FDA.reportPublic FDA data

Chlorhexidine Gluconate Solution 0.75% Antiseptic

Manufacturer
USA Medical Supply LLC
Effective date
2021-06-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:55

Label at a glance#

ProductChlorhexidine Gluconate Solution 0.75% Antiseptic
Active ingredientCHLORHEXIDINE GLUCONATE
Label structure9 sections

Dosage and administration

use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns. wet hands with water dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 30 seconds rinse and dry thoroughly

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate solution, 0.75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease

Warnings

WARNINGS SECTION

For external use only

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.

Do not use

OTC - DO NOT USE SECTION

  • if you are allergic to chlorhexidine gluconate or any other ingredient in this product

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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
  • do not use routinely if you have wounds which involve more than the superficial layers of the skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Healthcare personnel handwash:

DOSAGE & ADMINISTRATION SECTION

  • wet hands with water
  • dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 30 seconds
  • rinse and dry 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

citric acid, cocamide DEA, FD&C yellow #5, FD&C red #4, fragrance, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water, ricinoleamidopropyl trimethyl ammonium chloride

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-581-2528, 24 hours a day, 7 days a week

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Dean

Chlorhexidine Gluconate

Solution

0.75%

Up to 6 Hour Protection

Antimicrobial Skin Soap

FOR EXTERNAL USE ONLY

Distributed by USA Medical Supply

Northbrook, IL 60062

www.usamedicalsupply.com

4 fl oz (118 mL)

NDC 81657-001-01

MADE IN THE USA

FDA APPROVED

California Prop 65 WARNING

Keep from freezing.

fourwhtfourwht

Dr. Dean

Chlorhexidine Gluconate

Solution

0.75%

Up to 6 Hour Protection

Antimicrobial Skin Soap

FOR EXTERNAL USE ONLY

Distributed by USA Medical Supply

Northbrook, IL 60062

www.usamedicalsupply.com

8 fl oz (236 mL)

NDC 81657-001-02

MADE IN THE USA

FDA APPROVED

California Prop 65 WARNING

Keep from freezing.

eightwhteightwht

Dr. Dean

Chlorhexidine Gluconate

Solution

0.75%

Up to 6 Hour Protection

Antimicrobial Skin Soap

FOR EXTERNAL USE ONLY

Distributed by USA Medical Supply

Northbrook, IL 60062

www.usamedicalsupply.com

8 fl oz (236 mL)

NDC 81657-001-04

MADE IN THE USA

FDA APPROVED

California Prop 65 WARNING

Keep from freezing.

eightovleightovl

Dr. Dean

Chlorhexidine Gluconate

Solution

0.75%

Up to 6 Hour Protection

Antimicrobial Skin Soap

FOR EXTERNAL USE ONLY

Distributed by USA Medical Supply

Northbrook, IL 60062

www.usamedicalsupply.com

128 fl oz (3785 mL)

NDC 81657-001-03

MADE IN THE USA

FDA APPROVED

California Prop 65 WARNING

Keep from freezing.

galwhtgalwht

OTHER SAFETY INFORMATION

Keep from freezing.

calstatcalstat

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
81657-001-012023-01-30C16284748780-1f386c649-ef7a-0266-e053-dadaa90a7c1aDrug Facts
81657-001-022023-01-30C16284748780-1f386c649-ef7a-0266-e053-dadaa90a7c1aDrug Facts
81657-001-032023-01-30C16284748780-1f386c649-ef7a-0266-e053-dadaa90a7c1aDrug Facts
81657-001-042023-01-30C16284748780-1f386c649-ef7a-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81657-001-01Chlorhexidine Gluconate Solution 0.75% Antiseptic118 mL in 1 BOTTLE, PLASTICSOLUTION1181
81657-001-02Chlorhexidine Gluconate Solution 0.75% Antiseptic236 mL in 1 BOTTLE, PLASTICSOLUTION2361
81657-001-03Chlorhexidine Gluconate Solution 0.75% Antiseptic3785 mL in 1 JUGSOLUTION37851
81657-001-04Chlorhexidine Gluconate Solution 0.75% Antiseptic236 mL in 1 BOTTLE, PUMPSOLUTION2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81657-001CHLORHEXIDINE GLUCONATE SOLUTION 0.75% ANTISEPTIC SOLUTION [USA MEDICAL SUPPLY LLC]1Legacy NDC, 4 package rows20210620_c516ebf4-f3b8-6039-e053-2a95a90a4184.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81657-00181657-001-01, 81657-001-02, 81657-001-03, 81657-001-04
61037-414

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
COCO DIETHANOLAMIDE92005F972DIACT
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)8136Y38GY5IACT
ISOPROPYL ALCOHOLND2M416302IACT
LAURAMINE OXIDE4F6FC4MI8WIACT
RICINOLEAMIDOPROPYLTRIMONIUM CHLORIDE93OU7D1C3UIACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C RED NO. 4X3W0AM1JLXIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EACTIB

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
N020111-001CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-11

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
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2026-09-14 22:38:342026-08N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-1184e616aacf4f…
2026-08-18 06:07:402026-07N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-1187673890dc5c…
2021-03-12 10:30 UTC2021-03N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-113f01610625f2…
2019-09-15 20:21 UTC2019-09N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-11b00525d2431f…
2019-07-19 19:46 UTC2019-07N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-113f0d92c62455…
2023-05-13 08:27 UTC2023-05N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-11053a50430f4f…
2023-01-26 05:58 UTC2023-01N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020111-001CHLORHEXIDINE GLUCONATE0.75%SOLUTION / TOPICAL1997-09-113a93d1ddd44b…

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
Chlorhexidine Gluconate Solution 0.75% AntisepticCHLORHEXIDINE GLUCONATE SOLUTION 0.75% ANTISEPTICBajaj Medical, LLC014a5f36-0396-498b-901f-9a86df4e11fe2022-12-26WarningsExact identifier
ndc (product): 61037-414
c516fa22-f099-5a13-e053-2a95a90adff1c516ebf4-f3b8-6039-e053-2a95a90a41842021-06-18WarningsExact identifier
spl id: c516fa22-f099-5a13-e053-2a95a90adff1
spl set id: c516ebf4-f3b8-6039-e053-2a95a90a4184

Reported adverse events (FAERS/openFDA)#

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