Label: 4% CHG SKIN CLEANSING KIT- kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Exempt device

Drug Label Information

Updated August 20, 2015

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

  • ACTIVE INGREDIENT

    Active ingredient

    Chlorhexidine Gluconate 4% Solution

  • Purposes

    surgical hand scrub

    healthcare personnel handwash

    patient preoperative skin preparation

    skin wound and general skin cleansing

  • Uses

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

    For external use only

  • DO NOT USE

    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

    When using this product

    • 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 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

    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

    Surgical hand scrub

    • wet hands and forearms under running water for 30 seconds
    • scrub for 3 minutes with about 5 mL of product with or without a wet brush, paying close attention to the nails, cuticles and interdigital spaces
    • rinse thoroughly 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
    • dry with a sterile towel
    • repeat procedure for an additional 2 minutes and dry with a sterile towel

    Skin wound and general 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 °C (68-77 °F)
    • avoid excessive heat above 40 °C (104 °F)
  • Inactive ingredients

    cocamide DEA, fragrance POFL 147, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    4% Chlorhexidine Gluconate, 128 oz

    82 286 Label

  • INGREDIENTS AND APPEARANCE
    4% CHG SKIN CLEANSING KIT 
    fiber, medical, absorbent kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NHRIC:52380-7001
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:52380-7001-01 in 1 KIT; Type 1: Convenience Kit of Co-Package
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1
    Part 21 BOTTLE 118 mL
    Part 1 of 2
    NON-COTTON CLEANSING WIPES 
    fiber, medical, absorbent
    Product Information
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    exempt deviceABC07/01/2014
    Part 2 of 2
    APLICARE ANTISEPTIC CHLORHEXIDINE GLUCONATE 
    chlorhexidine gluconate solution
    Product Information
    Item Code (Source)NDC:52380-1272
    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)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    WATER (UNII: 059QF0KO0R)  
    TRIDECYL ALCOHOL (UNII: 8I9428H868)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-1272-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01912509/01/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    exempt deviceABC07/01/2014
    Labeler - Aplicare, Inc. (058377631)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aplicare, Inc.058377631pack(52380-7001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium, Inc.007470579manufacture(52380-1272)