FDA.reportPublic FDA data

Antiseptic Skin Cleanser (Chlorhexidine Gluconate 4% Solution)

Manufacturer
AVA, Inc.
Effective date
2012-12-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:33:56

Label at a glance#

ProductANTISEPTIC SKIN CLEANSER
Active ingredientCHLORHEXIDINE GLUCONATE
Label structure11 sections

Indications and uses

surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery skin wound and general skin cleansing

Dosage and administration

wet hands and forearms under running water scrub for 3 minutes with about 5 ml of product and a wet brush, paying close attention to the nails, cuticles, and interdigital spaces a separate nail cleaner may be used rinse thoroughly wash for an additional 3 minutes with 5 ml of product and rinse under running water dry thoroughly wet hands with water dispense about 5 ml of product into cupped hands and wash in a vig...

Storage and handling

store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate 4% solution

Purposes

OTC - PURPOSE SECTION

surgical hand scrub
healthcare personnel handwash
patient preoperative skin preparation
skin wound and general skin cleansing

Uses

INDICATIONS & USAGE SECTION

  • surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery
  • skin wound and general skin cleansing

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if you are allergic to chlorhexidine gluconate or any other ingredients
  • in contact with meninges
  • in the genital area
  • as a preoperative skin preparation of the head or face

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums
  • if solution should contact these areas, rinse out promptly and thoroughly with water
  • wounds which involve more than the superficial layers of the skin should not be routinely treated
  • repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population 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.

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

DOSAGE & ADMINISTRATION SECTION

Surgical hand scrub

SPL UNCLASSIFIED SECTION

  • wet hands and forearms under running water
  • scrub for 3 minutes with about 5 ml of product and a wet brush, paying close attention to the nails, cuticles, and interdigital spaces
  • a separate nail cleaner may be used
  • rinse thoroughly
  • wash for an additional 3 minutes with 5 ml of product and rinse under running water
  • dry thoroughly

Healthcare personnel handwash

SPL UNCLASSIFIED SECTION

  • wet hands with water
  • dispense about 5 ml of product into cupped hands and wash in a vigorous manner for 15 seconds
  • rinse and dry thoroughly

Patient preoperative skin preparation

SPL UNCLASSIFIED SECTION

  • apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel
  • repeat procedure for an additional 2 minutes and dry with a sterile towel

Skin wound and general skin cleansing

SPL UNCLASSIFIED SECTION

  • thoroughly rinse the area to be cleaned with water
  • apply the minimum amount of product necessary to cover the skin or wound area and wash gently
  • rinse again thoroughly

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-855-552-8274

SPL UNCLASSIFIED SECTION

Manufactured by:
AVA, Inc.
7051 S. Adams St.
Willowbrook, IL 60527

PRINCIPAL DISPLAY PANEL - 947 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42939-102-04

ANTISEPTIC SKIN CLEANSER

(Chlorhexidine Gluconate 4% Solution)

ANTISEPTIC/ANTIMICROBIAL SKIN CLEANSER

FOR EXTERNAL USE ONLY

32 fl.oz. (974 mL)

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

AVA Incorporated

Lot:

Exp:

PRINCIPAL DISPLAY PANEL - 947 mL Bottle LabelPRINCIPAL DISPLAY PANEL - 947 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSN1
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCD1
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSY1
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSY1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42939-102-012020-01-31C16284748780-19d75b9cf-e444-f424-e053-dadaa90a57ceAntiseptic Skin Cleanser (Chlorhexidine Gluconate 4% Solution)
42939-102-022020-01-31C16284748780-19d75b9cf-e444-f424-e053-dadaa90a57ceAntiseptic Skin Cleanser (Chlorhexidine Gluconate 4% Solution)
42939-102-032020-01-31C16284748780-19d75b9cf-e444-f424-e053-dadaa90a57ceAntiseptic Skin Cleanser (Chlorhexidine Gluconate 4% Solution)
42939-102-042020-01-31C16284748780-19d75b9cf-e444-f424-e053-dadaa90a57ceAntiseptic Skin Cleanser (Chlorhexidine Gluconate 4% Solution)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42939-102-01ANTISEPTIC SKIN CLEANSER118 mL in 1 BOTTLESOLUTION1181
42939-102-02ANTISEPTIC SKIN CLEANSER237 mL in 1 BOTTLESOLUTION2371
42939-102-03ANTISEPTIC SKIN CLEANSER473 mL in 1 BOTTLESOLUTION4731
42939-102-04ANTISEPTIC SKIN CLEANSER947 mL in 1 BOTTLESOLUTION9471

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42939-102ANTISEPTIC SKIN CLEANSER (CHLORHEXIDINE GLUCONATE) SOLUTION [AVA, INC.]14 package rows20121212_76cfedb3-25ed-4c12-8ebc-b57f029fedaa.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8E1
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52L1
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POT1
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%)INACTIVE INGREDIENTL605B5892V1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163021
LAURAMINE OXIDEINACTIVE INGREDIENT4F6FC4MI8W1
PEG-75 LANOLININACTIVE INGREDIENT09179OX7TB1
TRIDECYL ALCOHOLINACTIVE INGREDIENT8I9428H8681
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42939-10242939-102-04, 42939-102-03, 42939-102-02, 42939-102-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORHEXIDINE GLUCONATEMOR84MUD8EACTIB
GLUCONOLACTONEWQ29KQ9POTIACT
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%)L605B5892VIACT
ISOPROPYL ALCOHOLND2M416302IACT
LAURAMINE OXIDE4F6FC4MI8WIACT
PEG-75 LANOLIN09179OX7TBIACT
WATER059QF0KO0RIACT
TRIDECYL ALCOHOL8I9428H868IACT

Source Document#

Source XML

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 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PEG-75 LANOLINPEG-75 LANOLIN09179OX7TBSOLUTION / TOPICAL1 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
PEG-75 LANOLINPEG-75 LANOLIN09179OX7TBEMULSION / TOPICAL1.5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
LAURAMINE OXIDELAURAMINE OXIDE4F6FC4MI8WSOLUTION / TOPICAL3.5 %w/vExact identifier — unii candidate
2 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSPONGE / TOPICALADJ PHExact identifier — unii candidate
6 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTINJECTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
6 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
PEG-75 LANOLINPEG-75 LANOLIN09179OX7TBAEROSOL / TOPICAL1.5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTINJECTION / INTRAVENOUSADJ PHExact identifier — unii candidate
6 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTCLOTH / TOPICALNAExact identifier — unii candidate
6 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTELIXIR / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates
LAURAMINE OXIDELAURAMINE OXIDE4F6FC4MI8WSPONGE / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 equally ranked IID candidates

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
5c4ecec7-868f-4ac0-a6e6-e48918a2536d76cfedb3-25ed-4c12-8ebc-b57f029fedaa2012-12-06WarningsExact identifier
spl id: 5c4ecec7-868f-4ac0-a6e6-e48918a2536d
spl set id: 76cfedb3-25ed-4c12-8ebc-b57f029fedaa

Reported adverse events (FAERS/openFDA)#

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