1986 Aplicare 4% CHG Solution

Manufacturer: Aplicare Products, LLC.
Effective date: 2020-01-27
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-01 23:42:45

Label at a glance#

ProductAplicare Antiseptic Chlorhexidine Gluconate

Active ingredientCHLORHEXIDINE GLUCONATE

Label structure9 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 with 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 produc...

Contacts and useful links#

PhoneLabel contact1-800-760-3236

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

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

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 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 with 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

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

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4% Chlorhexidine Gluconate

L987

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	1
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	1
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	1
GLUCONOLACTONE	INACTIVE INGREDIENT	WQ29KQ9POT	1
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	INACTIVE INGREDIENT	8136Y38GY5	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	1
LAURAMINE OXIDE	INACTIVE INGREDIENT	4F6FC4MI8W	1
PEG-75 LANOLIN	INACTIVE INGREDIENT	09179OX7TB	1
TRIDECYL ALCOHOL	INACTIVE INGREDIENT	8I9428H868	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Aplicare Antiseptic Chlorhexidine Gluconate
Chlorhexidine Gluconate
COCO DIETHANOLAMIDE
GLUCONOLACTONE
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)
ISOPROPYL ALCOHOL
LAURAMINE OXIDE
WATER
TRIDECYL ALCOHOL
PEG-75 LANOLIN
CHLORHEXIDINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52380-1987	52380-1987-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
COCO DIETHANOLAMIDE	92005F972D	IACT
GLUCONOLACTONE	WQ29KQ9POT	IACT
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	8136Y38GY5	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
LAURAMINE OXIDE	4F6FC4MI8W	IACT
WATER	059QF0KO0R	IACT
TRIDECYL ALCOHOL	8I9428H868	IACT
PEG-75 LANOLIN	09179OX7TB	IACT
CHLORHEXIDINE GLUCONATE	MOR84MUD8E	ACTIB

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 · 34 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SUSPENSION / TOPICAL	4 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SPONGE / TOPICAL	4 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	OIL / TOPICAL		72 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
PEG-75 LANOLIN	PEG-75 LANOLIN	09179OX7TB	AEROSOL / TOPICAL	1.5 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
GLUCONOLACTONE	GLUCONOLACTONE	WQ29KQ9POT	INJECTION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 6 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	FILM, SOLUBLE / BUCCAL		161 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SWAB / TOPICAL	43.9 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	OIL / AURICULAR (OTIC)		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
GLUCONOLACTONE	GLUCONOLACTONE	WQ29KQ9POT	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
PEG-75 LANOLIN	PEG-75 LANOLIN	09179OX7TB	EMULSION / TOPICAL	1.5 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SHAMPOO / TOPICAL		600 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SUSPENSION / ORAL		1200 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
GLUCONOLACTONE	GLUCONOLACTONE	WQ29KQ9POT	INJECTION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 6 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SYRUP / ORAL	100 mg/5ml		Exact identifier — unii candidate 9 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	CREAM / TOPICAL		30 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	GEL, METERED / TOPICAL		525 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
LAURAMINE OXIDE	LAURAMINE OXIDE	4F6FC4MI8W	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii candidate 9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	TABLET, FILM COATED / ORAL	1 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	FILM / BUCCAL		55 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
GLUCONOLACTONE	GLUCONOLACTONE	WQ29KQ9POT	SPONGE / TOPICAL	ADJ PH		Exact identifier — unii candidate 6 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	CAPSULE / ORAL		20 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PEG-75 LANOLIN	PEG-75 LANOLIN	09179OX7TB	SOLUTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
LAURAMINE OXIDE	LAURAMINE OXIDE	4F6FC4MI8W	SOLUTION / TOPICAL	3.5 %w/v		Exact identifier — unii candidate 2 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SOLUTION / TOPICAL	2.5 %w/v		Exact identifier — unii candidate 5 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	TABLET / ORAL		2 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	TABLET, EXTENDED RELEASE / ORAL	150 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
GLUCONOLACTONE	GLUCONOLACTONE	WQ29KQ9POT	ELIXIR / ORAL	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
GLUCONOLACTONE	GLUCONOLACTONE	WQ29KQ9POT	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii candidate 6 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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019125-001	DYNA-HEX 4	CHLORHEXIDINE GLUCONATE	4%	SOLUTION / TOPICAL			1984-12-24

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019125-001	DYNA-HEX 4	4%	SOLUTION / TOPICAL	1984-12-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019125-001	DYNA-HEX 4	4%	SOLUTION / TOPICAL	1984-12-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`f41ea6bd6efb…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
9d20a06d-b1fd-0a7b-e053-2995a90aee2c			1843c021-6566-5a0c-e054-00144ff8d46c	2020-01-27	Warnings	Exact identifier spl id: 9d20a06d-b1fd-0a7b-e053-2995a90aee2c spl set id: 1843c021-6566-5a0c-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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