ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate solution 
Xttrium Laboratories, Inc.

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Dyna-Hex 4: 4oz FM, 8oz, 16oz, 18oz, 32oz, 1 Gallon

Active Ingredient

Chlorhexidine gluconate

Drug Facts

Purpose

Antiseptic

Uses

Warnings

For external use only

Allergy alert:

This product may cause a severe allergic reaction. Symptoms may include:

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

  • as a preoperative skin preparation of the head or face (only in 4-oz)

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
  • 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.

Do not use

When using this product

Stop use and ask 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.

Direction

Surgical hand scrub:

Healthcare personnel handwash:

Skin wound and general skin cleaning:

Other information

Inactive ingredients

 cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, 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

Package label and principal display panel

NDC 0116-1061-08

DYNA-HEX 4 ®

(Chlorhexidine Gluconate 4% Solution)

Antiseptic

Contains: 4% Chlorhexidine Gluconate

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

FOR EXTERNAL USE ONLY

Net Contents: 8 fl oz (237 mL)

4DY08BTLLBLF

4 Dyna-Hex 8oz Single Panel

NDC 0116-1061-16

DYNA-HEX 4 ®

(Chlorhexidine Gluconate 4% Solution)

Antiseptic

Contains: 4% Chlorhexidine Gluconate

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

FOR EXTERNAL USE ONLY

Net Contents: 16 fl oz (473 mL)

4DY16BTLLBLF

16oz Dyna-Hex 4 single panel

NDC 0116-1061-32

DYNA-HEX 4 ®

(Chlorhexidine Gluconate 4% Solution)

Antiseptic

Contains: 4% Chlorhexidine Gluconate

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

FOR EXTERNAL USE ONLY

Net Contents: 32 fl oz (946 mL)

4DY32BTLLBLB

Dyna-Hex 4 32oz

NDC 0116-1061-01

DYNA-HEX 4 ®

(Chlorhexidine Gluconate 4% Solution)

Antiseptic

Contains: 4% Chlorhexidine Gluconate

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

FOR EXTERNAL USE ONLY

Net Contents: 128 fl oz (1 gal)

4DYN1GBTLLBLC

1 Gallon Dyna-Hex 4

NDC 0116-1061-40

DYNA-HEX 4®

Chlorhexidine Gluconate 4% Solution

Antiseptic

Contains:

4% Chlorhexidine Gluconate With foam pump

Distributed By:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

FOR EXTERNAL USE ONLY

Net Contents: 4 fl oz (118mL)

4DY04FM1061LBLB

4oz FM Dyna-Hex 4

NDC 0116-1061-18

DYNA-HEX 4®

Chlorhexidine Gluconate 4% Solution

Antiseptic

Contains:

4% Chlorhexidine Gluconate

Distributed By:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

FOR EXTERNAL USE ONLY

Net Contents: 18 fl oz (532mL)

4DY18FM1061LBLB

18oz Dyna-Hex 4 single panel

ANTISEPTIC SKIN CLEANSER 
chlorhexidine gluconate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-1061
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
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
WATER (UNII: 059QF0KO0R)  
TRIDECYL ALCOHOL (UNII: 8I9428H868)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0116-1061-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2011
2NDC:0116-1061-16437 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2011
3NDC:0116-1061-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2011
4NDC:0116-1061-0115142 mL in 1 JUG; Type 0: Not a Combination Product08/31/2011
5NDC:0116-1061-40118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
6NDC:0116-1061-18532 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912508/31/2011
Labeler - Xttrium Laboratories, Inc. (007470579)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc.007470579manufacture(0116-1061)

Revised: 12/2023
Document Id: 0c7ae60a-7f0c-45d0-e063-6394a90a9032
Set id: 9f6342f7-faa3-4d23-a860-054d04cb8d42
Version: 8
Effective Time: 20231214
 
Xttrium Laboratories, Inc.