Aplicare Antiseptic Chlorhexidine Gluconate

Manufacturer
Aplicare, Inc.
Effective date
2015-08-11
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-05-31 22:43:17

Label at a glance#

ProductAplicare Antiseptic Chlorhexidine Gluconate
Active ingredientCHLORHEXIDINE GLUCONATE
Label structure8 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 on premature infants or infants under 2 months of age. These products may cause irritation or chemical burns Surgical hand scrub: wet hands and forearms with water scrub for 3 minutes with about 5 mL of product with 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 p...

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

OTC - DO NOT USE SECTION

Do not use

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

OTC - WHEN USING SECTION

When using this product

  • single use when used for patient preoperative skin preparation
  • 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 installed in the middle ear through perforated ear drums.
  • 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. This 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 on premature infants or infants under 2 months of age. These products may cause irritation or chemical burns

Surgical hand scrub:

  • wet hands and forearms with water
  • scrub for 3 minutes with about 5 mL of product with 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:

  • 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:

  • 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments?

1-800-760-3236 (Mon.-Fri. 8:30AM - 5:00 PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4% Chlorhexidine Gluconate

82 286 Label82 286 Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSN13
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCD13
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52380-1272-42020-01-31C16284748780-19d75b9d0-4d23-f424-e053-dadaa90a57ceDrug Facts
52380-1272-62020-01-31C16284748780-19d75b9d0-4d23-f424-e053-dadaa90a57ceDrug Facts
52380-1272-72020-01-31C16284748780-19d75b9d0-4d23-f424-e053-dadaa90a57ceDrug Facts
52380-1272-82020-01-31C16284748780-19d75b9d0-4d23-f424-e053-dadaa90a57ceDrug Facts
52380-1272-92020-01-31C16284748780-19d75b9d0-4d23-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52380-1272-4Aplicare Antiseptic Chlorhexidine Gluconate118 mL in 1 BOTTLESOLUTION11813
52380-1272-6Aplicare Antiseptic Chlorhexidine Gluconate473 mL in 1 BOTTLESOLUTION47313
52380-1272-7Aplicare Antiseptic Chlorhexidine Gluconate946 mL in 1 BOTTLESOLUTION94613
52380-1272-8Aplicare Antiseptic Chlorhexidine Gluconate237 mL in 1 BOTTLESOLUTION23713
52380-1272-9Aplicare Antiseptic Chlorhexidine Gluconate3800 mL in 1 BOTTLESOLUTION380013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52380-1272APLICARE ANTISEPTIC CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE GLUCONATE) SOLUTION [APLICARE, INC.]13Legacy NDC, 5 package rows20150812_45c1e1b3-6d56-4fa2-a332-4e88d2f416dc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52380-1272-4ML - Milliliter52380-1272d4842be5-5fa9-4abe-918f-ba1519520dd612012-07-24
52380-1272-6ML - Milliliter52380-1272d76ccc3f-2b92-49e6-bda6-175e068c6b3d12012-07-24
52380-1272-7ML - Milliliter52380-1272bbe3a11a-6740-4eee-8925-a68edaac38d312012-07-24
52380-1272-8ML - Milliliter52380-12723d42a74a-a772-48de-8e0f-ef6685531e1812012-07-24
52380-1272-9ML - Milliliter52380-1272e30b9a2a-3463-4566-84b8-24188327a9d512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8E13
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52L13
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972D13
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POT13
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)INACTIVE INGREDIENT8136Y38GY513
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M41630213
LAURAMINE OXIDEINACTIVE INGREDIENT4F6FC4MI8W13
WATERINACTIVE INGREDIENT059QF0KO0R13

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52380-127252380-1272-4, 52380-1272-8, 52380-1272-6, 52380-1272-7, 52380-1272-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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 · 31 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTCLOTH / TOPICALNAExact identifier — unii candidate
6 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5FILM / BUCCAL55 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5TABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5SYRUP / ORAL100 mg/5mlExact identifier — unii candidate
9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5FILM, SOLUBLE / BUCCAL161 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSPONGE / TOPICALADJ PHExact identifier — unii candidate
6 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTINJECTION / INTRAVENOUSADJ PHExact identifier — unii candidate
6 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTELIXIR / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSHAMPOO / TOPICAL600 mgExact identifier — unii candidate
5 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
LAURAMINE OXIDELAURAMINE OXIDE4F6FC4MI8WSPONGE / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5SUSPENSION / ORAL1200 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DCREAM / TOPICAL30 mgExact identifier — unii candidate
5 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5SOLUTION / ORAL1867 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5TABLET, EXTENDED RELEASE / ORAL150 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTINJECTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
6 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSUSPENSION / TOPICAL4 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5TABLET / ORAL2 mgExact identifier — unii candidate
9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5CAPSULE / ORAL20 mgExact identifier — unii candidate
9 equally ranked IID candidates
LAURAMINE OXIDELAURAMINE OXIDE4F6FC4MI8WSOLUTION / TOPICAL3.5 %w/vExact identifier — unii candidate
2 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSOLUTION / TOPICAL2.5 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
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
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
1d107814-357c-68e4-e054-00144ff88e8845c1e1b3-6d56-4fa2-a332-4e88d2f416dc2015-08-11WarningsExact identifier
spl id: 1d107814-357c-68e4-e054-00144ff88e88
spl set id: 45c1e1b3-6d56-4fa2-a332-4e88d2f416dc

Reported adverse events (FAERS/openFDA)#

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