BACTOSHIELD CHG- chlorhexidine gluconate solution 
STERIS Corporation

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Bactoshield CHG ®
Chlorhexidine Gluconate Solution

Drug Facts

Active ingredient

chlorhexidine gluconate 4% solution

Purposes

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

Uses

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

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 additional 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

Inactive ingredients

cocamide DEA, fragrance POFL 147, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 473mL Bottle Label

Bactoshield ®
CHG 4%

Chlorhexidine Gluconate
4% Solution Antiseptic

NDC 0519-1344-34

Surgical Scrub

Surgical Scrub

4% CHG

Antimicrobial

REORDER #
1344-33

STERIS®

For Hospital and Professional Use Only.
Net Contents: 473mL (16 fl oz) (1 pt)

61340
1344-31F(613)
4BACT16BTLLBLC

Peel Open
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Principal Display Panel - 473mL Bottle Label
BACTOSHIELD CHG 
chlorhexidine gluconate solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0519-1344
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
COCO DIETHANOLAMIDE 
GLUCONOLACTONE 
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) 
ISOPROPYL ALCOHOL 
LAURAMINE OXIDE 
PEG-75 LANOLIN 
WATER 
TRIDECYL ALCOHOL 
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0519-1344-064 in 1 CASE
1NDC:0519-1344-083780 mL in 1 BOTTLE
2NDC:0519-1344-2112 in 1 CASE
2NDC:0519-1344-24946 mL in 1 BOTTLE
3NDC:0519-1344-3312 in 1 CASE
3NDC:0519-1344-34473 mL in 1 BOTTLE
4NDC:0519-1344-3948 in 1 CASE
4NDC:0519-1344-03118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912510/04/1999
Labeler - STERIS Corporation (139424188)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc.007470579MANUFACTURE(0519-1344)

Revised: 8/2013
Document Id: 01ab5f17-2ccf-41d6-bd83-56c9a9b9f717
Set id: cd223ce2-b307-4202-ae89-dd96c78c5d57
Version: 4
Effective Time: 20130816
 
STERIS Corporation