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 114 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Antiseptic BZK Towelette	BENZALKONIUM CHLORIDE	Cardinal Health 200, Inc.	8dd79ffe-f742-438c-9814-612f900ad6a9	2023-10-23	Warnings	Exact identifier application number: M003
Povidone Iodine Topical Solution Paint	POVIDONE IODINE 10%	Jianerkang Medical Co., Ltd	f231a572-a99d-4146-afa3-e73ea1cee027	2023-10-22	Warnings	Exact identifier application number: M003
Povidone Iodine Topical Solution Paint	POVIDONE IODINE 10%	Jianerkang Medical Co., Ltd	42778607-6170-4a5e-94d0-5e6cd064eec6	2023-10-22	Warnings	Exact identifier application number: M003
Alcohol	ISOPROPYL ALCOHOL	Jianerkang Medical Co., Ltd	76048b01-28f3-4e43-9da9-974b2b511a10	2023-10-22	Warnings	Exact identifier application number: M003
GENUINE FIRST AID Antiseptic Hand Sanitizer	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	d25f02f1-268c-44d8-9a55-c6efcbe8eed1	2023-10-19	Warnings	Exact identifier application number: M003
Brompton and Langley Moisturizing Hand Sanitizer Lavnder Vanilla	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	90bd3436-a8bc-4c19-a300-d59236a8de27	2023-10-19	Warnings	Exact identifier application number: M003
Up and Up 70 Isopropyl Alcohol Wipes	ISOPROPYL ALCOHOL	Target Corporation	becc8fe3-eaf5-4429-b462-a87dd09c4db8	2023-10-17	Warnings	Exact identifier application number: M003
Henry Schein Povidone-Iodine Swabsticks	POVIDONE-IODINE	Henry Schein, Inc.	766ad4df-2100-4f26-bd8b-5c5a0918698e	2023-10-13	Warnings	Exact identifier application number: M003
GoodSense Alcohol Swabs	ISOPROPYL ALCOHOL	Geiss, Destin and Dunn	968bab9f-5b74-270b-e053-2995a90a0df4	2023-10-13	Warnings	Exact identifier application number: M003
Henry Schein Povidone-Iodine Swabsticks	POVIDONE-IODINE	Henry Schein, Inc.	5854f241-6cfc-4e5a-ba72-92dd0703f728	2023-10-13	Warnings	Exact identifier application number: M003
DawnMist Alcohol Hand Sanitizer	ALCOHOL	Dukal LLC	a2df96a9-8514-6839-e053-2a95a90a9417	2023-10-13	Warnings	Exact identifier application number: M003
DUKAL STING RELIEF PAD	BENZOCAINE	Dukal LLC	67c1ddc7-8fde-4431-84cb-f757682d5f3e	2023-10-13	Warnings	Exact identifier application number: M003
First Aid Only First Aid/Burn	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	Acme United Corporation	07245b54-b193-178e-e063-6394a90a2581	2023-10-09	Warnings	Exact identifier application number: M003
Hand sanitizer 2oz 2pk original	ETHYL ALCOHOL	Rejoice International Corp.	06dc1730-216a-8b4d-e063-6294a90a4184	2023-10-04	Warnings	Exact identifier application number: M003
Hand sanitizer 1.8oz with extra clip original	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	06dcf8dc-0831-475e-e063-6394a90a9fef	2023-10-04	Warnings	Exact identifier application number: M003
Hand sanitizer 2oz 2pk original	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	06dd2427-097c-b0fa-e063-6294a90a4f82	2023-10-04	Warnings	Exact identifier application number: M003
Hand sanitizer 1.8oz with extra clip original	ETHYL ALCOHOL	Rejoice International Corp.	06da0cc1-95f2-4f88-e063-6394a90a25ea	2023-10-03	Warnings	Exact identifier application number: M003
First Aid Antiseptic Alcohol Pads Isopropyl Alcohol 70 Rite Aid	ISOPROPYL ALCOHOL	Rite Aid Corporation	aa0df5fe-62d1-407d-b8f9-a7fd9473d569	2023-10-02	Warnings	Exact identifier application number: M003
Foaming Instant Hand Sanitizer with Aloe	ETHANOL	MCKESSON MEDICAL-SURGICAL INC.	5c1f69b7-c8d8-477c-b614-47a3287b0e4c	2023-06-05	Warnings	Exact identifier application number: M003
Bactine Max Dry	LIDOCAINE HYDROCHLORIDE	WellSpring Pharmaceutical Corporation	466404cd-c46a-4944-b1ac-3b3b17f436a1	2022-12-27	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