Label: ANTISEPTIC SOLUTION- chlorhexidine gluconate 4% solution

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

Drug Label Information

Updated June 16, 2021

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

  • 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 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
    • as a preoperative skin preparation of the head or face
  • When using this product

    • keep out of the 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 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 seperate 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 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 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST

  • OTHER SAFETY INFORMATION

    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.

  • PRINCIPAL DISPLAY PANEL

    Micro-Guard® CHG Solution

    NDC 11701-172-52

    Chlorhexidine Gluconate 4% Solution Antiseptic

    4%

    CHG Solution

    Antiseptic

    Non-Sterile Solution

    For Single Use

    Manufactured for and Distributed by:

    Coloplast Corp, 1601 W River Rd N, Minneapolis, MN 55411 U.S.A.

    1-800-533-0464 www.coloplast.us Product #67770

    ©2021-05, Coloplast Corp. Micro-Guard is a registered trademark

    of Coloplast A/S. Made in the U.S.A.

    4 fl. oz. (118 mL)

    E21-1475

    4COL04BTLLBL

    4COL04 PDP

    4COL04 DF1

    4COL04 DF2

    4COL04 DF3

    4COL04 DF4

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC SOLUTION 
    chlorhexidine gluconate 4% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-172
    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
    TRIDECYL ALCOHOL (UNII: 8I9428H868)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    WATER (UNII: 059QF0KO0R)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11701-172-52118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01912507/01/2021
    Labeler - Coloplast Corp (110326675)
    Registrant - Xttrium Laboratories, Inc (007470579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories, Inc007470579manufacture(11701-172)