CETAPHIL PRO ECZEMA SOOTHING MOISTURIZER- colloidal oatmeal lotion

Cetaphil PRO Eczema Soothing Moisturizer by

Drug Labeling and Warnings

Cetaphil PRO Eczema Soothing Moisturizer by is a Otc medication manufactured, distributed, or labeled by Galderma Laboratories, L.P., G Production Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients......Purpose

Colloidal Oatmeal 1%......Skin Protectant

PURPOSE

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

CETAPHIL PRO ECZEMA SOOTHING MOISTURIZER 
colloidal oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4130
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-4130-10	296 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/01/2018
2	NDC: 0299-4130-01	1 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/01/2018

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

Establishment
Name	Address	ID/FEI	Business Operations
G Production Inc.		251676961	manufacture(0299-4130)