CETAPHIL ECZEMA FLARE-UP CREAM- colloidal oatmeal cream
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 2%......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, ETHYLHEXYL PALMITATE, GLYCERIN, BUTYROSPERMUM PARKII (SHEA) BUTTER, CETEARYL ALCOHOL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, DIMETHICONE, PENTYLENE GLYCOL, GLYCERYL STEARATE, 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.
Dallas, TX 75201

All trademarks are the property of their respective owners

Made in Canada

cetaphil.com

PRINCIPLE DISPLAY PANEL - 8 OZ tube

Dermatologist Recommended
For Sensitive Skincare

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

NET WT 8 OZ (227 g)

P57252-0

CETAPHIL ECZEMA FLARE-UP CREAM
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0299-4139
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0299-4139-00	227 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2023
2	NDC:0299-4139-05	10 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	02/01/2023

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

Name	Address	ID/FEI	Business Operations
Establishment
G Production Inc.		251676961	manufacture(0299-4139)

Revised: 4/2023

Document Id: ac87f003-9c36-417e-a4f3-d05b0b2c6a8a

Set id: b4b824f4-dd29-4b64-a943-ce5c6124ce19

Version: 1

Effective Time: 20230403

Galderma Laboratories, L.P.