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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Allantoin, Arginine, Behenyl Alcohol, Butyrospermum Parkii, (Shea) Butter, Caprylic/Capric, Triglyceride, Caprylyl Glycol, Ceramide NP, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Cyclopentasiloxane, Dimethiconol, Disodium EDTA, Disodium Ethylene, Dicocamide PEG-15, Disulfate, Glycerin, Glyceryl Stearate, Glyceryl Stearate Citrate, Helianthus Annuus, (Sunflower) Seed Oil, Niacinamide, Panthenol, Pentylene Glycol, Sodium Hyaluronate, Sodium PCA, Sodium Polyacrylate, Sorbitol, Tocopheryl Acetate, Water

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

Cetaphil®

PRO

RESTORADERMTM

Eczema
Soothing
Moisturizer

Colloidal Oatmeal
Skin Protectant                 

Fillagrin and Ceramide Complex

Soothes itchy, irritated skin

Steroid free

 10 FL OZ (296 mL)

[SEAL]

ACCEPTED
NATIONALECZEMA.ORG

NATIONAL
ECZEMA
ASSOCIATION

P53976-2 Cetaphil PRO Restoraderm Eczema Soothing Moisturizer Front Label
Cetaphil PRO Eczema Soothing Moisturizer Back Label
CETAPHIL PRO ECZEMA SOOTHING MOISTURIZER 
colloidal oatmeal lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4130
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
Allantoin (UNII: 344S277G0Z)  
Arginine (UNII: 94ZLA3W45F)  
Docosanol (UNII: 9G1OE216XY)  
Shea Butter (UNII: K49155WL9Y)  
Medium-chain Triglycerides (UNII: C9H2L21V7U)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Ceramide 3 (UNII: 4370DF050B)  
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Dimethiconol (100000 Cst) (UNII: OSA9UP217S)  
Edetate Disodium (UNII: 7FLD91C86K)  
Disodium Ethylene Dicocamide Peg-15 Disulfate (UNII: QI9A6U005W)  
Glycerin (UNII: PDC6A3C0OX)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Glyceryl Stearate Citrate (UNII: WH8T92A065)  
Sunflower Oil (UNII: 3W1JG795YI)  
Niacinamide (UNII: 25X51I8RD4)  
Panthenol (UNII: WV9CM0O67Z)  
Pentylene Glycol (UNII: 50C1307PZG)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
Sodium Polyacrylate (2500000 Mw) (UNII: 05I15JNI2J)  
Sorbitol (UNII: 506T60A25R)  
.alpha.-tocopherol Acetate (UNII: 9E8X80D2L0)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0299-4130-10296 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/201802/07/2023
2NDC:0299-4130-011 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/201802/07/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/01/201802/07/2023
Labeler - Galderma Laboratories, L.P. (047350186)
Establishment
NameAddressID/FEIBusiness Operations
G Production Inc.251676961manufacture(0299-4130)

Revised: 2/2023
 
Galderma Laboratories, L.P.