FDA.reportPublic FDA data

Relief - Advanced 13-in-1 Extra Soothing Eczema & Dermatitis Cream

Manufacturer
Era Organics, Inc.
Effective date
2025-11-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:18:19

Label at a glance#

ProductRelief
Active ingredientOATMEAL
Label structure9 sections

Label contents#

Full prescribing information#

Relief - Advanced 13-in-1 Extra Soothing Eczema & Dermatitis Cream

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice*, Aqua, Cetearyl Alcohol (and) Behentrimonium Chloride (and) Polyquaternium-37, Cetyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride*, Glycerin, Theobroma Cacao (Cocoa) Seed Butter*, Butyrospermum Parkii (Shea) Butter*, Cera Alba (Beeswax), Fruit Oil*, Ascorbic Acid, Sodium PCA, Anasataiva (Oat) Kernel Oil, Manuka Honey, Cocos Nucifera (Coconut) Oil, Avena Sativa (Oat) Kernel Extract, Xanthan Gum, Rosmarinus Officinalis (Rosemary) Leaf Extract*, Chamomilla Recutita (Matricaria) Extract, Glycyrrhiza Glabra (Licorice) Root Extract, DL-Panthenol (Vitamin B5), Polysorbate-4, Oleate, Methylsulfonylmethane (MSM), Zinc Oxide. (*Organic Ingredients)

Relief - Advanced 13-in-1 Extra Soothing Eczema & Dermatitis Cream

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1%

Relief - Advanced 13-in-1 Extra Soothing Eczema & Dermatitis Cream

OTC - PURPOSE SECTION

Skin protectant

Relief - Advanced 13-in-1 Extra Soothing Eczema & Dermatitis Cream

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.

Relief - Advanced 13-in-1 Extra Soothing Eczema & Dermatitis Cream

OTC - ASK DOCTOR SECTION

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.

Relief - Advanced 13-in-1 Extra Soothing Eczema & Dermatitis Cream

DOSAGE & ADMINISTRATION SECTION

Apply as needed. For external use only. When using this product • do not get into eyes

Relief - Advanced 13-in-1 Extra Soothing Eczema & Dermatitis Cream

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to eczema and rashes.

Relief - Advanced 13-in-1 Extra Soothing Eczema & Dermatitis Cream

WARNINGS SECTION

For external use only. When using this product - do not get into eyes.
Stop use and ask a doctor if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days.

Relief - Advanced 13-in-1 Extra Soothing Eczema & Dermatitis Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Relief - Advanced 13-in-1 Extra Soothing Eczema & Dermatitis CreamRelief - Advanced 13-in-1 Extra Soothing Eczema & Dermatitis Cream

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
BarcodeEAN-130850004022986GTIN-13: 0850004022986
EAN-13: 0850004022986
GTIN-12: 850004022986
UPC-A: 850004022986
GTIN storage (14 digits): 00850004022986		209c1c04-fb50-a7f2-e063-6294a90a731c.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72400-203-04Relief113 g in 1 JARCREAM1133
72400-203-08Relief227 g in 1 JARCREAM2273

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72400-20372400-203-04, 72400-203-08

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YACTIB

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
ReliefCOLLOIDAL OATMEAL 1%Era Organics, Inc.0ad58a99-e41a-a830-e063-6294a90af9cb2025-11-27WarningsExact identifier
ndc (package): 72400-203-04
ndc (package): 72400-203-08
ndc (product): 72400-203
ndc11 (package): 72400020308
ndc11 (package): 72400020304
spl id: 449856df-cace-dfc1-e063-6394a90a1b95
spl set id: 0ad58a99-e41a-a830-e063-6294a90af9cb

Reported adverse events (FAERS/openFDA)#

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