CETAPHIL ECZEMA ITCH RELIEF GEL- colloidal oatmeal gel 
Galderma Laboratories, L.P.

----------

Drug Facts

Active ingredients......Purpose

Colloidal Oatmeal 0.5%......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

ARGININE, BUTYLENE GLYCOL, C13-15 ALKANE, CARBOMER, CERAMIDE NP, ETHYLHEXYLGLYCERIN, GLYCERIN, HYDROXYPHENYL PROPAMIDOBENZOIC ACID, LAURYL LACTATE, MALTODEXTRIN, OPHIOPOGON JAPONICUS ROOT EXTRACT, PENTYLENE GLYCOL, PHENOXYETHANOL, PROPANEDIOL, SODIUM GLUCONATE, SODIUM HYDROXIDE, SODIUM PCA, TOCOPHEROL (VITAMIN E), WATER, XANTHAN GUM

Questions or comments?

1-866-735-4137

Distributed By:
Galderma Laboratories, L.P.
Dallas, TX 75201 USA

All trademarks are the property of their respective owners

cetaphil.com

PRINCIPLE DISPLAY PANEL - 2 OZ carton

Dermatologist Recommended
For Sensitive Skin

Cetaphil®

ECZEMA

RESTORADERM®

Itch Relief Gel

1 Relieve, 2 Repair, 3 Protect        

Instantly soothes skin and relieves
itch for up to 12 hours

Skin Protectant Colloidal Oatmeal

Microbiome gentle Ad-Resyl®
Steroid free

National Eczema Association logo

2 FL OZ (59 mL)

P56603-1

(084009) P56603-1 Eczema Itch Relief Gel 2oz Carton
CETAPHIL ECZEMA ITCH RELIEF GEL 
colloidal oatmeal gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4129
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y) Oatmeal0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Arginine (UNII: 94ZLA3W45F)  
Butylene Glycol (UNII: 3XUS85K0RA)  
C13-15 Alkane (UNII: 114P5I43UJ)  
Carbomer Copolymer Type A (Allyl Pentaerythritol Crosslinked) (UNII: 71DD5V995L)  
Ceramide Np (UNII: 4370DF050B)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Glycerin (UNII: PDC6A3C0OX)  
Hydroxyphenyl Propamidobenzoic Acid (UNII: 25KRT26H77)  
Lauryl Lactate (UNII: G5SU0BFK7O)  
Maltodextrin (UNII: 7CVR7L4A2D)  
Ophiopogon Japonicus Root (UNII: 90PS6JV9GZ)  
Pentylene Glycol (UNII: 50C1307PZG)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Propanediol (UNII: 5965N8W85T)  
Sodium Gluconate (UNII: R6Q3791S76)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
Tocopherol (UNII: R0ZB2556P8)  
Water (UNII: 059QF0KO0R)  
Xanthan Gum (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0299-4129-001 in 1 CARTON05/01/2022
159 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
2NDC:0299-4129-0510 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01605/01/2022
Labeler - Galderma Laboratories, L.P. (047350186)
Establishment
NameAddressID/FEIBusiness Operations
Fruit of The Earth, Inc.080086802manufacture(0299-4129)

Revised: 12/2023
Document Id: cba9dbd5-9100-4a07-ac6e-620aff818641
Set id: 7526b862-47c9-46b3-8f80-6baf03a3b903
Version: 3
Effective Time: 20231208
 
Galderma Laboratories, L.P.