ANTISEPTIC SKIN CLEANSER EXIDINE-2 CHG- chlorhexidine gluconate solution 
Xttrium Laboratories, Inc.

----------

Quality Choice 2%

Active ingredient

chlorhexidine gluconate 2% solution

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 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 placed or kept in the eye during surgical procedures 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
  • do not use routinely if you have wounds which involve more than the superficial layers of the skin

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.

Directions

Surgical hand scrub:

Healthcare personnel handwash:

Other information

Inactive ingredients

citric acid, 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

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products. Rinse completely and use only non-chlorine detergents.

Warning: This product can expose you too coconut oil diethanolamine condensate (cocamide diethanolamine), whichs is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

Package Label

NDC 63868-280-02

Chlorhexidine Gluconate 2% Solution

Antiseptic

Distributed by:

C,D,M,A,Inc.

Novi, MI 48376 USA

qualitychoice.com

2QC02BTLLBLB

Quality Choice ®

Net Wt 2 fl oz (60 mL)

PDP

Page 1

Page 2

Page 3

Page 4

Page 5

Page 6.

NDC 63868-280-08

QUALITY CHOICE

Antiseptic Skin Cleanser

Antiseptic/Antimicrobial Skin Cleaner

Chlorhexidine Gluconate 2% Solution

Reduces Bacteria on the Skin

FOR EXTERNAL USE ONLY

TRICLOSAN FREE

FDA APPROVED

8.5 fl oz (250 mL)

2QC85BTLLBLFB

2QC85 PDP

2QC85 DF1

2QC85 DF2

2QC85 DF3

ANTISEPTIC SKIN CLEANSER  EXIDINE-2 CHG
chlorhexidine gluconate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-2800
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0116-2800-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/201602/29/2020
2NDC:0116-2800-08250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01942207/01/2016
Labeler - Xttrium Laboratories, Inc. (007470579)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttirum Laboratories, Inc.007470579manufacture(0116-2800)

Revised: 10/2020
Document Id: b1bc2086-5f5f-29b5-e053-2995a90ad40f
Set id: 468ae2b4-b2b6-19d8-e054-00144ff88e88
Version: 14
Effective Time: 20201015
 
Xttrium Laboratories, Inc.