FDA.reportPublic FDA data

XtraCare with cooling action Oatmeal Skin Relief Calmin

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
XtraCare with cooling action Oatmeal Skin Relief Calmin
Generic name
DIMETHICONE
Manufacturer
Rejoice International
Product type
HUMAN OTC DRUG
SPL set ID
29abd476-c32d-49f0-b283-30f4ba570ab4
SPL ID
126e086f-ebd9-cffb-e063-6294a90afdc5
Version
3
Effective date
2024-02-28
Source export date
2026-08-01
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/5a565ce64c898c83223b815b9579cd46fb0c6d54977c3cace2133e40124f7fbb/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:09:45
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only. When using this product avoid contact with eyes. In case of eye contact, flush with water. Stop use and ask a doctor if condition worsens. Symptoms last more than 7 days or clear up and occur again within a few days.