Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 02a405fa-8ae9-41e9-b86f-ef5fb6e3844a
Route
TOPICAL
Published
Effective Date 2024-05-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (2 g)
Inactive Ingredients
Water Ethylhexyl Palmitate Glycerin Sheanut Oil Cetostearyl Alcohol Sunflower Oil Dimethicone Pentylene Glycol Glyceryl Monostearate Peg-100 Stearate Microcrystalline Cellulose Sodium Pyrrolidone Carboxylate Arginine Caprylyl Glycol Citric Acid Monohydrate Phytate Sodium Carboxymethylcellulose Sodium, Unspecified Ophiopogon Japonicus Root Xanthan Gum .alpha.-tocopherol Acetate Maltodextrin Ceramide Np

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-01

Description

Colloidal Oatmeal 2%......Skin Protectant

Purpose

Colloidal Oatmeal 2%......Skin Protectant


Medication Information

Purpose

Colloidal Oatmeal 2%......Skin Protectant

Description

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

Active Ingredients......purpose

Colloidal Oatmeal 2%......Skin Protectant

Principle Display Panel 8 Oz Tube

NEW LOOK

Cetaphil®

ECZEMA

RESTORADERM ®

Rapid Relief

Cream


2% Colloidal Oatmeal

Skin Protectant

Relieves symptoms after 1 use

and repairs skin's barrier

Steroid free

National Eczema Association logo

NET WT 8 OZ (227 g)



P57252-1




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, 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? (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

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

Colloidal Oatmeal 2%......Skin Protectant

Principle Display Panel 8 Oz Tube (PRINCIPLE DISPLAY PANEL - 8 OZ tube)

NEW LOOK

Cetaphil®

ECZEMA

RESTORADERM ®

Rapid Relief

Cream


2% Colloidal Oatmeal

Skin Protectant

Relieves symptoms after 1 use

and repairs skin's barrier

Steroid free

National Eczema Association logo

NET WT 8 OZ (227 g)



P57252-1




Advanced Ingredient Data


Raw Label Data

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