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 11 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Humco Gentian Violet 2%	GENTIAN VIOLET 2%	Humco Holding Group, Inc.	a07f61e5-0215-419a-a68a-1d814417c35f	2026-07-09	Warnings	Exact identifier application number: M003
GNP Gentian Violet 1%	GENTIAN VIOLET 1%	Amerrisource Bergen	5d07274f-e848-6c60-e053-2991aa0a40d8	2026-07-09	Warnings	Exact identifier application number: M003
Drs pharmacy triple antibiotic Pain plus itch plus Scar	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENT	OL PHARMA TECH, LLC	16273878-2f58-0d26-e063-6394a90a47d2	2026-07-09	Warnings	Exact identifier application number: M003
Drs. Pharmacy Triple Antibiotic Plus Pain relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE	OL PHARMA TECH, LLC Drs PHARMACY	1626fa89-cec0-6467-e063-6294a90aa2a4	2026-07-09	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical Mango	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	56148c12-7d6f-26bf-e063-6294a90a93df	2026-07-08	Warnings	Exact identifier application number: M003
Povidone-Iodine	POVIDONE-IODINE	CARDINAL HEALTH 110, LLC. DBA LEADER	4f0d8da5-a75b-acc7-e063-6394a90ae839	2026-07-08	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical Mango	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	5600cf8a-5aba-1a22-e063-6394a90a8083	2026-07-07	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pink Sugar	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	5600dc30-192d-19b1-e063-6394a90a66d3	2026-07-07	Warnings	Exact identifier application number: M003
70%	ISOPROPYL ALCOHOL	Save-A-Lot Food Stores Ltd	a592326c-c062-4ebf-b8dd-83f7e6f2f22b	2026-07-07	Warnings, Adverse reactions	Exact identifier application number: M003
Amazon Basics Citrus Scent Antibacterial Hand Wipes	BENZALKONIUM CHLORIDE	Amazon.com Services LLC	52e5b1a4-3a84-c4cb-e063-6394a90a822c	2026-07-07	Warnings	Exact identifier application number: M003
Amazon Basics Fresh Scent Antibacterial Hand Wipes	BENZALKONIUM CHLORIDE	Amazon.com Services LLC	5256f38a-74b6-0d18-e063-6294a90a5b46	2026-07-07	Warnings	Exact identifier application number: M003
Hand Sanitizer	ETHYL ALCOHOL	EverywhereAire LLC	b48f9e6b-c616-3607-e053-2995a90a37f5	2026-07-06	Warnings	Exact identifier application number: M003
PlaneAire Hands hand sanitizer	ETHYL ALCOHOL	EverywhereAire LLC	b6af3009-78c2-2312-e053-2995a90af90a	2026-07-06	Warnings	Exact identifier application number: M003
Hand Sanitizer gel	ALCOHOL	EverywhereAire LLC	d2a6c866-3f1e-20f1-e053-2995a90a26cc	2026-07-06	Warnings	Exact identifier application number: M003
PlaneAire Hands	HAND SANITIZER ETHANOL-BASED	EverywhereAire LLC	eab3ab67-cb27-6c2b-e053-2a95a90ace12	2026-07-06	Warnings	Exact identifier application number: M003
PlaneAire Hands Sandalwood	ETHANOL HAND SANITIZER	EverywhereAire LLC	18612a10-8667-b0ef-e063-6394a90a208e	2026-07-06	Warnings	Exact identifier application number: M003
PlaneAire Hands	ETHANOL HAND SANITIZER	EverywhereAire LLC	b86824c2-4fae-d597-e053-2995a90ad1da	2026-07-06	Warnings	Exact identifier application number: M003
PlaneAire Hands Lemon Olive Oil Hand Sanitizer	ETHANOL HAND SANITIZER	EverywhereAire LLC	42f8c2fb-a4e6-9416-e063-6294a90af9d5	2026-07-06	Warnings	Exact identifier application number: M003
PlaneAire Hands	HAND SANITIZER ETHANOL BASED	EverywhereAire LLc	eab52ae1-f588-b08b-e053-2995a90a96b2	2026-07-06	Warnings	Exact identifier application number: M003
PlaneAire Hands hand sanitizer	HAND SANITIZER ETHANOL-BASED	EverywhereAire LLC	eab19649-21fc-2fa4-e053-2995a90a90f9	2026-07-06	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