Colloidal oatmeal
Colloidal oatmeal is an FDA drug label for the active ingredient COLLOIDAL OATMEAL manufactured by Amazon.com Services 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 20260429.
- Generic name
- COLLOIDAL OATMEAL
- Manufacturer
- Amazon.com Services LLC
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 72288-965
- Application
- M016
- Label effective
- 20260429
About this product
Colloidal oatmeal is an FDA-registered drug product whose active ingredient is COLLOIDAL OATMEAL. It is labelled by Amazon.com Services LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 72288-965, application M016, label effective 20260429. 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
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 REACTIONS Made in USA of domestic and foreign materials DISTRIBUTED BY: Amazon.com Services LLC Seattle, WA 98109 1-877-485-0385 ©2026 Amazon.com, Inc. or its affilates. All rights reserved. www.amazon.com/amazonessentials PLASTIC TUBE Do Not Recycle how2recycle.info
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View labelHow 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 form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | The Procter & Gamble Manufacturing Company | 8 |
| — | — | JCS Global Distribution, Inc. | 2 |
| — | — | SilverCeuticals | 2 |
| — | — | Wisconsin Pharmacal Company | 2 |
| — | — | Allure Labs | 1 |
Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0553-2026 | MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037. | Wisconsin Pharmacal Company | Class I | Ongoing | 20260527 |
| D-0206-2025 | First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6 | First Aid Beauty Ltd | Class II | Ongoing | 20250129 |
| D-0657-2024 | BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8 10129 11007 4 | PREQUEL SKIN | Class II | Ongoing | 20240918 |
| D-0782-2020 | Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET WT 14 OZ (396 g), NDC 65365-266-01, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. | Sigan Industries Inc. | Class III | Terminated | 20200122 |
| D-0241-2018 | Earth's Care Eczema Lotion (2% Colloidal Oatmeal) Skin Protectant with Aloe and Almond Oil, 8 fl. oz. (237 mL) HPDE bottle, Distributed by: Earth's Care Natural Products, Inc. Long Beach, California 90805, NDC 24286-1569-08, UPC 85730700307. | DLC Laboratories, Inc | Class II | Terminated | 20180131 |
Frequently asked questions
What is Colloidal oatmeal used for?
Uses temporarily protects and helps relieve minor skin irritation and itching due to: eczema rashes
Who makes Colloidal oatmeal?
Amazon.com Services LLC is the labeler of record for Colloidal oatmeal. 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 Colloidal oatmeal 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 Colloidal oatmeal 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 Colloidal oatmeal been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
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.