XtraCare Antibacterial Hand Cleanse

Product NDC: 57337-023
11-digit product format: 573370023
Labeler code: 57337
Product ID: 57337-023_126c40d2-9d18-e72a-e063-6294a90ad790
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: 2013-08-30
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: Strawberry Pomegranate
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
b68a7d64-2650-4fc6-a89e-05de9098a2a3	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-023-01	2024-02-28	C162847	48780-1	1030e365-0bcf-111a-e063-dadaa90a10e2	XtraCare Antibacterial Hand Cleanse
57337-023-01	2024-01-30	C162847	48780-1	1030e365-0bcf-111a-e063-dadaa90a10e2	XtraCare Antibacterial Hand Cleanse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-023-01	XtraCare Antibacterial Hand CleanseStrawberry Pomegranate	221 mL in 1 BOTTLE	SOAP	221		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRICLOSAN	ACTIVE INGREDIENT	4NM5039Y5X	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
TRICLOSAN	ACTIVE MOIETY	4NM5039Y5X	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
PEG-150 DISTEARATE	INACTIVE INGREDIENT	6F36Q0I0AC	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
SODIUM C14-16 OLEFIN SULFONATE	INACTIVE INGREDIENT	O9W3D3YF5U	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-023	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	6	Current NDC, Legacy NDC, 1 package rows	20240229_b68a7d64-2650-4fc6-a89e-05de9098a2a3.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 104 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nourishing Hand Sanitizer Limon	ALCOHOL	Noshinku	d70fba7a-513f-0341-e053-2a95a90add86	2024-05-15	Warnings	Exact identifier application number: M003
Nourishing Hand Sanitizer Vetiver	ALCOHOL	Noshinku	d70fb84c-fdbc-6ba8-e053-2995a90ab529	2024-05-15	Warnings	Exact identifier application number: M003
Safly BZK Antiseptic Towelette	BENZALKONIUM CHLORIDE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	5cd9043e-daf2-43eb-9568-54775fc4f84a	2024-05-15	Warnings	Exact identifier application number: M003
Noshinku Bergamot Hand Sanitizer	ALCOHOL	Noshinku	53fea81e-4482-6fae-e054-00144ff8d46c	2024-05-14	Warnings	Exact identifier application number: M003
Noshinku Eucalyptus Hand Sanitizer	ALCOHOL	Noshinku	9dcb8b51-d1bb-4305-a5ff-8cc8bdcdc4c0	2024-05-14	Warnings	Exact identifier application number: M003
Noshinku Lavender Hand Sanitizer	ALCOHOL	Noshinku	a57e44b2-f5fa-4c3c-a59c-aa73bfbb66cf	2024-05-14	Warnings	Exact identifier application number: M003
LEADER 2% Mild Iodine Tincture	IODINE AND SODIUM IODIDE AND ALCOHOL LIQUID	Cardinal Health, 110 dba Leader	7f810b92-60f6-2f72-e053-2991aa0ab973	2024-05-13	Warnings	Exact identifier application number: M003
Leader Decolorized Iodine	ALCOHOL LIQUID	Cardinal Health, 110 dba Leader	822f6f28-956f-dd82-e053-2991aa0ae752	2024-05-13	Warnings	Exact identifier application number: M003
Inverness Ear Care	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	180a2995-334c-2e93-e063-6294a90aecf7	2024-05-09	Warnings	Exact identifier application number: M003
Helzberg Diamonds Ear Care	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	180a3776-0edd-26f3-e063-6294a90a740d	2024-05-09	Warnings	Exact identifier application number: M003
Ulta Beauty Ear Care	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	180a37f4-8718-3e40-e063-6294a90acaad	2024-05-09	Warnings	Exact identifier application number: M003
Guardian Vaginal	BENZALKONIUM CHLORIDE	Eastern Century Pharmaceuticals	1605ba44-02b7-4c72-9fec-89a5aa962b44	2024-04-24	Warnings	Exact identifier application number: M003
Inverness Hygienic Ear Care Antiseptic	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	0ccd72e7-16a2-47c7-9ce6-dffb63a0344b	2024-04-18	Warnings	Exact identifier application number: M003
Lovisa Piercing Care Solution	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	74f46b81-cc5b-4e3f-a36e-0bd86d370c22	2024-04-18	Warnings	Exact identifier application number: M003
CliniClean BZK Cleansing Contains Benzalkonium Chloride	BENZALKONIUM CHLORIDE	HR HealthCare	b6916466-0931-408f-a430-0797a449c32e	2024-04-18	Warnings	Exact identifier application number: M003
Handy Solutions First Aid Kit	BENZALKONIUM CHLORIDE	Navajo Manufacturing Company Inc.	130237ff-3db4-1288-e063-6394a90ab1af	2024-04-16	Warnings	Exact identifier application number: M003
BZK	BENZALKONIUM CHLORIDE	Henry Schein Inc.	ff877b63-fa58-4770-a882-694eda33203b	2024-04-02	Warnings	Exact identifier application number: M003
First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine Hydrochloride	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	M-star (Hubei) Health&Care Products Co., Ltd.	8e1f35ff-d4e6-4940-ad8f-dce2b73e595d	2024-04-01	Warnings	Exact identifier application number: M003
Antiseptic Towelette TOALLITAS ANTISEPTICAS	BENZALKONIUM CHLORIDE	M-star (Hubei) Health&Care Products Co., Ltd.	b267e186-cf7a-458f-9c28-a48a8554af40	2024-04-01	Warnings	Exact identifier application number: M003
Antiseptic Povidone Iodine Prep Pad	POVIDONE-IODINE	M-star (Hubei) Health&Care Products Co., Ltd.	fc76c1f3-b48e-4276-890d-5b8e5a894e62	2024-04-01	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	b68a7d64-2650-4fc6-a89e-05de9098a2a3	6
1020118	triclosan 1.5 MG/ML Medicated Liquid Soap	SCD	b68a7d64-2650-4fc6-a89e-05de9098a2a3	6
1020118	triclosan 0.15 % Medicated Liquid Soap	SY	b68a7d64-2650-4fc6-a89e-05de9098a2a3	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-023-01	57337002301	221 mL in 1 BOTTLE (57337-023-01)	221 ml	2013-08-30	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	6