Label: SCRUB, SCRUB-STAT, FOAM SAFE, MICRO-GUARD- chlorhexidine gluconate solution

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

Drug Label Information

Updated December 26, 2022

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  • Active ingredient

    Chlorhexidine gluconate, 2%

  • Purpose

    Surgical hand scrub

    Healthcare personnel handwash

    Skin wound and general skin cleanser

  • 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
    • skin wound and general cleanser: helps reduce bacteria on the skin
  • 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 are allergic to chlorhexidine gluconate or any other ingredients in this preparation
    • as a properative skin preparation (especially on the head or face)
    • in contact with meninges
    • in the genital area

    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 during surgical procedures or may cause deafness when instilled in the middle ear through perforated ear drums.
    • if contact occurs, rinse with cold water right away
    • 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 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 and lasts for 72 hours. 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 product may cause irritation or chemical burns.
    • use full strength
    • do not dilute

    Surgical hand scrub

    • remove jewelry
    • wet hands and forearms with water and apply 5 mL of the product
    • wash/scrub hands and forearms for 3 minutes paying particular attention to the nails, cuticles, and interdigital spaces
    • rinse thoroughly with water
    • washfor an additional 3 minutes with 5 mL of the product and rinse under running water
    • 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 30 seconds
    • rinse and dry thoroughly

    Skin wound and general skin cleanser

    • thoroughly rinse the area to be cleansed with water
    • apply the minimum amount of product necessary to cover the skin or wound area and wash gently. Rinse thoroughly with water.
    • rinse again thoroughly
  • Other information

    • store between 20-25 °C (68-77 °F)
    • avoid excessive heat (above 104 °F/40 °C)
    • for additional information, see Material Safety Data Sheet (MSDS)
    • if swallowed get medical help or contact a Poison Control Center immediately
  • Inactive ingredients

    cocamide DEA, cocamine oxide, fragrance, gluconic acid*, gluconolactone*, hydroxyethylcellulose, isopropyl alcohol 4%, PEG-75 lanolin, PEG-150 distearate, propylene glycol, quaternium-60, water

    *contains one or more of these ingredients

  • Questions or comments?

    call 1.800.581.2528, 24 hours a day, 7 days a week

  • Representative label and principal display panel

    drum

    AVA, Inc.

    NDC 42939-127-24

    SCRUB ™

    2% Chorhexidine Gluconate Antiseptic Liquid Solution

    Surgical Hand Scrub, Healthcare Personnel Handwash, and Skin Wound and General Skin Cleanser

    Net Content: 200 kgs



    WARNING: This product can expose you to cocamide DEA, which is known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov

    Keep from freezing.

    www.SCRUBchg.com

    AVA, Inc.

    7051 South Adams Street

    Willowbrook, IL 60527-7592

  • INGREDIENTS AND APPEARANCE
    SCRUB, SCRUB-STAT, FOAM SAFE, MICRO-GUARD 
    chlorhexidine gluconate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42939-127(NDC:47593-463)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    GLUCONIC ACID (UNII: R4R8J0Q44B)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    QUATERNIUM-33 (UNII: XPS4174QZJ)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42939-127-24208000 mL in 1 DRUM; Type 0: Not a Combination Product07/22/1986
    2NDC:42939-127-251134000 mL in 1 CONTAINER; Type 0: Not a Combination Product07/22/1986
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01925807/22/1986
    Labeler - AVA, Inc. (615317075)
    Establishment
    NameAddressID/FEIBusiness Operations
    AVA, Inc.615317075analysis(42939-127) , api manufacture(42939-127) , manufacture(42939-127) , repack(42939-127)