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Dyna-Hex 2 Prescribing Information

Package insert / product label
Generic name: chlorhexidine gluconate
Dosage form: topical liquid
Drug classes: Antiseptic and germicides, Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Feb 2, 2024.

Drug Facts

Active ingredient

chlorhexidine gluconate 2% solution

Purpose

Antiseptic

Indications and Usage for Dyna-Hex 2

  • 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.

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

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.

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.

Dyna-Hex 2 Dosage and Administration

  • 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

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

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)

Dyna-Hex 2 8oz single panel

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

2DYN85 Front

2DYN85 DF1

2DYN85 DF2

2DYN85 DF3

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)

Dyna-Hex 2 16oz single panel

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)

Nat 1

Nat 2

nat 3

nat 4

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)

PDP 32-oz Page 1

PDP 32-oz Page 2

PDP 32-oz Page 3

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)

Dyna-Hex 1 Gallon

DYNA-HEX 2
chlorhexidine gluconate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-1021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE2 g in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
WATER (UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0116-1021-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2014
2NDC:0116-1021-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2014
3NDC:0116-1021-17473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2014
4NDC:0116-1021-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2014
5NDC:0116-1021-0115142 mL in 1 JUG; Type 0: Not a Combination Product01/01/2014
6NDC:0116-1021-85250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01942201/01/2014
Labeler - Xttrium Laboratories, Inc. (007470579)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc.007470579manufacture(0116-1021)