Label: ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate solution

  • NDC Code(s): 68599-5401-0, 68599-5401-1, 68599-5401-2, 68599-5401-3, view more
    68599-5401-4, 68599-5401-5, 68599-5401-6, 68599-5401-7, 68599-5401-8, 68599-5401-9
  • Packager: McKesson Medical-Surgical
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 13, 2024

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

View All Sections
  • Active ingredient

    Chlorhexidine gluconate 4% solution

  • Purpose

    Antiseptic

  • 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
  • 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 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 ifirritation, 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.

    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 information

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

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

  • Questions?

    General Questions? Call 1-800-777-4908

    Technical Support? Call 1-800-587-3721

  • Principal Display Panel - McKesson Antiseptic Skin Cleanser 4 fl oz Bottle Label

    NDC 68599-5401-2

    4%

    McKESSON

    AntisepticSkin Cleanser

    4% CHLORHEXIDINE GLUCONATE SOLUTION

    Reduces the number of microorganisms on the skin prior to surgery or patient care.

    4 fl oz
    (118 mL)

    DO NOT REUSE

    MFR # 16-CHG4CHG4

  • Principal Display Panel - McKesson Antiseptic Skin Cleanser 8 fl oz Bottle Label

    NDC 68599-5401-3

    4%

    McKESSON

    Antiseptic Skin Cleanser

    4% CHLORHEXIDINE GLUCONATE SOLUTION

    Reduces the number of microorganisms on the skin prior to surgery or patient care.

    8 fl oz
    (237 mL)

    MFR # 16-CHG8

    CHG8

  • Principal Display Panel - McKesson Antiseptic Skin Cleanser 16 fl oz Bottle Label

    NDC 68599-5401-4

    4%

    McKESSON

    Antiseptic Skin Cleanser

    4% CHLORHEXIDINE GLUCONATE SOLUTION

    Reduces the number of microorganisms on the skin prior to surgery or patient care.

    16 fl oz

    (473 mL)

    MFR # 16-CHG16

    CHG16

  • Principal Display Panel - McKesson Antiseptic Skin Cleanser 32 fl oz Bottle Label

    NDC 68599-5401-5

    4%

    McKESSON

    Antiseptic Skin Cleanser

    4% CHLORHEXIDINE GLUCONATE SOLUTION

    Reduces the number of microorganisms on the skin prior to surgery or patient care.

    32 fl oz
    (946 mL)

    MFR # 16-CHG3216-CHG32

  • Principal Display Panel - McKesson Antiseptic Skin Cleanser 1 gal Bottle Label

    NDC 68599-5401-6

    McKESSON

    Antiseptic Skin Cleanser

    4% CHLORHEXIDINE GLUCONATE SOLUTION

    Reduces the number of microorganisms on the skin prior to surgery or patient care.

    1 gal
    (3.8 L)

    MFR # 16-CHGGL

    CHGGL

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC SKIN CLEANSER 
    chlorhexidine gluconate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-5401
    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)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    WATER (UNII: 059QF0KO0R)  
    TRIDECYL ALCOHOL (UNII: 8I9428H868)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-5401-148 in 1 CASE06/01/2017
    1NDC:68599-5401-2118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68599-5401-724 in 1 CASE06/01/2017
    2NDC:68599-5401-3237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:68599-5401-812 in 1 CASE06/01/2017
    3NDC:68599-5401-4473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:68599-5401-912 in 1 CASE06/01/2017
    4NDC:68599-5401-5946 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:68599-5401-04 in 1 CASE06/01/2017
    5NDC:68599-5401-63800 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01912506/01/2017
    Labeler - McKesson Medical-Surgical (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    XTTRIUM LABORATORIES, INC.007470579manufacture(68599-5401)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!