Dyna-hex 2: 8.5oz, 16oz (other)

Dyna-hex 2: 8.5oz, 16oz (other)
SPL v10
SPL
SPL Set ID 6cc89ac1-baef-40bb-85a3-d9ae9e3e7a63
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
Citric Acid Monohydrate Coco Diethanolamide Hydroxyethyl Cellulose (2000 Mpa.s At 1%) Isopropyl Alcohol Lauramine Oxide Water

Identifiers & Packaging

Marketing Status
NDA Completed Since 2014-01-01 Until 2026-02-28

Description

Drug Facts

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Drug Facts

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 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Section 51945-4

DYNA-HEX 2®

NDC 0116-1021-08

Chlorhexidine Gluconate 2% Solution

Antiseptic Foam Handwash

Distributed by:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

2BLDY08BTLLBLC

Net Wt 8 fl oz (237 mL)

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

NDC 0116-1021-16

Dyna-Hex 2 ®

Chlorhexidine Gluconate 2% Solution

Antiseptic Foam Handwash

Distributed by:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

2DYN16BTLLBLD

Net Wt 16 fl oz (473 mL)

NDC 0116-1021-17

Dyna-Hex 2®

Chlorhexidine Gluconate 2% Solution

Antiseptic Foam Handwash

Distributed by:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

2BLDYNATLBLD

Net Wt 16 fl oz (473 mL)

NDC 0116-1021-32

Dyna-Hex 2®

Chlorhexidine Gluconate 2% Solution

Antiseptic Foam Handwash

Distributed by:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

2DYN32BTLLBLA

Net Wt 32 fl oz (946 mL)

NDC 0116-1021-01

Dyna-Hex 2®

Chlorhexidine Gluconate 2% Solution

Antiseptic Foam Handwash

Distributed by:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

2DYN1GBTLLBLB

Net Wt 128 fl oz (1 gal)

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 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

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
Active Ingredient

chlorhexidine gluconate 2% solution

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

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.


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 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Section 51945-4 (51945-4)

DYNA-HEX 2®

NDC 0116-1021-08

Chlorhexidine Gluconate 2% Solution

Antiseptic Foam Handwash

Distributed by:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

2BLDY08BTLLBLC

Net Wt 8 fl oz (237 mL)

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

NDC 0116-1021-16

Dyna-Hex 2 ®

Chlorhexidine Gluconate 2% Solution

Antiseptic Foam Handwash

Distributed by:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

2DYN16BTLLBLD

Net Wt 16 fl oz (473 mL)

NDC 0116-1021-17

Dyna-Hex 2®

Chlorhexidine Gluconate 2% Solution

Antiseptic Foam Handwash

Distributed by:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

2BLDYNATLBLD

Net Wt 16 fl oz (473 mL)

NDC 0116-1021-32

Dyna-Hex 2®

Chlorhexidine Gluconate 2% Solution

Antiseptic Foam Handwash

Distributed by:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

2DYN32BTLLBLA

Net Wt 32 fl oz (946 mL)

NDC 0116-1021-01

Dyna-Hex 2®

Chlorhexidine Gluconate 2% Solution

Antiseptic Foam Handwash

Distributed by:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

2DYN1GBTLLBLB

Net Wt 128 fl oz (1 gal)

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 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

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
Active Ingredient (Active ingredient)

chlorhexidine gluconate 2% 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)

citric add. 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 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 (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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