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

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 2 of 116 · 2,301 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrating Hand Sanitizer JUICY APPLEALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585eb222-5495-65ed-e063-6394a90a7cfa2026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer PEACH GLOWALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585ed56e-362e-7c50-e063-6394a90a19322026-08-06WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percent ReadyInCaseISOPROPYL ALCOHOLP & L Development, LLC57c496b3-10ab-4a72-8d8f-42a2256189dd2026-08-06WarningsExact identifier
application number: M003
Wish Sanitizing Hand WipesBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.c81c0924-bb01-4fa2-b933-8777358e45e72026-08-05WarningsExact identifier
application number: M003
BBlove Hand Sanitizer JAPANESE CHERRY BLOSSOMALCOHOLShenzhen Lantern Scicence Co.,Ltd.5833c261-021a-2db2-e063-6394a90a22b02026-08-04WarningsExact identifier
application number: M003
BBlove Hand Sanitizer Soft PetalsALCOHOLShenzhen Lantern Scicence Co.,Ltd.583438a6-c06c-87f5-e063-6394a90adec12026-08-04WarningsExact identifier
application number: M003
BBlove Hand Sanitizer Hibiscus and AloeALCOHOLShenzhen Lantern Scicence Co.,Ltd.5834801e-20e5-bffb-e063-6394a90a03592026-08-04WarningsExact identifier
application number: M003
Medi-First Antiseptic WipesBENZALKONIUM CHLORIDEUnifirst First Aid Corporationd31fe110-6d75-bf15-e053-2a95a90a86942026-08-03WarningsExact identifier
application number: M003
First ShieldHYDROGEN PEROXIDEEVER READY FIRST AID94307d2f-5366-4fdb-b919-4a8658dda0582026-08-03WarningsExact identifier
application number: M003
BBlove Hand Sanitizer Passion Fruit SplashALCOHOLShenzhen Lantern Scicence Co.,Ltd.583159a9-331a-b53b-e063-6294a90a41a32026-08-03WarningsExact identifier
application number: M003
BBlove Hand Sanitizer Fresh Squeezed SpearmintALCOHOLShenzhen Lantern Scicence Co.,Ltd.581b4b8d-fe65-f297-e063-6394a90a5a432026-08-02WarningsExact identifier
application number: M003
BIOPURE50CT ANTI BACTERIAL HAND WIPESBIOPURE50CT ANTI BACTERIAL HAND WIPESZhejiang Furuisen Spunlaced Nonwovens Co., Ltd57d3e290-1343-4075-e063-6394a90a41a62026-07-30WarningsExact identifier
application number: M003
Meridian Unwrapped antibacterial deodorantBENZETHONIUM CHLORIDEBob Barker Company Inc.c2d13d97-99ce-4a24-bdd6-684fbbf242a42026-07-29WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 4pk - Fresh Gingerbread/Spiced Cranberry/Vanilla Heaven/Pistachio BruleeALCOHOLShenzhen Lantern Scicence Co.,Ltd.57bd148e-f9eb-dfb6-e063-6394a90a1e122026-07-29WarningsExact identifier
application number: M003
School HealthISOPROPYL ALCOHOLSchool Health Corporationdb5d0b22-f2d7-23e5-e053-2a95a90aeb512026-07-29WarningsExact identifier
application number: M003
Jelly SmackBENZALKONIUM CHLORIDEVULCAN MICROBIAL CORPORATIONeb79e11a-6c29-556b-e053-2a95a90a728a2026-07-29WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 4pk - Fresh Calming Lavender/Sweet Citrus/Coconut Breeze/ Cucumber MelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.57cb54f7-07be-524f-e063-6294a90a2c942026-07-29WarningsExact identifier
application number: M003
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57ccc28b-5f5f-30ec-e063-6294a90a081c2026-07-29WarningsExact identifier
application number: M003
Meridian wrapped antibacterial deodorantBENZETHONIUM CHLORIDEBob Barker Company Inc.de60d4d5-87bc-4400-94e2-8307a9bb08702026-07-29WarningsExact identifier
application number: M003
70% Isopropyl AlcoholISOPROPYL ALCOHOL4 Visions57ac6fef-21de-e214-e063-6394a90a6c9e2026-07-28WarningsExact 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