Label: BACTOSHIELD CHG- chlorhexidine gluconate solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 6, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    chlorhexidine gluconate 4% solution

  • Purposes

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

  • 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
  • Warnings

    For external use only

    Allergy alert:

    This product may cause a sever allergic reaction. Symptoms may include:

    • wheezing/difficulty breathing
    • shock
    • facial swelling
    • hives
    • rash

    If an allergic reaction occurs, stop use and seek medical help right away.

    Do not use

    • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
    • 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 deadness when instilled in the middle ear through perforated eardrums.
    • if solution should contact these areas, rinse out prompty 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 advised by a health care provider

    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.

  • 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
  • Other information

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

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

  • Questions or comments?

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

  • OTHER SAFETY INFORMATION

    WARNING: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.

  • PRINCIPAL DISPLAY PANEL

    Bactoshield ® CHG 4%

    NDC 11084-815-03

    Surgical Scrub

    Chlorhexidine Cluconate 4% Solution Antiseptic

    Non-sterile Solution

    Surgical Scrub

    4% CHG

    Antimicrobial

    For Single-Use

    Net Contents: 118 mL (4 fl oz)

    REORDER #1344-39

    1344-52F(319)

    61346

    4BACT04BTLLBLD

    4BACT04 PDP

    4BACT04 DF1

    4BACT04 DF2

    4BACT04 DF3

    Bactoshield ® CHG 4%

    NDC 11084-815-34

    Surgical Scrub

    Chlorhexidine Gluconate 4% Solution Antiseptic

    Surgical Scrub

    4% CHG

    Antimicrobial

    Net Contents: 473mL (16 fl oz) (1 pt)

    REORDER #1344-33

    61340

    1344-31H(319)

    4BACT16BTLLBLE

    4BACT16 PDP

    4BACT16 DF1

    4BACT16 DF2

    4BACT16 DF3

    Bactoshield ® CHG 4%

    NDC 11084-815-24

    Surgical Scrub

    4% Solution Antiseptic Chlorhexidine Gluconate

    Surgical Scrub

    4% CHG

    Antimicrobial

    Net Contents: 32 fl oz (946 mL)

    REORDER #1344-24

    61341

    1344-21H(319)

    4BACT32BTLLBLB

    4BACT32

    Bactoshield ® CHG 4%

    NDC 11084-815-08

    Surgical Scrub

    Chlorhexidine Gluconate 4% Solution Antiseptic

    Surgical Scrub

    4% CHG

    Antimicrobial

    Net Contents: 128 fl oz (1 Gal) (3.78 Liters)

    REORDER #1344-08

    1344-06G(319)

    51690

    4BACT1GLBLB

    4BACT1G PDP

    4BACT1G DF1

    4BACT1G DF2

  • INGREDIENTS AND APPEARANCE
    BACTOSHIELD CHG 
    chlorhexidine gluconate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-1344
    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)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    WATER (UNII: 059QF0KO0R)  
    TRIDECYL ALCOHOL (UNII: 8I9428H868)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0116-1344-083780 mL in 1 BOTTLE; Type 0: Not a Combination Product10/04/1999
    2NDC:0116-1344-24946 mL in 1 BOTTLE; Type 0: Not a Combination Product10/04/1999
    3NDC:0116-1344-34473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/04/1999
    4NDC:0116-1344-03118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/04/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01912510/04/1999
    Labeler - Xttrium Laboratories, Inc. (007470579)
    Registrant - Xttrium Laboratories, Inc. (007470579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories, Inc.007470579manufacture(0116-1344)
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