Label: BACTOSHIELD CHG- chlorhexidine gluconate solution 

  • NDC Code(s): 0519-1344-03, 0519-1344-06, 0519-1344-08, 0519-1344-21, view more
    0519-1344-24, 0519-1344-33, 0519-1344-34, 0519-1344-39
  • Packager: STERIS Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 08/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    chlorhexidine gluconate 4% solution

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  • Purposes

    surgical hand scrub
    healthcare personnel handwash
    patient preoperative skin preparation
    skin wound and general skin cleansing

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  • Uses

    • surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
    • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
    • patient preoperative skin preparation: preparation of the patient's skin prior to surgery
    • skin wound and general skin cleansing
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  • 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.

    Warning: This product contains a chemical known to the State of California to cause cancer.

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  • Directions

    • Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

    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
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  • Other information

    • store at 20-25°C (68-77°F)
    • void excessive heat above 40°C (104°F)
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  • Inactive ingredients

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

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  • Questions or comments?

    Call 1-800-548-4873 Monday through Friday 8:00 AM to 4:30 PM EST

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  • PRINCIPAL DISPLAY PANEL - 473mL Bottle Label

    Bactoshield ®
    CHG 4%

    Chlorhexidine Gluconate
    4% Solution Antiseptic

    NDC 0519-1344-34

    Surgical Scrub

    Surgical Scrub

    4% CHG

    Antimicrobial

    REORDER #
    1344-33

    STERIS®

    For Hospital and Professional Use Only.
    Net Contents: 473mL (16 fl oz) (1 pt)

    61340
    1344-31F(613)
    4BACT16BTLLBLC

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    Principal Display Panel - 473mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    BACTOSHIELD CHG 
    chlorhexidine gluconate solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0519-1344
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 40 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    COCO DIETHANOLAMIDE  
    GLUCONOLACTONE  
    HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%)  
    ISOPROPYL ALCOHOL  
    LAURAMINE OXIDE  
    PEG-75 LANOLIN  
    WATER  
    TRIDECYL ALCOHOL  
    Product Characteristics
    Color YELLOW Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0519-1344-06 4 in 1 CASE
    1 NDC:0519-1344-08 3780 mL in 1 BOTTLE
    2 NDC:0519-1344-21 12 in 1 CASE
    2 NDC:0519-1344-24 946 mL in 1 BOTTLE
    3 NDC:0519-1344-33 12 in 1 CASE
    3 NDC:0519-1344-34 473 mL in 1 BOTTLE
    4 NDC:0519-1344-39 48 in 1 CASE
    4 NDC:0519-1344-03 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA019125 10/04/1999
    Labeler - STERIS Corporation (139424188)
    Establishment
    Name Address ID/FEI Business Operations
    Xttrium Laboratories, Inc. 007470579 MANUFACTURE(0519-1344)
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