Home NDC 83465-421 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 Ingredient Strength GLYCERIN 25.9 g/30mL IODINE 95 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PDC6A3C0OX Internal UNII lookup 9679TC07X4 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83465-421-30 I2Pure I2Rx 30 mL in 1 TUBE GEL 30 1
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 22 of 117 · 2,333 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hand Guard High Foaming Antiseptic Hand and Body Wash CHLOROXYLENOL Wechem, Inc. 00956253-e0e8-49b7-9015-671a14f8df73 2026-05-11 Warnings Exact identifier application number: M003 Lynx Foamy PCMX Antiseptic Hand and Body Wash 6876 CHLOROXYLENOL ABC Compounding Co., Inc. 404a53ba-00dd-4952-9d58-4c46b9b45a56 2026-05-11 Warnings Exact identifier application number: M003 I2Pure I2Rx ANTISEPTIC AND SKIN PROTECTANT GEL I2Pure Corp 51941ac4-b20e-4da2-e063-6394a90aa7ee 2026-05-11 Warnings Exact identifier application number: M003 ndc (product): 83465-421 Kleenex Ultra Moisturizing Hand Sanitizer ALCOHOL Kimberly-Clark Corporation 75e884bf-8e0d-41e7-adbb-4400ee3d1e07 2026-05-08 Warnings Exact identifier application number: M003 Lightning X Prep Pad ISOPROPYL ALCOHOL Changzhou Maokang Medical Products Co., Ltd. 5136065e-8dc9-0dae-e063-6294a90a3f9d 2026-05-07 Warnings Exact identifier application number: M003 Lightning X Iodine Prep Pads POVIDONE-IODINE Changzhou Maokang Medical Products Co., Ltd. 5136a99b-ef40-937e-e063-6394a90a0a95 2026-05-07 Warnings Exact identifier application number: M003 Lucys Renewals Skin and Nails First Aid Antiseptic BENZETHONIUM CHLORIDE ACP Laboratories LLC a702297d-8f7e-4019-a987-7bd83becb5ee 2026-05-07 Warnings Exact identifier application number: M003 Scentfull Hand Sanitizer Sea Breeze ALCOHOL Scent Theory Products LLC 3cfac192-84c8-7897-e063-6294a90ae93d 2026-05-06 Warnings Exact identifier application number: M003 Scentfull Hand Sanitizer Whipped Coconut ALCOHOL Scent Theory Products LLC 3cfaadb3-1881-2dd9-e063-6394a90abcb4 2026-05-06 Warnings Exact identifier application number: M003 Scentfull Hand Sanitizer Pink Champagne ALCOHOL Scent Theory Products LLC 3cf7a910-28c8-bbe2-e063-6394a90aff73 2026-05-06 Warnings Exact identifier application number: M003 Minee Wipes Antibacterial Hand Wipe BENZALKONIUM CHLORIDE Ambition Power Brands 5132bc70-bf3b-180c-e063-6394a90afdad 2026-05-06 Warnings Exact identifier application number: M003 Kleenex Reveal Moisturizing Foam Hand Sanitizer ALCOHOL Kimberly-Clark 4a491f90-268e-470d-a74c-473f1efe7c8b 2026-05-06 Warnings Exact identifier application number: M003 Boo Crew Hand Care Essentials Boo Berry, Pumpkin Spice ALCOHOL Scent Theory Products LLC 51143d5c-4cd0-0b2e-e063-6294a90a2831 2026-05-05 Warnings Exact identifier application number: M003 Scott Moisturizing Foam Hand Sanitizer ALCOHOL Kimberly-Clark 25900e62-c8fd-4942-ad38-4b9924308460 2026-05-05 Warnings Exact identifier application number: M003 EVERLIT CARE PRODUCTS ANTISEPTIC MIST HYDROGEN PEROXIDE Nantong Health & Beyond Hygienic Products Inc. cb97ba55-d678-4e43-aa85-37e9f530e911 2026-05-04 Warnings Exact identifier application number: M003 EVERLIT CARE PRODUCTS ANTISEPTIC MIST HYDROGEN PEROXIDE EVERLIT GLOBAL INC. 4873b106-4ea2-412c-a7ab-756a11195984 2026-05-04 Warnings Exact identifier application number: M003 Limited Edition Hand Sanitizer Golden Vanilla, Starlight Frost, Pink Satin Prosecco ALCOHOL Scent Theory Products LLC 50f03829-eda8-3a25-e063-6294a90a6fd2 2026-05-03 Warnings Exact identifier application number: M003 DOUE 50% ISOPROPYL RUBBING ALCOHOL ISOPROPYL ALCOHOL ONEST LIMITED 414baa60-6af1-4966-9580-ce7871ab7142 2026-05-01 Warnings Exact identifier application number: M003 DOUE 50% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN ISOPROPYL ALCOHOL ONEST LIMITED fe008352-0643-4aa7-ae04-883c58832285 2026-05-01 Warnings Exact identifier application number: M003 DUBBLE BUBBLE HAND SANITIZER BUBBLE GUM ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 52084e0a-ffe2-83f4-e063-6294a90a305e 2026-05-01 Warnings Exact identifier application number: M003
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83465-421-30 83465042130 30 mL in 1 TUBE (83465-421-30) 30 ml 2026-05-11 No No Current