Label: ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate liquid

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

Drug Label Information

Updated November 2, 2023

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

  • Drug Facts

  • 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 meninges
    • in the genital area
  • When using this product

    • keep out of eyes, ears and mouth. May cause serious and permenant eye injury if permitted to enter and remain in the eye 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 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 of chemical burns.

    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 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 ºC (68-77ºF)
    • avoid excessive heat about 40ºC (104ºF)

  • Inactive ingredients

    cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

  • Questions?

    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.

    *This product is not manufactured or districuted by Regent Medical Limited (United Kingdom Corp.), owner of the registered trademark Hibiclens ®.

    WARNING: Cancer - www.P65Warnings.ca.gov

  • PDP

    NDC 70000-0407-1

    Leader

    Antisptic Skin Cleanser

    Chlorhexidine Gluconate 4% Solution

    Antiseptic/Antimicrobial Skin Cleanser

    Great For Hand Hygiene

    For Skin Wound and General Skin Cleansing

    Compare To Hibiclens® active ingredients*

    For External Use Only

    8 fl (237 mL)

    Tampering evident:

    Do not use if shrink seal neackband is broken or missing

    CIN 5454889 REV. 8/23

    Leader 8oz

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC SKIN CLEANSER 
    chlorhexidine gluconate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0407
    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
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    TRIDECYL ALCOHOL (UNII: 8I9428H868)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0407-1237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01912501/01/2012
    Labeler - Cardinal Health (063997360)
    Registrant - Xttrium Laboratories, Inc (007470579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories, Inc007470579manufacture(70000-0407)