XtraCare Hand Sanitizer

Product NDC: 57337-043
11-digit product format: 573370043
Labeler code: 57337
Product ID: 57337-043_126db003-135c-0ecb-e063-6394a90a1742
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: Rejoice International
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-01-24
Substance: ALCOHOL
Active strength: 146 g/236g
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 Hand Sanitizer
Brand name suffix: Moisturize with Vitamin E
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALCOHOL	146 g/236g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3K9958V90M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
581660	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
13c99570-0859-4310-843a-5eb266698eb3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-043-01	2024-02-28	C162847	48780-1	1030e365-53fd-111a-e063-dadaa90a10e2	XtraCare Hand Sanitizer
57337-043-01	2024-01-30	C162847	48780-1	1030e365-53fd-111a-e063-dadaa90a10e2	XtraCare Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-043-01	XtraCare Hand SanitizerMoisturize with Vitamin E	236 g in 1 BOTTLE	GEL	236		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
ALCOHOL	ACTIVE MOIETY	3K9958V90M	XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-043	XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	3	Current NDC, Legacy NDC, 1 package rows	20240229_13c99570-0859-4310-843a-5eb266698eb3.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 105 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Novex Hand Sanitizer	BENZALKONIUM CHLORIDE	Natural Essentials, Inc.	8b53dde5-c9f6-41c4-8ddb-bf0bf67008d3	2024-03-20	Warnings	Exact identifier application number: M003
Antiseptic	BENZALKONIUM CHLORIDE 0.13%	Trifecta Pharmaceuticals USA, LLC.	13f1c70f-3b44-8eef-e063-6294a90af634	2024-03-18	Warnings	Exact identifier application number: M003
Burn Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Trifecta Pharmaceuticals USA LLC	1308ce91-2858-310a-e063-6394a90a6810	2024-03-06	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer - Cocoa Butter	ETHYL ALCOHOL	Rejoice International, Inc.	97dee45e-53be-4b37-a427-fc24388c0e05	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer Aloe Vera	ETHYL ALCOHOL	Rejoice International, Inc.	1e28454c-f5d8-4d6e-91f9-bc4501b027c1	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer - Clear	ETHYL ALCOHOL	Rejoice International, Inc.	f0e637d9-d61e-466d-9e05-f906639dbaca	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer	ETHYL ALCOHOL	Rejoice International, Inc.	07b163e4-8f67-44e7-b5ef-f237023080e0	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer - Ice Clear	ETHYL ALCOHOL	Rejoice International, Inc.	605ec88a-2f4c-4716-8522-eb2748b43398	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer - Original	ETHYL ALCOHOL	Rejoice International, Inc.	bb9cc886-275e-4996-99dc-529f928b4905	2024-02-28	Warnings	Exact identifier application number: M003
Liquid Hand Cleanse	TRICLOSAN	Rejoice International, Inc.	23ff5450-8308-41c0-9052-1ac4c4433d6c	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Antibacterial Hand Cleanse Original	TRICLOSAN	Rejoice International, Inc.	b5ce6663-fe82-4da1-923e-acea293d7a00	2024-02-28	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
581660	ethanol 62 % Topical Gel	PSN	13c99570-0859-4310-843a-5eb266698eb3	3
581660	ethanol 0.62 ML/ML Topical Gel	SCD	13c99570-0859-4310-843a-5eb266698eb3	3
581660	ethanol 62 % Topical Gel	SY	13c99570-0859-4310-843a-5eb266698eb3	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-043-01	57337004301	236 g in 1 BOTTLE (57337-043-01)	236 g	2014-01-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XtraCare Hand Sanitizer	Rejoice International \| China Ningbo Shangge Cosmetic Technology Corp	2024-02-28	HUMAN OTC DRUG LABEL	3