Home NDC 83465-421 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 Ingredient Strength GLYCERIN 25.9 g/30mL IODINE 95 mg/30mL
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 48 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Freshnap Plus - 80% Ethyl Alcohol Towelette ALCOHOL TOWELETTE KARI-OUT LLC f4ae66e3-323b-5e2e-e053-2995a90acf42 2025-12-27 Warnings Exact identifier application number: M003 Guardelle BENZALKONIUM CHLORIDE Social Medical Supply LLC 8793e3be-7409-4f71-9397-abbeacd27cf8 2025-12-22 Warnings Exact identifier application number: M003 CareALL First Aid Burn Cream BENZALKONIUM CHLORIDE, LIDOCAINE HCL New World Imports, Inc 69eef888-0044-485c-96a1-247ed1204858 2025-12-22 Warnings Exact identifier application number: M003 Hand Sanitizer Pear Blossom Tea ALCOHOL SOLUTION Noshinku 46927edb-f8be-f0b9-e063-6294a90a8e56 2025-12-22 Warnings Exact identifier application number: M003 Hand Sanitizer Santal Blanc ALCOHOL SOLUTION Noshinku 4692c807-268e-6477-e063-6394a90aac0a 2025-12-22 Warnings Exact identifier application number: M003 Hand Sanitizer Vanilla Creme ALCOHOL SOLUTION Noshinku 4692e68c-2bc8-83f8-e063-6294a90a84e4 2025-12-22 Warnings Exact identifier application number: M003 Alcohol sanitizer wipes ALCOHOL/PURIFIED WATER SHANDONG HENGFA HYGIENIC PRODUCTS CO., LTD. ab9634bd-4226-2f73-e053-2995a90a802f 2025-12-19 Warnings Exact identifier application number: M003 Sanitizing Wipes BENZALKONIUM CHLORIDE Wipes LLC 9e9a76d9-23e0-4d3a-9903-8bf7aba54aa3 2025-12-19 Warnings Exact identifier application number: M003 Hand Sanitizer BENZALKONIUM CHLORIDE DGH Pharma, Inc. afeccd10-c7e5-6193-e053-2995a90a9a5a 2025-12-18 Warnings Exact identifier application number: M003 Hand Sanitizer BENZALKONIUM CHLORIDE DGH Pharma, Inc. ae4311f8-fc40-38a7-e053-2a95a90ae829 2025-12-18 Warnings Exact identifier application number: M003 Alcohol ALCOHOL Dynarex Corporation 88c5dcbe-185f-4966-b98b-25d50299e8df 2025-12-18 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE TwinMed LLC fc8cb10c-4973-c0bd-e053-6394a90a6fdb 2025-12-18 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE TwinMed LLC fcf27cbf-9535-1356-e053-6394a90a0362 2025-12-18 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE TwinMed LLC fcf30b3a-c25b-7aaf-e053-6394a90affda 2025-12-18 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Black Raspberry ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 462ab5e8-029a-fe9d-e063-6294a90ac14d 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Clementine Burst ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 462ad5ba-253f-2a30-e063-6294a90a261d 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Honeydew Tart ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 462af072-6709-546f-e063-6294a90aacc8 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Pear Blossom ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 462b1d38-c7fa-992f-e063-6294a90ab78f 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Black Raspberry ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 462b2d3f-67b0-c393-e063-6294a90a208a 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Clementine Burst ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 462b36d0-0a1f-bda8-e063-6294a90a5792 2025-12-17 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