Label: BACTOSHIELD CHG CHLORHEXIDINE GLUCONATE SOLUTION- chlorhexidine gluconate solution

  • NDC Code(s): 11084-815-03, 11084-815-08, 11084-815-24, 11084-815-34
  • Packager: Deb USA, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 4, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Chlorhexidine gluconate 4% solution

  • Purposes

    surgical hand scrub
    healthcare personnel handwash
    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
    • skin wound and general skin cleansing
  • Warnings

    For external use only

    Allergy alert

    This product may cause a severe 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

    When using this product

    • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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 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

    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)
    • avoid 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 1-866-783-0422 Monday through Friday 8:00 AM to 4:30 PM EST

  • Warning

    This product contains a chemical (cocamide DEA) known in the State of California to cause cancer.

  • PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

    Bactoshield ®
    CHG 4%

    deb med®

    NDC 11084-815-24

    Surgical Scrub

    4% Solution Antiseptic
    Chlorhexidine Gluconate

    Surgical Scrub

    4% CHG

    Antimicrobial

    REORDER #
    1344 - 24

    Net Contents: 946mL (32 fl oz)

    61341
    1344-21H(218)
    4BACT32BTLLBLA

    PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    BACTOSHIELD CHG  CHLORHEXIDINE GLUCONATE SOLUTION
    chlorhexidine gluconate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-815
    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:11084-815-083780 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2018
    2NDC:11084-815-24946 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2018
    3NDC:11084-815-34473 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2018
    4NDC:11084-815-03118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01912502/01/2018
    Labeler - Deb USA, Inc. (607378015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories, Inc.007470579MANUFACTURE(11084-815)