BACTOSHIELD CHG- chlorhexidine gluconate solution 
STERIS Corporation

----------

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

  • 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
  • patient preoperative skin preparation: preparation of the patient's skin prior to surgery
  • skin wound and general skin cleansing

Warnings

For external use only

Do not use

  • if you are allergic to chlorhexidine gluconate or any other ingredients
  • 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 the underlying condition makes it necessary to reduce the bacterial population 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.

Warning: This product contains a chemical known to the State of California to cause cancer.

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:
  • wet hands and forearms with water
  • scrub for 3 minutes with about 5 mL 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
  • wash for an additional 3 minutes with 5 ml of product and rinse under running water
  • dry thoroughly
    Healthcare personnel handwash:
  • wet hands with water
  • dispense about 5 ml of product into cupped hands and wash in a vigorous manner for 15 seconds
  • rinse and dry thoroughly
    Patient preoperative skin preparation:
  • apply product liberally to surgical site and swab for at least 2 minutes
  • dry with a sterile towel
  • repeat procedure for an addtional 2 minutes and dry with a sterile towel
    Skin wound and general skin cleansing:
  • thoroughly rinse the area to be cleaned with water
  • apply the minimum amount of product necessary to cover the skin or wound area and wash gently
  • rinse again thoroughly

Other information

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

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

PRINCIPAL DISPLAY PANEL - 1 Liter Bottle Label

Bactoshield®
CHG 2%

Chlorhexidine Gluconate
2% Solution Antiseptic

NDC 0519-1322-41

Healthcare Personnel
Handwash

 
Surgical Scrub
 
2% CHG
 
Antimicrobial

REORDER #
1322-87

For Hospital and Professional Use Only.
1 Liter SDS (33.8 fl oz) (1.05 qt)

STERIS®

61707
1322-86J(514)
SDSNATBTLLBLH

Peel Open
Here

Principal Display Panel - 1 Liter Bottle Label
BACTOSHIELD CHG 
chlorhexidine gluconate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0519-1322
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:0519-1322-064 in 1 CASE10/04/199911/30/2018
1NDC:0519-1322-083708 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0519-1322-2112 in 1 CASE10/04/199911/30/2018
2NDC:0519-1322-24946 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0519-1322-3948 in 1 CASE10/04/199911/30/2018
3NDC:0519-1322-03118 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0519-1322-8712 in 1 CASE10/04/199911/30/2018
4NDC:0519-1322-411000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01942210/04/199911/30/2018
Labeler - STERIS Corporation (139424188)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc.007470579MANUFACTURE(0519-1322)

Revised: 12/2018
 
STERIS Corporation