I2Pure I2Rx
- Product NDC
- 83465-421
- 11-digit product format
- 834650421
- Labeler code
- 83465
- Product ID
- 83465-421_51941ac4-b20f-4da2-e063-6394a90aa7ee
- 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
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 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | PDC6A3C0OX, 9679TC07X4 |
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 |
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 | Historical |