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 |
|---|---|
| GLYCERIN | 25.9 g/30mL |
| IODINE | 95 mg/30mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5f30b278-5791-4113-8781-878a9221ef8a | Product name | 2 | 20230125 |
| 2a70c781-a755-4d76-b20a-a958acfbdcdc | Product name | 2 | 20190619 |
| 304592ef-4a8a-4c22-8e8c-af73aa3d60e5 | Product name | 1 | 20180703 |
| ac0821a1-ce75-4ea7-880a-59eecaecdf22 | Product name | 1 | 20180703 |
| db5dc4f9-b907-46f6-8fb7-babcf04bbe5c | Product name | 1 | 20180619 |
| 41e9d6cf-3ed7-4c44-a57e-0685058d0896 | Product name | 1 | 20170824 |
| 5e652c92-68fd-426b-b0e7-5fc64e0b9f99 | Product name | 1 | 20170309 |
| ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c | Product name | 1 | 20150421 |
DailyMed Package Descriptions#
| 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| First Aid Only Sting Relief Pad | BENZOCAINE, ISOPROPYL ALCOHOL | Acme United Corporation | d71047f6-1353-c758-e053-2995a90a962c | 2024-11-26 | Warnings | M003 |
| First Aid Only Alcohol Antiseptic Pad | ISOPROPYL ALCOHOL | Acme United Coporation | a01fec1b-1339-40b9-e053-2995a90aeda5 | 2024-11-23 | Warnings | M003 |
| Med-Nap Sterile Alcohol Prep Pads | ISOPROPYL ALCOHOL | Acme United Corporation | c6eff57b-d537-69c8-e053-2a95a90adc3a | 2024-11-23 | Warnings | M003 |
| First Aid Only Alcohol Antiseptic | ISOPROPYL ALCOHOL | Acme United Corporation | a810e723-ad0c-8c71-e053-2995a90a0acc | 2024-11-23 | Warnings | M003 |
| Universal 50% Rubbing Alcohol | ISOPROPYL ALCOHOL | Universal Distribution Center LLC | 0dcc9bd2-aea5-4c27-9956-47d56221726b | 2024-11-22 | Warnings | M003 |
| Universal 70% Rubbing Alcohol with Wintergreen and Glycerin | ISOPROPYL ALCOHOL | Universal Distribution Center LLC | 9a9d42ad-79d5-4acc-b5d9-cb7468961d47 | 2024-11-22 | Warnings | M003 |
| Universal 50% Rubbing Alcohol with Wintergreen and Glycerin | ISOPROPYL ALCOHOL | Universal Distribution Center LLC | 044a6287-f568-4cfa-a813-7fc0e6ffc352 | 2024-11-22 | Warnings | M003 |
| NEXXGEN 70% RUBBING ALCOHOL | ISOPROPYL ALCOHOL | A & A Nexxgen LLC | ce73ac48-c5af-4a35-950c-62ff0232aa30 | 2024-11-22 | Warnings | M003 |
| Universal 70% Rubbing Alcohol | ISOPROPYL ALCOHOL | Universal Distribution Center LLC | d8b9b0e7-2cb8-4fc5-af55-790e64d6cfe8 | 2024-11-22 | Warnings | M003 |
| Alcohol sterile | ISOPROPYL ALCOHOL | Cardinal Health, Inc | bb7c530f-5d80-4158-b715-09c1c837299d | 2024-11-21 | Warnings | M003 |
| Alcohol sterile | ISOPROPYL ALCOHOL | Cardinal Health 200 LLC | 10135db9-f614-4511-96ac-faa6a02a1b61 | 2024-11-21 | Warnings | M003 |
| BZK Antiseptic Swabsticks 4 Triple | BENZALKONIUM CHLORIDE | Changzhou Maokang Medical Products Co., Ltd | d9f35c14-2f5a-4e1a-bc2b-a7e163134213 | 2024-11-21 | Warnings | M003 |
| Povidone-lodine Swabsticks Triple | POVIDONE-IODINE | Changzhou Maokang Medical Products Co., Ltd | 74e70ea9-640b-4295-a40f-56f65fca1300 | 2024-11-21 | Warnings | M003 |
| MK Alcohol Prep Pads Medium | ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd | 37f10b1f-b73c-4d71-91c2-1252f3d9d4ce | 2024-11-21 | Warnings | M003 |
| BZK Antiseptic Towelette | BENZALKONIUM CHLORIDE | Changzhou Maokang Medical Products Co., Ltd | 1936d749-bf38-a433-e063-6294a90aba8c | 2024-11-21 | Warnings | M003 |
| Maokang 10 Povidone Iodine | POVIDONE-IODINE | Changzhou Maokang Medical Products Co., Ltd | 7c17ce40-0358-44ff-aa60-53711666914b | 2024-11-21 | Warnings | M003 |
| MK Alcohol Prep Pads Medium | ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd | 11390854-9e72-40a2-9c89-3c29a585dced | 2024-11-21 | Warnings | M003 |
| Instant Hand Sanitizeing Wipe | ISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTS | Shandong Yayun Sanitary Products Co., Ltd. | aa0dc01a-2c6b-7402-e053-2a95a90af6a2 | 2024-11-21 | Warnings | M003 |
| Dynarex Povidone Iodine Prep Solution | POVIDONE IODINE PREP SOLUTION | Dynarex Corporation | 6bb4d55b-2be7-3549-e053-2a91aa0a2bb0 | 2024-11-20 | Warnings | M003 |
| Dynarex Povidone Iodine Surgical Scrub | POVIDONE IODINE SURGICAL SCRUB SOLUTION | Dynarex Corporation | 6f053e55-cbf6-9072-e053-2991aa0a2edd | 2024-11-20 | Warnings | M003 |
Packages#
| 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 |