SPL v18
SPL
SPL Set ID 8bf8fe8e-76cb-4eda-a18d-1687050285ae
Route
TOPICAL
Published
Effective Date 2024-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (8.3 mg) Alcohol (506.3 mg)
Inactive Ingredients
Beheneth-10 Docosanol Cetyl Palmitate Dimethicone Glycerin Polyethylene Glycol, Unspecified Squalane Water

Identifiers & Packaging

Marketing Status
NDA Active Since 2001-06-14

Description

Drug Facts

Purpose

Antiseptic Antiseptic


Medication Information

Purpose

Antiseptic

Antiseptic

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50570-1

Do not use if you are allergic to chlorhexidine gluconate or any other ingredient in this product

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.

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
Questions?

Call 1-800-228-3957

Other Information

store at 20-25°C (68-77°F)

Active Ingredients

Chlorhexidine gluconate 1% w/w

Ethyl alcohol 61% w/w

Inactive Ingredients

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

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
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 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


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50570-1 (50570-1)

Do not use if you are allergic to chlorhexidine gluconate or any other ingredient in this product

Purpose

Antiseptic

Antiseptic

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.

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
Questions?

Call 1-800-228-3957

Other Information (Other information)

store at 20-25°C (68-77°F)

Active Ingredients (Active ingredients)

Chlorhexidine gluconate 1% w/w

Ethyl alcohol 61% w/w

Inactive Ingredients (Inactive ingredients)

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

When Using 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
Principle Display Panel – 500ml Bottle Label (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 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


Advanced Ingredient Data


Raw Label Data

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