3M Avagard - Solventum US LLC | Grain Processing Corporation

Manufacturer
Solventum US LLC | Grain Processing Corporation
Effective date
2026-04-22
Label type
HUMAN OTC DRUG LABEL
Version
19
Source
full-release
Hydrated at
2026-06-01 01:54:44

Label at a glance#

Product3M Avagard
Active ingredientChlorhexidine Gluconate, Alcohol
Label structure10 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. 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 ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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.

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

  • 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 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

Principle Display Panel – 500mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Principle Display Panel – 500mL Bottle LabelPrinciple Display Panel – 500mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1090000avagard (chlorhexidine gluconate 1 % / ethanol 61 % ) Topical LotionPSN19
1089996chlorhexidine gluconate 1 % / ethanol 61 % Topical LotionPSN19
1090000chlorhexidine gluconate 10 MG/ML / ethanol 0.61 ML/ML Topical Lotion [Avagard]SBD19
1089996chlorhexidine gluconate 10 MG/ML / ethanol 0.61 ML/ML Topical LotionSCD19
1090000avagard (chlorhexidine gluconate 1 % / ethanol 61 % ) Topical LotionSY19

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORHEXIDINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17518-051-013M Avagard8 in 1 CASELOTION819
17518-051-013M Avagard500 mL in 1 BOTTLELOTION50019
17518-051-043M Avagard4 in 1 CASELOTION419
17518-051-043M Avagard1200 mL in 1 BOTTLELOTION120019

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AlcoholACTIVE INGREDIENT3K9958V90M4
Chlorhexidine GluconateACTIVE INGREDIENTMOR84MUD8E4
AlcoholACTIVE MOIETY3K9958V90M4
ChlorhexidineACTIVE MOIETYR4KO0DY52L4
beheneth-10INACTIVE INGREDIENT313S43DM164
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08X4
dimethiconeINACTIVE INGREDIENT92RU3N3Y1O4
docosanolINACTIVE INGREDIENT9G1OE216XY4
glycerinINACTIVE INGREDIENTPDC6A3C0OX4
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1A4
squalaneINACTIVE INGREDIENTGW89575KF94
waterINACTIVE INGREDIENT059QF0KO0R4

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
17518-05117518-051-01, 17518-051-04

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 · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
docosanolDOCOSANOL9G1OE216XYSOLUTION / TOPICAL1.1 %w/wExact identifier — unii+route
6 equally ranked IID candidates
cetyl palmitateCETYL PALMITATE5ZA2S6B08XSOLUTION / TOPICAL0.05 %w/wExact identifier — unii+route
9 equally ranked IID candidates
cetyl palmitateCETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii+route
9 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
squalaneSQUALANEGW89575KF9SOLUTION / TOPICAL1 %w/wExact identifier — unii+route
12 equally ranked IID candidates
cetyl palmitateCETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii+route
9 equally ranked IID candidates
squalaneSQUALANEGW89575KF9SOLUTION / TOPICAL1 %w/wExact identifier — unii+route
12 equally ranked IID candidates
squalaneSQUALANEGW89575KF9CREAM / TOPICAL6 %w/wExact identifier — unii+route
12 equally ranked IID candidates
docosanolDOCOSANOL9G1OE216XYAEROSOL, FOAM / TOPICAL1.1 %w/wExact identifier — unii+route
6 equally ranked IID candidates
squalaneSQUALANEGW89575KF9CREAM, AUGMENTED / TOPICAL120 mgExact identifier — unii+route
12 equally ranked IID candidates
cetyl palmitateCETYL PALMITATE5ZA2S6B08XSOLUTION / TOPICAL0.05 %w/wExact identifier — unii+route
9 equally ranked IID candidates
docosanolDOCOSANOL9G1OE216XYSOLUTION / TOPICAL1.1 %w/wExact identifier — unii+route
6 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
squalaneSQUALANEGW89575KF9AEROSOL, FOAM / TOPICAL2.23 %w/wExact identifier — unii+route
12 equally ranked IID candidates
cetyl palmitateCETYL PALMITATE5ZA2S6B08XOINTMENT / TOPICALNAExact identifier — unii+route
9 equally ranked IID candidates
cetyl palmitateCETYL PALMITATE5ZA2S6B08XSOLUTION / TOPICAL0.05 %w/wExact identifier — unii+route
9 equally ranked IID candidates
docosanolDOCOSANOL9G1OE216XYAEROSOL, FOAM / TOPICAL1.1 %w/wExact identifier — unii+route
6 equally ranked IID candidates
cetyl palmitateCETYL PALMITATE5ZA2S6B08XOINTMENT / TOPICALNAExact identifier — unii+route
9 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
docosanolDOCOSANOL9G1OE216XYAEROSOL, FOAM / TOPICAL1.1 %w/wExact identifier — unii+route
6 equally ranked IID candidates
squalaneSQUALANEGW89575KF9CREAM, AUGMENTED / TOPICAL120 mgExact identifier — unii+route
12 equally ranked IID candidates
squalaneSQUALANEGW89575KF9SOLUTION / TOPICAL1 %w/wExact identifier — unii+route
12 equally ranked IID candidates
squalaneSQUALANEGW89575KF9CREAM / TOPICAL6 %w/wExact identifier — unii+route
12 equally ranked IID candidates
squalaneSQUALANEGW89575KF9AEROSOL, FOAM / TOPICAL2.23 %w/wExact identifier — unii+route
12 equally ranked IID candidates
squalaneSQUALANEGW89575KF9CREAM, AUGMENTED / TOPICAL120 mgExact identifier — unii+route
12 equally ranked IID candidates
squalaneSQUALANEGW89575KF9AEROSOL, FOAM / TOPICAL2.23 %w/wExact identifier — unii+route
12 equally ranked IID candidates
docosanolDOCOSANOL9G1OE216XYSOLUTION / TOPICAL1.1 %w/wExact identifier — unii+route
6 equally ranked IID candidates
squalaneSQUALANEGW89575KF9CREAM / TOPICAL6 %w/wExact identifier — unii+route
12 equally ranked IID candidates
cetyl palmitateCETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii+route
9 equally ranked IID candidates
cetyl palmitateCETYL PALMITATE5ZA2S6B08XOINTMENT / TOPICALNAExact identifier — unii+route
9 equally ranked IID candidates

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 43.

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-10-28 04:53 UTC2022-10N021074-001AVAGARD61%;1%SOLUTION / TOPICALRLD, RS2001-06-07f41ea6bd6efb…

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 · 1 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 (package): 17518-051-04
ndc (package): 17518-051-01
ndc (product): 17518-051
ndc11 (package): 17518005104
ndc11 (package): 17518005101
spl id: a62bdc56-7a01-4c95-ab20-6098ade5a0b2
spl set id: 8bf8fe8e-76cb-4eda-a18d-1687050285ae

Reported adverse events (FAERS/openFDA)#

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