FDA.reportPublic FDA data

Cetaphil Eczema Flare-Up Cream

Manufacturer
Galderma Laboratories, L.P. | G Production Inc.
Effective date
2023-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:19:10

Label at a glance#

ProductCetaphil Eczema Flare-Up Cream
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 2%......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, ETHYLHEXYL PALMITATE, GLYCERIN, BUTYROSPERMUM PARKII (SHEA) BUTTER, CETEARYL ALCOHOL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, DIMETHICONE, PENTYLENE GLYCOL, GLYCERYL STEARATE, AVENA SATIVA (OAT) KERNEL FLOUR, PEG-100 STEARATE, MICROCRYSTALLINE CELLULOSE, SODIUM PCA, ARGININE, SODIUM POLYACRYLATE STARCH, CAPRYLYL GLYCOL, CITRIC ACID, SODIUM PHYTATE, CELLULOSE GUM, OPHIOPOGON JAPONICUS ROOT EXTRACT, XANTHAN GUM, TOCOPHERYL ACETATE, MALTODEXTRIN, CERAMIDE NP

Questions or comments?

OTC - QUESTIONS SECTION

1-866-735-4137

Distributed by:
Galderma Laboratories, L.P.
Fort Worth, TX 76177

All trademarks are the property of their respective owners

Made in Canada

Cetaphil.com

PRINCIPLE DISPLAY PANEL - 8 OZ tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW
#1 Doctor Recommended
Sensitive Skincare Brand

Cetaphil®

ECZEMA

RESTORADERM®

Flare - Up
Relief Cream

1 Relieve, 2 Repair, 3 Protect        

Relieves eczema symptoms after
1 use and repairs skin's barrier

Skin Protectant Colloidal Oatmeal

Microbiome gentle Ad-Resyl®
Steroid free

National Eczema Association logo

8 FL OZ (226 mL)

P56553-0

052733 P56553-0 RD Eczema Flare-up Cream 8oz Tube
052733 P56553-0 RD Eczema Flare-up Cream 8oz Tube

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-4127CETAPHIL ECZEMA FLARE-UP CREAM (COLLOIDAL OATMEAL) CREAM [GALDERMA LABORATORIES, L.P.]2Legacy NDC20231207_a42afe1a-c061-4083-bbfc-e6b6478fb850.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0299-41270299-4127-00, 0299-4127-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
Oatmeal8PI54V663YACTIB
Water059QF0KO0RIACT
Ethylhexyl Palmitate2865993309IACT
GlycerinPDC6A3C0OXIACT
Sheanut OilO88E196QRFIACT
Cetostearyl Alcohol2DMT128M1SIACT
Sunflower Oil3W1JG795YIIACT
Dimethicone92RU3N3Y1OIACT
Pentylene Glycol50C1307PZGIACT
Glyceryl Monostearate230OU9XXE4IACT
Peg-100 StearateYD01N1999RIACT
Microcrystalline CelluloseOP1R32D61UIACT
Sodium Pyrrolidone Carboxylate469OTG57A2IACT
Arginine94ZLA3W45FIACT
Caprylyl Glycol00YIU5438UIACT
Citric Acid Monohydrate2968PHW8QPIACT
Phytate Sodium88496G1ERLIACT
Carboxymethylcellulose Sodium, UnspecifiedK679OBS311IACT
Ophiopogon Japonicus Root90PS6JV9GZIACT
Xanthan GumTTV12P4NEEIACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT
Maltodextrin7CVR7L4A2DIACT
Ceramide Np4370DF050BIACT

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
b03daa25-b293-44b0-847b-83495c68f197a42afe1a-c061-4083-bbfc-e6b6478fb8502025-11-24WarningsExact identifier
spl set id: a42afe1a-c061-4083-bbfc-e6b6478fb850

Reported adverse events (FAERS/openFDA)#

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