CETAPHIL ECZEMA ITCH RELIEF GEL- colloidal oatmeal gel

Cetaphil Eczema Itch Relief Gel by

Drug Labeling and Warnings

Cetaphil Eczema Itch Relief Gel by is a Otc medication manufactured, distributed, or labeled by Galderma Laboratories, L.P., Fruit of The Earth, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients......Purpose

Colloidal Oatmeal 0.5%......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

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

INGREDIENTS AND APPEARANCE

CETAPHIL ECZEMA ITCH RELIEF GEL 
colloidal oatmeal gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y)	Oatmeal	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-4129-00	1 in 1 CARTON	05/01/2022
1		59 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
2	NDC: 0299-4129-05	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
Fruit of The Earth, Inc.		080086802	manufacture(0299-4129)