Home > Drugs A-Z > Bactoshield

Bactoshield (STERIS Corporation)

Available Formats

Dosage Form Package Information Links
SPONGE 1 APPLICATOR in 1 PACKAGE (0519-1364-09) > 25 mL in 1 APPLICATOR Label Information

Complete Bactoshield Information

  • SPL UNCLASSIFIED SECTION

    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 â–ª 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

  • INGREDIENTS AND APPEARANCE
    BACTOSHIELD 
    chlorhexidine gluconate sponge
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0519-1364
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 40 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color YELLOW (PALE) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0519-1364-11 10 in 1 CASE
    1 NDC:0519-1364-10 30 in 1 CARTON
    1 NDC:0519-1364-09 1 in 1 PACKAGE
    1 25 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    2 NDC:0519-1364-12 8 in 1 CASE
    2 NDC:0519-1364-10 30 in 1 CARTON
    2 NDC:0519-1364-09 1 in 1 PACKAGE
    2 25 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA019822 03/27/2003
    Labeler - STERIS Corporation (139424188)
    Establishment
    Name Address ID/FEI Business Operations
    Biomed Packaging Systems, Inc. 622463388 MANUFACTURE(0519-1364)