FDA — authorised 29 September 2022
- Application: NDA019125
- Marketing authorisation holder: XTTRIUM
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Cleanser in United States
FDA authorised Cleanser on 29 September 2022 · 28,871 US adverse-event reports
Marketing authorisation
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 28,871
Most-reported reactions
- Drug Ineffective — 6,921 reports (23.97%)
- Acne — 3,756 reports (13.01%)
- Dry Skin — 3,624 reports (12.55%)
- Skin Burning Sensation — 3,188 reports (11.04%)
- Erythema — 2,842 reports (9.84%)
- Skin Irritation — 2,529 reports (8.76%)
- Inappropriate Schedule Of Product Administration — 2,068 reports (7.16%)
- Overdose — 1,487 reports (5.15%)
- Skin Exfoliation — 1,446 reports (5.01%)
- Pain Of Skin — 1,010 reports (3.5%)
Cleanser in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Cleanser approved in United States?
Yes. FDA authorised it on 29 September 2022.
Who is the marketing authorisation holder for Cleanser in United States?
XTTRIUM holds the US marketing authorisation.