FDA.reportPublic FDA data

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 113 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand SanitizerETHYL ALCOHOLRaining Rose, Inc.416267f2-85c5-6633-e054-00144ff8d46c2023-11-03WarningsExact identifier
application number: M003
Alcohol Prep Pads70%ISOPROPYL ALCOHOLRaya Pharmaceuticals LLCda108e12-4327-db1c-e053-2a95a90a211b2023-10-27WarningsExact identifier
application number: M003
POVIDONE-IODINE PAD- povidone-iodine swabPOVIDONE IODINE 10% W/W (EQUIVALENT TO IODINE 1%)Raya Pharmaceuticals LLCdbcbd1be-5274-3de3-e053-2995a90abf1c2023-10-27WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltd4bfea435-f40d-4976-8450-a699f7640c652023-10-23WarningsExact identifier
application number: M003
Sting ReliefBENZOCAINE, ISOPROPYL ALCOHOLJianerkang Medical Co., Ltd3a32398a-3f7e-4da0-bb1d-b3f369914b2a2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0c0-030a-e054-00144ff88e882023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0af-030a-e054-00144ff88e882023-10-23WarningsExact identifier
application number: M003
BZKBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdd96c6ad2-c7e9-4079-9db2-59d108f284bb2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5690c-08bf-5092-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5726f-d314-50d9-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5690c-08ad-5092-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd1c7f9a00-6600-4b0d-af11-fa776b22e6782023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd1c9f2c8b-6ed6-4e54-a151-5be4acb290e42023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd878bfaa7-d553-40db-8311-19010930abd92023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltdc1273e40-5c09-435b-adf3-e352fdd01e9e2023-10-23WarningsExact identifier
application number: M003
POVIDONE IODINE SCRUB SWABSTICK 3sPOVIDONE-IODINEJianerkang Medical Co., Ltd65783da9-acca-41c7-860b-1de108edc5832023-10-23WarningsExact identifier
application number: M003
Obstetrical ToweletteBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd8db4eb14-85b6-4c8e-9623-39a43b3827a12023-10-23WarningsExact identifier
application number: M003
POVIDONE IODINE PREP PAD SterilePOVIDONE-IODINEJianerkang Medical Co., Ltdac3aa401-a124-4eb7-9598-119be0f24ddd2023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltdc13af96e-f76a-4577-8d57-811ccc6527382023-10-23WarningsExact identifier
application number: M003
Povidone-Iodine Prep PadPOVIDONE-IODINECardinal Health 200, Inc.06c8a6f6-2fc8-4292-a3b5-6311a918a5212023-10-23WarningsExact 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