CETAPHIL ECZEMA FLARE-UP CREAM- colloidal oatmeal cream 
Galderma Laboratories, L.P.

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Drug Facts

Active ingredients......Purpose

Colloidal Oatmeal 2%......Skin Protectant

Uses

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

Warnings

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

● apply as needed

Inactive Ingredients

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?

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

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
CETAPHIL ECZEMA FLARE-UP CREAM 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4127
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y) Oatmeal2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Ethylhexyl Palmitate (UNII: 2865993309)  
Glycerin (UNII: PDC6A3C0OX)  
Sheanut Oil (UNII: O88E196QRF)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Sunflower Oil (UNII: 3W1JG795YI)  
Dimethicone (UNII: 92RU3N3Y1O)  
Pentylene Glycol (UNII: 50C1307PZG)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Peg-100 Stearate (UNII: YD01N1999R)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
Arginine (UNII: 94ZLA3W45F)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Phytate Sodium (UNII: 88496G1ERL)  
Carboxymethylcellulose Sodium, Unspecified (UNII: K679OBS311)  
Ophiopogon Japonicus Root (UNII: 90PS6JV9GZ)  
Xanthan Gum (UNII: TTV12P4NEE)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Maltodextrin (UNII: 7CVR7L4A2D)  
Ceramide Np (UNII: 4370DF050B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0299-4127-00266 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2022
2NDC:0299-4127-0510 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01605/01/2022
Labeler - Galderma Laboratories, L.P. (047350186)
Establishment
NameAddressID/FEIBusiness Operations
G Production Inc.251676961manufacture(0299-4127)

Revised: 12/2023
Document Id: 1554ce57-1d3a-4472-9e1f-a75fa8403ab8
Set id: a42afe1a-c061-4083-bbfc-e6b6478fb850
Version: 2
Effective Time: 20231204
 
Galderma Laboratories, L.P.