Calamine
Active ingredient
Sold as REMEDY Calazime Skin…
- Drug class
- -
- Availability
- Over-the-counter
- Routes
- Topical
- Markets covered
- 3
- Products on record
- 11
- FDA reports (12 mo)
- 32
Overview
Plain-language summary, compiled from the cited regulatory records
Calamine is an active ingredient used in skin protectant products [1]. It is approved for providing temporary relief from skin irritations, itching, and discomfort in the perianal area [1]. Calamine may also offer temporary pain relief and a cooling sensation [1].
This ingredient can be found in various over-the-counter products, including REMEDY Calazime Skin Protectant [1]. In the past 12 months, there have been 32 adverse event reports associated with calamine-containing products [2]. The most frequently reported reactions include "Drug Ineffective," rash, neutropenia, pruritus, and mucosal inflammation [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 4 | February 20, 2026 |
| US United States | FDA | 3 | February 17, 2026 |
| CA Canada | Health Canada | 4 | March 26, 2026 |
GBUnited Kingdom· MHRA
4 products
Uses
For the relief of minor skin irritation and pruritus.
How to take
USUnited States· FDA
3 products
Uses
Uses Provides temporary relief from skin irritations, itching and discomfort in the perianal area For the temporary relief of pain May provide a cooling sensation
How to take
CACanada· Health Canada
4 products
4 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].
Sources & citations
- [1]MHRA (UK) · PL183740034 · revised December 29, 2015
- [2]FDA DailyMed · 1295cfcc-5b61-48… · revised January 29, 2025 [PDF]
- [3]Health Canada (DPD) · 00538493 · revised March 22, 2025
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.