Liquid Hand Cleanse

Product NDC: 57337-016
11-digit product format: 573370016
Labeler code: 57337
Product ID: 57337-016_126c392a-2f25-cd97-e063-6294a90a4f99
Type: HUMAN OTC DRUG
Nonproprietary name: Triclosan
Dosage form: GEL
Route: TOPICAL
Labeler: Rejoice International, Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-07-05
Substance: TRICLOSAN
Active strength: 10 mg/500mg
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Liquid Hand Cleanse
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRICLOSAN	10 mg/500mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4NM5039Y5X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
413246	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
23ff5450-8308-41c0-9052-1ac4c4433d6c	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-016-01	2024-02-29	C162847	48780-1	1030e365-4af0-111a-e063-dadaa90a10e2	Liquid Hand Cleanse
57337-016-01	2024-01-30	C162847	48780-1	1030e365-4af0-111a-e063-dadaa90a10e2	Liquid Hand Cleanse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-016-01	Liquid Hand Cleanse	500 mg in 1 BOTTLE	GEL	500		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRICLOSAN	ACTIVE INGREDIENT	4NM5039Y5X	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
TRICLOSAN	ACTIVE MOIETY	4NM5039Y5X	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
CETETH-7	INACTIVE INGREDIENT	4ST6952Q67	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
DIETHANOLAMINE	INACTIVE INGREDIENT	AZE05TDV2V	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
ETHYL SULFATE	INACTIVE INGREDIENT	P3LK0HF3B7	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
OCTHILINONE	INACTIVE INGREDIENT	4LFS24GD0V	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-016	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240301_23ff5450-8308-41c0-9052-1ac4c4433d6c.zip

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 112 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Septihol Hand Sanitizer	ALCOHOL	STERIS Corporation	279c5c6f-bf45-499f-a5a2-ddb535382146	2023-12-06	Warnings	Exact identifier application number: M003
Zany Antiseptic Gel	ALCOHOL	Laboratorios Zepol S.A.	ee085cb5-0ebf-498c-b622-b2c29d34bb9b	2023-12-01	Warnings	Exact identifier application number: M003
Prep Pad Sterile	POVIDONE-IODINE	Changzhou Maokang Medical Products Co., Ltd	758abf53-ad8a-62ac-e053-2991aa0a8f0c	2023-11-15	Warnings	Exact identifier application number: M003
FIRSTAR Alcohol Prep Pad	ISOPROPYL ALCOHOL	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	49a86020-b888-423f-99a5-02fa938105ec	2023-11-15	Warnings	Exact identifier application number: M003
CVS Health Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	CVS Health	4678074a-16f1-5480-e054-00144ff8d46c	2023-11-10	Warnings	Exact identifier application number: M003
Care One 70 Isopropyl Alcohol Wipes	ISOPROPYL ALCOHOL	Ahold U.S.A., Inc.	607b6917-2880-4b1c-83c6-f1297a828ecc	2023-11-10	Warnings	Exact identifier application number: M003
Topcare 3 Hydrogen Peroxide Wipes	HYDROGEN PEROXIDE	Topco Associates LLC	dc4b07b6-6476-4e32-901a-da8115d6a197	2023-11-10	Warnings	Exact identifier application number: M003
Topcare 70 Isopropyl Alcohol Wipes	ISOPROPYL ALCOHOL	Topco Associates LLC	bf9ee7da-69d9-47a2-8748-6b978ca3c298	2023-11-10	Warnings	Exact identifier application number: M003
MK Alcohol Swabstick Sterile	ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd	40c7cfc6-ef3b-4759-b9e9-6d7e1319a847	2023-11-09	Warnings	Exact identifier application number: M003
BZK Antiseptic Wipe	BENZALKONIUM CHLORIDE	Changzhou Maokang Medical Products Co., Ltd	fe5eb694-4b1b-4c47-95d5-6074155c438a	2023-11-09	Warnings	Exact identifier application number: M003
Leader Alcohol 70 Isopropyl Alcohol	ISOPROPYL ALCOHOL	Cardinal Health	4b5d50cb-a8b4-4997-a8dd-26506c4cdc6d	2023-11-09	Warnings	Exact identifier application number: M003
BZK Cleansing Swabsticks 4 Triple	BENZALKONIUM CHLORIDE	Changzhou Maokang Medical Products Co., Ltd	52c74f75-d7ef-481b-b580-fba402d03d75	2023-11-09	Warnings	Exact identifier application number: M003
MK Alcohol Swabstick Sterile	ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd	48d198f0-d505-4e45-b7c9-dd70658fd5fa	2023-11-09	Warnings	Exact identifier application number: M003
Maokang 3 Hydrogen Peroxide	HYDROGEN PEROXIDE	Changzhou Maokang Medical Products Co., Ltd	b4b478b9-426d-4864-a64c-31de9bbf5dc3	2023-11-09	Warnings	Exact identifier application number: M003
MK Sting Relief Pads	BENZOCAINE, ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd	1a60dd1b-0116-42a2-a501-4f74e326a2e9	2023-11-09	Warnings	Exact identifier application number: M003
terrasil First Aid Antiseptic Wound and Burn Care Kit	HEXYLRESORCINOL	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	5ddb84e9-cdf7-4034-acd2-625f8d6e4601	2023-11-08	Warnings	Exact identifier application number: M003
Inverness Ear Piercing	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	bcec8099-939b-4cff-b388-f4046164f2d4	2023-11-08	Warnings	Exact identifier application number: M003
Hygienic Ear Care Antiseptic	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	98b70f22-cd53-e61b-e053-2995a90a730d	2023-11-06	Warnings	Exact identifier application number: M003
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	Degasa, S.A. de C.V.	b4145aa4-d810-4c20-8493-311a7e222eb9	2023-11-05	Warnings	Exact identifier application number: M003
HYDROGEN PEROXIDE	HYDROGEN PEROXIDE	DEGASA SA DE CV	26bae595-6e76-4946-b98f-1aba2e69250d	2023-11-05	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4NM5039Y5X	TRICLOSAN	3380-34-5	TRICLOSAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
413246	triclosan 0.2 % Medicated Liquid Soap	PSN	23ff5450-8308-41c0-9052-1ac4c4433d6c	3
413246	triclosan 2 MG/ML Medicated Liquid Soap	SCD	23ff5450-8308-41c0-9052-1ac4c4433d6c	3
413246	triclosan 0.2 % Medicated Liquid Soap	SY	23ff5450-8308-41c0-9052-1ac4c4433d6c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-016-01	57337001601	500 mg in 1 BOTTLE (57337-016-01)	500 mg	2013-07-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Liquid Hand Cleanse	Rejoice International, Inc. \| China Ningbo Shangge Cosmetic Technology Corp.	2024-02-28	HUMAN OTC DRUG LABEL	3