BETASEPT

Manufacturer
Atlantis Consumer Healthcare, Inc.
Effective date
2025-12-24
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:29:19

Label at a glance#

ProductBETASEPT
Active ingredientChlorhexidine Gluconate
Label structure15 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Drug Facts
Active ingredient Purpose
Chlorhexidine gluconate 4% solution

OTC - PURPOSE SECTION

Purpose
Antiseptic

OTC - WHEN USING SECTION

Uses

  • surgical hand scrub: significantly reducesthe number of microorganisms on the hands and forearms prior to surgery or patient care
  • healthcare personnel handwash: helps reducebacteria that potentially can cause disease
  • skin wound and general skin cleansing

WARNINGS SECTION

Warnings
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.

OTC - DO NOT USE SECTION

Do not use

  • if you or the patient is allergic to chlorhexidine gluconateor any other ingredient in this product
  • in contact with meninges
  • in the genital area

OTC - WHEN USING SECTION

When using this product

  • keep out of eyes, ears, and mouth. May cause serious andpermanent eye injury if permitted to enter and remain in the eye ormay cause deafness when instilled in the middle ear through perforatedeardrums.
  • if solution should contact these areas, rinse out promptlyand thoroughly with water
  • wounds which involve more than the superficial layers ofthe skin should not be routinely treated
  • repeated general skin cleansing of large body areas shouldnot be done except when advised by a health care provider

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation,sensitization, or allergic reaction occurs. These may be signs ofa serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Ifswallowed, get medical help or contact a Poison Control Center rightaway.

OTHER SAFETY INFORMATION

Directions

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

INDICATIONS & USAGE SECTION

Surgical hand scrub:

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

DOSAGE & ADMINISTRATION SECTION

Healthcare personnelhandwash:

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

DOSAGE FORMS & STRENGTHS SECTION

Skin wound and general skin cleansing:

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

OTHER SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT SECTION

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

Questions or comments? call 1-888-827-0624 (8am-5pm, EST, Mon-Fri.)

WARNING: This product can expose you to chemicals including coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

Dist. by: Avrio Health L.P. Stamford, CT 06901-3431

304978-0A

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BETASEPT
Antiseptic Surgical Scrub
NDC: 67618–200–30

304978-0A
304978-0A

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
834150BETASEPT 4 % Medicated Liquid SoapPSN13
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSN13
834150chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Betasept]SBD13
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCD13
834150Betasept 4 % Medicated Liquid SoapSY13
834150Betasept 4 % Surgical ScrubSY13
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSY13
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSY13

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
67618-200-01BETASEPT3785 mL in 1 BOTTLESOLUTION378513
67618-200-04BETASEPT118 mL in 1 BOTTLESOLUTION11813
67618-200-08BETASEPT237 mL in 1 BOTTLESOLUTION23713
67618-200-16BETASEPT473 mL in 1 BOTTLESOLUTION47313
67618-200-30BETASEPT946 mL in 1 BOTTLESOLUTION94613
67618-200-32BETASEPT946 mL in 1 BOTTLESOLUTION94613

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67618-200-01ML - Milliliter67618-2005702a901-38c3-493d-be08-8ece61e7853812013-02-13
67618-200-04ML - Milliliter67618-2003f81ce9c-97d1-4c53-9ea4-499277cccfae12013-02-13
67618-200-08ML - Milliliter67618-200bdfcd9fd-4e2d-41d3-be6f-eb8e864e6cba12013-02-13
67618-200-16ML - Milliliter67618-200c73e9a20-ed84-464c-b26e-a39732ec5c0a12013-02-13
67618-200-30ML - Milliliter67618-200239f33e8-6bf9-4785-a9bc-4a7dd58c43e612013-02-13
67618-200-32ML - Milliliter67618-20005c1a18c-da15-4ff3-8818-e2e12a463a8f12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Chlorhexidine GluconateACTIVE INGREDIENTMOR84MUD8E2
ChlorhexidineACTIVE MOIETYR4KO0DY52L2
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972D2
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POT2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163022
LAURAMINE OXIDEINACTIVE INGREDIENT4F6FC4MI8W2
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 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67618-20067618-200-04, 67618-200-08, 67618-200-16, 67618-200-30, 67618-200-32, 67618-200-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 · 35 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+route+dosage form
7 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
LAURAMINE OXIDELAURAMINE OXIDE4F6FC4MI8WSOLUTION / TOPICAL3.5 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSOLUTION / TOPICAL2.5 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
7 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
7 equally ranked IID candidates
LAURAMINE OXIDELAURAMINE OXIDE4F6FC4MI8WSOLUTION / TOPICAL3.5 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
PEG-75 LANOLINPEG-75 LANOLIN09179OX7TBSOLUTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
7 equally ranked IID candidates
PEG-75 LANOLINPEG-75 LANOLIN09179OX7TBSOLUTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
7 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSOLUTION / TOPICAL2.5 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSOLUTION / TOPICAL2.5 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
7 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
7 equally ranked IID candidates
LAURAMINE OXIDELAURAMINE OXIDE4F6FC4MI8WSOLUTION / TOPICAL3.5 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSOLUTION / TOPICAL2.5 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
LAURAMINE OXIDELAURAMINE OXIDE4F6FC4MI8WSOLUTION / TOPICAL3.5 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
LAURAMINE OXIDELAURAMINE OXIDE4F6FC4MI8WSOLUTION / TOPICAL3.5 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
PEG-75 LANOLINPEG-75 LANOLIN09179OX7TBSOLUTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
7 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSOLUTION / TOPICAL2.5 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
PEG-75 LANOLINPEG-75 LANOLIN09179OX7TBSOLUTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
7 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
7 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
PEG-75 LANOLINPEG-75 LANOLIN09179OX7TBSOLUTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
7 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSOLUTION / TOPICAL2.5 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
7 equally ranked IID candidates
LAURAMINE OXIDELAURAMINE OXIDE4F6FC4MI8WSOLUTION / TOPICAL3.5 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
PEG-75 LANOLINPEG-75 LANOLIN09179OX7TBSOLUTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
7 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSOLUTION / TOPICAL2.5 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
LAURAMINE OXIDELAURAMINE OXIDE4F6FC4MI8WSOLUTION / TOPICAL3.5 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
7 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
BETASEPTANTISEPTIC SURGICAL SCRUBAtlantis Consumer Healthcare, Inc.7e64e7bf-e88f-4056-c9e1-b49a277daa6c2025-12-24WarningsExact identifier
ndc (package): 67618-200-30
ndc (package): 67618-200-04
ndc (package): 67618-200-08
ndc (package): 67618-200-32
ndc (package): 67618-200-01
ndc (package): 67618-200-16
ndc (product): 67618-200
ndc11 (package): 67618020030
ndc11 (package): 67618020032
ndc11 (package): 67618020008
ndc11 (package): 67618020004
ndc11 (package): 67618020001
ndc11 (package): 67618020016
spl id: 872a571c-88d2-45f9-ae87-5b0b3c900939
spl set id: 7e64e7bf-e88f-4056-c9e1-b49a277daa6c

Reported adverse events (FAERS/openFDA)#

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