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 9 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MISTIFY WATERMELON HYDRATING HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	574bf021-6352-e3fc-e063-6394a90ad6de	2026-07-23	Warnings	Exact identifier application number: M003
FRESH THEORY ANTIBACTERIAL HAND WIPES - Vanilla, Strawberry, Fresh	BENZALKONIUM CHLORIDE	Quest USA Corp	5719809b-1c74-4bf3-e063-6294a90ab008	2026-07-23	Warnings	Exact identifier application number: M003
First Aid Antiseptic	POVIDONE-IODINE 5%	Walgreen Company	262ea2c8-f571-1c0b-e063-6394a90af20b	2026-07-22	Warnings	Exact identifier application number: M003
Verifine Alcohol Swabs	ALCOHOL SWABS	Promisemed Hangzhou Meditech Co.,LTD.	5738a502-c5ab-21b0-e063-6294a90a20a7	2026-07-22	Warnings	Exact identifier application number: M003
KeepGoing Sting Relief Pad	BENZOCAINE AND ISOPROPYL ALCOHOL	J&A Digital Inc.	a630db1b-1674-4659-a60f-56994b0a1564	2026-07-22	Warnings	Exact identifier application number: M003
KeepGoing Alcohol Prep Pad	ISOPROPYL ALCOHOL	J&A Digital Inc.	5d1e776b-4027-4d05-b02f-8a2701d7bc7a	2026-07-22	Warnings	Exact identifier application number: M003
KeepGoing Non Sting Cleaning Wipe	BENZALKONIUM CHLORIDE	J&A Digital Inc.	1a6303ce-8df7-4e8b-93f2-e162fdd2540c	2026-07-22	Warnings	Exact identifier application number: M003
Lights Povidone Iodine Swabsticks	POVIDONE-IODINE	Lights Medical Manufacture Co., Ltd.	664bbf9f-650a-45fd-b9b8-d93f0ba63190	2026-07-22	Warnings	Exact identifier application number: M003
DOCTOR INKS TOPICAL ANTISEPTIC	BENZALKONIUM CHLORIDE	Enviro Specialty Chemicals Inc	d503a2db-e326-4a31-bc6a-5034ad74bf0b	2026-07-21	Warnings	Exact identifier application number: M003
MY-SHIELD TOPICAL ANTISEPTIC	BENZALKONIUM CHLORIDE	Enviro Specialty Chemicals Inc	c2c1f5d9-cd6e-4314-9dfc-961ed877c293	2026-07-21	Warnings	Exact identifier application number: M003
Germ Free Topical Antiseptic	BENZALKONIUM CHLORIDE	Enviro Specialty Chemicals Inc	5e004412-1797-4cbf-83e3-7001286ad157	2026-07-21	Warnings	Exact identifier application number: M003
Midnight Magic Hand Sanitizer	ALCOHOL	Scent Theory Products LLC	5721d186-ec6d-fa26-e063-6294a90a76d2	2026-07-21	Warnings	Exact identifier application number: M003
McKesson PVP Prep Solution	POVIDONE-IODINE	McKesson Medical-Surgical	33fa233c-b43c-42d8-af37-a58f098a0d51	2026-07-21	Warnings	Exact identifier application number: M003
Twisted Caramel Apple Hand Sanitizer	ALCOHOL	Scent Theory Products LLC	572a82e3-93ec-9af4-e063-6294a90a9c26	2026-07-21	Warnings	Exact identifier application number: M003
Molten Marshmallow Hand Sanitizer	ALCOHOL	Scent Theory Products LLC	572aa67e-52f7-b424-e063-6394a90ac4ae	2026-07-21	Warnings	Exact identifier application number: M003
FRESH THEORY ANTIBACTERIAL HAND WIPES FRESH AND FRUITY	BENZALKONIUM CHLORIDE	Quest USA Corp	57135b3f-884d-1a03-e063-6294a90ae3e9	2026-07-20	Warnings	Exact identifier application number: M003
FRESH THEORY ANTIBACTERIAL HAND WIPES - PEACH PROSECCO	BENZALKONIUM CHLORIDE	Quest USA Corp	571709fb-ca50-f7b1-e063-6394a90a8d35	2026-07-20	Warnings	Exact identifier application number: M003
FRESH THEORY ANTIBACTERIAL HAND WIPES - TROPICAL ESCAPE	BENZALKONIUM CHLORIDE	Quest USA Corp	57180e7a-1134-9ecd-e063-6294a90af5bf	2026-07-20	Warnings	Exact identifier application number: M003
Biopure 70% Isopropyl Alcohol Wipe	ISOPROPYL ALCOHOL, WIPE	QUEST USA CORP	3a7932c4-6f90-a008-e063-6294a90aa769	2026-07-19	Warnings	Exact identifier application number: M003
Urgent First Aid BZK Antiseptic Wipe	BENZALKONIUM CHLORIDE	Changzhou Maokang Medical Products Co., Ltd	5701c813-4346-a727-e063-6294a90a8e05	2026-07-19	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