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 37 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Smart Care Hand Sanitizer Citrus Sunset	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	49f67a60-a6d8-0aa4-e063-6394a90a9859	2026-02-03	Warnings	Exact identifier application number: M003
WIPES4HEALTH	BENZALKONIUM CHLORIDE	Bubble Marketing LLC	5d6dd15b-d087-4f25-bd2b-035ecacd5f97	2026-02-03	Warnings	Exact identifier application number: M003
Isopropyl alcohol	ISOPROPYL ALCOHOL	Concordance Healthcare Solutions, LLC	1c051d6a-61a8-4a75-aeb6-7c1258bda2b2	2026-02-02	Warnings, Adverse reactions	Exact identifier application number: M003
Dealmed Sterile Alcohol Prep Pads Large	ISOPROPYL ALCOHOL	Dealmed Medical Supplies, LLC.	75908e89-abd9-4760-bd11-fb71133ae2c0	2026-02-02	Warnings	Exact identifier application number: M003
Dealmed Sterile Alcohol Prep Pads Medium	ISOPROPYL ALCOHOL	Dealmed Medical Supplies, LLC.	0cdfc6b4-7d66-4333-b38d-c465d4864b5c	2026-02-02	Warnings	Exact identifier application number: M003
Medline	POVIDONE-IODINE	Medline Industries, LP	494d7e97-a3a8-2c7a-e063-6394a90a3ae1	2026-02-02	Warnings	Exact identifier application number: M003
Aplicare	ISOPROPYL ALCOHOL	Aplicare Products, LLC	4950e07f-36a5-b6f5-e063-6294a90a8f98	2026-02-02	Warnings	Exact identifier application number: M003
RELEEV Cold Sore Treatment	BENZALKONIUM CHLORIDE	Merix Pharmaceutical Corp.	fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf	2026-02-02	Warnings	Exact identifier application number: M003
WISH RUBBING ALCOHOL 91%	ISOPROPYL ALCOHOL	LJ Pharma	07cba887-a568-4b92-91ab-2e7831f24ab5	2026-01-30	Warnings	Exact identifier application number: M003
First Aid Antiseptic	POVIDONE-IODINE	Rite Aid Corporation	2f8abb6f-460f-47bf-811d-734126aa3f0b	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Rite Aid Corporation	c074bbaf-2fd7-485a-9e22-a368d8dd4701	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M003
Drs. pharmacy triple antibiotic plus lidocaine	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, LIDOCAINE OINTMENT	OL PHARMA TECH, LLC	49a73b0f-90d9-3a4b-e063-6294a90acfb0	2026-01-30	Warnings	Exact identifier application number: M003
HAND SANITIZER WIPES	HAND SANITIZER WIPES	Shandong Baihe Sanitary Products Co., Ltd.	49822c99-1181-ae42-e063-6394a90a8202	2026-01-29	Warnings	Exact identifier application number: M003
WISH RUBBING ALCOHOL 50%	ISOPROPYL ALCOHOL	LJ Pharma	15b4a45d-3dbf-48e4-8f90-15dca7e650d9	2026-01-29	Warnings	Exact identifier application number: M003
WISH RUBBING ALCOHOL 50% Winter Green	ISOPROPYL ALCOHOL	LJ Pharma	fbb45bde-b733-4524-bfa9-ae819ad39973	2026-01-29	Warnings	Exact identifier application number: M003
Walmart	ISOPROPYL ALCOHOL	Walmart Inc.	1d75799d-081e-a38b-e063-6294a90adf35	2026-01-29	Warnings	Exact identifier application number: M003
Liquid Bandage	BENZETHONIUM CHLORIDE AND DYCLONINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	f3911d79-3169-71c3-e053-2a95a90ae843	2026-01-29	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Amerifoods Trading Co	38b15693-7e5f-4c85-915e-9937ea018a83	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M003
IRIS	ISOPROPYL ALCOHOL	Amerifoods Trading Co	100e0c3d-96eb-44af-8684-df45a8ab3065	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M003
First Aid Antiseptic	FIRST AID ANTISEPTIC	Amerisource Bergen	6719db46-a6e3-4f0a-828c-fe89a5187989	2026-01-29	Warnings, Adverse reactions	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