Label: APLICARE CHLORHEXIDINE GLUCONATE 2% SOLUTION- chlorhexidine gluconate solution

  • NDC Code(s): 52380-1919-4
  • Packager: Aplicare Products, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 27, 2020

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

  • ACTIVE INGREDIENT

    Active ingredient

    Chlorhexidine Gluconate 2% solution

  • Purpose

    Antiseptic

  • Uses

    • surgical hand scrub: si8gnificantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
    • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
    • patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery
    • skin wound general skin cleansing
  • WARNINGS

    Warnings



    For external use only

    Do not use

    • if you are allergic to chlorhexidine gluconate or any other ingredients
    • in contact with meninges
    • in the genital area
    • as a preoperative skin preparation of the head or face

    When using this product

    • single use when used for patient preoperative skin preparation
    • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated ear drums
    • 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 the underlying condition makes it necessary to reduce the bacterial population 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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    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 under running water for 30 seconds. Clean fingernails using a nail stick or similar cleaner.
    • scrub for 1.5 minutes with about 8 mL of product with or without a wet brush paying close attention to the nails, cuticles and skin between the fingers.
    • rinse thoroughly under running water for 30 seconds
    • wash for an additional 1.5 minutes with 8 mL of product and rinse under running water for 30 seconds
    • 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 15 seconds
    • rinse and dry thoroughly

    Patient preoperative skin preparation

    • apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel
    • repeat procedure for an additional 2 minutes and dry with a sterile towel

    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 deg C (68-77 deg F)
    • avoid excessive heat above 40 deg C (104 deg F)
  • Inactive ingredients

    citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

  • QUESTIONS

    Questions or comments?

    1-800-760-3236 (Mon.-Fri. 8:30AM - 5:00 PM EST)

  • PRINCIPAL DISPLAY PANEL

    Aplicare

    CHLORHEXIDINE GLUCONATE 2% SOLUTION

    ANTISEPTIC

    L919-0914

  • INGREDIENTS AND APPEARANCE
    APLICARE CHLORHEXIDINE GLUCONATE 2% SOLUTION 
    chlorhexidine gluconate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-1919
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-1919-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/199807/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01942209/01/199807/01/2021
    Labeler - Aplicare Products, LLC. (081054904)