| Active ingredient (INN) | Systane |
|---|---|
| Brand names | Systane, Lubricant Eye Gel, Night Gel, Sterile |
| Therapeutic category | Auto-created by FDA MedWatch — Drug Safety Alerts scraper |
| Controlled substance | No |
|---|
| Marketing-authorisation holders | ALCON LABORATORIES, INC., Alcon Research Ltd, Alcon Laboratories Australia Pty Ltd, ALCON CANADA INC |
|---|
| Registrations on file | 15 |
|---|
| Patient information leaflet (PIL) | Not on file |
|---|
| Summary of product characteristics (SPC) | Not on file |
|---|
| Product | Strength | Form | Market | MA holder | Status |
|---|---|---|---|---|---|
| Systane Lubricant | 4; 3mg/mL; mg/mL | solution | 🇺🇸 US | ALCON LABORATORIES, INC. | Active |
| Systane | 4; 3mg/mL; mg/mL | solution | 🇺🇸 US | Alcon Research Ltd | Active |
| Systane | 3mg/g | gel | 🇺🇸 US | ALCON LABORATORIES, INC. | Active |
| Systane COMPLETE | .06mg/mL | emulsion | 🇺🇸 US | ALCON LABORATORIES, INC. | Active |
| Systane Nighttime | 30; 940mg/g; mg/g | ointment | 🇺🇸 US | ALCON LABORATORIES, INC. | Active |
| Systane Ultra | 4; 3mg/mL; mg/mL | solution | 🇺🇸 US | ALCON LABORATORIES, INC. | Active |
| Systane Balance | .06mg/mL | emulsion | 🇺🇸 US | ALCON LABORATORIES, INC. | Active |
| Systane Hydration Pf Preservative Free | 4; 3mg/mL; mg/mL | solution | 🇺🇸 US | ALCON LABORATORIES, INC. | Active |
| Systane Day and Night Value Pack | — | kit | 🇺🇸 US | ALCON LABORATORIES, INC. | Active |
| Systane Ultra Preservative Free | 4; 3mg/mL; mg/mL | solution | 🇺🇸 US | ALCON LABORATORIES, INC. | Active |
| Systane COMPLETE PF | .06mg/mL | emulsion | 🇺🇸 US | ALCON LABORATORIES, INC. | Active |
| Systane Pro PF | 6mg/mL | emulsion | 🇺🇸 US | ALCON LABORATORIES, INC. | Active |
| SYSTANE RED EYES naphazoline hydrochloride | 1 mg | — | 🇦🇺 AU | Alcon Laboratories Australia Pty Ltd | Active |
| Systane Lubricant Eye Drops | — | solution | 🇨🇦 CA | ALCON CANADA INC | Cancelled |
| Systane Ointment | — | ointment | 🇨🇦 CA | ALCON CANADA INC | Cancelled |