ANTISEPTIC SKIN CLEANSER

Manufacturer
Cardinal Health | Xttrium Laboratories, Inc.
Effective date
2020-03-20
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:38:42

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

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. Surgical hand scrub: 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 seperate nail cleaner may be used rinse thoroughly wash for an additional 3 minutes with 5 m...

Storage and handling

store at 20-25ºC (68-77ºF) avoid excessive heat above 40ºC (104ºF)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate 4% Solution

Purpose

OTC - PURPOSE SECTION

Antiseptic

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

Stop use and ask a doctor if

OTC - ASK DOCTOR 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 or infants under 2 months of age. These products may cause irritation or chemical burns.

Surgical hand scrub:

  • 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 seperate 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:

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

Patient preoperative skin preparation:

  • 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:

  • 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 20-25ºC (68-77ºF)
  • avoid excessive heat above 40ºC (104ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-587-3721, Monday through Friday 8:00 AM to 4:30 PM CST

OTHER SAFETY INFORMATION

Warning: This product contains a chemical (cocamide DEA) known to the State of California to cause cancer.

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products. Rinse completely and use only non-chlorine detergents.

*This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.

RECENT MAJOR CHANGES SECTION

Indications and Usage

Dosage and Administration

Uses

Directions

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 37205-595-32

LEADER

Compare to Hibiclens active ingredient

Antiseptic Skin Cleanser

(CHLORHEXIDINE GLUCONATE 4% SOLUTION)

ANTISEPTIC / ANTIMICROBIAL SKIN CLEANSER

FOR EXTERNAL USE ONLY

DYE FREE

8 FL OZ (237 mL)

TAMPER EVIDENT: DO NOT USE IF

shrink seal neckband is broken or missing

4LEAD08 PDP4LEAD08 PDP

4LEAD08 DF14LEAD08 DF1

4LEAD08 DF24LEAD08 DF2

4LEAD08 DF34LEAD08 DF3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-595-34ML - Milliliter37205-5954437779d-ed64-4c46-aebc-baca176006c712017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8E2
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52L2
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972D2
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POT2
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN162
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163022
PEG-75 LANOLININACTIVE INGREDIENT09179OX7TB2
TRIDECYL ALCOHOLINACTIVE INGREDIENT8I9428H8682
WATERINACTIVE INGREDIENT059QF0KO0R2

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
37205-59537205-595-34

Ingredients#

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

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

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 · 38 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SPRAY / NASAL0.1 mg/0.2mlExact identifier — unii candidate
15 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSPONGE / TOPICALADJ PHExact identifier — unii candidate
6 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16LOTION / TOPICAL0.2 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / TOPICAL0.69 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 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
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / ORAL100 mgExact identifier — unii candidate
15 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16POWDER, FOR SUSPENSION / ORAL560 mgExact identifier — unii candidate
15 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / AURICULAR (OTIC)1 mgExact identifier — unii candidate
15 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 ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTINJECTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
6 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
PEG-75 LANOLINPEG-75 LANOLIN09179OX7TBEMULSION / TOPICAL1.5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SYRUP / ORAL2 mg/5mlExact identifier — unii candidate
15 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSOLUTION / TOPICAL2.5 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16GEL / TOPICAL4 mgExact identifier — unii candidate
15 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16TABLET, EXTENDED RELEASE / ORAL350 mgExact identifier — unii candidate
15 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSUSPENSION / TOPICAL4 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION/ DROPS / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PEG-75 LANOLINPEG-75 LANOLIN09179OX7TBSOLUTION / TOPICAL1 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSHAMPOO / TOPICAL600 mgExact identifier — unii candidate
5 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / TOPICAL0.21 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTINJECTION / INTRAVENOUSADJ PHExact identifier — unii candidate
6 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DCREAM / TOPICAL30 mgExact identifier — unii candidate
5 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / ORAL3 mgExact identifier — unii candidate
15 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16TABLET, CHEWABLE / ORAL5.9 mgExact identifier — unii candidate
15 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
N019125-001DYNA-HEX 4CHLORHEXIDINE GLUCONATE4%SOLUTION / TOPICAL1984-12-24

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 22:38:342026-08N019125-001DYNA-HEX 44%SOLUTION / TOPICAL1984-12-2484e616aacf4f…
2026-08-18 06:07:402026-07N019125-001DYNA-HEX 44%SOLUTION / TOPICAL1984-12-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-2487673890dc5c…
2021-03-12 10:30 UTC2021-03N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-243f01610625f2…
2019-09-15 20:21 UTC2019-09N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24b00525d2431f…
2019-07-19 19:46 UTC2019-07N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-243f0d92c62455…
2023-05-13 08:27 UTC2023-05N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24053a50430f4f…
2023-01-26 05:58 UTC2023-01N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24f41ea6bd6efb…

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
a14eef7a-91a7-0de9-e053-2995a90a66d65577ecbb-cf2c-45e1-a0fb-17df0417eea52020-03-20WarningsExact identifier
spl id: a14eef7a-91a7-0de9-e053-2995a90a66d6
spl set id: 5577ecbb-cf2c-45e1-a0fb-17df0417eea5

Reported adverse events (FAERS/openFDA)#

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