Label: HIBICLENS FOR GEORGIA PACIFIC- chlorhexidine gluconate solution

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

Drug Label Information

Updated December 15, 2022

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

  • ACTIVE INGREDIENT

    Chlorhexidine gluconate solution 4% w/v

  • PURPOSE

    Antiseptic

  • Uses

    • antimicrobial skin cleanser helps reduce bacteria that potentially can cause disease
    • surgical hand scrub
    • healthcare personnel 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
  • 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
    • do not use routinely if you have wounds which involve more than the superficial layers of the skin
  • 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 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 5mL (8 pumps) of the product with a brush. Rinse thoroughly under running water. Repeat. Dry thoroughly.
    • healthcare personnel handwash. Wet hands with water. Dispense about 5mL (8 pumps) 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 ingredients

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

  • PRINCIPAL DISPLAY PANEL

    54622-575-73_Drug Facts and PDP

  • INGREDIENTS AND APPEARANCE
    HIBICLENS FOR GEORGIA PACIFIC 
    chlorhexidine gluconate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54622-575
    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)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    POLOXAMER 237 (UNII: JT3U72U71K)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54622-575-731200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01776803/01/2022
    Labeler - Georgia-Pacific Consumer Products LP (806142217)