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 |
|---|---|---|---|---|---|---|
| Up and Up Max Pain Relieving Cleansing | BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE | TARGET CORPORATION | 2c3e72eb-5d98-1f3f-e063-6394a90ab00c | 2025-01-21 | Warnings | M003 |
| Sierrasoft Clear Antibacterial Wash Foam | CHLOROXYLENOL | CWGC LA Inc. | 013a36fa-5a9a-46ea-b9d0-ac366257612e | 2025-01-20 | Warnings | M003 |
| TM TITUS MEDICAL ANTISEPTIC Non Sterile | POVIDONE-IODINE | Titus Medical LLC | 690b87d0-d889-43c6-b99e-cd9f26fd682a | 2025-01-17 | Warnings | M003 |
| TM Titus Medical Povidone Iodine | POVIDONE-IODINE | Titus Medical LLC | af7840c0-239e-4ff6-8d27-614e7d71ca99 | 2025-01-17 | Warnings | M003 |
| Smart Care Sanitizer Spray. 01 | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 1b125c5d-7041-c71b-e063-6394a90add9b | 2025-01-17 | Warnings | M003 |
| Berry Hand Sanitizer Spray. 01 | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 1f128054-4c57-8055-e063-6294a90adc4e | 2025-01-17 | Warnings | M003 |
| ROAME Moisturizing Hand Sanitizer Cloud 999 | ALCOHOL HAND SANITIZER | Roame LLC | 2bb1003e-8e4c-8dd8-e063-6294a90ad37d | 2025-01-14 | Warnings | M003 |
| Antiseptic Towelettes | BENZALKONIUM CHLORIDE | CMC Group Inc. | d7470f98-4278-415b-92e7-9eca2036bc09 | 2025-01-13 | Warnings | M003 |
| Alcohol Cleansing | ISOPROPYL ALCOHOL | CMC Group Inc. | e3985ef1-503a-4193-a5b5-7910aefa7814 | 2025-01-13 | Warnings | M003 |
| Antibiotic Application | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | CMC Group, Inc. | da436c35-a98f-4df7-9d23-885564734cef | 2025-01-13 | Warnings | M003 |
| Burn Treatment | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | CMC Group Inc. | 9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce40 | 2025-01-13 | Warnings | M003 |
| Hand Sanitizer | ALCOHOL | CMC Group Inc. | dcca50e6-0935-401d-a23e-be4d1231dde9 | 2025-01-13 | Warnings | M003 |
| Refill 2 | BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | CMC Group, Inc. | 45dde3f0-546c-4ec5-beb0-c3d0432f4983 | 2025-01-13 | Warnings | M003 |
| Refill 3 | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | CMC Group Inc. | e5cb395f-5037-4b0e-9c9d-2d78b5b01b25 | 2025-01-13 | Warnings | M003 |
| Refill 4 | ISOPROPYL ALCOHOL | CMC Group Inc. | 6f4a4538-7522-4bcf-b3cf-8dea60438a4d | 2025-01-13 | Warnings | M003 |
| Refill 6 | ALCOHOL, WATER | CMC Group, Inc. | 7849ae59-5484-4b86-a0b9-ec9b93d9afe0 | 2025-01-13 | Warnings | M003 |
| EVR Povidone lodine Wipe | POVIDONE LODINE | Changzhou Maokang Medical Products Co., Ltd. | 2b57e301-74e0-e1db-e063-6294a90a6c18 | 2025-01-10 | Warnings | M003 |
| EVR Sting Relief Wipe | BENZOCAINE, ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd. | 2b584d09-916c-00f8-e063-6294a90adbcf | 2025-01-10 | Warnings | M003 |
| Medzah Ditek Alcohol Prep Pads | ISOPROPYL ALCOHOL | Medzah Industries | 4e6e5b6b-147c-4e7c-9b8c-6a3116c4bdac | 2025-01-10 | Warnings | M003 |
| Alcohol Prep Pad-Large | ISOPROPYL ALCOHOL | Global Biomedical Technologies, LLC | 93d00515-e93f-48a3-b66b-7d933e734e54 | 2025-01-10 | 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 |