BACTOSHIELD CHG - chlorhexidine gluconate solution 
STERIS Corporation

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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.

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

Manufactured For:
STERIS Corporation
7501 Page Avenue
St. Louis, MO 63133 USA

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 0519-1344-34

BACTOSHIELD® CHG 4%

Chlorhexidine Gluconate 4% Solution
Antiseptic

Net Contents: 473 mL (16 fl oz) (1 pt)
1344-33

Drug Facts

Active ingredient
chlorhexidine gluconate 4% solution

Open Label

STERIS®

Manufactured For:
STERIS Corporation
7501 Page Avenue
St. Louis, MO 63133 USA
800-548-4873 www.steris.com

1344-31D(804)
61340

LIFT HERE

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

BACTOSHIELD CHG 
chlorhexidine gluconate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0519-1344
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE4 mL  in 100 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 DescriptionMultilevel Packaging
1NDC:0519-1344-083780 mL in 1 BOTTLENone
2NDC:0519-1344-24946 mL in 1 BOTTLENone
3NDC:0519-1344-34473 mL in 1 BOTTLENone
4NDC:0519-1344-03118 mL in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912510/04/1999

Labeler - STERIS Corporation (139424188)
Establishment
NameAddressID/FEIOperations
Xttrium Laboratories, Inc.005140611MANUFACTURE

Revised: 04/2012 STERIS Corporation