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 31 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
70%ISOPROPYL ALCOHOLUnited Natural Foods, Inc. dba UNFId39bc652-442d-4d91-9eba-a496636b95332026-02-26Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLUnited Natural Foods, Inc. dba UNFIf6be70d5-763c-42d8-9b4e-a55e84c747852026-02-26Warnings, Adverse reactionsExact identifier
application number: M003
RubbingETHYL ALCOHOLUnited Natural Foods, Inc. dba UNFIcd03611f-879a-4888-8d45-f8bdfd82529c2026-02-26Warnings, Adverse reactionsExact identifier
application number: M003
Lightning X POVIDONE IODINE WIPEPOVIDONE IODINE WIPEChangzhou Maokang Medical Products Co., Ltd.04be4c2f-742b-7058-e063-6394a90a460d2026-02-25WarningsExact identifier
application number: M003
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLBetter Living Brands, LLC4817df03-05a2-4e85-bec2-a06f9d57d0b82026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLBetter Living Brands, LLC4031ea5d-cba4-44f5-9a81-0cab2367d97e2026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEBetter Living Brands, LLC1b2decdf-58be-4ab9-a481-6c78bd91faf02026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLBetter Living Brands, LLC6391432a-a5b8-4528-88a6-862bc2062f682026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEFamily Dollar Stores, Inc58157bc5-54ea-49f8-9f17-f0eeb57323952026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
IsopropylISOPROPYL ALCOHOLH E B25fea857-9ed8-49e7-b892-b24f639f83ca2026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLH E B403e52e8-bac1-460a-81ef-bac5a7b5de102026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLH E B28cd16f5-61c5-4943-9dd6-a9864fa358062026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
50% Isopropyl AlcoholISOPROPYL ALCOHOLH E B0ed762dd-9432-45b4-9e75-c24fb28ff9562026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
Sunvine 70 Isopropyl Alcohol First Aid AntisepticISOPROPYL ALCOHOLMac Innovations, LLC8435ef45-5d2c-4bbb-b9e0-0b00c1ec8c762026-02-24WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLALCOVE BRANDS4bad1fee-b4fe-c518-e063-6294a90a03182026-02-24WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEBetter Living Brands, LLC3ce6e6af-b513-ed9f-e063-6394a90a4ce72026-02-23Warnings, Adverse reactionsExact identifier
application number: M003
Scent Theory Hand Sanitizers Cherry Pop, Ocean Splash, Juicy PearALCOHOLScent Theory Products LLC4b865d82-71c3-1023-e063-6294a90ac7742026-02-23WarningsExact identifier
application number: M003
Hydrogen Peroxide 3%HYDROGEN PEROXIDE 3%4 Visions LLC4b87254a-8dc5-3873-e063-6394a90a3f3b2026-02-23WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOL4 Visions LLC4b87d4cc-163e-1432-e063-6294a90af4832026-02-23WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOL4 Visions LLC4b88008f-fe78-4b7e-e063-6294a90ab9ae2026-02-23WarningsExact 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