XtraCare Antibacterial Hand Cleanse

Product NDC: 57337-020
11-digit product format: 573370020
Labeler code: 57337
Product ID: 57337-020_126c5107-3eeb-f016-e063-6294a90a07d4
Type: HUMAN OTC DRUG
Nonproprietary name: Triclosan
Dosage form: SOAP
Route: TOPICAL
Labeler: Rejoice International, Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-09-03
Substance: TRICLOSAN
Active strength: 3.3 mg/221mL
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: XtraCare Antibacterial Hand Cleanse
Brand name suffix: Mountain Spring
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRICLOSAN	3.3 mg/221mL

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
1020118	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
c31723d5-a313-448a-8b69-ca5f8dec25ed	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-020-01	2024-02-28	C162847	48780-1	1030e365-3025-111a-e063-dadaa90a10e2	XtraCare Antibacterial Hand Cleanse
57337-020-01	2024-01-30	C162847	48780-1	1030e365-3025-111a-e063-dadaa90a10e2	XtraCare Antibacterial Hand Cleanse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-020-01	XtraCare Antibacterial Hand CleanseMountain Spring	221 mL in 1 BOTTLE	SOAP	221		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRICLOSAN	ACTIVE INGREDIENT	4NM5039Y5X	XTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
TRICLOSAN	ACTIVE MOIETY	4NM5039Y5X	XTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	XTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	XTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	XTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	XTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	XTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	XTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	XTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	XTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
PEG-150 DISTEARATE	INACTIVE INGREDIENT	6F36Q0I0AC	XTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
SODIUM C14-16 OLEFIN SULFONATE	INACTIVE INGREDIENT	O9W3D3YF5U	XTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	XTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	XTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-020	XTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20240229_c31723d5-a313-448a-8b69-ca5f8dec25ed.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 28 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AshleyBelle Moisturizing Hand Sanitizer Coconut Lime	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	4da93596-ec59-1e56-e063-6394a90afceb	2026-03-22	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Island Vanilla	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	4da951ff-37fe-4ca4-e063-6394a90a4baf	2026-03-22	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Pink Sugar	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	4da9cb12-3aaf-c0f9-e063-6394a90ae4a4	2026-03-22	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Bellini Glow	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	4da8a7b6-d147-87c3-e063-6394a90a784c	2026-03-22	Warnings	Exact identifier application number: M003
ALCOHOL PREP AWABS	ISOPROPYL ALCOHOL PATCH	Henan Bingqing Yujie wipes Co., LTD	2e67e417-4dba-73a2-e063-6294a90aa4b2	2026-03-20	Warnings	Exact identifier application number: M003
First Aid Antiseptic	POVIDONE-IODINE	Amazon.com Services LLC	3e2b255c-e3b7-468c-9ac1-b63279c5ac7f	2026-03-20	Warnings, Adverse reactions	Exact identifier application number: M003
MediChoice OB Cleansing	BENZALKONIUM CHLORIDE	O&M HALYARD, INC.	ed38fb97-b67d-430b-8f6b-4fc78c16aead	2026-03-17	Warnings	Exact identifier application number: M003
MedPRIDE	ISOPROPYL ALCOHOL	Shield Line LLC	f2177bd3-259d-4231-88b2-4a98e48e4df6	2026-03-17	Warnings	Exact identifier application number: M003
MedPride 91% Rubbing Alcohol	ISOPROPYL ALCOHOL	Shield Line LLC	e6ffe41e-efdc-0e0a-e053-2995a90a9e6a	2026-03-17	Warnings	Exact identifier application number: M003
MedPRIDE with Wintergreen Oil	ISOPROPYL ALCOHOL	Shield Line LLC	57ac1a5c-758a-4422-8795-40391584434a	2026-03-17	Warnings	Exact identifier application number: M003
NOVITA ISOPROPYL ALCOHOL 50%	ISOPROPYL ALCOHOL	Shield Line LLC	3ad79e91-377d-6587-e054-00144ff8d46c	2026-03-17	Warnings	Exact identifier application number: M003
NOVITA 50% ISOPROPYL RUBBING ALCOHOL W/ WINTERGREEN	ISOPROPYL ALCOHOL	Shield Line LLC	3bd9fc61-b135-51f5-e054-00144ff8d46c	2026-03-17	Warnings	Exact identifier application number: M003
Walgreens Burn Gel Packettes	BURN GEL PACKETTES	Walgreens	3fa09045-d4c0-8119-e063-6394a90ab6a0	2026-03-17	Warnings	Exact identifier application number: M003
Limited Edition Hand Sanitizer Pink Satin Prosecco	ALCOHOL	Scent Theory Products LLC	4d278204-9331-aeb8-e063-6394a90a87a4	2026-03-16	Warnings	Exact identifier application number: M003
Limited Edition Hand Sanitizer Cherry Chai	ALCOHOL	Scent Theory Products LLC	4d27a964-6e91-27c0-e063-6294a90ad994	2026-03-16	Warnings	Exact identifier application number: M003
HealthWise Advanced Hand Sanitizer with Lavender	ETHYL ALCOHOL 70%	Veridian Healthcare	4d144fb3-b4b7-135f-e063-6394a90a366e	2026-03-15	Warnings	Exact identifier application number: M003
Biopure Alcohol Cotton Swabs	ISOPROPYL ALCOHOL, COTTON SWAB	QUEST USA CORP	3a60362b-b397-da15-e063-6394a90a45ff	2026-03-15	Warnings	Exact identifier application number: M003
BIOPURE20CT ANTI BACTERIAL HAND WIPES(2010C)	ANTIBACTERIAL HAND WIPE	Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.	a9318c76-7c41-1634-e053-2a95a90a6d44	2026-03-13	Warnings	Exact identifier application number: M003
Iodine	IODINE	Nice-Pak Products, LLC	857f13fe-51c9-4e5b-b5e2-a981dedabf71	2026-03-12	Warnings, Adverse reactions	Exact identifier application number: M003
Limited Edition Hand Sanitizer Cashmere Skin	ALCOHOL	Scent Theory Products LLC	4cdc4282-eb49-3120-e063-6294a90a2d61	2026-03-12	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
1020118	triclosan 0.15 % Medicated Liquid Soap	PSN	c31723d5-a313-448a-8b69-ca5f8dec25ed	5
1020118	triclosan 1.5 MG/ML Medicated Liquid Soap	SCD	c31723d5-a313-448a-8b69-ca5f8dec25ed	5
1020118	triclosan 0.15 % Medicated Liquid Soap	SY	c31723d5-a313-448a-8b69-ca5f8dec25ed	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-020-01	57337002001	221 mL in 1 BOTTLE (57337-020-01)	221 ml	2013-09-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XtraCare Antibacterial Hand Cleanse	Rejoice International, Inc. \| China Ningbo Shangge Cosmetic Technology Corp.	2024-02-28	HUMAN OTC DRUG LABEL	5