Label: ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate 4% liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 25, 2021

If you are a healthcare professional or from the pharmaceutical industry 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 proir to surgery or patient care
    • healthcare personnel handwash: helkps 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:

    • wheexing/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
  • 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

    irritationm 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 about 15 seconds
    • rinse and dry thoroughly

    Skin wound and general skin cleansing:

    • thoroughly rinse the area to be cleaned with water
    • apply this 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 Instrucitons: 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

    NDC 11822-0116-5

    daylogic

    ADVANCED

    ANTIMICROBIAL

    handwash

    4% CHLORHEXIDINE GLUCONATE

    Antiseptic Solution

    Clinically Proven to Reduce Bacteria on the Skin

    FDA Approved Formula

    Used by Healthcare Professionals

    NO PHTHALATES

    NO TRICLOSAN

    DYE FREE

    4DAY08BTLLBL

    8 FL OZ (237 mL)

    DAY08 PDP

    4DAY08 DF1

    4DAY08 DF2

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC SKIN CLEANSER 
    chlorhexidine gluconate 4% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0116
    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)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    WATER (UNII: 059QF0KO0R)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    TRIDECYL ALCOHOL (UNII: 8I9428H868)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0116-5237 mL in 1 BOTTLE; Type 0: Not a Combination Product03/25/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01912503/25/2021
    Labeler - Rite Aid (014578892)
    Registrant - Xttrium Laboratories, Inc. (007470579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories, Inc007470579manufacture(11822-0116)