Label: CLINICLEAN- chlorhexidine gluconate 4% solution

  • NDC Code(s): 0116-0901-05
  • Packager: Xttrium Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 19, 2023

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

    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 the 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 eardurms.
    • 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 healthcare 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 4 full pumps (6 grams) 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 4 full pumps(6 grams) of product and rinse under running water
    • dry thoroughly

    Healthcare personnel handwash:

    • wet hands with water
    • dispense 4 full pumps (6 grams) of product into cupped hands and wash in a vigrous 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 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST

  • Laudering/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.

  • Package Label

    NDC 69464-901-05

    REF 90604

    CliniClean

    Chlrohexidine Gluconate 4%

    Antiseptic/Antimicrobial Solution with Foaming Pump

    Surgical Hand Scrub, Heath Personnel Hand Wash, General Skin & Wound Cleanser

    Net Content: 4fl oz (118 mL)

    DYE FREE

    Manufactured for:

    HR Pharmaceuticals, Inc.

    York, PA 17402

    cliniclean.com

    Rev 4176 Rev 2

    (12/2023)

    4HRP04FMBTLLBLA

    HRP 4oz FM single

  • INGREDIENTS AND APPEARANCE
    CLINICLEAN 
    chlorhexidine gluconate 4% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-0901
    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
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    WATER (UNII: 059QF0KO0R)  
    TRIDECYL ALCOHOL (UNII: 8I9428H868)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0116-0901-05118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01912503/15/2023
    Labeler - Xttrium Laboratories, Inc. (007470579)
    Registrant - Xttrium Laboratories, Inc. (007470579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories, Inc007470579manufacture(0116-0901)