3M Avagard

Manufacturer
3M Company
Effective date
2020-10-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:11:33

Label at a glance#

Product3M Avagard
Active ingredientChlorhexidine Gluconate, Alcohol
Label structure9 sections

Indications and 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

Dosage and administration

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. apply to clean, dry hands and nails. For the first use of each day, clean under nails with a nail stick. dispense two pumps (2 mL; 1 mL per pump) 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 ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate 1% w/w

Ethyl alcohol 61% w/w

Purpose

OTC - PURPOSE SECTION

Antiseptic

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

SPL UNCLASSIFIED SECTION

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 SECTION

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

When using this product

OTC - WHEN USING SECTION

  • 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 SECTION

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 SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

Surgical hand antiseptic

SPL UNCLASSIFIED SECTION

  • apply to clean, dry hands and nails. For the first use of each day, clean under nails with a nail stick.
  • dispense two pumps (2 mL; 1 mL per pump) 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

SPL UNCLASSIFIED SECTION

  • apply to clean, dry hands and nails
  • dispense two pumps (2 mL; 1 mL per pump) 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 SAFETY INFORMATION

store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call 1-800-228-3957

Principal Display Panel – 500mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3M

NDC 17518-051-05

Avagard™

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

Surgical and Healthcare Personnel Hand Antiseptic with Moisturizers

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

LOT

EXP

Dispense two

pumps per use

16 fl oz • 500 mL

Made in USA with Globally Sourced

Materials for 3M Company

2510 Conway Ave., St. Paul, MN 55144

1-800-228-3957

www.3M.com/Medical

3M and Avagard are trademarks of 3M.

© 2020, 3M. All rights reserved.

Patent: 3M.com/Patents

34-8726-2008-2

REF 9218

Principal Display Panel – 500mL Bottle Label
Principal Display Panel – 500mL Bottle Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17518-051-01ML - Milliliter17518-051757a4fb8-a521-4953-8559-11342fb57c1e12022-06-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17518-05117518-051-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021074-001AVAGARDALCOHOL; CHLORHEXIDINE GLUCONATE61%;1%SOLUTION / TOPICALRLD, RS2001-06-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-07c2088c7a36db…
2026-09-14 22:38:342026-08N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-0784e616aacf4f…
2026-08-18 06:07:402026-07N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-0787673890dc5c…
2021-03-12 10:30 UTC2021-03N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-073f01610625f2…
2019-09-15 20:21 UTC2019-09N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-07b00525d2431f…
2019-07-19 19:46 UTC2019-07N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-073f0d92c62455…
2023-05-13 08:27 UTC2023-05N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-07053a50430f4f…
2023-01-26 05:58 UTC2023-01N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-073a93d1ddd44b…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3M AvagardCHLORHEXIDINE GLUCONATE AND ALCOHOLSolventum US LLC8bf8fe8e-76cb-4eda-a18d-1687050285ae2026-04-22WarningsExact identifier
ndc (product): 17518-051
58d1c300-ad89-4d49-b6c1-0b94b07b5ab73085cbc5-05f2-4cc6-97a8-1a2f9bcc32532021-03-10WarningsExact identifier
spl set id: 3085cbc5-05f2-4cc6-97a8-1a2f9bcc3253

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.