BACTOSHIELD CHG- chlorhexidine gluconate solution 
Xttrium Laboratories, Inc.

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Bactoshield ® CHG 2%

Chlorhexidine Gluconate 2% Solution

Drug Facts

Active ingredient

chlorhexidine gluconate 2% solution

Purposes

surgical hand scrub
healthcare personnel handwash
patient preoperative skin preparation
skin wound and general skin cleansing

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

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
  • 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.

Directions

Surgical hand scrub:

Healthcare personnel handwash:

Patient preoperative skin preparation:

Skin wound and general skin cleansing:

Other information

Inactive ingredients

citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Questions or comments?

Call 1-800-548-4873 Monday through Friday 8:00 AM to 4:30 PM CST

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

Bactoshield ® CHG 2%

NDC 11084-814-03

Surgical Scrub

Chlorhexidine Gluconate 2% Solution Antiseptic

Non-sterile Solution

Surgical Scrub

2% CHG

Antimicrobial

For Single-Use

Net Contents: 118 mL (4 fl oz)

1322-52G(319)

REORDER #1322-39

61345

2BACT04BTLLBLE

2BACT04 PDP

2BACT04 DF1

2BACT04 DF2

2BACT04 DF3

Bactoshield® CHG 2%

NDC 11084-814-24

Surgical Scrub

2% Solution Antiseptic

Chlorhexidine Gluconate

Surgical Scrub

2% CHG

Antimicrobial

Net Contents: 32 fl oz (946 mL)

REORDER #1322-24

61335

1322-21J(319)

2BACT32BTLLBLJ

2BACT32

Bactoshield ® CHG 2%

NDC 11084-814-08

Surgical Scrub

Chlorhexidine Gluconate 2% Solution Antiseptic

Surgical Scrub

2% CHG

Antimicrobial

Net Contents: 128 fl oz (1Gal)(3.78 Liters)

1322-06G(319)

REORDER #1322-08

62662

2BACT1GLBLB

2BACT1G PDP

2BACT1G DF1

2BACT1G DF2

NDC 11084-814-41

Bactoshield CHG 2%

Chlorhexidine Gluconate 2% Solution

Antiseptic

Healthcare Personnel Handwash

REORDER #: 1322-87

Manufactured for:

Deb USA, Inc.

Charlotte, NC 28217

1-866-783-0422

www.debmed.com

Contents: 33.8 fl oz (1.05 qt) (1 Liter)

61707

1322-86K (319)

SDSNATBKLBLA

2BACTSDS F PDP

2BACTSDS F DF1

2BACTSDS F DF2

NDC 11084-814-41

SDSNATFTLBLA

2BACTSDS B PDP

BACTOSHIELD CHG 
chlorhexidine gluconate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-1322
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Coloryellow (Clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0116-1322-083708 mL in 1 BOTTLE; Type 0: Not a Combination Product10/04/1999
2NDC:0116-1322-24946 mL in 1 BOTTLE; Type 0: Not a Combination Product10/04/1999
3NDC:0116-1322-03118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/04/1999
4NDC:0116-1322-411000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/04/1999
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01942210/04/1999
Labeler - Xttrium Laboratories, Inc. (007470579)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc.007470579manufacture(0116-1322)

Revised: 11/2019
Document Id: 96a0e963-abba-d566-e053-2a95a90add49
Set id: 4a5483c2-10b7-0f08-e054-00144ff8d46c
Version: 7
Effective Time: 20191105
 
Xttrium Laboratories, Inc.