Cetaphil Eczema Soothing Moisturizer by Galderma Laboratories, L.P. / G Production Inc. Drug Facts

Drug Details [pdf]

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

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 - 10 FL OZ bottle

NEW LOOK
SAME FORMULA

#1 Dermatologist Recommended
Facial Skincare Brand

Cetaphil®

ECZEMA

RESTORADERM®

Soothing Moisturizer

Dry, Itchy Senstitive Skin

Soothes and hydrates dry, itchy,
irritated eczema-prone skin

Skin Protectant
1% Colloidal Oatmeal

Filaggrin and Ceramide Complex

National Eczema Association logo

10 FL OZ (296 mL)

CETAPHIL ECZEMA SOOTHING MOISTURIZER
colloidal oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4124
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y)	Oatmeal	1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 0299-4124-00	296 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/01/2018	02/01/2024
2	NDC: 0299-4124-05	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2018	02/01/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	05/01/2018	02/01/2024

Labeler - Galderma Laboratories, L.P. (047350186)

Name	Address	ID/FEI	Business Operations
Establishment
G Production Inc.		251676961	manufacture(0299-4124)

Revised: 12/2023

Document Id: 695eeb38-ab0c-4437-91e2-5bf96f1c64ac

Set id: e0aac85a-1158-42ad-901a-8efabae1bd9e

Version: 2

Effective Time: 20231215