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ChloraPrep Hi-Lite Orange
ChloraPrep Hi-Lite Orange is a chlorhexidine-based antiseptic skin preparation that kills microorganisms on the skin surface to prevent surgical site infections.
ChloraPrep Hi-Lite Orange is a chlorhexidine-based antiseptic skin preparation that kills microorganisms on the skin surface to prevent surgical site infections. Used for Surgical site antisepsis and preparation prior to surgical procedures.
At a glance
| Generic name | ChloraPrep Hi-Lite Orange |
|---|---|
| Also known as | ChloraPrep One-Step, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, Chlorhexidine gluconate 2% w/v / Isopropyl alcohol 70% v/v, 2% CHG / 70% IPA, ChloraPrep |
| Sponsor | Solventum US LLC |
| Drug class | Topical antiseptic |
| Target | Bacterial cell membrane and proteins |
| Modality | Small molecule |
| Therapeutic area | Surgical prophylaxis / Infection prevention |
| Phase | Phase 3 |
Mechanism of action
The product contains chlorhexidine gluconate, a broad-spectrum antimicrobial agent that disrupts bacterial cell membranes and denatures proteins, providing rapid and sustained antimicrobial activity. It is applied topically to the surgical site prior to procedures to reduce the microbial load and lower infection risk. The orange dye serves as a visual indicator to ensure complete coverage of the surgical field.
Approved indications
- Surgical site antisepsis and preparation prior to surgical procedures
Common side effects
- Skin irritation or erythema
- Contact dermatitis
- Allergic reaction
Key clinical trials
- In-vivo Efficacy Study of Patient Preoperative Preps (PHASE3)
- In-vivo Efficacy Study of Patient Pre-operative Preps (PHASE3)
- Effectiveness of an Antimicrobial Agent for Preoperative Skin Preparation (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ChloraPrep Hi-Lite Orange CI brief — competitive landscape report
- ChloraPrep Hi-Lite Orange updates RSS · CI watch RSS
- Solventum US LLC portfolio CI