ONEXTON

Bausch Health US, LLC🇺🇸 United States

FDA Page

Effective Date: Jul 23, 2025
Approval ID: 697e760a-c206-4565-8f4e-a8085e215827
Products: 1 registered
Version: 15

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ONEXTON Gel safely and effectively. See full prescribing information for ONEXTON Gel. ONEXTON® (clindamycin phosphate and benzoyl peroxide) gel, 1.2%/3.75% for topical use Initial U.S. Approval: 2000

Quick Stats

Total Products1

Labelers2

Label Sections36

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.