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 94 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Englewood Amenity BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc 7c9ce1bf-6aa2-4073-ad09-2ddf845102a2 2024-12-17 Warnings Exact identifier application number: M003 Mentholatum Moisturizing Hand Sanitizer BENZALKONIUM CHLORIDE The Mentholatum Company 365c93bc-2299-4e69-ba3a-69414bfe78d7 2024-12-13 Warnings Exact identifier application number: M003 Curaplex Alcohol Prep Pad ISOPROPYL ALCOHOL Sarnova, Inc. da1a4baa-05eb-4a75-82bb-39c547daef64 2024-12-12 Warnings Exact identifier application number: M003 Foaming Hand Sanitizer ALCOHOL Empack Spraytech Inc. 8bb072f2-9cd4-499d-9d7f-7166451b8f20 2024-12-12 Warnings Exact identifier application number: M003 Extra Stength Hand Sanitizer Zytec Germ Buster ALCOHOL 80%W/W Empack Spraytech Inc. da854195-3a50-4fae-a5ea-183bf524c973 2024-12-12 Warnings Exact identifier application number: M003 Zytec Hand Sanitizer Wipes 80% w/w Alcohol ALCOHOL Empack Spraytech Inc. ab86fd0c-40cd-0bb6-e053-2a95a90a76e2 2024-12-12 Warnings Exact identifier application number: M003 Dermoplast Kids First Aid BENZETHONIUM CHLORIDE AND BENZOCAINE Advantice Health, LLC. 29a18018-5214-4080-ac40-e646319e95ce 2024-12-12 Warnings Exact identifier application number: M003 New Skin Bandage BENZETHONIUM CHLORIDE Advantice Health, LLC. 5846f414-8329-4034-b99f-92721bdb3d14 2024-12-12 Warnings Exact identifier application number: M003 CVS Hand Sanitizer ALCOHOL CVS b5faeb31-67c7-2000-e053-2995a90a1409 2024-12-10 Warnings Exact identifier application number: M003 NEXXGEN 70% RUBBING ALCOHOL with Wintergreen ISOPROPYL ALCOHOL A & A Nexxgen LLC 8d1a5c98-8169-4f40-8601-a6f6bbbbebe7 2024-12-09 Warnings Exact identifier application number: M003 NEXXGEN 91% RUBBING ALCOHOL with Wintergreen ISOPROPYL ALCOHOL A & A Nexxgen LLC 12b8c85a-da0c-47a1-9531-c9f2858c4f31 2024-12-09 Warnings Exact identifier application number: M003 NEXXGEN 91% RUBBING ALCOHOL ISOPROPYL ALCOHOL A & A Nexxgen LLC 609267da-3ee6-4bd3-aecf-610d9047774c 2024-12-09 Warnings Exact identifier application number: M003 Isopropyl Alcohol ISOPROPYL ALCOHOL Sarnova, Inc. 62be13a6-da24-4ab0-b0f4-f2894324c20c 2024-12-06 Warnings Exact identifier application number: M003 Instant Hand Antiseptic ALCOHOL ASP Global b84075db-be0c-4265-b262-825bc6ade9d8 2024-12-06 Warnings Exact identifier application number: M003 Instant Hand Antiseptic BENZALKONIUM CHLORIDE ASP Global 47276148-08e5-400e-94ac-d2d9db423b51 2024-12-06 Warnings Exact identifier application number: M003 Instant Hand Antiseptic ALCOHOL ASP Global 9aca3f89-cdde-430c-8eb6-43a3ac3fc0df 2024-12-06 Warnings Exact identifier application number: M003 Instant Hand Antiseptic BENZALKONIUM CHLORIDE ASP Global 4eef4b0f-9209-45a4-8a0e-7891fc380fe5 2024-12-05 Warnings Exact identifier application number: M003 MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 1.5 BENZETHONIUM CHLORIDE Yangzhou H&R Plastic Daily Chemical Co., Ltd. 2998b2bd-6208-4cb4-982b-0ffb97d7d75d 2024-12-05 Warnings Exact identifier application number: M003 MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 0.5 BENZETHONIUM CHLORIDE Yangzhou H&R Plastic Daily Chemical Co., Ltd. 68003c71-5959-476f-b252-1f131e9305e2 2024-12-05 Warnings Exact identifier application number: M003 MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 3 BENZETHONIUM CHLORIDE Yangzhou H&R Plastic Daily Chemical Co., Ltd. e35e468a-1f0c-4a3f-ac6a-cd55a72f3cc2 2024-12-05 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