XtraCare Instant Hand Sanitizer

Product NDC: 57337-058
11-digit product format: 573370058
Labeler code: 57337
Product ID: 57337-058_126e0eee-4717-d01b-e063-6294a90a08ac
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl Alcohol
Dosage form: LIQUID
Route: TOPICAL
Labeler: Rejoice International
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-02-18
Substance: ALCOHOL
Active strength: 37 g/60g
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 Instant Hand Sanitizer
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALCOHOL	37 g/60g

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
247835	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
f15a90e2-4a1e-452a-b9ac-5eb6f7b3dc72	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-058-02	2024-02-28	C162847	48780-1	1030e365-301f-111a-e063-dadaa90a10e2	XtraCare Instant Hand Sanitizer
57337-058-02	2024-01-30	C162847	48780-1	1030e365-301f-111a-e063-dadaa90a10e2	XtraCare Instant Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-058-01	XtraCare Instant Hand Sanitizer	60 g in 1 PACKAGE	LIQUID	60		4
57337-058-02	XtraCare Instant Hand Sanitizer	2 in 1 PACKAGE	LIQUID	2		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	XTRACARE INSTANT HAND SANITIZER (ETHYL ALCOHOL) LIQUID [REJOICE INTERNATIONAL]	2
ALCOHOL	ACTIVE MOIETY	3K9958V90M	XTRACARE INSTANT HAND SANITIZER (ETHYL ALCOHOL) LIQUID [REJOICE INTERNATIONAL]	2
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	XTRACARE INSTANT HAND SANITIZER (ETHYL ALCOHOL) LIQUID [REJOICE INTERNATIONAL]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	XTRACARE INSTANT HAND SANITIZER (ETHYL ALCOHOL) LIQUID [REJOICE INTERNATIONAL]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	XTRACARE INSTANT HAND SANITIZER (ETHYL ALCOHOL) LIQUID [REJOICE INTERNATIONAL]	2
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	XTRACARE INSTANT HAND SANITIZER (ETHYL ALCOHOL) LIQUID [REJOICE INTERNATIONAL]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	XTRACARE INSTANT HAND SANITIZER (ETHYL ALCOHOL) LIQUID [REJOICE INTERNATIONAL]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE INSTANT HAND SANITIZER (ETHYL ALCOHOL) LIQUID [REJOICE INTERNATIONAL]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-058	XTRACARE INSTANT HAND SANITIZER (ETHYL ALCOHOL) LIQUID [REJOICE INTERNATIONAL]	4	Current NDC, Legacy NDC, 2 package rows	20240229_f15a90e2-4a1e-452a-b9ac-5eb6f7b3dc72.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 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
XtraCare Antibacterial Hand Cleanse Strawberry Pomegranate	TRICLOSAN	Rejoice International, Inc.	b68a7d64-2650-4fc6-a89e-05de9098a2a3	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Antibacterial Hand Cleanse Mountain Spring	TRICLOSAN	Rejoice International, Inc.	c31723d5-a313-448a-8b69-ca5f8dec25ed	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Pink Cherry Blossom	BENZALKONIUM CHLORIDE	Rejoice International	a9a1467c-abcc-4ccb-88f6-430279609788	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Pink Cherry Blossom	BENZALKONIUM CHLORIDE	Rejoice International	9fa9d955-7167-4a0a-935b-2a600f439eb0	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower	BENZALKONIUM CHLORIDE	Rejoice International	157a14bf-f46e-49f8-96f4-a6c472eb5cb8	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foaming Hand Sanitizer	BENZALKONIUM CHLORIDE	Rejoice International	3082cbbb-a0ed-45eb-a116-ad1c65357dd1	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Wild Berry Blast	BENZALKONIUM CHLORIDE	Rejoice International	45b3ca49-edb4-4840-b857-d24045494a3a	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Vanilla Passion Flower	BENZALKONIUM CHLORIDE	Rejoice International	4890f81e-7994-4ea2-9412-5614c405a2a3	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Wild Berry Blast	BENZALKONIUM CHLORIDE	Rejoice International	5c109f7c-1f4d-484a-b6ea-3bbcf572bbac	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
247835	ethanol 62 % Topical Solution	PSN	f15a90e2-4a1e-452a-b9ac-5eb6f7b3dc72	4
247835	ethanol 0.62 ML/ML Topical Solution	SCD	f15a90e2-4a1e-452a-b9ac-5eb6f7b3dc72	4
247835	ethanol 62 % Topical Solution	SY	f15a90e2-4a1e-452a-b9ac-5eb6f7b3dc72	4
247835	ethyl alcohol 62 % Topical Solution	SY	f15a90e2-4a1e-452a-b9ac-5eb6f7b3dc72	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-058-01	57337005801	60 g in 1 PACKAGE	60 g					Historical
57337-058-02	57337005802	2 PACKAGE in 1 PACKAGE (57337-058-02) / 60 g in 1 PACKAGE (57337-058-01)	2 package	2014-02-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XtraCare Instant Hand Sanitizer	Rejoice International \| China Ningbo Shangge Cosmetic Technology Corp	2024-02-28	HUMAN OTC DRUG LABEL	4