Antiseptic Skin Cleanser

Manufacturer: Rite Aid Corporation | Xttrium Laboratories, Inc.
Effective date: 2023-11-06
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-05-31 23:59:40

Label at a glance#

ProductAntiseptic Skin Cleanser

Active ingredientCHLORHEXIDINE GLUCONATE

Label structure25 sections

Indications and uses

healthcare personnel handwash : helps reduce bacteria that potentially can cause disease 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. Healthcare personnel handwash: wet hands with water dispense about 5 mL of product into cupped hands and wash in a vigorous manner for about 15 seconds rinse and dry thoroughly repeat procedure for an additional 2 minutes and dry with a sterile towel Skin wound and normal skin cleansing: thor...

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-800-587-3721

Websitewww.p65warnings.ca.gov

www.P65Warnings.ca.gov

Websitewww.riteaid.com

www.riteaid.com

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine Gluconate 4% Solution

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
skin wound and general skin cleansing

Warnings

WARNINGS SECTION

For external use only

Allergy alert: This product may cause severe allergic reaction. Symptoms may include:

wheezing/difficulty breathing
shock
facial swelling
hives
rash

If an allergc reaction occurs, stop use and seek medical help right away.

Do not use

OTC - DO NOT USE SECTION

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

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.

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.

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 eardurms.
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 advised by a health care provider

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.

Healthcare personnel handwash:

wet hands with water
dispense about 5 mL of product into cupped hands and wash in a vigorous manner for about 15 seconds
rinse and dry thoroughly
repeat procedure for an additional 2 minutes and dry with a sterile towel

Skin wound and normal 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 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F)

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

1-800-587-3721

OTHER SAFETY INFORMATION

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as bleach.

WARNING: Cancer - www.P65Warnings.ca.gov

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

TAMPER-EVIDENT: Don't not use if shrink seal neackband is broken or missing.

DISTRIBUTED BY: RITE AID,

200 Newberry Commons, Etter, PA 17319

www.riteaid.com

IF YOU'RE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY.

4RA08BTLLBLJ

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate 4% solution

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
skin wound and general skin cleansing

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 or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
in contact with the meninges
in the genital area

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
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 advised by a health care provider

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 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.

Healthcare personnel handwash:

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

Skin wound and general skin cleansing:

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

Inactive ingredient

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-587-3721

OTHER SAFETY INFORMATION

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as bleach.

WARNING: Cancer - www.P65Warnings.ca.gov

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

TAMPER-EVIDENT: Don't not use if shrink seal neackband is broken or missing.

DISTRIBUTED BY: RITE AID,

200 Newberry Commons, Etter, PA 17319

www.riteaid.com

IF YOU'RE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY.

4RA16BTLLBLC

RECENT MAJOR CHANGES SECTION

Uses

Dosage and Administration

Uses: removal of surgical handscrub (11/23)

Direction: removal of surgical handscurb (11/23)

Package label and principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Hibiclens®*

NDC 11822-3678-8

ANTISEPTIC/ANTIMICROBIAL

SKIN CLEANSER

CHLORHEXIDINE GLUCONATE

4% SOLUTION

dye free

for external use only

TAMPER-EVIDENT: DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING

8 FL OZ (237mL)

Rite Aid 8oz

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Hibiclens®*

NDC 11822-3678-7

ANTISEPTIC/ANTIMICROBIAL

SKIN CLEANSER

CHLORHEXIDINE GLUCONATE

4% SOLUTION

dye free

for external use only

TAMPER-EVIDENT: DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING

16 FL OZ (473 mL)

Rite Aid 16oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	PSN	8
211365	chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap	SCD	8
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	SY	8
211365	chlorhexidine gluconate 4 % Medicated Surgical Scrub	SY	8

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CHLORHEXIDINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68	Product name	1	20160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11822-3678-7	Antiseptic Skin Cleanser	473 mL in 1 BOTTLE	LIQUID	473		8
11822-3678-8	Antiseptic Skin Cleanser	237 mL in 1 BOTTLE, PLASTIC	LIQUID	237		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11822-3678	ANTISEPTIC SKIN CLEANSER (CHLORHEXIDINE GLUCONATE 4%) LIQUID [RITE AID CORPORATION]	8	Current NDC, Legacy NDC, 2 package rows	20231110_12c4ced7-2ec7-3b07-e054-00144ff88e88.zip

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 (2000 CPS AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	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 · 12 matching rows.

Antiseptic Skin Cleanser
Chlorhexidine Gluconate 4%
GLUCONOLACTONE
CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE
LAURAMINE OXIDE
COCO DIETHANOLAMIDE
PEG-75 LANOLIN
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
ISOPROPYL ALCOHOL
WATER
TRIDECYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11822-3678	11822-3678-8, 11822-3678-7

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
GLUCONOLACTONE	WQ29KQ9POT	IACT
CHLORHEXIDINE GLUCONATE	MOR84MUD8E	ACTIB
LAURAMINE OXIDE	4F6FC4MI8W	IACT
COCO DIETHANOLAMIDE	92005F972D	IACT
PEG-75 LANOLIN	09179OX7TB	IACT
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	S38J6RZN16	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
WATER	059QF0KO0R	IACT
TRIDECYL ALCOHOL	8I9428H868	IACT

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 2 · 72 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PEG-75 LANOLIN	PEG-75 LANOLIN	09179OX7TB	SOLUTION / TOPICAL	1 %w/w		Exact identifier — unii+route 9 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
PEG-75 LANOLIN	PEG-75 LANOLIN	09179OX7TB	AEROSOL / TOPICAL	1.5 %w/w		Exact identifier — unii+route 9 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii+route 21 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	OIL / TOPICAL		72 mg	Exact identifier — unii+route 21 equally ranked IID candidates
PEG-75 LANOLIN	PEG-75 LANOLIN	09179OX7TB	AEROSOL / TOPICAL	1.5 %w/w		Exact identifier — unii+route 9 equally ranked IID candidates
LAURAMINE OXIDE	LAURAMINE OXIDE	4F6FC4MI8W	SPONGE / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	LOTION / TOPICAL	0.2 %w/v		Exact identifier — unii+route 12 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii+route 21 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	LOTION / TOPICAL	0.2 %w/v		Exact identifier — unii+route 12 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	CREAM / TOPICAL		30 mg	Exact identifier — unii+route 15 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SWAB / TOPICAL	43.9 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii+route 21 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	GEL / TOPICAL		4 mg	Exact identifier — unii+route 12 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii+route 21 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SOLUTION / TOPICAL	2.5 %w/v		Exact identifier — unii+route 15 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SUSPENSION / TOPICAL	0.69 %w/v		Exact identifier — unii+route 12 equally ranked IID candidates
GLUCONOLACTONE	GLUCONOLACTONE	WQ29KQ9POT	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii+route 9 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SOLUTION / TOPICAL	2.5 %w/v		Exact identifier — unii+route 15 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SOLUTION / TOPICAL	0.21 %w/v		Exact identifier — unii+route 12 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	GEL, METERED / TOPICAL		525 mg	Exact identifier — unii+route 21 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	GEL, METERED / TOPICAL		525 mg	Exact identifier — unii+route 21 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	GEL / TOPICAL		4 mg	Exact identifier — unii+route 12 equally ranked IID candidates
LAURAMINE OXIDE	LAURAMINE OXIDE	4F6FC4MI8W	SOLUTION / TOPICAL	3.5 %w/v		Exact identifier — unii+route 6 equally ranked IID candidates
GLUCONOLACTONE	GLUCONOLACTONE	WQ29KQ9POT	SPONGE / TOPICAL	ADJ PH		Exact identifier — unii+route 9 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	OIL / TOPICAL		72 mg	Exact identifier — unii+route 21 equally ranked IID candidates
LAURAMINE OXIDE	LAURAMINE OXIDE	4F6FC4MI8W	SOLUTION / TOPICAL	3.5 %w/v		Exact identifier — unii+route 6 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SHAMPOO / TOPICAL		600 mg	Exact identifier — unii+route 15 equally ranked IID candidates
LAURAMINE OXIDE	LAURAMINE OXIDE	4F6FC4MI8W	SPONGE / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SUSPENSION / TOPICAL	0.69 %w/v		Exact identifier — unii+route 12 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SPONGE / TOPICAL	4 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SPONGE / TOPICAL	4 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SOLUTION / TOPICAL	0.21 %w/v		Exact identifier — unii+route 12 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SWAB / TOPICAL	43.9 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
PEG-75 LANOLIN	PEG-75 LANOLIN	09179OX7TB	EMULSION / TOPICAL	1.5 %w/w		Exact identifier — unii+route 9 equally ranked IID candidates
LAURAMINE OXIDE	LAURAMINE OXIDE	4F6FC4MI8W	SOLUTION / TOPICAL	3.5 %w/v		Exact identifier — unii+route 6 equally ranked IID candidates
GLUCONOLACTONE	GLUCONOLACTONE	WQ29KQ9POT	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii+route 9 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SHAMPOO / TOPICAL		600 mg	Exact identifier — unii+route 15 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	LOTION / TOPICAL	0.2 %w/v		Exact identifier — unii+route 12 equally ranked IID candidates
PEG-75 LANOLIN	PEG-75 LANOLIN	09179OX7TB	SOLUTION / TOPICAL	1 %w/w		Exact identifier — unii+route 9 equally ranked IID candidates
GLUCONOLACTONE	GLUCONOLACTONE	WQ29KQ9POT	CLOTH / TOPICAL	NA		Exact identifier — unii+route 9 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii+route 21 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SUSPENSION / TOPICAL	4 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SPONGE / TOPICAL	4 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SOLUTION / TOPICAL	0.21 %w/v		Exact identifier — unii+route 12 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	CREAM / TOPICAL		30 mg	Exact identifier — unii+route 15 equally ranked IID candidates
GLUCONOLACTONE	GLUCONOLACTONE	WQ29KQ9POT	CLOTH / TOPICAL	NA		Exact identifier — unii+route 9 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SUSPENSION / TOPICAL	4 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii+route 21 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SWAB / TOPICAL	43.9 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
PEG-75 LANOLIN	PEG-75 LANOLIN	09179OX7TB	SOLUTION / TOPICAL	1 %w/w		Exact identifier — unii+route 9 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	OIL / TOPICAL		72 mg	Exact identifier — unii+route 21 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii+route 21 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii+route 21 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SOLUTION / TOPICAL	2.5 %w/v		Exact identifier — unii+route 15 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	GEL / TOPICAL		4 mg	Exact identifier — unii+route 12 equally ranked IID candidates
GLUCONOLACTONE	GLUCONOLACTONE	WQ29KQ9POT	CLOTH / TOPICAL	NA		Exact identifier — unii+route 9 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SUSPENSION / TOPICAL	4 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
PEG-75 LANOLIN	PEG-75 LANOLIN	09179OX7TB	AEROSOL / TOPICAL	1.5 %w/w		Exact identifier — unii+route 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-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
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 4%	Rite Aid Corporation	12c4ced7-2ec7-3b07-e054-00144ff88e88	2023-11-06	Warnings	Exact identifier ndc (package): 11822-3678-7 ndc (package): 11822-3678-8 ndc (product): 11822-3678 ndc11 (package): 11822367807 ndc11 (package): 11822367808 spl id: 098117db-ecc3-d9f3-e063-6394a90a05fc spl set id: 12c4ced7-2ec7-3b07-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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