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 45 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Biopure Antibacterial Hand Wipe Berry Strawberry	BENZALKONIUM CHLORIDE	Quest USA Corp	47d6574c-0d4c-392e-e063-6394a90a590f	2026-01-07	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe Vallina Dream	BENZALKONIUM CHLORIDE	Quest USA Corp	47d7090d-036b-870b-e063-6394a90a80c3	2026-01-07	Warnings	Exact identifier application number: M003
99 Plus Hand Sanitizer	BENZEALKONIUM CHLORIDE	Momar Incorporated	f972a8f1-c928-4e4b-a8dd-a2fb77052d21	2026-01-06	Warnings	Exact identifier application number: M003
Benzocaine	BENZOCAINE	Dynarex Corporation	6161e94c-7849-466e-8da3-a6f1b085bdf9	2026-01-06	Warnings	Exact identifier application number: M003
Biopure Anti-bacterial Hand Wipes Fresh Morning Breeze Scent	BENZALKONIUM CHLORIDE	Quest USA Corp	47c105a8-7c76-9cde-e063-6294a90a9284	2026-01-06	Warnings	Exact identifier application number: M003
SPA HAND SANITIZER VANILLA	ETHYL ALCOHOL	Rejoice International Corp.	47c3c187-da54-7c3b-e063-6294a90af3ce	2026-01-06	Warnings	Exact identifier application number: M003
SPA HAND SANITIZER CHAMPAGNE BLASH	ETHYL ALCOHOL	Rejoice International Corp.	47c5e9af-4ea8-fb39-e063-6394a90aa5ab	2026-01-06	Warnings	Exact identifier application number: M003
Antiseptic Cleaning wipe	ANTISEPTIC CLEANING WIPE	SHENZHEN BENLIJU BIO-TECH CO.,LTD	203d01ae-d99e-bce3-e063-6294a90a1a2d	2026-01-05	Warnings	Exact identifier application number: M003
Povidone-lodine prep pad	POVIDONE-LODINE PREP PAD	SHENZHEN BENLIJU BIO-TECH CO.,LTD	201545b8-0697-5601-e063-6394a90a12f4	2026-01-05	Warnings	Exact identifier application number: M003
Sting Relief prep Pad	STING RELIEF PREP PAD	SHENZHEN BENLIJU BIO-TECH CO.,LTD	202c7b77-1a48-52a5-e063-6394a90a2eb2	2026-01-05	Warnings	Exact identifier application number: M003
Skin Cleaning Care Wipes	SKIN CLEANING CARE WIPES	SHENZHEN BENLIJU BIO-TECH CO.,LTD	203d7a95-65fe-ca65-e063-6294a90acc6e	2026-01-05	Warnings	Exact identifier application number: M003
ANTISEPTIC CLEANSING WIPE(0.9% NACL)	ANTISEPTIC CLEANSING WIPE(0.9% NACL)	SHENZHEN BENLIJU BIO-TECH CO.,LTD	33e1c026-8a35-a47a-e063-6294a90a2406	2026-01-05	Warnings	Exact identifier application number: M003
Hand Sanitizing Wipes	HAND SANITIZING WIPES	SHENZHEN BENLIJU BIO-TECH CO.,LTD	37487da6-4e0e-6625-e063-6394a90a0af1	2026-01-05	Warnings	Exact identifier application number: M003
Hand wipes	HAND WIPES	SHENZHEN BENLIJU BIO-TECH CO.,LTD	39f3acca-7275-88ca-e063-6394a90ad1a2	2026-01-05	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Vanilla Heaven	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	47a0781b-9b25-f04b-e063-6294a90ae7e5	2026-01-05	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Berry	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	47a16397-dff3-7d79-e063-6394a90a040f	2026-01-05	Warnings	Exact identifier application number: M003
IDOSWAB B	ISOPROPYL ALCOHOL	IDO PHARM	16d19630-b67a-f3e1-e063-6394a90a7429	2026-01-05	Warnings	Exact identifier application number: M003
Sure Comfort Alcohol Prep Pads	ISOPROPYL ALCOHOL	IDO PHARM	27def94b-d3a6-18b7-e063-6394a90a22a6	2026-01-05	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Lemon Lime	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	47aeaae9-740d-a28a-e063-6294a90a6460	2026-01-05	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Calming Lavender	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	47aeeef9-0eed-e7d0-e063-6394a90a6d31	2026-01-05	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