8bf8fe8e-76cb-4eda-a18d-1687050285ae

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

Purpose

Antiseptic Antiseptic

Description

Drug Facts


Medication Information

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.

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
Purpose

Antiseptic

Antiseptic

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

Description

Drug Facts

Questions?

Call 1-800-228-3957

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

Active Ingredients

Chlorhexidine gluconate 1% w/w

Ethyl alcohol 61% w/w

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

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.

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
Purpose

Antiseptic

Antiseptic

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 (Other information)

store at 20-25°C (68-77°F)

Inactive Ingredients (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

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

Active Ingredients (Active ingredients)

Chlorhexidine gluconate 1% w/w

Ethyl alcohol 61% w/w

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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