Soteri Skin Active Flare-Up Eczema Relief Cream

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: Soteri Skin Active Flare-Up Eczema Relief Cream
Generic name: COLLOIDAL OATMEAL
Manufacturer: Soteri Skin, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 41b558d9-55ba-97ff-e063-6394a90a963b
SPL ID: 45a1740f-c4a0-d3a0-e063-6294a90ab46b
Version: 2
Effective date: 2025-12-10
Source export date: 2026-09-28
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:16:56

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M016	openfda.application_number
brand name		Soteri Skin Active Flare-Up Eczema Relief Cream	openfda.brand_name
generic name		COLLOIDAL OATMEAL	openfda.generic_name
manufacturer name		Soteri Skin, Inc.	openfda.manufacturer_name
ndc	package	85265-102-01	openfda.package_ndc
ndc	product	85265-102	openfda.product_ndc
ndc11	package	85265010201	derived:openfda.package_ndc
rxcui		1654721	openfda.rxcui
spl id		45a1740f-c4a0-d3a0-e063-6294a90ab46b	id
spl set id		41b558d9-55ba-97ff-e063-6394a90a963b	set_id
unii		8PI54V663Y	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 do not get into eyes Stop use and ask doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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