Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 0d01c3fb-d420-484d-aae1-33234c9e383e
Route
TOPICAL
Published
Effective Date 2024-03-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (1 g)
Inactive Ingredients
Water Glycerin Medium-chain Triglycerides Sunflower Oil Pentylene Glycol Sheanut Oil Cyclomethicone 5 Cetostearyl Alcohol Sorbitol Docosanol Glyceryl Monostearate Cetyl Alcohol .alpha.-tocopherol Acetate Arginine Niacinamide Glyceryl Stearate Citrate Sodium Polyacrylate (2500000 Mw) Disodium Ethylene Dicocamide Peg-15 Disulfate Caprylyl Glycol Polyoxyl 20 Cetostearyl Ether Sodium Pyrrolidone Carboxylate Panthenol Citric Acid Monohydrate Allantoin Dimethiconol (100000 Cst) Ophiopogon Japonicus Root Edetate Disodium Maltodextrin Hyaluronate Sodium Ceramide Np Pantolactone, (r)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-01

Description

Colloidal Oatmeal 1%......Skin Protectant

Purpose

Colloidal Oatmeal 1%......Skin Protectant


Medication Information

Purpose

Colloidal Oatmeal 1%......Skin Protectant

Description

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, 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.

Dallas, TX 75201 USA

All trademarks are the property of their respective owners

Made in Canada

cetaphil.com

Active Ingredients......purpose

Colloidal Oatmeal 1%......Skin Protectant

Principle Display Panel 10 Fl Oz Bottle

NEW LOOK



Cetaphil®

ECZEMA

RESTORADERM ®

Daily

Soothing

Moisturizer


1% Colloidal Oatmeal

Skin Protectant 
    

Relieves and protects

for fewer eczema

symptoms over time

Steroid Free

National Eczema Association logo

10 FL OZ (296 mL)



P56332-2




Structured Label Content

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, 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? (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

Made in Canada

cetaphil.com

Active Ingredients......purpose (Active ingredients......Purpose)

Colloidal Oatmeal 1%......Skin Protectant

Principle Display Panel 10 Fl Oz Bottle (PRINCIPLE DISPLAY PANEL - 10 FL OZ bottle)

NEW LOOK



Cetaphil®

ECZEMA

RESTORADERM ®

Daily

Soothing

Moisturizer


1% Colloidal Oatmeal

Skin Protectant 
    

Relieves and protects

for fewer eczema

symptoms over time

Steroid Free

National Eczema Association logo

10 FL OZ (296 mL)



P56332-2




Advanced Ingredient Data


Raw Label Data

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