SQLBL

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

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:)

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.


Advanced Ingredient Data


Raw Label Data

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