# Urea 20% by PureTek Corporation: new human prescription drug listing

**Launch Signal Score:** 40/100

| Field | Value |
|---|---|
| Product | Urea 20% |
| Generic name | Urea 20% |
| NDC | 59088-258 |
| Labeler | PureTek Corporation |
| Product type | HUMAN PRESCRIPTION DRUG |
| Approval pathway | UNAPPROVED DRUG OTHER |
| Dosage form | CREAM |
| Route | TOPICAL |
| Active ingredients | UREA 200 mg/g |
| Marketing start | 2026-10-06 |
| Package configurations | 1 |

## Why this score
- Prescription or biologic product.

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=59088-258). Last refreshed: 2026-11-04T18:12:05.743Z.
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.