Label: 3M AVAGARD- chlorhexidine gluconate and alcohol lotion

  • NDC Code(s): 17518-051-01, 17518-051-04
  • Packager: 3M Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 30, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Chlorhexidine gluconate 1% w/w

    Ethyl alcohol 61% w/w

  • Purpose

    Antiseptic

    Antiseptic

  • Uses

    • surgical hand antiseptic: significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care
    • healthcare personnel hand antiseptic: hand rub to help reduce bacteria that potentially can cause disease
    • recommended for repeated use
  • Warnings

    For external use only. Flammable, keep away from fire or flames.

    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 ingredient in this product

    When using this product

    • do not touch the eye with hands that have been treated with this preparation
    • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye.
    • if contact occurs, 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 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.

    Surgical hand antiseptic

    • apply to clean, dry hands and nails. For the first use of each day, clean under nails with a nail stick.
    • dispense one pump (2 mL) into the palm of one hand
    • dip the fingertips of the opposite hand into the lotion and work it under the nails
    • spread the remaining lotion over the hand and up to just above the elbow
    • using another 2 mL of lotion, repeat with the other hand
    • dispense another 2 mL of lotion into either hand; reapply to all aspects of both hands up to the wrists
    • allow to dry before donning gloves

    Healthcare personnel hand antiseptic

    • apply to clean, dry hands and nails
    • dispense one pump (2 mL) into the palm of one hand
    • paying particular attention to the spaces between the fingers and under fingernails, apply the lotion evenly to cover both hands up to the wrists
    • allow to dry without wiping
  • Other information

    store at 20-25°C (68-77°F)

  • Inactive ingredients

    beheneth 10, behenyl alcohol, C20-40 pareth-24, cetyl palmitate, diisopropyl dimer dilinoleate, dimethicone, glycerin, polyethylene glycol, squalane, water

  • Questions?

    Call 1-800-228-3957

  • Principle Display Panel – 500mL Bottle Label

    3M

    NDC 17518-051-01

    Avagard™

    (Chlorhexidine Gluconate 1% Solution and Ethyl Alcohol 61% w/w)

    Surgical and Healthcare Personnel Hand Antiseptic āwith āMoisturizers

    Peel to read Drug Facts Panel before use

    Made in U.S.A. for 3M Health Care

    2510 Conway Ave., St. Paul, MN 55144

    1-800-228-3957

    www.3M.com/infectionprevention

    © 2017, 3M. All rights reserved. The shape and colors of the bottle and wall bracket are trademarks of 3M.

    Patent: 3M.com/Patents

    MAL10110039XC

    Flammable, keep away from fire or flame, heat, sparks and sources of static discharge.

    LOT 0000000000

    EXP 0000-00-00

    16 fl oz • 500 mL

    REF 9200

    Principle Display Panel – 500mL Bottle Label

    Principal Display Panel – 500mL Drug Facts

  • INGREDIENTS AND APPEARANCE
    3M AVAGARD 
    chlorhexidine gluconate and alcohol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17518-051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L) Chlorhexidine Gluconate8.3 mg  in 1 mL
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol506.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Beheneth-10 (UNII: 313S43DM16)  
    Docosanol (UNII: 9G1OE216XY)  
    Cetyl Palmitate (UNII: 5ZA2S6B08X)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Glycerin (UNII: PDC6A3C0OX)  
    polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
    Squalane (UNII: GW89575KF9)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17518-051-018 in 1 CASE06/14/2001
    1500 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:17518-051-044 in 1 CASE06/14/2001
    21200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02107406/14/2001
    Labeler - 3M Company (006173082)