I2Pure I2Rx

Product NDC
83465-421
11-digit product format
834650421
Labeler code
83465
Product ID
83465-421_5ca0fa08-564f-06c5-e063-6294a90a5593
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

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 61 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Hand Sanitizer Lakeshore FreshALCOHOLShenzhen Lantern Scicence Co.,Ltd.41533b69-05e7-d5f7-e063-6294a90a2d2b2025-10-16WarningsExact identifier
application number: M003
Meijer Hand Sanitizer Pine ForestALCOHOLShenzhen Lantern Scicence Co.,Ltd.4153ac2a-e51c-f167-e063-6394a90a80d82025-10-16WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.412e961a-b7d4-b1c2-e063-6294a90a6b852025-10-15WarningsExact identifier
application number: M003
equate First Aid AntisepticPOVIDONE-IODINEWalmart Inc.43bbedec-be30-482a-8552-949b13d4bea12025-10-14WarningsExact identifier
application number: M003
TridergelBENZALKONIUM CHLORIDETrifluent Pharma LLCf12d9e8c-1d69-49d9-a9e9-a392c681aa6c2025-10-13WarningsExact identifier
application number: M003
Be Smart Get Prepared Sting Relief WipeBENZOCAINE, ALCOHOLTotal Resources International, Inc5415073f-aa1d-4ed3-aa30-7470cd2efed12025-10-10WarningsExact identifier
application number: M003
Lemyn Organics Medical-Grade Hand SanitizerALCOHOLLemyn LLCb106289d-346a-74df-e053-2995a90aa4262025-10-10WarningsExact identifier
application number: M003
Dr Lift Antibacterial Body WashBENZALKONIUM CHLORIDESpa de Soleilab9dde33-1bd2-062f-e053-2a95a90a4d182025-10-10WarningsExact identifier
application number: M003
Dr Lift AntibacterialBENZALKONIUM CHLORIDESpa de Soleilaf89675e-e66f-0922-e053-2995a90ab9d22025-10-10WarningsExact identifier
application number: M003
ANTISEPTIC WIPE 01BENZALKONIUM CHLORIDETotal Resources International Inc.cf4a6a97-529e-7f11-e053-2a95a90a75a92025-10-10WarningsExact identifier
application number: M003
Be Smart Get Prepared Sting Relief WipeALCOHOL, LIDOCAINE HYDROCHLORIDETotal Resources International, Incfff6f057-739e-40f1-8427-e1364c65af052025-10-09WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLZhejiang Hudson Import& Export Co., Ltd40b6c96c-e36f-6588-e063-6394a90adb462025-10-09WarningsExact identifier
application number: M003
CuradISOPROPYL ALCOHOLMedline Industries, LPc42de981-4e3f-1ac9-e053-2995a90aea982025-10-09WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLAvaria Health & Beauty Corpa3d87ef6-752b-b54b-e053-2a95a90af9632025-10-08WarningsExact identifier
application number: M003
Iodo Blanco (Iodine Tincture Decolorized) First Aid AntisepticIODINE 2%Germa Products, LLCbf54254f-2ef3-102e-e053-2995a90ac0832025-10-08WarningsExact identifier
application number: M003
MediChoice BZK AntisepticBENZALKONIUM CHLORIDEO&M HALYARD, INC.82a7710d-a9fa-4f68-8322-046a765ae9292025-10-08WarningsExact identifier
application number: M003
MediChoice CleansingBENZALKONIUM CHLORIDEO&M HALYARD, INC.79d41cf0-301f-44d4-a76c-f4850c7ddce92025-10-08WarningsExact identifier
application number: M003
MediChoice Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLO&M HALYARD, INC.8b84c8ed-040e-4c07-94cb-d5bdda7446482025-10-08WarningsExact identifier
application number: M003
MediChoice of Hydrogen Peroxide 3 10 VolumeHYDROGEN PEROXIDEO&M HALYARD, INC.34e77ef4-297d-4362-8f6e-abf80158b7f02025-10-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEO&M HALYARD, INC.0ad5990a-a18d-4753-826b-6da3139266982025-10-08WarningsExact 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