Label: ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate 4% solution

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

Drug Label Information

Updated November 9, 2023

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

  • Active ingredient

    Chlorhexidine gluconate 4% solution

  • Purpose

    Antiseptic

  • Uses

    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 ete 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 two months of age. These products may cause irritation or chemical burns.

    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?

    1-800-587-3721

  • OTHER SAFETY INFORMATION

    Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach.

    WARNING: CANCER - WWW.P65WARNINGS.CA.GOV

  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredient in Hibiclens®*

    NDC 11822-0891-2

    ANTISEPTIC/ANTIMICROBIAL

    SKIN CLEANSER

    CHLORHEXIDINE GLUCONATE

    4% SOLUTION

    dye free

    for external use only

    TAMPER-EVIDENT: DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING

    18 FL OZ (532 mL)

    4RA18FM1061LBLB

    18 FM Rite Aid

    *This product is not manufactured or distributed by Molnlycke Healthcare, owner of the registered trademark Hibiclens®.

    DISTRIBUTED BY: RITE AID, 200 NEWBERRY COMMONS
    ETTERS, PA 17319
    www.riteaid.com
    SATISFACTION GUARANTEE: If you’re not satisfied, we’ll happily refund your money.

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC SKIN CLEANSER 
    chlorhexidine gluconate 4% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0891
    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
    DIHYDROXYETHYL LAURAMINE OXIDE (UNII: JD265DM4U6)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0891-2532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/14/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01912504/14/2021
    Labeler - Rite Aid (014578892)
    Registrant - Xttrium Laboratories, Inc. (007470579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories, Inc007470579api manufacture(11822-0891)