Label: MAXICLENS CHLORHEXIDINE GLUCONATE LIQUID SOLUTION, 4%- chlorhexidine gluconate solution

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

Drug Label Information

Updated February 28, 2023

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

  • ACTIVE INGREDIENT

    Active ingredient
    Chlorhexidine gluconate solution, 4%

  • PURPOSE

    Purposes

    Surgical hand scrub Healthcare personnel handwash Skin wound and general skin cleanser

  • 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: handwash to help reduce bacteria that potentially can cause disease
    • skin wound and general skin cleanser: helps reduce bacteria on the skin
  • 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

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

  • DO NOT USE

    Do not use

    • if you are allergic to chlorhexidine gluconate or any other ingredient in this preparation
    • as a patient preoperative skin preparation (especially on the head or face)
    • in contact with meninges
    • in the genital area
  • WHEN USING

    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 contact occurs, rinse with cold water right away
    • 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 an underlying condition makes it necessary to reduce the bacterial population of the skin
  • STOP USE

    Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs and lasts for 72 hours. 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 cause irritation or chemical burns.
    • use full strength
    • do not dilute

    Surgical hand scrub:

    • remove jewelry
    • wet hands and forearms with water and apply 5 mL of the product
    • wash/scrub hands and forearms for 3 minutes paying particular attention to the nails, cuticles, and interdigital spaces
    • rinse thoroughly with water
    • wash for an additional 3 minutes with 5 mL of the 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 30 seconds
    • rinse and dry thoroughly

    Skin wound and general skin cleanser:

    • thoroughly rinse the area to be cleansed with water
    • apply the minimum amount of product necessary to cover the skin or wound area and wash gently. Rinse thoroughly with water.
    • rinse again thoroughly
  • STORAGE AND HANDLING

    Other information

    • store between 20-25°C (68-77°F)
    • avoid excessive heat (above 104°F/40°C)
    • for additional information, see Safety Data Sheet (SDS)
    • if swallowed get medical help or contact a Poison Control Center immediately
  • INACTIVE INGREDIENT

    Inactive ingredients

    cocamide DEA, cocamine oxide, fragrance, gluconic acid*, gluconolactone*, hydroxyethyl cellulose, isopropyl alcohol 4%, PEG-75 lanolin, PEG-150 distearate, propylene glycol, quaternium-60, water

    *contains one or more of these ingredients

  • QUESTIONS

    Questions or comments?

    aCall 1-800-581-2528 Monday through Friday 8:00 AM to 5:00 PM EST

  • PRINCIPAL DISPLAY PANEL

    NDC 0404-0175-02

    Maxiclens TM

    Antiseptic Skin Cleanser

    (Chlorhexidine Gluconate 4%)

    FOR EXTERNAL USE ONLY

    Distributed By

    HENRY SCHEIN INC.

    135 Duryea Road

    Melville, NY 11747 USA

    Net Contents

    32 fl oz (1 qt)(946-mL)

    Made in U.S.A.

    Product Made in U.S.A.
    Keep from freezing.

    Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers
    will cause stains if used with chlorine releasing products, such as chlorine
    bleach. Rinse completely and use only non-chlorine detergents.

    bWARNING: 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

    1

  • INGREDIENTS AND APPEARANCE
    MAXICLENS CHLORHEXIDINE GLUCONATE LIQUID SOLUTION, 4% 
    chlorhexidine gluconate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0175
    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
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    QUATERNIUM-33 (UNII: XPS4174QZJ)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLUCONIC ACID (UNII: R4R8J0Q44B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-0175-02946 mL in 1 BOTTLE; Type 0: Not a Combination Product11/17/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01925811/17/2021
    Labeler - Henry Schein, Inc. (012430880)