BACTOSHIELD- chlorhexidine gluconate sponge 
STERIS Corporation

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Bactoshield® CHG 4% Surgical Scrub

Drug Facts

Active Ingredient

Chlorhexidine gluconate 4% solution
Approximate volume 25mL

Purpose

Antiseptic

Uses

  • surgical hand scrub: significantly reduces the number of micro-organisms 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.

Warning

This product contains a chemical (cocamide DEA) 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.
  • 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 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 nails, cuticles 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 CST)

PRINCIPAL DISPLAY PANEL - 25 mL Applicator Package Label

Bactoshield ® CHG 4%

Chlorhexidine Gluconate
4% Solution Antiseptic
Surgical Hand Scrub

NDC 0519-1364-09

Surgical Scrub

1 Brush-sponge
and Nail Cleaner

REORDER #
1364 - PJ

Surgical Scrub
4% CHG
Antimicrobial

STERIS®

1364-0E(815)

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

51874
Lot No. & Expiration Date
Embossed on upper peel flap
Product Made in U.S.A.

Principal Display Panel - 25 mL Applicator Package Label
BACTOSHIELD 
chlorhexidine gluconate sponge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0519-1364
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
LANOLIN (UNII: 7EV65EAW6H)  
WATER (UNII: 059QF0KO0R)  
TRIDECYL ALCOHOL (UNII: 8I9428H868)  
Product Characteristics
ColorYELLOW (PALE) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0519-1364-1110 in 1 CASE03/27/200301/25/2019
1NDC:0519-1364-1030 in 1 CARTON
1NDC:0519-1364-091 in 1 PACKAGE
125 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2NDC:0519-1364-128 in 1 CASE03/27/200301/25/2019
2NDC:0519-1364-1030 in 1 CARTON
2NDC:0519-1364-091 in 1 PACKAGE
225 mL in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01982203/27/200301/25/2019
Labeler - STERIS Corporation (139424188)

Revised: 1/2019
 
STERIS Corporation