CETAPHIL ECZEMA SOOTHING MOISTURIZER- colloidal oatmeal lotion 
Galderma Laboratories, L.P.

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Drug Facts

Active ingredients......Purpose

Colloidal Oatmeal 1%......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, 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?

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 - 10 FL OZ bottle

NEW LOOK

Cetaphil®

ECZEMA

RESTORADERM®

Daily
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)

P56332-2

New front and back label
CETAPHIL ECZEMA SOOTHING MOISTURIZER 
colloidal oatmeal lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4128
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y) Oatmeal1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Sunflower Oil (UNII: 3W1JG795YI)  
Pentylene Glycol (UNII: 50C1307PZG)  
Sheanut Oil (UNII: O88E196QRF)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Sorbitol (UNII: 506T60A25R)  
Docosanol (UNII: 9G1OE216XY)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Cetyl Alcohol (UNII: 936JST6JCN)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Arginine (UNII: 94ZLA3W45F)  
Niacinamide (UNII: 25X51I8RD4)  
Glyceryl Stearate Citrate (UNII: WH8T92A065)  
Sodium Polyacrylate (2500000 Mw) (UNII: 05I15JNI2J)  
Disodium Ethylene Dicocamide Peg-15 Disulfate (UNII: QI9A6U005W)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
Panthenol (UNII: WV9CM0O67Z)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Allantoin (UNII: 344S277G0Z)  
Dimethiconol (100000 Cst) (UNII: OSA9UP217S)  
Ophiopogon Japonicus Root (UNII: 90PS6JV9GZ)  
Edetate Disodium (UNII: 7FLD91C86K)  
Maltodextrin (UNII: 7CVR7L4A2D)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Ceramide Np (UNII: 4370DF050B)  
Pantolactone, (R)- (UNII: J288D7O0JS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0299-4128-00296 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2022
2NDC:0299-4128-0529 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2022
3NDC:0299-4128-10473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2024
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(0299-4128)

Revised: 5/2024
Document Id: a3c464d3-83b8-495e-bfef-369d23fae338
Set id: 0d01c3fb-d420-484d-aae1-33234c9e383e
Version: 5
Effective Time: 20240502
 
Galderma Laboratories, L.P.