Label: HIBICLENS- chlorhexidine gluconate solution

  • NDC Code(s): 0234-0575-04, 0234-0575-08, 0234-0575-16, 0234-0575-32, view more
    0234-0575-91
  • Packager: Molnlycke Health Care
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 10, 2019

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

  • ACTIVE INGREDIENT

    Chlorhexidine gluconate solution 4.0% w/v

  • PURPOSE

    Antiseptic

  • Uses

    • antimicrobial skin cleanser helps to reduce bacteria that potentially can cause disease
    • for skin wound and general skin cleansing
    • surgical hand scrub
    • healthcare peronnel handwash
  • 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 eardrums
    • if contact occurs in any of these areas, rinse with cold water right away
    • wounds which involve more than the superficial layers of the skin should not be routinely treated
    • repeated general 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.
    • skin wound and general skin cleansing. Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of the product necessary to cover the skin or wound area and wash gently. Rinse thoroughly.
    • surgical hand scrub. Wet hands and forearms with water. Scrub for 3 minutes with about 5mL of the product with a brush. Rinse thoroughly under running water. Repeat. Dry thoroughly.
    • healthcare personnel handwash. Wet hand with water. Dispense about 5mL of the product into cupped hands and wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.
  • Other information

    • store between 20-25°C (68-77°F)
    • avoid excessive heat above 40°C (104°F)
  • INACTIVE INGREDIENT

    fragrance, gluconolactone, isopropyl alcohol 4% w/v, lauramine oxide, poloxamer 237, purified water and red 40

  • Questions?

    1-800-843-8497

  • PRINCIPAL DISPLAY PANEL

    Hibiclens_PDP_16ozHibiclens_PDP_1galHibiclens_PDP_32ozHibiclens_PDP_4ozHibiclens_PDP_8oz

  • INGREDIENTS AND APPEARANCE
    HIBICLENS 
    chlorhexidine gluconate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0234-0575
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE213 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLOXAMER 237 (UNII: JT3U72U71K)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0234-0575-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/17/1976
    2NDC:0234-0575-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product09/17/1976
    3NDC:0234-0575-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/17/1976
    4NDC:0234-0575-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product09/17/1976
    5NDC:0234-0575-913790 mL in 1 BOTTLE; Type 0: Not a Combination Product09/17/1976
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01776809/17/1976
    Labeler - Molnlycke Health Care (165301032)