FDA.reportPublic FDA data

Soteri Skin Active Flare-Up Eczema Relief Cream

Manufacturer
Soteri Skin, Inc.
Effective date
2025-12-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:22:08

Label at a glance#

ProductSoteri Skin Active Flare-Up Eczema Relief Cream
Active ingredientOATMEAL
Label structure8 sections

Indications and uses

temporarily protect and helps relieve minor skin irritation and itching due to: eczema

Dosage and administration

Apply twice per day, AM and PM and always after cleansing. Apply as needed.

Storage and handling

Store below 30C (86F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1.5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

temporarily protect and helps relieve minor skin irritation and itching due to: eczema

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply twice per day, AM and PM and always after cleansing.
  • Apply as needed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Oil, Glycerin, Cetearyl Alcohol, Ceteareth-20, Lactobacillus Ferment, Dimethicone, Hydrolyzed Oat Protein, Sodium Citrate, Camellia Sinensis Leaf Extract, Niacinamide, Glyceryl Laurate, Glutamic Acid, Aspartic Acid, Histidine, Citric Acid, Sodium Gluconate, Ceramide NP, Ceramide AP, Ceramide EOP, Phytosphingosine, Sodium Lauroyl Lactylate, Cholesterol, Xanthan Gum, Caprylyl Glycol, 1,2-Hexanediol, Phenoxyethanol, Disodium EDTA.

Other Information

STORAGE AND HANDLING SECTION

Store below 30C (86F)

Package Label PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

CartonCarton

Dou CartonDou Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1654721colloidal oatmeal 1.5 % Topical CreamPSN2
1654721colloidal oatmeal 15 MG/ML Topical CreamSCD2
1654721colloidal oatmeal 1.5 % Topical CreamSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codesoteriskin.com/pages/get-started-with-soteri-skinSoteri Skin Active Flare-Up Unit Carton PDP.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85265-102-01Soteri Skin Active Flare-Up Eczema Relief Cream100 mL in 1 BOTTLE, PUMPEMULSION1002
85265-102-01Soteri Skin Active Flare-Up Eczema Relief Cream1 in 1 CARTONEMULSION12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85265-10285265-102-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
AQUA059QF0KO0RIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
CETEARETH-20YRC528SWUYIACT
OAT AMINO ACIDSNU3FAK86IPIACT
LACTOBACILLUS5307V7XW8IIACT
DIMETHICONE92RU3N3Y1OIACT
CETEARYL ALCOHOL2DMT128M1SIACT
NIACINAMIDE25X51I8RD4IACT
GLYCERYL LAURATEY98611C087IACT
GLUTAMIC ACID3KX376GY7LIACT
SODIUM CITRATE1Q73Q2JULRIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
XANTHAN GUMTTV12P4NEEIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
GLYCERINPDC6A3C0OXIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
OATMEAL8PI54V663YACTIB
HISTIDINE4QD397987EIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
CHOLESTEROL97C5T2UQ7JIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
EDETATE DISODIUM7FLD91C86KIACT
CERAMIDE APF1X8L2B00JIACT
ASPARTIC ACID30KYC7MIAIIACT
SODIUM GLUCONATER6Q3791S76IACT
CERAMIDE NP4370DF050BIACT
CERAMIDE 15THT33P7X7IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Soteri Skin Active Flare-Up Eczema Relief CreamCOLLOIDAL OATMEALSoteri Skin, Inc.41b558d9-55ba-97ff-e063-6394a90a963b2025-12-10WarningsExact identifier
ndc (package): 85265-102-01
ndc (product): 85265-102
ndc11 (package): 85265010201
spl id: 45a1740f-c4a0-d3a0-e063-6294a90ab46b
spl set id: 41b558d9-55ba-97ff-e063-6394a90a963b

Reported adverse events (FAERS/openFDA)#

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