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

----------

DYNA-HEX 15mL

Drug Facts

Active ingredient

Chlorhexidine gluconate 4% solution

Purpose

Antiseptic

Uses

Warnings

For external use only

Allergy alert:

This product may vause a severe allergic reaction. Symptoms may nclude:

If an allergic reaction occurs, stop use and seek medical help right away.

Do not use

When using this product

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occur. 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

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:

Helathcare personnel handwash:

Patient preoperative skin preparation:

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 through 4:30 PM CST

NDC 0116-1061-15

DYNA-HEX 4 ®

(CHlorhexidine Gluconate 4% Solution)

Antiseptic

Non-Sterile SOlution

Contains: 4% CHlorhexidine Gluconate

Distributed by: Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

FOR EXTERNAL USE ONLY

Net Contents: 50 Single-Use 0.5 fl oz (15-mL) Packettes

4DYN15PACKLBL

PDP Page 1

PDP Page 2PDP Page 3

PDP Page 4

PDP Page 5

PDP Page 6

Carton Page 1

Carton Page 2

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
TRIDECYL ALCOHOL (UNII: 8I9428H868)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
WATER (UNII: 059QF0KO0R)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0116-1061-1515 mL in 1 CARTON; Type 0: Not a Combination Product08/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912508/01/2018
Labeler - Xttrium Laboratories, Inc. (007470579)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc.007470579manufacture(0116-1061)

Revised: 6/2018
Document Id: 6e62eb50-ebab-361e-e053-2991aa0aba6f
Set id: 6e62eb50-ebaa-361e-e053-2991aa0aba6f
Version: 1
Effective Time: 20180611
 
Xttrium Laboratories, Inc.