CETAPHIL ECZEMA FLARE-UP CREAM- colloidal oatmeal cream

Cetaphil Eczema Flare-Up Cream by

Drug Labeling and Warnings

Cetaphil Eczema Flare-Up Cream 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 2%......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

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

INGREDIENTS AND APPEARANCE

CETAPHIL ECZEMA FLARE-UP CREAM 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y)	Oatmeal	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-4127-00	266 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2022
2	NDC: 0299-4127-05	10 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	05/01/2022

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

Establishment
Name	Address	ID/FEI	Business Operations
G Production Inc.		251676961	manufacture(0299-4127)