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Bactoshield

STERIS Corporation

Bactoshield CHG 4% Surgical Scrub


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient

Chlorhexidine gluconate 4% solution
Approximate volume 25mL

Purpose

Antiseptic

Bactoshield 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 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

Bactoshield 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

Bactoshield ® CHG 4%

Chlorhexidine Gluconate
4% Solution Antiseptic
Surgical Hand Scrub

NDC 0519-1364-09

Surgical Scrub

For Hospital and
Professional Use Only.

1 Brush-sponge
and Nail Cleaner

REORDER
1364-PX

Surgical Scrub
4% CHG
Antimicrobial

STERIS ®

1364-0D(913)

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.

Bactoshield

Bactoshield

CHLORHEXIDINE GLUCONATE SPONGE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0519-1364
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
chlorhexidine gluconate CHLORHEXIDINE 40 mg

Inactive Ingredients

Ingredient Name Strength
Coco Diethanolamide
GLUCONOLACTONE
ISOPROPYL ALCOHOL
LAURAMINE OXIDE
LANOLIN
water
TRIDECYL ALCOHOL

Product Characteristics

Color
YELLOW (PALE)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 25 in 1 APPLICATOR
2 NDC:0519-1364-09 1 in 1 PACKAGE
3 NDC:0519-1364-10 30 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019822 2003-03-27


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