Eczema Soothing Moisturizing Cream

COLLOIDAL OATMEAL TOPICAL HUMAN OTC DRUG

Eczema Soothing Moisturizing Cream is an FDA drug label for the active ingredient COLLOIDAL OATMEAL manufactured by Nice-Pak Products, LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260909.

Generic name
COLLOIDAL OATMEAL
Manufacturer
Nice-Pak Products, LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
11344-965
Application
M016
Label effective
20260909

About this product

Eczema Soothing Moisturizing Cream is an FDA-registered drug product whose active ingredient is COLLOIDAL OATMEAL. It is labelled by Nice-Pak Products, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 11344-965, application M016, label effective 20260909. It is one of 27 FDA drug label records sharing the active ingredient COLLOIDAL OATMEAL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing COLLOIDAL OATMEAL are most often described in connection with: temporarily protects, helps relieve, minor skin, itching due, eczema rashes. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient Colloidal oatmeal 1%

Indications & Usage

Uses temporarily protects and helps relieve minor skin irritation and itching due to: eczema rashes

Dosage & Administration

Directions apply as needed

Warnings

Warnings For external use only

Adverse Reactions

Adverse reaction Distributed by: Nice-Pak Products, LLC St. Louis, MO 63114 1-888-593-0593

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COLLOIDAL OATMEAL

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Cetaphil Baby Eczema Soothing

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How products containing COLLOIDAL OATMEAL compare

FDA lists 27 drug label records with COLLOIDAL OATMEAL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — The Procter & Gamble Manufacturing Company 8
— — JCS Global Distribution, Inc. 2
— — SilverCeuticals 2
— — Wisconsin Pharmacal Company 2
— — Allure Labs 1

Frequently asked questions

What is Eczema Soothing Moisturizing Cream used for?
Uses temporarily protects and helps relieve minor skin irritation and itching due to: eczema rashes

Who makes Eczema Soothing Moisturizing Cream?
Nice-Pak Products, LLC is the labeler of record for Eczema Soothing Moisturizing Cream. 27 FDA label records share the active ingredient COLLOIDAL OATMEAL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Eczema Soothing Moisturizing Cream come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Eczema Soothing Moisturizing Cream prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing COLLOIDAL OATMEAL?
Yes. 27 FDA drug label records list COLLOIDAL OATMEAL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Eczema Soothing Moisturizing Cream been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.