XtraCare Antibacterial Hand Cleanse

Manufacturer: Rejoice International, Inc. | China Ningbo Shangge Cosmetic Technology Corp.
Effective date: 2024-02-28
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:09:09

Label at a glance#

ProductXtraCare Antibacterial Hand Cleanse Original

Active ingredientTRICLOSAN

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Triclosan 0.15%........................Antibacterial

OTC - PURPOSE SECTION

Antibacterial Moisturizing Hand Soap

Original

Kills the germs
Eliminates bacteria on hands
Moisturizes the skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Uses

for hand washing to decrease bacteria on the skin.

WARNINGS SECTION

Warnings

for external use only.

When using this product avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if irritation and redness develops.

DOSAGE & ADMINISTRATION SECTION

Directions

pump into hands
lather vigorously for at least 15 seconds
rinse and dry thoroughly.

INACTIVE INGREDIENT SECTION

water, sodium c14-16 olefin sulfonate, sodium laureth sulfate, cocamide DEA, sodium chloride, PEG-150 distearate, fragrance, citric acid, glycerin, disodium EDTA, aloe barbadensis leaf juice, methylchloroisothiazolinone, methylisothiazolinone, fd&c yellow no.5, d&c red no. 33.

OTHER SAFETY INFORMATION

Other Information

store at room temperature

DISTRIBUTED BY:

REJOICE INTERNATIONAL, INC.

48325 BINGHAMPTON DR.,

NORTHVILLE, MI 48168, USA

MADE IN CHINA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1020118	triclosan 0.15 % Medicated Liquid Soap	PSN	5
1020118	triclosan 1.5 MG/ML Medicated Liquid Soap	SCD	5
1020118	triclosan 0.15 % Medicated Liquid Soap	SY	5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-021-01	2024-02-28	C162847	48780-1	1030e365-2d71-111a-e063-dadaa90a10e2	XtraCare Antibacterial Hand Cleanse
57337-021-01	2024-01-30	C162847	48780-1	1030e365-2d71-111a-e063-dadaa90a10e2	XtraCare Antibacterial Hand Cleanse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-021-01	XtraCare Antibacterial Hand CleanseOriginal	221 mL in 1 BOTTLE	SOAP	221		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-021	XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20240229_b5ce6663-fe82-4da1-923e-acea293d7a00.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TRICLOSAN	ACTIVE INGREDIENT	4NM5039Y5X	3
TRICLOSAN	ACTIVE MOIETY	4NM5039Y5X	3
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	3
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	3
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	3
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	3
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	3
PEG-150 DISTEARATE	INACTIVE INGREDIENT	6F36Q0I0AC	3
SODIUM C14-16 OLEFIN SULFONATE	INACTIVE INGREDIENT	O9W3D3YF5U	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	3
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

XtraCare Antibacterial Hand Cleanse Original
Triclosan
WATER
SODIUM C14-16 OLEFIN SULFONATE
SODIUM LAURETH SULFATE
COCO DIETHANOLAMIDE
PEG-150 DISTEARATE
SODIUM CHLORIDE
CITRIC ACID MONOHYDRATE
GLYCERIN
EDETATE DISODIUM
ALOE VERA LEAF
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
FD&C YELLOW NO. 5
D&C RED NO. 33

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57337-021	57337-021-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
SODIUM C14-16 OLEFIN SULFONATE	O9W3D3YF5U	IACT
SODIUM LAURETH SULFATE	BPV390UAP0	IACT
COCO DIETHANOLAMIDE	92005F972D	IACT
PEG-150 DISTEARATE	6F36Q0I0AC	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
GLYCERIN	PDC6A3C0OX	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
METHYLCHLOROISOTHIAZOLINONE	DEL7T5QRPN	IACT
METHYLISOTHIAZOLINONE	229D0E1QFA	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
TRICLOSAN	4NM5039Y5X	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 52 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	OINTMENT / TOPICAL		1 mg	Exact identifier — unii+route 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii+route 22 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SHAMPOO / TOPICAL		600 mg	Exact identifier — unii+route 10 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOAP / TOPICAL	0.5 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii+route 22 equally ranked IID candidates
SODIUM LAURETH SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	CREAM / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SOLUTION / TOPICAL	2.5 %w/v		Exact identifier — unii+route 10 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii+route 22 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO / TOPICAL	1 %w/w		Exact identifier — unii+route 22 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	SHAMPOO / TOPICAL	NA		Exact identifier — unii+route 2 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii+route 22 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SOLUTION / TOPICAL	2.5 %w/v		Exact identifier — unii+route 10 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SHAMPOO / TOPICAL		600 mg	Exact identifier — unii+route 10 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SUSPENSION / TOPICAL	4 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
SODIUM LAURETH SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	CREAM / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOAP / TOPICAL	0.5 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	POWDER / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
SODIUM LAURETH SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	SHAMPOO / TOPICAL		3192 mg	Exact identifier — unii+route 6 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii+route 22 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii+route 22 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOAP / TOPICAL	1.26 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii+route 22 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii+route 22 equally ranked IID candidates
SODIUM LAURETH SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	SPRAY / TOPICAL	0.1 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
SODIUM LAURETH SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	SPRAY / TOPICAL	0.1 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii+route 22 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii+route 22 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii+route 22 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii+route 22 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	CREAM / TOPICAL		30 mg	Exact identifier — unii+route 10 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii+route 22 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	SHAMPOO / TOPICAL	NA		Exact identifier — unii+route 2 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO / TOPICAL	1 %w/w		Exact identifier — unii+route 22 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOAP / TOPICAL	1.26 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	CREAM / TOPICAL		30 mg	Exact identifier — unii+route 10 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii+route 22 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii+route 22 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	OINTMENT / TOPICAL		1 mg	Exact identifier — unii+route 22 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii+route 22 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii+route 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	POWDER / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SUSPENSION / TOPICAL	4 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii+route 22 equally ranked IID candidates
SODIUM LAURETH SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	SHAMPOO / TOPICAL		3192 mg	Exact identifier — unii+route 6 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XtraCare Antibacterial Hand Cleanse Original	TRICLOSAN	Rejoice International, Inc.	b5ce6663-fe82-4da1-923e-acea293d7a00	2024-02-28	Warnings	Exact identifier ndc (package): 57337-021-01 ndc (product): 57337-021 ndc11 (package): 57337002101 spl id: 126c392a-2f26-cd97-e063-6294a90a4f99 spl set id: b5ce6663-fe82-4da1-923e-acea293d7a00

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.