Cetaphil Eczema Soothing Moisturizer Lotion
FDA Label NDC 0299-4128

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Galderma Laboratories, L.p. for the product Cetaphil Eczema Soothing Moisturizer (NDC 0299-4128). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients......purpose, uses, warnings, directions, inactive ingredients, questions or comments?, principle display panel - 10 fl oz bottle, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients......Purpose

Colloidal Oatmeal 1%......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, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, PENTYLENE GLYCOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, CYCLOPENTASILOXANE, CETEARYL ALCOHOL, SORBITOL, BEHENYL ALCOHOL, GLYCERYL STEARATE, AVENA SATIVA (OAT) KERNEL FLOUR, CETYL ALCOHOL, TOCOPHERYL ACETATE, ARGININE, NIACINAMIDE, GLYCERYL STEARATE CITRATE, SODIUM POLYACRYLATE, DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE, CAPRYLYL GLYCOL, CETEARETH-20, SODIUM PCA, PANTHENOL, CITRIC ACID, ALLANTOIN, DIMETHICONOL, OPHIOPOGON JAPONICUS ROOT EXTRACT, DISODIUM EDTA, MALTODEXTRIN, SODIUM HYALURONATE, CERAMIDE NP, PANTOLACTONE

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 - 10 Fl Oz Bottle

NEW & IMPROVED

#1 Doctor Recommended
Sensitive Skincare Brand

Cetaphil®

ECZEMA

RESTORADERM®

Soothing Moisturizer

1 Relieve, 2 Repair, 3 Protect        

Protects skin for fewer eczema
flare-up symptoms with
continued use

Skin Protectant Colloidal Oatmeal

Microbiome gentle Ad-Resyl®
Steroid free

National Eczema Association logo

10 FL OZ (296 mL)

P56332-0

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