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Dyna-Hex 4 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.

Active ingredient

Chlorhexidine gluconate 4% solution

Purpose

Antiseptic

Indications and Usage for Dyna-Hex 4


 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

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 are allergic to chlorhexidine gluconate or any other ingredient in 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

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 4 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 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

Storage and Handling

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

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

Questions or comments?

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

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.

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.

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
Dyna-Hex 32oz RND

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

32oz Dyna-Hex 4 SQ

DYNA-HEX 4
chlorhexidine gluconate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-1060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE4 g in 100 mL
Inactive Ingredients
Ingredient NameStrength
PEG-75 LANOLIN (UNII: 09179OX7TB)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
TRIDECYL ALCOHOL (UNII: 8I9428H868)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0116-1060-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/15/2023
2NDC:0116-1060-33946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/14/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912711/15/2023
Labeler - Xttrium Laboratories, Inc. (007470579)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc.007470579manufacture(0116-1060)