3M AVAGARD- chlorhexidine gluconate and alcohol lotion

3M Avagard by

Drug Labeling and Warnings

3M Avagard by is a Otc medication manufactured, distributed, or labeled by 3M Health Care . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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.

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

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 and 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.

LOT 0000000000

EXP 0000-00-00 

16 fl oz 500 mL

REF 9200

INGREDIENTS AND APPEARANCE

3M AVAGARD 
chlorhexidine gluconate and alcohol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17518-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L)	Chlorhexidine Gluconate	8.3 mg  in 1 mL
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	506.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17518-051-01	8 in 1 CASE	06/14/2001
1		500 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 17518-051-04	4 in 1 CASE	06/14/2001
2		1200 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021074	06/14/2001

Labeler - 3M Health Care (006173082)