FDA.reportPublic FDA data

Drug Facts

Manufacturer
Galderma Laboratories, L.P. | G Production Inc.
Effective date
2025-11-25
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-09-22 03:02:37

Label at a glance#

ProductCetaphil Eczema Soothing Moisturizer
Active ingredientOatmeal
Label structure7 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to: ●Eczema  ●Rashes

Dosage and administration

Apply as needed

Label contents#

Full prescribing information#

Active ingredients......Purpose

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1%......Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to:
●Eczema  ●Rashes

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.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, PENTYLENE GLYCOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, CYCLOPENTASILOXANE, CETEARYL ALCOHOL, SORBITOL, BEHENYL ALCOHOL, GLYCERYL STEARATE, CETYL ALCOHOL, TOCOPHERYL ACETATE, ARGININE, NIACINAMIDE, GLYCERYL STEARATE CITRATE, SODIUM POLYACRYLATE, DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE, CAPRYLYL GLYCOL, CETEARETH-20, SODIUM PCA, PANTHENOL, CITRIC ACID, ALLANTOIN, DIMETHICONOL, OPHIOPOGON JAPONICUS ROOT EXTRACT, DISODIUM EDTA, MALTODEXTRIN, SODIUM HYALURONATE, CERAMIDE NP, PANTOLACTONE

Questions or comments?

OTC - QUESTIONS SECTION

1-866-735-4137

Distributed By:
Galderma Laboratories, L.P.
Dallas, TX 75201 USA

All trademarks are the property of their respective owners

Made in Canada

cetaphil.com

PRINCIPLE DISPLAY PANEL - 16 FL OZ bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

16oz front label P58045-0
16oz front label P58045-0

NEW LOOK
SAME GREAT FORMULA

Cetaphil®

ECZEMA

RESTORADERM®

Eczema Soothing Moisturizer

1% Colloidal Oatmeal Skin Protectant      

Relieves and protects
for fewer eczema
symptoms over time

Steroid Free

National Eczema Association logo

10 FL OZ (296 mL)

P58045-0

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0299-41280299-4128-00, 0299-4128-05, 0299-4128-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
Oatmeal8PI54V663YACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Medium-Chain TriglyceridesC9H2L21V7UIACT
Sunflower Oil3W1JG795YIIACT
Pentylene Glycol50C1307PZGIACT
Sheanut OilO88E196QRFIACT
Cyclomethicone 50THT5PCI0RIACT
Cetostearyl Alcohol2DMT128M1SIACT
Sorbitol506T60A25RIACT
Docosanol9G1OE216XYIACT
Glyceryl Monostearate230OU9XXE4IACT
Cetyl Alcohol936JST6JCNIACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT
Arginine94ZLA3W45FIACT
Niacinamide25X51I8RD4IACT
Glyceryl Stearate CitrateWH8T92A065IACT
Sodium Polyacrylate (2500000 Mw)05I15JNI2JIACT
Disodium Ethylene Dicocamide Peg-15 DisulfateQI9A6U005WIACT
Caprylyl Glycol00YIU5438UIACT
Polyoxyl 20 Cetostearyl EtherYRC528SWUYIACT
Sodium Pyrrolidone Carboxylate469OTG57A2IACT
PanthenolWV9CM0O67ZIACT
Citric Acid Monohydrate2968PHW8QPIACT
Allantoin344S277G0ZIACT
Dimethiconol (100000 Cst)OSA9UP217SIACT
Ophiopogon Japonicus Root90PS6JV9GZIACT
Edetate Disodium7FLD91C86KIACT
Maltodextrin7CVR7L4A2DIACT
Hyaluronate SodiumYSE9PPT4THIACT
Ceramide Np4370DF050BIACT
PantolactoneJ288D7O0JSIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-05-02full-release2026-06-01 00:12:08

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
a3c464d3-83b8-495e-bfef-369d23fae3380d01c3fb-d420-484d-aae1-33234c9e383e2024-05-02WarningsExact identifier
spl set id: 0d01c3fb-d420-484d-aae1-33234c9e383e

Reported adverse events (FAERS/openFDA)#

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