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 109 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RevitaDERM Wound Care	BENZALKONIUM CHLORIDE	Blaine Labs Inc.	9254dada-4e32-43a0-892b-c488d68e23e7	2023-12-21	Warnings	Exact identifier application number: M003
NUMSTAT Antiseptic and Pain Relieving Prep Pad	ALCOHOL, MENTHOL, AND BENZOCAINE PREP PAD	Spectra Medical Devices, LLC	07d20040-9dd9-0aba-e063-6294a90ab7cf	2023-12-20	Warnings	Exact identifier application number: M003
Health Mart Iodides	ALCOHOL	Strategic Sourcing Services LLC	8d9f2112-c678-4559-b567-9d6d287c5fa3	2023-12-20	Warnings	Exact identifier application number: M003
Health Mart Iodine Tincture Mild	IODINE AND SODIUM IODIDE AND ALCOHOL	Strategic Sourcing Services LLC	72eeb3e6-c0a1-4b18-87f1-8db06f9bd111	2023-12-20	Warnings	Exact identifier application number: M003
Health Mart Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Strategic Sourcing Services LLC	cbe02fa1-c167-4b77-8f63-817362090e19	2023-12-20	Warnings	Exact identifier application number: M003
Health Mart Isopropyl Alcohol 91 Percent	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	fbd2aa69-b1c7-4a28-9642-a436ae09faaf	2023-12-20	Warnings	Exact identifier application number: M003
Quality Choice Povidone Iodine	POVIDONE IODINE 10%	Chain Drug Market Association	9fa49a3c-ad09-4d35-8cd9-e1a0f2da0d2d	2023-12-20	Warnings	Exact identifier application number: M003
Quality Choice Iodine Tincture Mild	IODINE AND SODIUM IODIDE AND ALCOHOL	Chain Drug Market Association	55c970ed-13a9-4ea2-a8cb-aaf14d3a214d	2023-12-20	Warnings	Exact identifier application number: M003
Quality Choice Iodides Tincture	ETHYL ALCOHOL	Chain Drug Market Association	71aedfd5-e81f-4b69-b163-527ff1ce30b1	2023-12-20	Warnings	Exact identifier application number: M003
Quality Choice Merthiolate	BENZALKONIUM CHLORIDE	Chain Drug Market Association	5b7303b9-b8c4-4e7c-876f-70ed76443055	2023-12-20	Warnings	Exact identifier application number: M003
Premier Value Povidone Iodine	POVIDONE IODINE 10%	Chain Drug Consortium	5cc9d782-5f7e-27d9-e053-2991aa0a2428	2023-12-20	Warnings	Exact identifier application number: M003
Harris Teeter Iodine Tincture Mild	IODINE AND SODIUM IODIDE AND ALCOHOL	Harris Teeter, LLC	5c88d7cb-2917-54e9-e053-2991aa0a0bd9	2023-12-20	Warnings	Exact identifier application number: M003
CVS Iodine	IODINE, SODIUM IODIDE AND ALCOHOL	CVS Pharmacy	b11db4e5-6a6d-4d4a-b980-600692b54176	2023-12-20	Warnings	Exact identifier application number: M003
CVS Povidone-Iodine	POVIDONE IODINE	CVS Pharmacy	402d571f-e1e8-43fd-9e7b-05aab1837905	2023-12-20	Warnings	Exact identifier application number: M003
Sanitizing wipes with aloe Grapefruit Grove	ALCOHOL	The Honest Company	faa3690b-ce0d-43d4-9e5c-f2ce77daabe7	2023-12-19	Warnings	Exact identifier application number: M003
Sanitizing Wipes Fragrance Free	ALCOHOL	The Honest Company	0ce3e7ee-aa50-16bc-e063-6294a90a527d	2023-12-19	Warnings	Exact identifier application number: M003
sunmark Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	46da2750-37d1-4ed1-baf3-1fd426617567	2023-12-19	Warnings	Exact identifier application number: M003
Sunmark Iodine	IODINE, SODIUM IODIDE, ALCOHOL	Strategic Sourcing Services LLC	e8dae2d6-58b1-4c4e-a4c1-371db055b7ae	2023-12-19	Warnings	Exact identifier application number: M003
Sunmark Isopropyl Alcohol 70 Percent With Wintergreen Oil	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	515dd733-1b44-4df0-928f-a3b202b5f9c2	2023-12-19	Warnings	Exact identifier application number: M003
Sunmark Isopropyl Alcohol 91 Percent	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	92afb1ce-6a9e-456e-b3ee-e8a8d93ebc5e	2023-12-19	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