BACTOSHIELD- chlorhexidine gluconate sponge 
STERIS Corporation

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Bactoshield® CHG 4%
Chlorhexidine Gluconate 4% Solution Brush Sponge

Drug Facts

Active Ingredient

Chlorhexidine gluconate 4% solution
Approximate volume 25mL

Purpose

Antiseptic

Uses

  • surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Warnings

For external use only

Do not use

  • if you are allergic to chlorhexidine gluconate or any other ingredients in this product
  • as a patient preoperative skin preparation (especially of the head and face)
  • in contact with meninges
  • in the genital area

When using this product

  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter or allowed to remain
  • if contact occurs, rinse with cold water right away
  • 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 and lasts more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
  • open package
  • wet hands and forearms to the elbows with warm water
  • clean under nails with nail pick provided. Nails should be maintained with a 1 millimeter free edge
  • wet sponge and squeeze
  • wet sponge and squeeze to work up lather
  • scrub thoroughly for 3 minutes, paying particular attention to the nails, cuticles and interdigital spaces. Use the brush side to clean the and interdigital spaces between the fingers and the sponge side to scrub the hands and forearms
  • rinse thoroughly with warm water
  • scrub for an additional 3 minutes using the sponge side
  • discard brush-sponge
  • rinse hands and forearms thoroughly and dry with a sterile towel

Other information

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

Inactive Ingredients

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

Questions?

1-800-548-4873 (Monday to Friday 8 AM - 5 PM EST)

PRINCIPAL DISPLAY PANEL - 25 mL Applicator Package

NDC 0519-1364-09

Peel Open

BACTOSHIELD® CHG 4%

Chlorhexidine Gluconate 4% Solution
Surgical Hand Scrub

1 Brush-sponge and Nail Cleaner
1364-PX

STERIS®

1364-0C(1012) 51874

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

Lot No. & Expiration Date
embossed on upper peel flap
Product Made in U.S.A.

Principal Display Panel - 25 mL Applicator Package
BACTOSHIELD 
chlorhexidine gluconate sponge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0519-1364
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 
ISOPROPYL ALCOHOL 
LAURAMINE OXIDE 
LANOLIN 
WATER 
Product Characteristics
ColorYELLOW (PALE) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0519-1364-091 in 1 PACKAGE
125 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01982203/27/2003
Labeler - STERIS Corporation (139424188)
Establishment
NameAddressID/FEIBusiness Operations
Biomed Packaging Systems, Inc.622463388MANUFACTURE(0519-1364)

Revised: 3/2013
Document Id: ea6ea3ad-b663-41f9-b77c-642c5dbb8de0
Set id: ec19f244-662c-4643-8be0-6d96a0d07801
Version: 1
Effective Time: 20130318
 
STERIS Corporation