Calamine Lotion

Form: Liquid lotion

Strength: Typically contains 8-10% calamine combined with zinc oxide and other soothing agents

Reference Brands: Caladryl, Calamine, Icy Hot

Category: Medical Devices

Calamine lotion in the EU and US is regulated to ensure safety, efficacy, and quality. In the US, FDA approval requires validation, safety testing, and GMP compliance, while in the EU, CE marking certifies conformity with MDR standards. These products undergo validation, stability testing, and audits, with comprehensive documentation including safety profiles, clinical data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to safe, effective calamine formulations that provide soothing relief from skin irritation, insect bites, and rashes, supporting skin health worldwide in both healthcare and veterinary applications.