FDA.reportPublic FDA data

I2Pure I2Rx

Product NDC
83465-421
11-digit product format
834650421
Labeler code
83465
Product ID
83465-421_51941ac4-b20f-4da2-e063-6394a90aa7ee
Type
HUMAN OTC DRUG
Nonproprietary name
Antiseptic and Skin Protectant Gel
Dosage form
GEL
Route
TOPICAL
Labeler
I2Pure Corp
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-11
Substance
GLYCERIN; IODINE
Active strength
25.9; 95 g/30mL; mg/30mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
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
I2Pure I2Rx
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN25.9 g/30mL
IODINE95 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup
9679TC07X4Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
51941ac4-b20e-4da2-e063-6394a90aa7eeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83465-421-30I2Pure I2Rx30 mL in 1 TUBEGEL301

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 25 of 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Megababe - Squeaky Clean Hand SanitizerETHYL ALCOHOLMEGABABE, LLC249e00ef-fe9d-dc07-e063-6394a90a9f4c2026-04-16WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCIProstat First Aid4f9adbac-5497-e7be-e063-6294a90a75182026-04-16WarningsExact identifier
application number: M003
Megababe - Squeaky Clean Hand SanitizerETHYL ALCOHOLMEGABABE, LLC2d940d35-6a73-e494-e063-6394a90a9d162026-04-14WarningsExact identifier
application number: M003
Freskaro Povidone IodinePOVIDONE IODINE 10%Pharma Nobis, LLC4f711d3b-5ed6-5dd4-e063-6294a90afeaa2026-04-14WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLPerrigo Direct, Incec43a3f5-c5f3-439b-8764-ca92fefb45c92026-04-10Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEWalmart Inc.ebd02cd3-75cc-444b-8284-d28733a2855b2026-04-10Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLMSC Industrial Supplyb248ad4a-ed92-4d03-b0da-9639c46e19492026-04-10Warnings, Adverse reactionsExact identifier
application number: M003
Smart Care Hand Sanitizer Sunset GuavaALCOHOLShenzhen Lantern Scicence Co.,Ltd.4f01fc3a-5b01-4b6b-e063-6294a90aefb42026-04-09WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Fresh RainALCOHOLShenzhen Lantern Scicence Co.,Ltd.4f02adaa-1440-5778-e063-6294a90a344a2026-04-09WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Watermelon WaveALCOHOLShenzhen Lantern Scicence Co.,Ltd.4f031f62-e56c-9063-e063-6394a90af9c12026-04-09WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk with Leather CaseALCOHOLShenzhen Lantern Scicence Co.,Ltd.4f036ba3-3f21-d04b-e063-6294a90ad7d72026-04-09WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Pistachio CremeALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eeedd3e-d4b4-9967-e063-6394a90abf332026-04-08WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer French VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eef33c2-695a-3a32-e063-6394a90a0a7b2026-04-08WarningsExact identifier
application number: M003
Smart Care Licensed Hand Sanitizer Squishmallows PinkALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eefc5bc-7dd4-e4c8-e063-6394a90a9a512026-04-08WarningsExact identifier
application number: M003
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.4ef56b6c-ad46-2d02-e063-6294a90ad4072026-04-08WarningsExact identifier
application number: M003
RubbingETHYL ALCOHOLPerrigo Direct, Incba2266d7-da25-495a-b035-97e149551c302026-04-08Warnings, Adverse reactionsExact identifier
application number: M003
Smart Care Licensed Hand Sanitizer Squishmallows PurpleALCOHOLShenzhen Lantern Scicence Co.,Ltd.4efeb523-0a73-2e48-e063-6394a90aac5e2026-04-08WarningsExact identifier
application number: M003
Smart Care Licensed Hand Sanitizer Hot Wheels RedALCOHOLShenzhen Lantern Scicence Co.,Ltd.4efefd07-c1df-695a-e063-6294a90a51eb2026-04-08WarningsExact identifier
application number: M003
Smart Care Licensed Hand Sanitizer Hot Wheels PurpleALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eff601c-7bcd-1ddd-e063-6294a90a80402026-04-08WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Ocean BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.4effb28e-fa83-5a06-e063-6394a90aa2f52026-04-08WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83465-421-308346504213030 mL in 1 TUBE (83465-421-30) 30 ml2026-05-11NoNoCurrent