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: f99606f6-83bc-436e-aa21-53e77eb87b9c
SPL ID: 2dc099cd-a08d-d907-e063-6394a90a2929
Version: 7
Effective date: 2025-02-09
Source export date: 2026-10-27
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/2026-10-27/35717de05250cd386420cc8ede3b6010b48d18eea2af59afb0617fcabca634ec/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:04:59

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M016	openfda.application_number
brand name		XtraCare with cooling action Oatmeal Skin Relief Calmin	openfda.brand_name
generic name		DIMETHICONE	openfda.generic_name
manufacturer name		Rejoice International	openfda.manufacturer_name
ndc	package	57337-038-02	openfda.package_ndc
ndc	package	57337-038-01	openfda.package_ndc
ndc	product	57337-038	openfda.product_ndc
ndc11	package	57337003802	derived:openfda.package_ndc
ndc11	package	57337003801	derived:openfda.package_ndc
rxcui		891710	openfda.rxcui
spl id		2dc099cd-a08d-d907-e063-6394a90a2929	id
spl set id		f99606f6-83bc-436e-aa21-53e77eb87b9c	set_id
unii		92RU3N3Y1O	openfda.unii

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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.