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 21 of 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl alcoholISOPROPYL ALCOHOLHARRIS TEETERb3fa1454-25cd-4801-bbec-5da43a70ec7f2026-05-14WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLHARRIS TEETERc4e816c7-a8a2-404c-9354-eaaed6dbf0f52026-05-14WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Midnight MuskALCOHOLShenzhen Lantern Scicence Co.,Ltd.51ae8f8d-8969-9605-e063-6394a90a42252026-05-13WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Meadow MirageALCOHOLShenzhen Lantern Scicence Co.,Ltd.51af80be-dcc8-f5c3-e063-6394a90a32542026-05-13WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Whispering WoodsALCOHOLShenzhen Lantern Scicence Co.,Ltd.51ab5d03-1199-75c8-e063-6294a90ab6712026-05-12WarningsExact identifier
application number: M003
Lightning X Sting and Bite Relief PadsBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.518698c0-a1ae-760f-e063-6394a90a51602026-05-11WarningsExact identifier
application number: M003
Lightning X BZK WIPEBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd.5182df99-d825-376e-e063-6394a90a54352026-05-11WarningsExact identifier
application number: M003
I2Pure HypodineHYPODINEI2Pure Corp518a1c1a-a5f9-5c80-e063-6294a90a69f22026-05-11WarningsExact identifier
application number: M003
Sani Mango Antiseptic Hand and Body WashCHLOROXYLENOLABC Compounding Co., Inc.29496844-08e6-456d-aa7b-9eb5c866fd872026-05-11WarningsExact identifier
application number: M003
Surgent AntisepticCHLOROXYLENOLSunCoast Paper Inc.c8cea8f7-8f51-4dc7-99e3-aca786b9ca672026-05-11WarningsExact identifier
application number: M003
PalmCHLOROXYLENOLABC Compounding Co., Inc.a641ad83-1a28-4be7-a5ce-7ef5a192f3262026-05-11WarningsExact identifier
application number: M003
Antiseptic HandCHLOROXYLENOLImage Supply, Inc.7edd2630-bd0b-473f-85ab-34c74e8a3a0f2026-05-11WarningsExact identifier
application number: M003
ChemsepticCHLOROXYLENOLRochester Midland Corporationf3109c8d-c684-47a7-b26a-32e3ba64b8382026-05-11WarningsExact identifier
application number: M003
Lynx AntibacterialCHLOROXYLENOLABC Compounding Co., Inc.b469cfb7-35bf-419d-b1dc-95dcfad611f52026-05-11WarningsExact identifier
application number: M003
1012 AntimicrobialCHLOROXYLENOLABC Compounding Co., Inc.4dc6367c-5347-4a5c-b0d0-e93a4277a8492026-05-11WarningsExact identifier
application number: M003
Ban-AidCHLOROXYLENOLPro Chem, Inc.a251093c-77d1-4a2b-ba3d-e8768656cf6c2026-05-11WarningsExact identifier
application number: M003
SANAR DECOLORIZED IODINEETHYL ALCOHOLEVI LABS518d399a-009e-c54f-e063-6294a90ab8382026-05-11WarningsExact identifier
application number: M003
Handtastic Foamy Mango Antiseptic Hand and Body WashCHLOROXYLENOLMomar Incorporateda0df742f-185c-4a7a-87f1-d22ff361e3b62026-05-11WarningsExact identifier
application number: M003
Suds High Foaming Antiseptic Hand and Body WashCHLOROXYLENOLPro chem, Inc.00214c45-8453-49f5-b3e9-c3602fe96e202026-05-11WarningsExact identifier
application number: M003
Sani Foam Mango Antiseptic Hand and Body WashCHLOROXYLENOLDelta Foremost Chemical Corporationce1b2056-8553-4ac1-985f-9327de60a0c22026-05-11WarningsExact 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