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 69 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 Cherry Blossom 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	2869cb20-9cd4-54f5-e063-6294a90a5fea	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Vanilla Sugar 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	28694168-3362-de4f-e063-6394a90a2e35	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care Cucumber Melon Hand Sanitizer	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3e0a5382-7b58-fd6e-e063-6394a90abf66	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Watermelon	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3e09c0aa-0241-0816-e063-6294a90a481e	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care Sweet Pea Hand Sanitizer sweet pea 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3080d8a2-a780-e79b-e063-6294a90ac654	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care 1oz Hand Sanitizer Japanese Cherry Blossom 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3081e1b5-66b4-77a8-e063-6394a90a8dd3	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care 1oz Hand Sanitizer Island Mango 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	30847dd5-e378-1a35-e063-6294a90a43da	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care 1oz Hand Sanitizer Vanilla Heaven 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3084d980-29ca-91ca-e063-6294a90a6c67	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer 3pk 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3099e6af-8072-d26b-e063-6394a90a39ef	2025-09-05	Warnings	Exact identifier application number: M003
Povidone Iodine Prep	POVIDONE IODINE	Sion Biotext Medical Ltd	e05af551-647d-4278-bb7f-86f888ddbb8b	2025-09-04	Warnings	Exact identifier application number: M003
X3 Clean	BENZALKONIUM CHLORIDE	X3 Labs Inc.	a8eedcfd-3b97-497a-9a34-d59b0dd78439	2025-09-03	Warnings	Exact identifier application number: M003
X3 Clean	BENZALKONIUM CHLORIDE	X3 Labs Inc.	40cc6501-3cee-24cc-e054-00144ff88e88	2025-09-03	Warnings	Exact identifier application number: M003
5OCT ANTIBACTERL HAND WIPES	5OCT ANTIBACTERL HAND WIPES	Jinhua Aidi Daily Chemical Co., Ltd.	3dbd8ca9-1ca0-ac4f-e063-6394a90a3cfa	2025-09-01	Warnings	Exact identifier application number: M003
AeroWipe	STING RELIEF PAD	Aero Healthcare US LLC	3d851c98-c9b9-f084-e063-6294a90acde2	2025-08-29	Warnings	Exact identifier application number: M003
wet wipes 01	BENZALKONIUM CHLORIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	3d3d7e8b-1ec1-9f9f-e063-6294a90ade0e	2025-08-25	Warnings	Exact identifier application number: M003
Solar Flare Hand Sanitizer Brazilian Caramel Dreams	ALCOHOL	Scent Theory Products LLC	3d0d4ccf-ea31-cab2-e063-6294a90a4c69	2025-08-23	Warnings	Exact identifier application number: M003
Solar Flare Hand Sanitizer Sunset Samba	ALCOHOL	Scent Theory Products LLC	3d0d7d6b-33a0-5cd1-e063-6394a90ac8f6	2025-08-23	Warnings	Exact identifier application number: M003
Solar Flare Hand Sanitizer Set Sea Veil, Pink Glow, Coco Creme	ALCOHOL	Scent Theory Products LLC	3d0d7e73-8a83-9577-e063-6294a90aff6c	2025-08-23	Warnings	Exact identifier application number: M003
Burn Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Trifecta Pharmaceuticals USA LLC	fe439c60-5a02-648f-e053-6294a90a1403	2025-08-23	Warnings	Exact identifier application number: M003
OP-First Aid Series ALCOHOL PREP PADS STERILE	ISOPROPYL ALCOHOL CLOTH	Yiwu Ori-Power Medtech Co.,Ltd.	351f4b1e-75c9-abec-e063-6294a90a2875	2025-08-22	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