Label: CHLORHEXIDINE GLUCONATE- antiseptic skin cleanser gel

  • NDC Code(s): 68599-5400-1, 68599-5400-2, 68599-5400-3
  • Packager: McKesson
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 12, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient
    Chlorhexidine gluconate 4% solution

  • PURPOSE

    Purpose
    Antiseptic

  • INDICATIONS & USAGE

    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: for the preparation of the patient's skin prior to surgery skin wound and general skin cleansing
    • Skin wound and general skin cleansing
  • WARNINGS

    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

    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.

  • STOP USE

    If an allergic reaction occurs, stop use and seek medical help right away.
    Do not use

    • if you are allergic to chlorhexidine gluconate or any other ingredients 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 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 doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • use with care in premature infants or infants under 2 months of age. These products may causeirritation or chemical burns.

    Surgical hand s crub:

    • 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 and dry with a sterile towel
    • repeat procedure for an additional 2 minutes and dry with a sterile towel

    Skin wound and general skin cleaning:

    • 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 SAFETY INFORMATION

    Other information

    • store at 68-77ºF (20-25°C)
    • avoid excessive heat above 104°F (40°C)
  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Questions?
    General Questions? Call 1-800-777-4908
    Technical Support? Call 1-800-587-3721

  • PRINCIPAL DISPLAY PANEL

    NDC 68599-5400-2
    McKesson
    Antiseptic Skin Cleanser
    4% CHLORHEXIDINE GLUCONATE SOLUTION
    A non-sterile solution that reduces the number of
    microorganisms on the skin prior to surgery or patient care.
    0.5 fl oz
    (15 mL)
    50
    PER BOX
    FOR SINGLE-USE
    MFR # 16-CHG15

    16-CHG15

  • INGREDIENTS AND APPEARANCE
    CHLORHEXIDINE GLUCONATE 
    antiseptic skin cleanser gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-5400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    TRIDECYL ALCOHOL (UNII: 8I9428H868)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-5400-310 in 1 CASE03/12/2018
    1NDC:68599-5400-250 in 1 BOX
    1NDC:68599-5400-115 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01912503/12/2018
    Labeler - McKesson (023904428)