FDA Label for 3m Avagard

View Indications, Usage & Precautions

3m Avagard Product Label

The following document was submitted to the FDA by the labeler of this product Solventum Us Opco Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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 flame.
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.


Otc - Do Not Use



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

Otc - Stop Use



Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition


Otc - 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.


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


Package Label.Principal Display Panel



Principal Display Panel – 500mL Bottle Label

3M

NDC 17518-051-01

Avagard™

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

Surgical & Healthcare Personnel Hand Antiseptic with Moisturizers

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.

16 fl oz • 500 mL

REF 9200


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