FDA.reportPublic FDA data

Soteri Skin Baby Eczema Relief Cream

Manufacturer
Soteri Skin, Inc | Creative Essences 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 Baby 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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 2%

Uses

INDICATIONS & USAGE SECTION

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

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Warnings

WARNINGS SECTION

For external use only

When using this product

  • do not get into eyes

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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, Glycerin, Helianthus Annuus (Sunflower) Oil, Cetearyl Alcohol, Cocos Nucifera
(Coconut) Oil, Lactobacillus Ferment, Ceteareth-20, Hydrolyzed Oat Protein, Dimethicone, Sodium Citrate, Niacinamide, 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.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

lablab

cartcart

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1189915colloidal oatmeal 2 % Topical CreamPSN2
1189915colloidal oatmeal 20 MG/ML Topical CreamSCD2
1189915colloidal oatmeal 2 % 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 Baby Carton.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
85265-104-01Soteri Skin Baby Eczema Relief Cream100 mL in 1 BOTTLE, PUMPEMULSION1002
85265-104-01Soteri Skin Baby Eczema Relief Cream1 in 1 CARTONEMULSION12

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85265-10485265-104-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHOLESTEROL97C5T2UQ7JIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
OATMEAL8PI54V663YACTIB
DIMETHICONE92RU3N3Y1OIACT
SODIUM GLUCONATER6Q3791S76IACT
OATZ6J799EAJKIACT
GLUTAMIC ACID3KX376GY7LIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
LACTOBACILLUS5307V7XW8IIACT
GLYCERINPDC6A3C0OXIACT
NIACINAMIDE25X51I8RD4IACT
HISTIDINE4QD397987EIACT
XANTHAN GUMTTV12P4NEEIACT
EDETATE DISODIUM7FLD91C86KIACT
CETEARYL ALCOHOL2DMT128M1SIACT
CETEARETH-20YRC528SWUYIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ASPARTIC ACID30KYC7MIAIIACT
CERAMIDE NP4370DF050BIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CERAMIDE 15THT33P7X7IACT
CERAMIDE APF1X8L2B00JIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
SODIUM CITRATE1Q73Q2JULRIACT

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 Baby Eczema Relief CreamCOLLOIDAL OATMEALSoteri Skin, Inc41d88ff2-22aa-8447-e063-6294a90aea0e2025-12-10WarningsExact identifier
ndc (package): 85265-104-01
ndc (product): 85265-104
ndc11 (package): 85265010401
spl id: 45a1740f-c49f-d3a0-e063-6294a90ab46b
spl set id: 41d88ff2-22aa-8447-e063-6294a90aea0e

Reported adverse events (FAERS/openFDA)#

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