FDA.reportPublic FDA data

Instant Hand Sanitizer

Product NDC
57337-018
11-digit product format
573370018
Labeler code
57337
Product ID
57337-018_126c246a-dc56-eaed-e063-6294a90a2e8a
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Rejoice International, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-07-05
Substance
ALCOHOL
Active strength
6 mL/10mL
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
Instant Hand Sanitizer
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL6 mL/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
07b163e4-8f67-44e7-b5ef-f237023080e0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-018-022024-02-28C16284748780-11030e364-ff9b-111a-e063-dadaa90a10e2Instant Hand Sanitizer
57337-018-022024-01-30C16284748780-11030e364-ff9b-111a-e063-dadaa90a10e2Instant Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-018-01Instant Hand Sanitizer10 mL in 1 BOTTLEGEL103
57337-018-02Instant Hand Sanitizer2 in 1 PACKAGEGEL23

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MINSTANT HAND SANITIZER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]1
ALCOHOLACTIVE MOIETY3K9958V90MINSTANT HAND SANITIZER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0INSTANT HAND SANITIZER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XINSTANT HAND SANITIZER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINSTANT HAND SANITIZER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MINSTANT HAND SANITIZER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXINSTANT HAND SANITIZER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RINSTANT HAND SANITIZER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-018INSTANT HAND SANITIZER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]3Current NDC, Legacy NDC, 2 package rows20240229_07b163e4-8f67-44e7-b5ef-f237023080e0.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 70 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLJell Pharmaceuticals Pvt. Ltd.3cf2ff12-0220-3307-e063-6394a90abf082025-08-22WarningsExact identifier
application number: M003
Chain Drug Marketing Association, Inc.ISOPROPYL ALCOHOLChain Drug Marketing Association Inc.18fe4787-8986-4d64-e063-6394a90a35132025-08-22WarningsExact identifier
application number: M003
Scentfull Hand Sanitizer Eucalyptus AloeALCOHOLScent Theory Products LLC3cf7e175-239d-e13b-e063-6294a90a79062025-08-22WarningsExact identifier
application number: M003
Scentfull Hand Sanitizer Sunrise GlowALCOHOLScent Theory Products LLC3cf7fce1-3112-0d66-e063-6294a90a98652025-08-22WarningsExact identifier
application number: M003
AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d7d0e8-12b4-e410-e053-2a95a90a7f302025-08-21WarningsExact identifier
application number: M003
American Red Cross 3 Hydrogen PeroxideHYDROGEN PEROXIDEMY IMPORTS USA LLCde46ffc7-3b66-dd8b-e053-2a95a90a28d82025-08-21WarningsExact identifier
application number: M003
Antibacterial Hand wipesBENZALKONIUM CHLORIDEMY IMPORTS USA LLC2ba77bab-7d02-d7c7-e063-6294a90aae872025-08-19WarningsExact identifier
application number: M003
SANITIZING HAND WIPESSANITIZING HAND WIPESJinhua Aidi Daily Chemical Co., Ltd.3cb82a83-3067-80a6-e063-6394a90a8ab02025-08-19WarningsExact identifier
application number: M003
MedPride PrepPadsPOVIDONE IODINEShield Line LLC289e92a2-f03f-4b8a-e054-00144ff8d46c2025-08-19WarningsExact identifier
application number: M003
I-70 FoamingALCOHOL SANITIZERPeople's Janitorial Supply3cbabb95-c72f-6984-e063-6294a90adae02025-08-19WarningsExact identifier
application number: M003
Non-proprietary nameALCOHOL PREP PADGuangzhou Four E's Scientific Co., Ltd.edaff0ca-f305-71a4-e053-2a95a90a5dca2025-08-18WarningsExact identifier
application number: M003
Non-proprietary nameALCOHOL PREP PADGuangzhou Four E's Scientific Co., Ltd.edb4a43a-5b55-3404-e053-2a95a90ada272025-08-18WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk - SOURBETALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c9fe5a6-a729-4710-e063-6294a90a0da12025-08-18WarningsExact identifier
application number: M003
Premium Hand Sanitizer with AloeETHANOLMCKESSON MEDICAL-SURGICAL INC.13d42582-df02-41d5-bada-1d67c61310152025-08-18WarningsExact identifier
application number: M003
MedPride Povidone Iodine Scrub Solution Skin CleanserPOVIDONE-IODINEShield Line LLC88dfef39-c6c2-44fc-e053-2995a90a805a2025-08-18WarningsExact identifier
application number: M003
MedPride Prep Solution Topical Antiseptic MicrobicidePOVIDONE-IODINEShield Line LLC88cb1b8d-3dae-be00-e053-2995a90a0d112025-08-18WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk - Romance GourmondALCOHOLShenzhen Lantern Scicence Co.,Ltd.3caf5726-8d4c-9d36-e063-6294a90a3cf12025-08-18WarningsExact identifier
application number: M003
Hand Sanitizer plus Serum EdenALCOHOLMoam LLC93c9f1ad-e08a-4859-bf24-db37e6b1d3082025-08-18WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer OceanALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c9c71e5-fe7a-d342-e063-6294a90a774a2025-08-17WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Calming LavenderALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c76e629-96a0-7031-e063-6294a90a05ae2025-08-16WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-018-015733700180110 mL in 1 BOTTLE10 mlHistorical
57337-018-02573370018022 BOTTLE in 1 PACKAGE (57337-018-02) / 10 mL in 1 BOTTLE (57337-018-01) 2 bottle2013-07-050000-00-00NoNoCurrent