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 |
|---|---|---|---|---|---|---|
| Povidone-Iodine Pad | POVIDONE-IODINE | Shandong Haiyan Medical Manufacture Co., Ltd. | c9187a07-92d5-15ac-e053-2995a90af4cb | 2022-03-19 | Warnings | M003 |
| Alcohol Prep Pad | ISOPROPYL ALCOHOL | Shandong Haiyan Medical Manufacture Co., Ltd. | 1a117840-22d0-4a88-b1a6-e43162a444ab | 2022-03-19 | Warnings | M003 |
| FIRSTAR BZK Antiseptic Towelette | BENZALKONIUM CHLORIDE | JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. | 28591a97-9291-48c8-a8e3-c419180331b3 | 2021-07-06 | Warnings | M003 |
| Bactine Max | BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE | WellSpring Pharmaceutical Corporation | 28e8a311-20a4-45a1-8d5d-ca42b101c275 | 2021-02-24 | Warnings | M003 |
| Hand Sanitizer Lemon 2oz | ALCOHOL | Ningbo Rejoice International | b0a4159a-cb07-4ce6-e053-2995a90a76e7 | 2020-10-02 | Warnings | M003 |
| Sanix Alcohol Hand Rub | ALCOHOL | Topiderm, Inc | a4fbb714-4f20-400a-ab98-f1c8807ce6fc | 2020-03-24 | 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 |