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 |
|---|---|---|---|---|---|---|
| Guardian Vaginal | BENZALKONIUM CHLORIDE | Eastern Century Pharmaceuticals | 1605ba44-02b7-4c72-9fec-89a5aa962b44 | 2024-04-24 | Warnings | M003 |
| Inverness Hygienic Ear Care Antiseptic | BENZALKONIUM CHLORIDE | The Richline Group, Inc. | 0ccd72e7-16a2-47c7-9ce6-dffb63a0344b | 2024-04-18 | Warnings | M003 |
| Lovisa Piercing Care Solution | BENZALKONIUM CHLORIDE | The Richline Group, Inc. | 74f46b81-cc5b-4e3f-a36e-0bd86d370c22 | 2024-04-18 | Warnings | M003 |
| CliniClean BZK Cleansing Contains Benzalkonium Chloride | BENZALKONIUM CHLORIDE | HR HealthCare | b6916466-0931-408f-a430-0797a449c32e | 2024-04-18 | Warnings | M003 |
| Handy Solutions First Aid Kit | BENZALKONIUM CHLORIDE | Navajo Manufacturing Company Inc. | 130237ff-3db4-1288-e063-6394a90ab1af | 2024-04-16 | Warnings | M003 |
| BZK | BENZALKONIUM CHLORIDE | Henry Schein Inc. | ff877b63-fa58-4770-a882-694eda33203b | 2024-04-02 | Warnings | M003 |
| First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine Hydrochloride | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | M-star (Hubei) Health&Care Products Co., Ltd. | 8e1f35ff-d4e6-4940-ad8f-dce2b73e595d | 2024-04-01 | Warnings | M003 |
| Antiseptic Towelette TOALLITAS ANTISEPTICAS | BENZALKONIUM CHLORIDE | M-star (Hubei) Health&Care Products Co., Ltd. | b267e186-cf7a-458f-9c28-a48a8554af40 | 2024-04-01 | Warnings | M003 |
| Antiseptic Povidone Iodine Prep Pad | POVIDONE-IODINE | M-star (Hubei) Health&Care Products Co., Ltd. | fc76c1f3-b48e-4276-890d-5b8e5a894e62 | 2024-04-01 | Warnings | M003 |
| Novex Hand Sanitizer | BENZALKONIUM CHLORIDE | Natural Essentials, Inc. | 8b53dde5-c9f6-41c4-8ddb-bf0bf67008d3 | 2024-03-20 | Warnings | M003 |
| Antiseptic | BENZALKONIUM CHLORIDE 0.13% | Trifecta Pharmaceuticals USA, LLC. | 13f1c70f-3b44-8eef-e063-6294a90af634 | 2024-03-18 | Warnings | M003 |
| Burn Cream | BENZALKONIUM CHLORIDE, LIDOCAINE HCI | Trifecta Pharmaceuticals USA LLC | 1308ce91-2858-310a-e063-6394a90a6810 | 2024-03-06 | Warnings | M003 |
| Instant Hand Sanitizer - Cocoa Butter | ETHYL ALCOHOL | Rejoice International, Inc. | 97dee45e-53be-4b37-a427-fc24388c0e05 | 2024-02-28 | Warnings | M003 |
| Instant Hand Sanitizer Aloe Vera | ETHYL ALCOHOL | Rejoice International, Inc. | 1e28454c-f5d8-4d6e-91f9-bc4501b027c1 | 2024-02-28 | Warnings | M003 |
| Instant Hand Sanitizer - Clear | ETHYL ALCOHOL | Rejoice International, Inc. | f0e637d9-d61e-466d-9e05-f906639dbaca | 2024-02-28 | Warnings | M003 |
| Instant Hand Sanitizer | ETHYL ALCOHOL | Rejoice International, Inc. | 07b163e4-8f67-44e7-b5ef-f237023080e0 | 2024-02-28 | Warnings | M003 |
| Instant Hand Sanitizer - Ice Clear | ETHYL ALCOHOL | Rejoice International, Inc. | 605ec88a-2f4c-4716-8522-eb2748b43398 | 2024-02-28 | Warnings | M003 |
| Instant Hand Sanitizer - Original | ETHYL ALCOHOL | Rejoice International, Inc. | bb9cc886-275e-4996-99dc-529f928b4905 | 2024-02-28 | Warnings | M003 |
| Liquid Hand Cleanse | TRICLOSAN | Rejoice International, Inc. | 23ff5450-8308-41c0-9052-1ac4c4433d6c | 2024-02-28 | Warnings | M003 |
| XtraCare Antibacterial Hand Cleanse Original | TRICLOSAN | Rejoice International, Inc. | b5ce6663-fe82-4da1-923e-acea293d7a00 | 2024-02-28 | 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 |